FDA Pressure to Regulate CBD, Recent Decisions on Deference

FDLI MEMBER MAGAZINE | WWW.FDLI.ORG | SPRING 2020

Food and Drug Law Institute

IN THIS ISSUE: FDA Pressure to Regulate CBD, Recent Decisions on Deference, Modified Risk Tobacco Product Decision, Patient-Focused Drug Development PLUS: Vaping Regulations in Mexico, 7th Annual Blumberg Lecture SHARE YOUR IDEAS WITH FDLI!

Submit a Conference Proposal Looking to get involved with FDLI? Submit a topic you would like to see addressed at the following conferences: • Advertising and Promotion for Medical Products Conference: Opens March 31 • Tobacco and Nicotine Products Regulation and Policy Conference: Opens March 24 • Food Advertising, Labeling, and Litigation Conference: Opens March 24

Author Articles What legal and regulatory issues interest you? Share your expertise by submitting articles to FDLI publications, including Update magazine and Food and Drug Law Journal. For questions, please contact [email protected].

Suggest Webinar Ideas Have a subject you’d like to learn more about? The FDLI Webinar Programs Committee invites food and drug law community stakeholders to submit a proposal recommending a topic using our webinar portal!

fdli.org/ideas July/August 2007

EMERGENCY PREPAREDNESS

FDLI Published by the Food and Drug Law Institute www.fdli.org The Bioterrorism Act after 5 Years – Is it Working? contents BioShield II – A Step in the Right Direction?Spring 2020 Pandemic Influenza: Companies Should Plan for the Worst and Assess Legal Exposure Liability Protection: Shielding Vaccine Makers from Litigation Features Pet Food Recall – ExposingDepartments Holes in U.S. Food Safety Defenses Global Focus: You Can Smoke Tobacco, Sugarcane, A Cannabidiol Catalyst? Recent Events Increase Pressure or Newspapers, but You Cannot Vape on FDA to Regulate CBD by José Alberto Campos Vargas...... 25 by Frederick R. Ball & Justin M. L. Stern ...... 6 7th Annual Blumberg Lecture by Richard M. Cooper...... 28

Chevron’s Hard-Hitting Footnote Nine Revived by Kisor v. Wilkie and Recent Decisions on Deference FDLI News by Chad Landmon, Alexander Alfano, & FDLI Welcomes New Board Members...... 39 Michelle Divelbiss ...... 10 2020 Committees and Members...... 40

Academic Programs: Maryland Health Law Competition...... 44 Highlights and Insights from the General Snus Modified Risk Tobacco Product Decision Documents by James M. Solyst...... 17

Taking Stock of PFDD: Envisioning a Vibrant Future for Patient-Focused Drug Development by PFDDworks...... 21

FDLI Spring 2020 Update 1 FDLI Update Staff Editor in Chief Paige Samson, JD Assistant Editor Ren White Design Sarah Hill Food and Drug Law Institute FDLI 1155 15th St., NW, Ste. 910 ISSN: 1075-7635 - 2020 Spring Washington, DC 20005 General Information: Ph: 202-371-1420 E-mail: [email protected] Update is published four times per year by the Food and Drug Law Institute (FDLI). Website: fdli.org

FDLI is a nonprofit membership organization that offers education, training, publications, Update Editorial and professional networking opportunities in the field of food and drug law. As a neutral Advisory Board convener, FDLI provides a venue for stakeholders to inform innovative public policy, law, and regulation. Kenita Barrow, Otsuka America Pharmaceutical, Inc.

Articles and any other material published in Update represent the opinions of the author(s) Royce B. DuBiner, McGuireWoods LLP and should not be construed to reflect the opinions of FDLI, its staff, or its members. The Emily Hussey, Reed Smith LLP factual accuracy of all statements in the articles and other materials is the sole responsibility of the authors. Sara Wexler Koblitz, Hyman, Phelps & McNamara, PC

Membership: Areta L. Kupchyk, Foley Hoag LLP Update magazine is an FDLI member benefit. For more information on other member benefits Dan Logan, Kleinfeld, Kaplan & Becker, LLP or to join, please visit fdli.org/membership. Eileen M. McMahon, Torys LLP Article Contributions: Elizabeth Oestreich, Greenleaf Health, Inc.

We invite you to share your expertise and perspective and to comment on articles or ideas Beth G. Oliva, Fox Rothschild LLP covered in recent issues of Update. All manuscripts are subject to editing for style, clarity, and length. Manuscripts and inquiries should be directed to Paige Samson, Editor in Chief, at Neha Patel, Arnold & Porter LLP [email protected], or at 202-222-0891. Tyler Scandalios, Benjamin L. England & Associates Send notices of change of address to FDLI six to eight weeks in advance. Please include LLC/FDAImports.com both old and new addresses. Notices may be sent to [email protected]. FDLI Officers © 2020 Food and Drug Law Institute Chair Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP

Vice Chair Daniel A. Kracov, Partner, Arnold & Porter LLP ECO BOX Secretary and General Counsel Freddy A. Jimenez, Vice President, Law and Compliance, Update text and cover pages are printed on SFI®-certified Orion Matte paper using soy ink. Celldex Therapeutics • The SFI certified sourcing label is proof FDLI is using fiber from responsible and legal sources. Treasurer Frederick R. Ball, Partner, Duane Morris LLP • The Sustainable Forestry Initiative® program integrates the perpetual growing and harvesting of trees with the protection of wildlife, plants, soils, and water. President and CEO Amy Comstock Rick, • The Sustainable Forestry Initiative® program promotes responsible forest management. Food and Drug Law Institute

ISSN: 1075-7635 Issue 1 (2020) SFI-00665

SFI-CS-A-HC

2 Update Spring 2020 www.fdli.org UPCOMING PROGRAMS

fdli.org/programs

COVID-19 Update: All programs will be held virtually through April.

Introduction to Biologics and Biosimilars Food Advertising, Labeling, and Litigation Law and Regulation Conference March 31–April 1 | Virtual Event October 1–2 | Washington, DC Regenerative Medicine: Regulatory, Introduction to Advertising and Promotion Enforcement, and Legal Challenges for Cell for Medical Products and Gene Therapies October 5 | Washington, DC April 2 | Virtual Event Advertising and Promotion for Medical Introduction to Medical Device Law and Products Conference Regulation October 6–7 | Washington, DC April 7–8 | Virtual Event Introduction to Tobacco and Nicotine Law Introduction to Drug Law and Regulation and Regulation April 15–16 | Virtual Event October 21 | Washington, DC FDLI Annual Conference Tobacco and Nicotine Products Regulation To Be Announced | Washington, DC and Policy Conference Introduction to Food Law and Regulation October 22–23 | Washington, DC September 29–30 | Washington, DC July/August 2007

EMERGENCY LATESTFDLIPREPAREDNESS RESOURCES RELEASES

Published by the Food and Drug Law Institute www.fdli.org FDLI ESSENTIALESSENTIAL COMPREHENSIVE The Bioterrorism Act after 5 Years – Is it Working? RESOURCESREFERENCESBioShield II – A Step in the Right Direction? GUIDE Pandemic Influenza: Companies Should Plan for the Worst and Assess Legal Exposure Liability Protection: Shielding Vaccine Makers from Litigation Pet Food Recall – Exposing Holes in U.S. Food Safety Defenses FDCA S FDCA S tatutory Supplementtatutory 2018 tatutory Supplementtatutory 2018 FDCA Statutory Supplement

Edited by Deborah M. Shelton and Joy J. Liu Edited by Deborah M. Shelton and Joy J. Liu 2018

EditedEdited byby DeborahDeborah M.M. SheltonShelton andand JoyJoy J.J. LiuLiu

FOODFOOD ANDAND DRUGDRUG LAWLAW INSTITUTEINSTITUTE 11551155 15th15th StreetStreet NW,NW, SuiteSuite 910910 Washington, DC 20005 p:p: 202-371-1420202-371-1420 fdli.orgfdli.org [email protected]@fdli.org

PRACTICEPRACTICE TOPICSTOPICS TOPICS IN FOOD AND DRUG LAW TOPICS IN FOOD AND DRUG LAW TOPICS IN FOOD AND DRUG LAW TOPICS IN FOOD AND DRUG LAW

TOPICS IN FOOD AND DRUG LAW TOPICSTOPICS IN FOODIN FOOD AND AND DRUG DRUG LAW LAW Effective Review and Approval

EffectiveReview and Approval of Digital Promotional 2nd Tactics, Edition Dale Cooke Effective Review and Approval EffectiveReview and Approval of Digital Promotional 2nd Tactics, Edition Dale Cooke How to Comply with Drug CGMPs Cathy L. Burgess and Daniel G. Jarcho How to Comply with Drug CGMPs Cathy L. Burgess and Daniel G. Jarcho HowHow to to Comply Comply of Digital Promotional Tactics WithWith Drug Drug CGMPs CGMPs 2nd Edition Dale Cooke Cathy L.Cathy Burgess L. Burgess and and Daniel G.Daniel Jarcho G. Jarcho

FOOD ANDFOOD DRUG AND LAW DRUG INSTITUTE LAW INSTITUTE 1155 15th1155 Street 15th NW, Street Suite NW,910 Suite 910 Washington,Washington, DC 20005 DC 20005 FOODFOOD ANDAND DRUGDRUG LAWLAW INSTITUTEINSTITUTE p: 202-371-1420p: 202-371-1420 11551155 15th15th StreetStreet NW,NW, SuiteSuite 910910 fdli.org fdli.org Washington, DC 20005 [email protected]@fdli.org p:p: 202-371-1420202-371-1420 fdli.orgfdli.org [email protected]@fdli.org fdli.org/books fdli.org/books July/August 2007 July/August 2007

EMERGENCY EMERGENCY PREPAREDNESS PREPAREDNESS LATESTFDLI RESOURCES RELEASES letter from the chair Dear FDLI Members, Published by the Food and Drug Law Institute www.fdli.org Published by the Food and Drug Law Institute www.fdli.org FDLI ESSENTIALESSENTIAL COMPREHENSIVEFDLI As Chair of the Food and Drug Law Institute, it is my pleasure to welcome both new and The Bioterrorism Act after 5 Years – Is it Working? The Bioterrorismreturning Act membersafter 5 to Years another year– Is and it aWorking? new decade. As every member of the food and RESOURCESREFERENCESBioShield II – A Step in the Right Direction? GUIDE BioShield IIdrug – A law Step community in the knows, Right ours Direction?is a field of constant change and growth; 2019 saw many Pandemic Influenza: Companies Should Plan for the Worst and Assess Legal Exposure Pandemic Influenza: Companies excitingShould new medicalPlan for products the andWorst breakthroughs and Assess as well as publicLegal health Exposure challenges that Liability Protection: Shielding Vaccine Makers from Litigation Liability Protection: Shieldingaffect us all. 2020 Vaccine is starting Makersout at the same from fast pace,Litigation if not faster. Pet Food Recall – Exposing Holes in U.S. Food Safety Defenses Pet Food Recall – Exposing Holes in U.S. Food Safety Defenses As a long-time member of FDLI, I am delighted to see the many ways that FDLI is helping our community stay FDCA S FDCA S up-to-date with all of the changes that are afoot for FDA’s regulated industries. For example, 2019 saw FDLI host its first tatutory Supplementtatutory 2018 tatutory Supplementtatutory 2018 conference dedicated to examining the legal and regulatory issues in cannabis regulation. FDLI also launched its Law FDCA Statutory Over Lunch (LOL) series in 2019, which was an immediate hit. For those who have not yet participated in LOL, I encourage you to give it a try. LOL allows FDLI members to gather over the lunch hour for conversation on topics of Supplement mutual interest. This new program is another example of how FDLI strives to engage with our professional community

Edited by Deborah M. Shelton and Joy J. Liu and build community. Edited by Deborah M. Shelton and Joy J. Liu 2018

In addition to our many in-person gatherings, FDLI is also evolving with its publications. Toward that end, Update magazine is going green (or greener) and electronic. Beginning with this issue, our articles will be available online for EditedEdited byby DeborahDeborah M.M. SheltonShelton andand JoyJoy J.J. LiuLiu

FOODFOOD ANDAND DRUGDRUG LAWLAW INSTITUTEINSTITUTE you to read as soon as they are ready. The hard copy magazine will still be compiled and mailed, but four times per year 11551155 15th15th StreetStreet NW,NW, SuiteSuite 910910 Washington, DC 20005 p:p: 202-371-1420202-371-1420 fdli.orgfdli.org instead of six. We hope that this change allows for more immediate access to valuable information for our community. [email protected]@fdli.org

FDLI is about member engagement and maintaining the high standards of the food and drug law community. In all FDLI programs and publications, FDLI is committed to promoting dialogue across multiple viewpoints, and we can't do PRACTICEPRACTICE this without you. As we enter a new decade, I encourage you to engage with FDLI—come to our events, contribute ideas, TOPICSTOPICS share your viewpoints—all are welcome. I look forward to continuing to work with members and staff to further this great mission.

Jennifer L. Bragg

TOPICS IN FOOD AND DRUG LAW Partner, Skadden, Arps, Slate, Meagher & Flom LLP TOPICS IN FOOD AND DRUG LAW TOPICS IN FOOD AND DRUG LAW TOPICS IN FOOD AND DRUG LAW Chair, FDLI Board of Directors TOPICS IN FOOD AND DRUG LAW TOPICSTOPICS IN FOODIN FOOD AND AND DRUG DRUG LAW LAW Effective Review and Approval

EffectiveReview and Approval of Digital Promotional 2nd Tactics, Edition Dale Cooke Effective Review and Approval EffectiveReview and Approval of Digital Promotional 2nd Tactics, Edition Dale Cooke How to Comply with Drug CGMPs Cathy L. Burgess and Daniel G. Jarcho How to Comply with Drug CGMPs Cathy L. Burgess and Daniel G. Jarcho HowHow to to Comply Comply of Digital Promotional Tactics FDLI 2019 by the numbers WithWith Drug Drug CGMPs CGMPs 2nd Edition Dale Cooke Cathy L.Cathy Burgess L. Burgess and and Daniel G.Daniel Jarcho G. Jarcho Conferences WEBINARS 19 808 SPEAKERS 9 11 introductory courses

262 COMMITTEE MEMBERS LAW OVER 97 AUTHORS JOIN US! LUNCH EVENTS FOOD AND DRUG LAW INSTITUTE 3 FOOD AND DRUG LAW INSTITUTE 1155 15th1155 Street 15th NW, Street Suite NW,910 Suite 910 Washington,Washington, DC 20005 DC 20005 FOODFOOD ANDAND DRUGDRUG LAWLAW INSTITUTEINSTITUTE p: 202-371-1420p: 202-371-1420 11551155 15th15th StreetStreet NW,NW, SuiteSuite 910910 fdli.org fdli.org Washington, DC 20005 [email protected]@fdli.org p:p: 202-371-1420202-371-1420 fdli.orgfdli.org [email protected]@fdli.org fdli.org/books FDLI Spring 2020 Update 5 fdli.org/books Generic Labeling

A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD by Frederick (Rick) R. Ball & Justin M. L. Stern

Introduction For consumers, the widespread availability of products contain- propose or issue formal regulations concerning the manufac- ing cannabidiol (CBD) is old news. But for those in the canna- ture, distribution, or sale of such products.1 At the same time, bis industry—and in particular, those monitoring applicable FDA has issued numerous warning letters to producers and regulatory developments—the state of CBD remains largely in retailers incorporating CBD into products operating in the flux and continues to be marred by uncertainty. complex gray area between state and federal law. Nevertheless, Under the 2018 Farm Bill, the U.S. Food and Drug Admin- recent events occurring across all three federal branches of gov- istration (FDA) retained its regulatory authority over products ernment may reflect an impetus for change in FDA’s approach derived from hemp, including CBD incorporated into products to CBD products. it traditionally regulates, such as food, dietary supplements, and cosmetics. Unfortunately for the industry, FDA has yet to

Frederick (Rick) R. Ball is one of Justin M. L. Stern is an Associate at the co-leads of Duane Morris’s Life Duane Morris and a member of the Sciences and Medical Technology firm’s Cannabis and Life Sciences Industry Group. He also serves as a industry groups. Focused primarily on member of the Executive Committee of complex litigation in heavily regulated the Board of FDLI. His primary focus industries, he routinely provides is helping pharmaceutical companies, regulatory advice to manufacturers, biologics manufacturers, medical distributors, and retailers of cannabis- device manufacturers, contract service derived products. providers, food companies (including supplement manufacturers), and other healthcare providers navigate the complex challenges faced by state and federal regulation of their industries.

6 Update Spring 2020 www.fdli.org A Cannabidiol Catalyst?

Surge in CBD-Related FDA its consumer update about CBD safety of many factors forcing FDA action on Activity concerns and specifically acknowledging CBD. Again, as with the fact that CBD prod- “that it cannot conclude that CBD is generally recognized as safe (GRAS) among USDA’s Interim Final Rule ucts are commonly sold, it is hardly on Hemp Production breaking news that FDA has been issuing qualified experts for its use in human or 6 While publication of the U.S. Depart- warning letters to CBD retailers and animal food.” The revised consumer up- ment of Agriculture’s (USDA’s) Interim marketers. In fact, FDA sent the first date was changed to specifically indicate Final Rule (IFR) on hemp production FDA warning letter concerning CBD-re- that “CBD has the potential to harm you” was welcomed by those in the industry lated products—to Twin Falls Bio Tech, and that it “can cause liver injury,” “in- (though subject to a number of cri- LLC, located in South Carolina—in crease . . . the risk of sedation and drows- tiques), that regulatory promulgation late February 2015.2 While there was a iness” when used with alcohol or other changed nothing with respect to FDA’s relative slump in the number of warning central nervous system depressants, 7 treatment of CBD products. In fact, in letters sent to CBD businesses in 2017 and lead to “irritability and agitation.” its introductory analysis section, the and 2018 (four and one, respectively), the The update also warned that laborato- IFR explained that “FDA has authority practice swelled again in 2019.3 Between ry studies involving animals showed to issue a regulation allowing the use of January and mid-October of last year, reproductive toxicity, “including in the [cannabis-derived ingredients] in food seven CBD companies received FDA male offspring of CBD-treated pregnant 8 and dietary supplements” and went so warning letters. Then, in November, FDA females.” (These stated risks are also far as to predict that if the “FDA does rattled the industry by announcing it had contained in the FDA-approved labeling not provide clarity about their plans for issued an additional fifteen warning let- for Epidiolex, the cannabidiol-based drug 9 future regulation of CBD, there will con- ters to CBD businesses—nearly tripling approved by FDA in 2018. ) tinue to be uncertainty and downward the number of warning letters it had Taken as a whole, the spike in warning pressure on the CBD portion of the hemp mailed out so far that year.4 The Federal letters, together with FDA’s simultaneous market.”11 Trade Commission, acting pursuant to announcement that it specificallycannot its authority under the Federal Trade state that CBD is GRAS, shook the indus- Pressure from Congress try and consumers alike. By way of the Commission Act, also got into the action The drafters of the USDA IFR are not letters, CBD companies received a harsh and issued, either jointly with FDA or on the only federal employees pushing 5 reminder that they continue to operate its own, seven warning letters. FDA to take action on CBD regulation. in murky waters where CBD is federally The fifteen warning letters issued In October of last year, Senator Chuck lawful and CBD-infused cosmetics and late last year to CBD retailers across the Schumer hosted a press call during topical products appear to be largely country strung together a number of which he touted the economic potential acceptable at both the state and local common themes concerning how FDA presented by CBD, but warned that with- level, but where CBD-infused ingestible believed recipients were violating the out clarity from FDA, industry partic- products are lawful in certain states and Federal Food, Drug, and Cosmetic Act ipants—“farmers, growers, producers, localities and illegal in the eyes of federal (FDCA) by manufacturing, distributing, consumers, and vendors”—will be left in agencies. Despite FDA’s position on CBD and marketing CBD-infused products. the dark about exactly which rules they as not GRAS and explicit health-related Among other things, in the letters, are to follow.12 As such, Senator Schumer warnings from FDA concerning use of FDA—as it has in the past—reiterated its called on FDA “to do its job in a timely CBD, consumers continue to purchase position that CBD is not a dietary supple- manner and issue guidance related to CBD products at startlingly increased ment and may not be marketed as such, CBD classification, labeling, quality, rates. According to one estimate, sales of that CBD may not be added to foods or marketing, and sales.” CBD products in 2019 were, at mid-year, beverages, and that retailers may not Other legislators, perhaps impa- on track to increase by 700% over the make disease claims or structure-func- tient with the speed at which FDA previous year, up to $5 billion.10 An in- tion claims with respect to CBD. But in has approached CBD regulation, have creasing market and insatiable consumer its November 25, 2019 announcement, taken a different route—one that may appetite for the products may be one FDA went a step further by revising force FDA’s hand notwithstanding its

FDLI Spring 2020 Update 7 A Cannabidiol Catalyst?

preferred pace. In mid-January of this other industry, this would be a routine 3. See id. year, a bipartisan group of lawmakers in matter, one that the court would be well- 4. FDA.Gov: FDA Warns 15 Companies for Illegally Selling Various Products the House of Representatives introduced equipped to manage. But at the begin- Containing Cannabidiol as Agency legislation that would require FDA to ning of this year, the court granted the Details Safety Concerns (last revised treat hemp-derived CBD as a dietary defendant’s motion to stay the proceed- Nov. 25, 2019), available at https://www. fda.gov/news-events/press-announce- supplement—something FDA has been ings pursuant to the primary jurisdiction ments/fda-warns-15-companies-ille- unwilling to do.13 The bill—H.R. 5587— doctrine, deferring to FDA’s authority gally-selling-various-products-contain- would accomplish this goal by amending over food labeling and recognizing that ing-cannabidiol-agency-details. 5. See Oestreich, Elizabeth, FDLI.org: the FDCA by making an exception for “the rulemaking processes at the federal CBD Enforcement – Who is Keep- hemp-derived CBD in both the law’s level is active.” Despite the fact that the ing Watch?, November/December provision explaining what is not a dietary state of Florida began regulating CBD 2019, available at https://www.fdli. org/2020/01/cbd-enforcement-who-is- supplement, 21 U.S.C. § 321(ff)(3)(B), and products—and their labels—on Janu- keeping-watch/#_ftn6. 14 in the law’s “Prohibited acts” section. ary 1, 2020, the court still found that all 6. Id.; see also FDA.Gov: What You This approach, as opposed to others that considerations weighed in favor of stay- Need to Know (last revised Nov. 25, have sought to sway the opinion of FDA ing the case pending FDA action. This 2019), available at https://www.fda. gov/consumers/consumer-updates/ decision-makers, is an effort to change case, and likely others that will follow what-you-need-know-and-what-were- FDA policy by altering its charter: the suit, demonstrate how machinations of working-find-out-about-products-con- FDCA. government—i.e., the courts—may be taining-cannabis-or-cannabis. 7. Id. impeded by FDA’s current position with Hiccups in Judicial 8. Id. respect to CBD regulation. 9. See Center for Drug Evalua- Proceedings tion and Research: App. No. Pressure to act on CBD also seems to be Conclusion 210365Orig1s000: Labeling, available at https://www.accessdata.fda.gov/ mounting in (or emanating from) the In a way, of course, FDA already does drugsatfda_docs/nda/2018/210365Orig- judicial branch, as an increasing number regulate the market for CBD products. 1s000lbl.pdf. of lawsuits targeting CBD manufacturers By determining that CBD is not a dietary 10. See CNN.Com: CBD Product Sales are Booming. Now FDA Needs to Weigh In and retailers have popped up in federal supplement and that its addition to food (last revised July 9, 2019), available at court. While discussions abound con- or beverages renders the resulting prod- https://www.cnn.com/2019/07/09/busi- cerning the ability of marijuana busi- ucts adulterated drugs, FDA is exercising ness/cbd-sales-fda/index.html. nesses to state claims or mount defenses its regulatory authority—just not in the 11. 7 CFR Part 990, Establishment of Domestic Hemp Production Program, 84 in federal court (given the illegal nature way that industry participants prefer. Fed. Reg. 58522, 58544. of marijuana under the Controlled Nevertheless, those who have waited for 12. Sen. Charles E. Schumer: Press Substances Act), those concerns have not a shift in FDA’s CBD policy may find Releases (October 23, 2019). 13. H.R. 5587 (116th Congress, 2d Session). been raised with respect to hemp-derived comfort in the increasingly turbulent en- 14. See id. at § 1. CBD, given that the substance is no lon- vironment, as systemic quagmires posed 15. Snyder v. Green Roads of Florida LLC, ger federally unlawful. Yet the treatment by the current regulatory framework give Case No. 0:19-cv-62342-UU, Dkt. 25 (S.D. Fla. Jan. 3, 2020). of CBD under federal law—or the lack rise to louder calls for change. FDLI thereof—recently placed a federal lawsuit over CBD products on ice. 1. The authors note that the treatment of cosmetic products incorporating CBD In Snyder v. Green Roads of Florida would be subject to the regulations LLC, a putative class action lawsuit governing cosmetics. brought in the Southern District of 2. See FDA.Gov: Warning Letters and Test Results for Cannabidiol-Related Florida, consumers alleged that Green Products (last revised Nov. 26, 2019), Roads sold CBD gummies, tea, and oil available at https://www.fda.gov/ that contained CBD concentrations news-events/public-health-focus/warn- different from that advertised.15 In any ing-letters-and-test-results-cannabidiol-related-products.

8 Update Spring 2020 www.fdli.org Specializing in FDA Regulatory Solutions and support for all your compliance needs

Pharmaceutical and Medical Device Services

D Regulatory Strategy Development D 510(k) Premarket Clearance, De Novo & PMA, IDE Submissions D DMF, NDA, ANDA, NADA, IND D ISO 13485 QSR & GMP Harmonization D Auditing GMPs/Quality Systems D CAPA, FDA 483 & Warning Letter D Quality Management System Support Remediation D Cosmetic to OTC Switch, RX to OTC Switch D Design History & Device Master Files D M&A Due Diligence Assessments D Contract Partner Audits D Registration and Drug Product Listing D Recall Assistance D SOP Writing & Support D Expert Witness Services D Good Laboratory Practices Audits D Facility Registration and UDI Numbers D U.S. Agent & Import Entry Assistance D Labeling and Claims Assistance D Facilitate FDA Meetings & Communications D Compliance with Part 11 Electronic Signatures

Pharmaceuticals • Medical Devices • Foods • Dietary Supplements • Cosmetics • Tobacco • CBD

EAS Consulting Group, a member of the Certified family of companies, is a leader in regulatory solutions for industries regulated by FDA. Our global network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory compliance.

From regulatory strategies, compliance assistance, preparation of technical submissions such as DMFs, 510(k)s, ANDAs, support with FDA Form 483s and Warning Letters and more, EAS offers the detailed knowledge and experience your company requires to ensure accurate and timely assistance. Choose EAS when you require expert witness services, regulatory due diligence assessments, or compliance support with market withdrawals, recalls and improvement plans. With our vast expertise in FDA’s policies and enforcement, EAS is the proven choice for assistance with FDA regulatory solutions. Let EAS help you with all of your compliance needs.

Join EAS and the discussion at the following FDLI events: • Intro to Drug Law and Regulation: ANDA Applications, and Patent and Exclusivity Issues • Annual Conference: Top Pharmaceutical GMP Observations and How FDA is Prioritizing Expectations

Experts | Respected | Ethical | With Integrity easconsultinggroup.com | 571-447-5500 Bryan J. Coleman, Senior Director: [email protected] Chevron's Hard-Hitting Footnote Nine Revived by Kisor v. Wilkie and Recent Decisions on Deference by Chad Landmon, Alexander Alfano, & Michelle Divelbiss

Introduction interpretations tell a different story.3 Despite some justices’ Although we have all become accustomed to courts deferring assertions to the contrary, it appears that the teachings of Kisor to decisions made by the Food and Drug Administration (FDA) may lead district courts to more stringently consider statutory or other federal agencies under the Supreme Court’s Chevron language under the Chevron analysis after all. test, such deference has come under increasing scrutiny by Chevron deference is a divisive topic. On one hand, Chevron certain scholars and has been questioned during recent confir- provides seemingly straightforward guidance to determine mation hearings for Supreme Court justices. Just last year in its first, whether the statute is clear, and second, whether the Kisor v. Wilkie1 decision, the Supreme Court had to wrestle with agency’s interpretation is reasonable. On the other hand, those the Chevron framework, and many commentators before the two steps are ripe for disagreement and interpretation. Perhaps decision was issued questioned if the Court was going to strike Chevron's divisiveness arises at least in part from its uneven a blow against agency deference. application, leading to unpredictability. While some judges But, has Chevron changed since Kisor? At the heart of Kisor may easily find language ambiguous, others might scour the was the principle that deference to agency decisions only record and refuse to consider unlikely constructions, leading applied to genuinely ambiguous terms, and that most terms— only to one unambiguous interpretation. Since Kisor, however, after employing all standard tools of interpretation—have it seems that courts have taken to heart Justice Kagan’s di- only one logical meaning. While the justices concurring in the rection to leave no stone unturned in the search for meaning. judgment generally agreed that the decision had no effect on This should be encouraging to practitioners and the regulated Chevron and simply clarifiedAuer deference,2 two subsequent industries. Parties may now have an expanded ability to make district court decisions addressing deference to FDA’s statutory creative arguments based on a deep dive into the statutory

10 Update Spring 2020 www.fdli.org Chevron's Hard-Hitting Footnote Nine and regulatory language and history. Although challenging an in 1982 for his yet-undiagnosed post-traumatic stress disor- agency decision in court is often an uphill battle,4 it appears that der (PTSD).13 Although it was acknowledged that Kisor had courts will not simply defer to agency decisions when there are participated in a particular military action that Kisor believed strong arguments against such decisions based on the statutory gave him PTSD, the VA psychiatrist failed to diagnose PTSD. and regulatory language. Of course, only time will tell as we see As a result, the VA denied benefits. Decades later, in 2006, Kisor further administrative challenges play out in court. moved to reopen his claim for benefits, and this time, Kisor was diagnosed with PTSD. Accordingly, Kisor was granted benefits, APA Gives Courts Power to Review but only retroactively from 2006, when he moved to reopen his Agency Action claim, and not from 1982, when he had first applied. The Administrative Procedure Act (APA) grants federal courts Regulations provided that the VA could grant retroactive jurisdiction to review actions taken by executive branch agen- benefits back to 1982 if there were “relevant official service cies like FDA. The APA states that “the reviewing court shall department records” that had not been considered at the time decide all relevant questions of law, interpret constitutional and of the initial denial in 1982.14 Although Kisor had presented statutory provisions, and determine the meaning or applica- new service records confirming his participation in the military 5 bility of the terms of an agency action.” The APA directs the action that had not been considered in the 1982 decision, the reviewing court to “compel agency action unlawfully withheld Board of Veterans’ Appeals found that the “records were not or unreasonably delayed” and to “hold unlawful and set aside ‘relevant’ because they did not go to the reason for the denial— agency action, findings, and conclusions” that are, among other that Kisor did not have PTSD.”15 After appealing to the Court of considerations, “arbitrary, capricious, an abuse of discretion, or Appeals for Veterans Claims, which affirmed the interpretation 6 otherwise not in accordance with law.” The APA thus estab- of “relevant,” Kisor appealed to the Federal Circuit. The Federal lishes that judges are the decision makers of all questions of law Circuit found it ambiguous as to whether “relevant” records properly before them and contemplates some level of deference were those that “counter[ed] the basis of the prior denial” or if the agency’s interpretation of the statute is reasonable, i.e., not “relat[ed] to the veteran’s claim more broadly.”16 Although the 7 arbitrary, capricious, or an abuse of discretion. Court found that there was an ambiguity as to the meaning of Courts have created doctrinal tests to determine when and the term, it found that both interpretations were reasonable and how much deference to give an agency’s interpretation of a statute or regulation. An agency’s interpretation of a statute is Chad Landmon is a partner at Axinn, subject to the two-step Chevron test, which defers to an agency’s Veltrop & Harkrider, LLP, where he reasonable interpretation of ambiguous statutory language.8 Chairs the firm’s FDA and Intellectual Chevron deference requires the reviewing court to (1) deter- Property Practice Groups and regularly works with companies developing mine whether Congress has directly spoken to the issue and drugs, biologics, medical devices, and give effect to Congress’s unambiguous intent; and then (2) defer regenerative medicine and human to the agency’s interpretation if the statute is ambiguous unless tissue products. that interpretation is not based on a permissible construction of the statute.9 When reviewing an agency’s interpretation of a regulation, Alexander Alfano is an associate in Axinn’s FDA and Intellectual Property a court will apply Auer deference, which requires the court to Practice Groups. defer to the agency’s interpretation of an ambiguous rule unless that interpretation is plainly erroneous or inconsistent with the regulation being interpreted.10 This framework was further clarified in the 2019 Supreme Court decisionKisor v. Wilkie.11 Kisor - There Must Be Genuine Ambiguity for Deference Michelle Divelbiss is an associate in Axinn’s Intellectual Property Practice Group. Kisor Assesses the VA’s Interpretation of “Relevant” Kisor v. Wilkie12 involves a veteran, James L. Kisor, who applied for benefits from the Department of Veterans Affairs (VA)

FDLI Spring 2020 Update 11 Chevron's Hard-Hitting Footnote Nine

subsequently invoked Auer deference. calling something ambiguous when it the majority borrows from foot- In applying deference to the agency’s is not truly and genuinely ambiguous. note 9 of this Court’s opinion in interpretation, the Federal Circuit found Perhaps this emphasis was a nod to Chevron to say that a reviewing that “[t]he agency’s construction of its then-Judge Gorsuch’s claim that agency court must “exhaust all the tradi- own regulation would govern unless deference is “a judge-made doctrine for tional tools of construction” before ‘plainly erroneous or inconsistent with the abdication of the judicial duty.”21 concluding that an agency rule the VA’s regulatory framework.’”17 Kisor’s Alternatively, maybe Kagan was framing is ambiguous and deferring challenge was ultimately reviewed by the ambiguousness as Justice Scalia might to an agency’s reasonable Supreme Court. have—rarely finding ambiguity because interpretation.29 using tools of construction will not often Justice Kagan Reiterates result in a genuinely ambiguous term or Justice Kavanaugh also explained that Requirements for Genuine Ambiguity regulation.22 “[i]f a reviewing court employs all of the When the Supreme Court granted Speculation aside, Justice Kagan wrote traditional tools of construction, the Kisor’s petition, opponents of adminis- that Auer deference “gives agencies court will almost always reach a conclu- trative deference hoped that this would their due, while also allowing—indeed, sion about the best interpretation of the be the case to finally bring down the obligating—courts to perform their regulation at issue.”30 Although Kavana- deference regime. Although those hopes reviewing and restraining functions.”23 ugh believes that “[f]ormally rejecting were dashed, Kisor leaves open the possi- And, paying respect to one of the most Auer would have been a more direct bility that destroying deference is still on vocal opponents of deference, Kagan approach, [] rigorously applying footnote some of the justices’ to-do lists. cited to Justice Scalia’s dissent in Pauley 9 should lead in most cases to the same One thing that Kisor did do, however, v. BethEnergy Mines, Inc.: “A regulation general destination.”31 The second point was reign in and clarify the bounds of is not ambiguous merely because ‘dis- that Kavanaugh made was to clarify his Auer deference. Justice Kagan, writing cerning the only possible interpretation agreement with Chief Justice Roberts— for the majority, explained that “Auer requires a taxing inquiry.’”24 One of the that this decision is not regarded as deference retains an important role in more surprising aspects of the majority having addressed Chevron deference. construing agency regulations,” and opinion was that the Supreme Court Turning the focus back to the majority in upholding Auer, the Supreme Court clarified that deference is not always opinion, the Supreme Court found that 18 “reinforce[d] its limits.” appropriate: “[N]ot every reasonable “the Federal Circuit jumped the gun in Quoting footnote nine of Chevron, agency reading of a genuinely ambiguous declaring the regulation ambiguous” Justice Kagan explained that “a court rule should receive Auer deference.”25 when it did not “make a conscientious must exhaust all the ‘traditional tools’ of The court should determine “whether effort to determine, based on indicia 19 construction” before finding ambiguity. the character and context of the agency like text, structure, history, and pur- Kagan emphasized that: interpretation entitles it to controlling pose, whether the regulation really has weight”26 and assess whether “Congress more than one reasonable meaning.”32 the possibility of deference can intended to invest interpretive power” Additionally, the majority noted that “the arise only if a regulation is genu- in that agency.27 Such deference is not Federal Circuit assumed too fast that inely ambiguous. And when we appropriate if the decision or interpre- Auer deference should apply in the event use that term, we mean it—genu- tation is not “the agency’s authoritative of genuine ambiguity” because “[a] court inely ambiguous, even after a court or official position,” does not “implicate must assess whether the interpretation is has resorted to all the standard [the agency’s] substantive expertise,” of the sort that Congress would want to 20 tools of interpretation. or does not reflect “fair and considered receive deference” before actually apply- judgment.”28 ing that deference.33 As if trying to teach through repeti- Justice Kavanaugh, joined by Justice tion, Justice Kagan repeated twelve times Alito, concurred in the judgment and Administrative Interpretations in a throughout the majority opinion that wrote separately to emphasize two Post- Regime ambiguity must be genuine. With this points. First, Kavanaugh pointed out Kisor repetition, Kagan might be implying that: In less than a year, Kisor has made its that courts have previously resorted to mark on administrative deference, but

12 Update Spring 2020 www.fdli.org Chevron's Hard-Hitting Footnote Nine it is unknown how consequential that buprenorphine drug product, Sublocade, “the agency reasonably construed the mark is. It is unclear how closely lower which is also administered monthly.41 statutory language, a standard that the courts are listening to Justice Kagan’s In a letter from FDA explaining that agency can fail.”47 In doing so, “an agency instructions to use “all the standard Brixadi Monthly was not yet eligible must give a reasonable explanation for tools of interpretation”34 to determine for final approval, FDA explained that how its interpretation serves the stat- whether something is genuinely ambig- the phrase “the conditions of approval” ute.”48 FDA “failed to say which factors uous. Although the Supreme Court’s was interpreted to “mean that the FDA in the clinical studies were important for majority opinion in Kisor cited Chevron may not approve any application under its determination,”49 and therefore did and referred to Chevron deference several § 355(b) for a drug product that shares not provide a reasonable explanation for times, Chief Justice Roberts and Justice the exclusivity-eligible drug’s ‘innova- its interpretation. Instead, FDA inter- Kavanaugh stated unequivocally that tion represented by its approved drug preted “the conditions of approval” “to they do not believe that Kisor addressed product that is supported by new clinical limit exclusivity to instances in which a Chevron deference.35 investigations essential to approval.’”42 follow-on drug product shares the ‘inno- Two notable cases against FDA have FDA’s interpretation “prevents the FDA vation’ supported by the first product’s come through the U.S. District Court for from approving a drug application if the ‘new clinical investigations essential to the District of Columbia and shed some applied-for drug [e.g., Brixadi Monthly] approval.’”50 This interpretation has the light on administrative deference in a shares a quality that the FDA deems effect of prohibiting approval of a second post-Kisor era: Braeburn Inc. v. FDA36 another drug sponsor to have innovated drug during the three years of exclusiv- and Athenex Inc. v. Azar.37 and to have obtained approval for in the ity for the first drug “no matter the two prior three years [e.g., Sublocade].”43 products’ differences, if the [second] Braeburn Successfully Disputes FDA explained that based on “the con- product incorporates the first’s innova- FDA’s Interpretation of “Conditions of ditions of approval,” “Sublocade blocked tive features.”51 Approval” [approval of] Brixadi Monthly because The court plainly rejected FDA’s Braeburn involves the interpretation of both are ‘a monthly depot buprenor- interpretation and found that “FDA’s the statutory language “the conditions phine product to treat moderate to severe standard simply supplants the ambigu- of approval” in the Federal Food, Drug, [opioid use disorder].’”44 Dissatisfied with ous phrase ‘the conditions of approval’ 38 and Cosmetic Act (FDCA), which was FDA’s interpretation of “the conditions of for the ambiguous term ‘innovation,’”52 challenged by Braeburn Inc. (Braeburn) approval” and wanting final approval for highlighting the unreasonableness of its as being arbitrary and contradictory. Brixadi Monthly, Braeburn sued FDA. explanation. Not only was FDA’s expla- Braeburn’s product, Brixadi, “delivers nation unreasonable in the eyes of the buprenorphine through an injectable “Conditions of Approval” is court, but it was also inconsistent with “Genuinely Ambiguous” and depot that releases buprenorphine over previous FDA decisions. 39 Proceeds to Chevron Step Two either a weekly or monthly period.” During the exclusivity approval pro- Both the weekly and monthly products The court determined that “whether an cess for Sublocade, FDA found that the were tested on de novo patients, patients already-approved drug product bars final drug was “not novel relative to previous who have not previously taken bu- approval of a later product [here, Brixadi buprenorphine drug products” but “was prenorphine, and non-de novo patients, Monthly,] depends . . . on the overlap the first product demonstrated to safely patients who have previously taken or are between ‘the conditions of approval’ of and effectively treat moderate-to-severe 40 45 currently taken buprenorphine. the two products.” In applying Chevron [opioid use disorder] through a monthly After going through the approval pro- step one, the court found that there are at buprenorphine depot.”53 FDA found that cess outlined in the FDCA, Brixadi re- least four plausible readings of the phrase the administration of Sublocade on a ceived tentative approval for both Brixadi “the conditions of approval.” Therefore, monthly basis was novel and “innova- Weekly and Monthly, and final approval “Congress has [not] directly spoken to tive” in light of existing buprenorphine of Brixadi Weekly was contingent on the precise question at issue” because products, and that the novelty was the submission of proposed labeling to “the statute is silent or ambiguous with deserving of exclusivity. 46 FDA. Brixadi Monthly, however, was not respect to the specific issue.” Comparing Brixadi Monthly with Su- eligible for final approval until expiration In proceeding to Chevron step two, blocade, the court questioned why FDA of the three-year exclusivity for Indivior’s the court (citing Kisor) analyzed whether found that a monthly administration was

FDLI Spring 2020 Update 13 Chevron's Hard-Hitting Footnote Nine

“innovative” and “novel relative to previ- In evaluating whether the statutory to both determinations is yes, then there ous buprenorphine drug products” and language “conditions of approval” was must also be “a basis to conclude that the thus deserving of approval and exclusiv- ambiguous, the court seems to have drug product proposed to be compound- ity but that testing on different patient used all of the tools of construction at its ed must be produced from a bulk drug populations was not “innovative” and disposal to determine the meaning of the substance rather than from an FDA-ap- “novel.”54 Sublocade had been tested only disputed phrase. Nevertheless, the court proved drug product.”68 on “new-to-treatment [opioid use disor- ultimately reasoned that the language FDA had determined that vasopressin der] patients ‘who have initiated treat- was ambiguous, particularly in light of is not a “bulk drug substance for which ment . . . followed by a dose adjustment FDA’s inconsistent actions. Although the there is a clinical need” because there is for a minimum of 7 days.’”55 In contrast, Supreme Court made clear that Kisor already an approved drug on the market Brixadi Monthly had been tested on dealt with Auer deference regarding that fulfills the “clinical need.”69 Based on patients “new-to-treatment and [patients] regulations and not Chevron deference this guidance, Athenex would not be able transitioning from prior buprenorphine regarding statutes, it seems that the to continue using vasopressin to com- treatment.”56 Even though the patient Braeburn court kept Kisor in mind as it pound their drug product unless FDA populations were different, FDA did searched for tools to discern the meaning determined there was a “clinical need” not address any differences in the drug of “conditions of approval.” and put vasopressin on the “clinical product based on the patient population Less than two weeks after theBrae - need” list.70 treated; FDA found that Brixadi was not burn decision, the district court issued its In challenging FDA’s decision, “innovative” or “novel” relative to Sublo- opinion in Athenex Inc., v. Azar,64 which Athenex argued that “clinical need” is cade, and was not deserving of approval also addressed administrative deference. determined by “asking whether there over Sublocade’s exclusivity.57 is a therapeutic use for the bulk drug In support of its argument that FDA Athenex Cannot Overcome FDA’s substance.”71 Athenex argued that, even Interpretation of “Clinical Need” was acting inconsistently, Braeburn though there was an approved drug, demonstrated that FDA had previously Athenex Inc. (Athenex) operated an Vasostrict, it “was medically unsuitable approved exclusivity for a drug, Envarsus outsourcing facility to use a bulk drug to treat certain patients because: (1) XR, when the only difference between it substance, vasopressin, to compound a Vasostrict contains chlorobutanol, an and the existing drug was in the pa- drug product. An outsourcing facility allergen for some patients, and (2) it is tient population treated.58 Specifically, may sell compounded drugs if certain not available in ready-to-use form but Envarsus XR was approved and granted statutory requirements are met. At issue must be diluted before use.”72 Therefore, exclusivity for its use in treating “con- here is the statutory requirement that Athenex’s product, which is free from the version patients” (non-de novo patients) there must be a “clinical need” for the allergen and is in ready-to-use form, fills 65 because the first drug was only approved bulk drug substance. a “clinical need.” for de novo patients.59 In March 2018, FDA issued a draft FDA disagreed because it interpreted The court explained that it is well-set- guidance regarding how it will determine “clinical need” as a currently unfulfilled tled that an agency decision is not whether there is a “clinical need” and, in clinical need. In support of its position, “reasonable and reasonably explained”60 March 2019, issued a final guidance on FDA argued that an allergen-free for- 66 if “it exhibits internally inconsistent the subject. FDA’s guidance explained mulation of Vasostrict already exists and reasoning”61 and if the agency “offer[s] that for the “clinical need” analysis, FDA that an absence of the ready-to-use form insufficient reasons for treating similar will consider whether there is “an attri- does not make a product inadequate for situations differently.”62 Based on the bute of the FDA-approved drug product a “clinical need.”73 Athenex and FDA’s differences in the patient populations, [that] makes it medically unsuitable to interpretations hinged on opposite sides the court found inconsistencies in both treat certain patients” and whether “the of whether “clinical need,” as used in the FDA’s rationale and actions; FDA’s inter- drug product proposed to be compound- FDCA, means any clinical or therapeutic 67 pretation was therefore not reasonable ed is intended to address that attribute.” use or an unmet clinical or therapeutic use. but instead was arbitrary and capricious, If the answer to either is no, then a “clini- and FDA’s action must be set aside.63 cal need” will not be found. If the answer

14 Update Spring 2020 www.fdli.org Chevron's Hard-Hitting Footnote Nine

“Clinical need” is not genuinely Congressional intent. Even absent Con- judicial inquiry should be expected. Nev- ambiguous gressional intent, any other construction ertheless, there will still be debate over In applying Chevron step one, the court would have rendered FDA’s determina- whether terms are genuinely ambiguous. first looked at whether “clinical need” tion of a “clinical need” superfluous. The Now, instead of a two-step Chevron anal- was defined by Congress and determined court seemed to take Kisor to heart when ysis, most disputes will stop at step one. that it does not appear in the FDCA or it resorted to various tools of construc- Some who have criticized Chevron for in the U.S. Code.74 Next, in finding that tion as a first line of inquiry and not causing unpredictability might be placat- “need” means “circumstances in which brushing past it and declaring deference. ed for now, but Chevron and Auer might something is necessary,” the court found Based on Braeburn and Athenex, the be on the chopping block once again if the term to be relative and ambiguous court seems to have taken Kisor’s lessons opponents of administrative deference and “must be measured against some seriously in rigorously exercising tools of continue to face an uphill battle in the 75 point of reference.” construction before finding ambiguity, fight against the deference regime. FDLI In an attempt to resolve the ambiguity, even in the face of statutory construction the court looked to ascertain Congress’ that would normally invoke Chevron. 1. 139 S. Ct. 2400 (2019). 2. Id. at 2425 (Roberts, C.J., concurring intent: “Congress plainly thought that Conclusion in the judgment) (“I do not regard the there are some bulk drug substances for Court’s decision today to touch upon which there is a ‘clinical need’ and others In upholding Auer deference, the [Chevron deference].”); id. at 2449 76 Supreme Court urged and instructed (Kavanaugh, J., concurring in the for which there is not.” Based on this, judgment) (“‘I do not regard the Court’s lower courts to conduct a thorough and the court found that if “clinical need” decision’ not to formally overrule Auer meant any clinical or therapeutic use, as detailed analysis of the agency’s inter- ‘to touch upon the latter question [of Chevron deference].’”). Athenex argued, then any bulk substance pretation. Although Kisor seems to have settled Auer deference for the time being, 3. See Athenex Inc. v. Azar, 397 F. Supp. would meet a clinical need and there 3d 56 (D.D.C. 2019); Braeburn Inc. v. would be no need for FDA to evaluate other deference challenges still lurk. In FDA, 389 F. Supp. 3d 1 (D.D.C. 2019). 4. See Chad Landmon, Alexander Alfano whether or not there is a “clinical need” Kisor, Justice Gorsuch stated that the & Michelle Divelbiss, Open the Flood- 77 Supreme Court “[thought] it past time at all, making the inquiry meaningless. gates: The Potential Impact on Litigation By determining that congressional to [reconsider Auer], [and] granted the Against FDA if the Supreme Court 80 intent resolves the meaning and any petition [for Writ of Certiorari].” From Reverses or Curtails Chevron Deference, Braeburn and Athenex, it seems likely 74 Food & Drug L.J. 358 (2019). purported ambiguity of “clinical need,” 5. 5 U.S.C. § 706 (2018). that courts might abide and use “all the the court found that FDA prevailed at 6. Id. 81 Chevron step one. Nevertheless, even if textual and structural clues” before 7. Ronald A. Cass, Auer Deference: Dou- finding ambiguity, a method that Justice bling Down on Delegation’s Defects, 87 the ambiguity had not been resolved, the FORDHAM L. REV. 531, 537 (2018). Scalia likely would have agreed with.82 court explained that FDA would have 8. EPA v. EME Homer City Generation, prevailed at Chevron step two because its Even though Gorsuch thought it was L.P., 572 U.S. 489, 512 (2014). 9. Chevron U.S.A. Inc. v. Nat. Res. Def. interpretation was reasonable and “based time to reconsider Auer, maybe adher- ence to this more strict framework will Council, Inc., 467 U.S. 837, 842–43 on a permissible construction of the (1984). statute.”78 appease the Supreme Court’s textualist 10. Auer v. Robbins, 519 U.S. 452 (1997). 11. 139 S. Ct. 2400 (2019). Here, as in Braeburn, the meaning justices. With an unambiguous instruction 12. Id. of a statute is at issue, which invokes a 13. See id. at 2409. Chevron analysis. Despite some justices from the Supreme Court to “exhaust all 14. Id.; 38 C.F.R. § 3.156(c)(1) (2013). in Kisor explicitly stating that they do not the ‘traditional tools’ of construction” 15. Kisor, 139 S. Ct. at 2409. before finding ambiguity,83 the scope 16. Id. (quoting Kisor v. Shulkin, 869 F.3d believe that Kisor addressed the issue of 1360, 1366–67 (Fed. Cir. 2017)). of possible interpretations for disputed Chevron deference,79 the Athenex court 17. Id. seems to have applied Kisor’s teachings terms will likely narrow. Practitioners 18. Id. at 2408. will need to be intimately familiar with 19. Id. at 2415 (quoting Chevron U.S.A. to its Chevron analysis. In its analysis, Inc. v. Nat. Res. Def. Council, Inc., 467 the purpose and history of a statute or the court exhausted at least some tools U.S. 837, 843 n.9 (1984)). of construction when it ascertained regulation to be adequately prepared to 20. Id. at 2414. defend a position. Moreover, detailed

FDLI Spring 2020 Update 15 Chevron's Hard-Hitting Footnote Nine

21. Gutierrez-Brizuela v. Lynch, 834 F.3d 45. Id. at 20. 69. Athenex Inc., 397 F. Supp. 3d at 58. 1142, 1152 (10th Cir. 2016). 46. Chevron, U.S.A., Inc. v. Nat. Res. Def. 70. Additionally, a substance may be put on 22. See, e.g., Hon. Antonin Scalia, Judicial Council, Inc., 467 U.S. 837, 842–43 the “drug shortage” list to gain approval Deference to Administrative Interpreta- (1984). for drug compounding with bulk drug tions of Law, 3 Duke L.J. 511, 521 (1989) 47. Braeburn Inc., 389 F. Supp. 3d at 21 substance, but that list is not at issue (“One who findsmore often (as I do) (citing Kisor v. Wilkie, 139 S.Ct. 2400, here. that the meaning of a statute is apparent 2416 (2019)). 71. Athenex Inc., 397 F. Supp. 3d at 58 from its text and from its relationship 48. Id. at 23 (citing Mako Commc’ns, LLC (emphasis added). with other laws, thereby finds less often v. FCC, 835 F.3d 146, 150 (D.C. Cir. 72. Id. 62. that the triggering requirement for 2016)). 73. See id. Chevron deference exists.”). 49. Chad Landmon, Alex Alfano & 74. See id. at 64. 23. Kisor, 139 S. Ct. at 2415. Ashton Copeland, Insight: Recent 75. Id. 24. Id. (quoting Pauley v. BethEnergy FDA Court Decision Shows Potential 76. Id. Mines, Inc., 501 U.S. 680, 707 (1991) Impact of SCOTUS Deference Decision, 77. See id. at 69 (where Athenex’s inter- (Scalia, J., dissenting)). Bloomberg Law (Aug. 20, 2019), pretation “would violate a basic rule of 25. Id. at 2416. https://news.bloomberglaw.com/us- statutory construction”). 26. Id. law-week/insight-recent-fda-court-de- 78. Id. at 73 (quoting Chevron, U.S.A., Inc. 27. Id. at 2417 (quoting Martin v. Occupa- cision-shows-potential-impact-of-sco- v. Nat. Res. Def. Council, Inc., 467 U.S. tional Safety & Health Review Comm’n, tus-deference-decision. 837, 843 (1984)). 499 U.S. 144, 153 (1991)). 50. Braeburn Inc., 389 F. Supp. 3d at 23. 79. See Kisor v. Wilkie, 139 S.Ct. 2400, 2425 28. Id. at 2416–17 (internal quotations 51. Id. (2019) (Roberts, C.J., concurring in the omitted). 52. Id. at 24. judgment) (“I do not regard the Court’s 29. Id. at 2448 (Kavanaugh, J., concurring 53. Id. (emphasis added). decision today to touch upon [Chevron in the judgment). 54. Id. deference].”); id. at 2449 (Kavanaugh, J., 30. Id. 55. Id. at 28. concurring in the judgment) (same). 31. Id. 56. Id. at 12. 80. Id. at 2431(Gorsuch, J., concurring in 32. Id. at 2423-24 (majority opinion). 57. See id. at 28–30. the judgment). 33. Id. at 2424. 58. See id. at 30–31. 81. Wisconsin Central Ltd. v. United States, 34. Id. at 2414. 59. See id. 138 S. Ct. 2067, 2074 (2018). 35. Id. at 2425 (Roberts, C.J., concurring 60. Id. at 28 (quoting ANR Storage Co. v. 82. See, e.g., Pauley v. BethEnergy Mines, in the judgment) (“I do not regard the FERC, 904 F.3d 1020, 1024 (D.C. Cir. Inc., 501 U.S. 680, 707 (1991) (Scalia, J., Court’s decision today to touch upon 2018)) (internal quotations omitted). dissenting) (“Chevron is a recognition [Chevron deference].”); id. at 2449 61. Id. that the ambiguities in statutes are to be (Kavanaugh, J., concurring in the judg- 62. Id. (quoting Cal. Cmtys. Against Toxics resolved by the agencies charged with ment) (same). v. EPA, 928 F.3d 1041, 1057 (D.C. Cir. implementing them, not a declaration 36. Braeburn Inc. v. FDA, 389 F. Supp. 3d 1 2019)) (internal quotations omitted). that, when statutory construction (D.D.C. 2019). 63. See id. at 30. becomes difficult, we will throw up our 37. Athenex Inc. v. Azar, 397 F. Supp. 3d 56 64. 397 F. Supp. 3d 56 (D.D.C. 2019). hands and let regulatory agencies do it (D.D.C. 2019). 65. See id. at 58. for us.”). 38. See 21 U.S.C. § 355(c)(3)(E)(iii) (2012) 66. Evaluation of Bulk Drug Substances 83. Kisor, 139 S. Ct. at 2415 (quoting Chev- (barring final approval under certain Nominated for Use in Compounding ron U.S.A. Inc. v. Nat. Res. Def. Coun- conditions). Under Section 503B of the Feder- cil, Inc., 467 U.S. 837, 843 n.9 (1984)). 39. Braeburn Inc., 389 F. Supp. 3d at 5. al Food, Drug, and Cosmetic Act, 40. See id. at 12. Guidance for Industry, U.S. FDA 41. See id.; 21 U.S.C. § 355(c)(3)(E)(iii). (Mar. 2019), https://www.fda.gov/ 42. Braeburn Inc., 389 F. Supp. 3d at 13. media/121315/download. 43. Id. 67. Id. at 11. 44. Id. 68. Id.

16 Update Spring 2020 www.fdli.org Highlights and Insights from the General Snus MRTP Decision Documents by James M. Solyst

Introduction The lackluster response was caused in part by the inevitability The October 22, 2019 Food and Drug Administration (FDA) of the decision: the widespread notion that if Swedish Match decision to authorize the marketing of the Swedish Match snus did not receive an MRTP certification, then no company USA line of General SNUS products as Modified Risk Tobacco or product would. For many, the question was not if, but when, Products (MRTPs) was a much-needed statement of support for a General Snus MRTP would be announced, particularly after tobacco harm reduction amidst a climate of controversy. The the products received Premarket Tobacco Applications (PMTA) 1 decision demonstrated that the MRTP process works, provided approval in November of 2015. The sense of inevitability the applicant has extensive evidence on an established product was strengthened by the encouraging discussion during the and is willing to stay the regulatory course. February 2019 Tobacco Product Scientific Advisory Committee 2 Although inspiring to many stakeholders, the decision did (TPSAC) meeting and the positive tone of the FDA-prepared 3 not receive the level of attention due a truly historic statement. TPSAC Briefing Document. Given the predictability of the decision, it is understandable that many stakeholders glossed over the core FDA decision doc- 4 James M. Solyst is Vice President, ument—the Technical Project Lead (TPL) report —or just read Federal Regulatory Affairs with the executive summary and quickly concluded that the main Swedish Match North America, where take away was after five years of rigorous review and interaction he directs the Company’s regulatory with the applicant, FDA was able to make the long-awaited science engagements. decision. But the story told in the TPL and related documents

FDLI Spring 2020 Update 17 Insights from the General Snus Modified Risk Tobacco Product Decision Documents

is much more than that, and this article for a regulatory decision. and continuing with the postmarket will examine a few of the key highlights In contrast to the TPL is a companion surveillance plan. and insights from the TPL and a resul- piece prepared by the CTP communi- At all steps along the way, the applicant tant communication article. cations team titled “FDA Authorizes submits evidence and methodologies and Modified Risk Tobacco Products,” which FDA responds by citing deficiencies and MRTP Decision and supplements the TPL General Snus offering suggestions. This may appear Communication Documents document but is clearly intended for a lay to be a somewhat controlling approach The General Snus MRTP decision was audience and presents information and by FDA, but another way to look at it is communicated by FDA in a few different messages in a more digestible manner.5 FDA is providing increasingly specific, written formats, ranging from the com- Although it is a reader friendly docu- and thus useful, guidance as the process prehensive and detailed TPL to a much ment, it does provide valuable insight evolves. Thus, a principal insight from more public-friendly question and answer into the CTP risk communication the background section is that FDA can presentation of the information. messages. provide guidance and encouragement to The TPL issued in 2019 is the latest of an applicant, even if it rejects (or partially 2019 Technical Project Lead three such reports that convey General rejects) the applicant’s initial marketing Report Snus-related decisions. The first TPL was claim. for the November 2015 PMTA authori- The 2019 TPL documenting the MRTP That was the case with the Decem- zation for the General Snus products, fol- certification of General Snus products is ber 2016 TPL that rejected part of the lowed by a December 2016 partial MRTP a dry and cautious document, as would Swedish Match marketing claim and cast decision rejecting the proposed claim be expected from a formal report with doubt on the entire claim but did suggest requesting removal of existing warning the term “Technical” in its title. However, a path forward. A key sentence that was labels and adding a “substantially less it is very necessary and useful as it pro- originally presented in the 2016 TPL and risky” warning. FDA specifically denied vides comprehensive documentation of included in the 2019 TPL is the following: the request to remove the tooth loss and the General Snus MRTP process, starting gum disease label and strongly suggested with the initial application in June 2014. For example, you may consider that the other warning label requests Of course, the history of the General pursuing explicit claims that would be denied. In September 2018, Snus MRTP experience may not be of appear outside of the health Swedish Match submitted an MRTP great interest to even the most ardent warning, elsewhere on the label or Amendment that addressed the deficien- stakeholder, but the point of this article in advertising, providing infor- cies cited in the 2016 partial decision. This is to demonstrate that a document as dry mation to consumers concerning Amendment is the basis for the 2019 TPL. as the TPL can contain information and the differences in mouth cancer A Technical Project Lead report is the messages that provide insight into the risks between the eight General format used by the Center for Tobacco regulatory science process. snus products and other tobacco Products (CTP) to document regula- products.6 tory decisions. As the name indicates, Background Section it is a technical report that presents the The bulk of the 2019 TPL is presenta- Swedish Match interpreted this sug- Center’s justification for approving or tion of background information and a gestion to mean that FDA believed the denying an application. The term “Lead” summary of the new scientific evidence. submitted evidence was better suited to a refers to the fact that the document is TheBackground section is essentially a disease-specific health claim rather than signed by the lead official involved in chronology of the General Snus MRTP a broader claim such as “substantially the analysis who considers the scientific experience, as documented in previous lower risk.” opinions expressed by the leaders of TPLs, and reinforces a fundamental the various scientific disciplines such as reality of the MRTP process: that it is a Summary of Scientific Evidence Section chemistry, epidemiology, addiction, etc. long journey in which the applicant must TheSummary of Scientific Evidence The TPL is the one essential document always initiate the process, starting with section of the 2019 TPL7 provides an for knowledgeable stakeholders who are the first application, followed by amend- overview of evidence analyzed in the pre- seeking to understand the justification ments (as was the case for General Snus), vious TPLs and assesses new evidence,

18 Update Spring 2020 www.fdli.org Insights from the General Snus Modified Risk Tobacco Product Decision Documents

particularly the Perceptions and Behav- to the assessment of the long-term health the TPL as the basis for developing the ior Intentions (PBI) study conducted by risks of the General snus products”11 communication piece titled “FDA Au- Swedish Match. The FDA assessment of and seems to imply that the evidence is thorizes Modified Risk Tobacco Prod- the PBI and how it applies to the pro- applicable to other pouched products ucts,” which follows a Q & A format and posed health marketing claim provides that comply with or are guided by the provides practical information about the significant insight into what FDA is look- GOTHIATEK® standard. products and touches on the continuum ing for in an MRTP consumer perception of risk. The article includes several cau- study. This section of the TPL (pages Appendix-The Public Health Ratio- tionary notes, such as that the products 29–42) could be the basis of a separate nale for Recommended Restrictions are not safe or “FDA approved”, but there Update magazine article analyzing how on Modified Risk Tobacco Product is also some breakthrough, albeit careful- FDA assessed an applicant-developed Labeling, Advertising, Marketing, and ly crafted, statements characterizing the consumer perception program. Promotion General Snus products as low risk. The scientific evidence section also The Appendix is essentially a stand-alone The first section,What is a modified provides a description, and more impor- report, more of a review memorandum risk tobacco product?, briefly describes tantly a characterization, of the February than a commentary on the General Snus MRTP statutory provisions, focusing 6, 2019 TPSAC meeting. The character- MRTP. It appears that FDA used the on the concept of benefiting the public ization is significant because there was MRTP decision opportunity to address health. The most intriguing language no vote taken during the meeting; rather, the controversial issue of youth usage of is in the third paragraph, which starts FDA was seeking a “thoughtful engage- alternative tobacco products. with the sentence: “FDA recognizes that ment and discussion.”8 How FDA viewed The core message of the Appendix is tobacco products exist on a continuum the discussion is summed up in the fol- that no product will receive an MRTP of risk, with combustible cigarettes being lowing sentence: “In general, TPSAC felt unless there are assurances that the appli- the deadliest.”12 What is not stated, but that the applicant’s study was reasonable cant will not engage in practices that con- seemingly implied, is that an MRTP and its proposed modified risk claim tribute to youth usage. Equally important, product should be placed lower on the seems to convey an accurate message.”9 FDA will require those companies that continuum of risk. The TPSAC meeting is also cited in a have received an MRTP order to submit The second section, What is snus?, is sub-section on the importance of the epi- planned labeling, advertising, marketing, simply a short paragraph followed by a demiological literature based on Swedish and promotional materials and plans, and photo of a can of snus. But it is significant, and Norwegian studies and the connec- for FDA to place restrictions on the mar- because it provides practical advice: “[I]t tion to the Swedish Match internal qual- keting of such products. Put another way, is placed in the mouth, typically between ity program GOTHIATEK®. The FDA the MRTP order is just the beginning of the lip and gums, but users do need to message appears to be that the Swedish/ another phase to the MRTP process. spit,” and the photo gives the products an Norwegian experience is applicable to identity that is not included in the TPL. products with low levels of tobacco-spe- FDA Authorizes Modified The article includes a section on youth Risk Tobacco Products cific nitrosamines, benzopyrene, and (Is FDA concerned that youth might start other HPHCs (Harmful and Potentially One of the important considerations in using snus because these products are Harmful Constituents)—levels required the MRTP process is the extent to which advertised as lower risk?), which states pursuant to GOTHIATEK®.10 The TPL FDA communicates the decision to a that evidence provided by the applicant states that during the TPSAC meeting, lay audience, particularly adult nicotine demonstrates the products will not “the applicant described the GOTHI- consumers. The challenge FDA faced increase youth usage: “The modified risk ATEK® standard as one that has changed was how to communicate that switching claim did not make them more likely to over time with the inclusion of new completely from smoking cigarettes to buy the products.” Seemingly to provide HPHCs and the reduction of maximum General Snus lowers the risk of certain some reassurance, the article states that allowable levels of HPHCs.” health effects, yet also ensure that non-us- Swedish Match “is required to restrict The TPA states that the Swedish/Nor- ers are not enticed to start using nicotine youth access and exposure to the market- wegian evidence is “particularly relevant products, including lower risk products. ing of General Snus.” The CTP communications staff used

FDLI Spring 2020 Update 19 Insights from the General Snus Modified Risk Tobacco Product Decision Documents

Conclusion The General Snus MRTP decision is a historic event, which is fully documented in the 2019 TPL and communicated to a lay audience in the “FDA Authorizes Modified Risk Tobacco Products” article. Neither are adventurous documents; the TPL by design is a dry chronology that includes an analysis of some new evidence, and “FDA Authorizes” is very cautious in its presentation of basic information. However, both contain useful insights. For the knowledgeable stakeholder, the TPL provides useful insights into the MRTP process, assesses consumer perception evidence, and offers some clues regarding the applicability of epidemiological evidence. In addition, it includes an appendix that is necessary reading for anyone interested in FDA’s evolv- Bright. ing position on youth usage. For the general public and particularly for cigarette smokers, “FDA Authorizes” provides much needed information and characterization of lower risk products. It provides mixed messages—for every pro harm reduction statement, there is seemingly a Modern. cautionary message—but it is a step in the right direction. FDLI

1. Premarket Tobacco Application (PMTA): Technical Project Lead (TPL) Review, Center for Tobacco Products, U.S. Food and Drug Administration (2015), https://www.fda.gov/media/94582/download. 2. Efficient. 2019 TPSAC Meeting Materials and Information, U.S. Food and Drug Administration, https://www.fda.gov/advisory-committees/tobacco-products-scientific-advisory-committee/2019-tpsac-meeting-materials-and-information. And a little different. 3. FDA Briefing Document, February 6, 2019 Meeting of the Tobacco Products Scientific Advisory Committee (TPSAC), Center for Tobacco Products, U.S. Food and Drug Administration, Helping clients address FDA https://www.fda.gov/media/122005/download. 4. Scientific Review of Modified Risk Tobacco Product Application concerns and anticipate hurdles (MRTPA) Under Section 911 (d) of the FD&C Act – Technical Proj- ect Lead, U.S. Food and Drug Administration (2019), https:// (before they appear...) www.fda.gov/media/131923/download [hereinafter 2019 TPL]. 5. FDA Authorizes Modified Risk Tobacco Products, U.S. Food and Drug Administration, https://www.fda.gov/tobacco-products/ advertising-and-promotion/fda-authorizes-modified-risk-tobacco-products. 6. 2019 TPL, supra note 4, at 15. 7. Id. at 20. 8. Transcript of Tobacco Products Scientific Advisory Committee Meeting, February 6, 2019, Center for Tobacco Products, U.S. 950 attorneys nationwide Food and Drug Administration, https://www.fda.gov/media/122002/download. Barry Schaevitz | 212.878.1437 9. 2019 TPL, supra note 4, at 19. [email protected] 10. Id. at 20. 11. Id. Beth Oliva | 646.601.7632 12. FDA Authorizes Modified Risk Tobacco Products, supra note 5. [email protected]

20 Update Spring 2020 www.fdli.org Taking Stock of PFDD: Envisioning a Vibrant Future for Patient-Focused Drug Development Authors: Leah Howard (National Psoriasis Foundation), Annie Kennedy (EveryLife Foundation for Rare Diseases), Debra Lappin (Faegre Drinker Consulting), Isabelle Lousada (Amyloidosis Research Consortium), Kim McCleary (The Kith Collective), Kristen Santiago (LUNGevity Foundation), Todd Sherer (The Michael J. Fox Foundation for Parkinson’s Research), Jamie Sullivan (Chronic Obstructive Pulmonary Disease Foundation), Pat Wildman (Lupus Foundation of America), Jill Yersak (The ALS Association), David Zook (Faegre Drinker Consulting)

PFDDworks is a collaborative forum for patient advocacy leaders communities that have led and embraced the movement it fu- to share learnings and advance understanding of how patient-fo- eled, and ultimately in how all medical products are developed cused drug development can be most effective and best deployed and reviewed in the U.S. and potentially beyond. while ensuring that patient organizations remain at the forefront. Some may wait for solid “proof” of PFDD’s merits—a partic- PFDDworks is convened by Faegre Drinker Consulting and the ular product approval, a label indication, or a coverage decision Kith Collective. based on patient experience data—but those at the forefront see evidence of its deep and wide impact throughout the biomedi- When the Food and Drug Administration Safety and cal ecosystem. In the first half of this article, we examine these Innovation Act (FDASIA) was signed into law on July 9, 2012, impacts. expectations for one of its high-profile provisions—the Patient This is a pivotal time for PFDD. Its full-scale adoption Focused Drug Development (PFDD) initiative—were modest. includes ways that truly improve individual and public health, A commitment by the U.S. Food and Drug Administration and its very future depends on keeping patients and their care- (FDA) to host twenty meetings designed to “more systematical- givers at the center of PFDD. Our recommendations for making ly obtain the patient perspective on specific diseases and their PFDD matter more and maintaining its authenticity follow in treatments” could not have been predicted to catalyze such the second half of the article. profound change—within the agency itself, among the patient

FDLI Spring 2020 Update 21 Taking Stock of PFDD

Impact on FDA and harder for sponsors to ignore due guidance, develop platform or master After being championed by FDA’s Center to its public presentations, a series of trials, assess medical product value, for Drug Evaluation and Research workshops and draft guidances, and etc. A growing number of organiza- (CDER) director Dr. Janet Woodcock, reports under the Patient-Focused tions host training events and pro- PFDD implementation has benefitted Impact Assessment now included in grams to equip community members from the dedicated efforts of Dr. Theresa product approvals. for these new opportunities. PFDD Mullin and her team. On a parallel path, meetings now are often an element of Impact on Patient Advocacy Dr. Jeffrey Shuren, director of FDA’s an overall PFDD strategy, not simply Organizations Center for Devices and Radiological a stand-alone event. Health (CDRH), was the force behind Although the “nothing about us with- • With greater emphasis on gather- the Patient Preference initiative. CDRH out us” mantra of the disability rights ing input from patients who reflect identified an ambitious goal to make sure movement stretches back to the 1960s, a broad spectrum of experience, at least ninety percent of their staff have enactment of PFDD may mark the organizations are pioneering new meaningful, direct contact with patients greatest shift for patient advocacy since approaches to expand outreach and relevant to their agency work by the end HIV/AIDS activism reset both roles and engagement beyond the connected of 2017. Infusing greater patient centric- tactics in the late 1980s and early 1990s. core of their communities. They ity throughout FDA was a high priority We provide three examples of new pa- partner in new ways to better reach for the two most recent FDA commis- tient advocacy frontiers opened by PFDD underserved groups, including ethnic sioners, first Dr. Robert Califf and then and related activities: and racial minorities, more severely Dr. Scott Gottlieb. affected individuals, those distant Here are just a few of changes resulting • While twenty PFDD meetings were from specialty care and universi- from these initiatives: initially planned, the combined ty-based clinical research centers, and success of and external interest in this people who may not view themselves • These programs expanded ways for program led to rapid-fire expansion as “patients,” such as at-risk individ- FDA to engage patients, caregivers, of “externally led” meetings where uals, people who have recovered or and advocates, giving them new advocacy organizations working on a are survivors, and people outside the venues and vocabulary for dialogues single condition could jointly apply to healthcare system. outside product-specific decisions FDA to host a meeting using a similar and means to better understand their format. FDA review staff attend these The role of patient organizations is experiences, unmet needs, expecta- meetings and resulting “Voice of the evolving to that of trusted convener tions, and preferences. Patient” reports are posted on the of industry, agencies, and academia to • FDA has recognized that what we can FDA website as a resource for the advance components and the impact measure is not always what we should agency, sponsors, and the public. of PFDD in an open and transparent, measure. The agency has under- Nearly fifty such meetings have been pre-competitive environment. scored that symptoms and functional held to date and demand continues to Impact on Life Science impairments that matter most to be strong. Companies patients with a variety of serious con- • Whether led by organizations ditions of high unmet medical need inspired by their participation in the Like other types of large-scale change, are often not the focus of sponsors’ formal PFDD process or those that the attention paid to PFDD and related programs. In response, the FDA has created other ways of bringing patient programs varies greatly across the indus- begun pushing back against use of perspectives to the agency and spon- try landscape. There are signs of change endpoints and outcome measures sors, there is more interest than ever and growing adoption as FDA and the when they do not match what they in preparing patients and caregivers European Medical Agency define new have heard from patients. for and engaging them in more direct expectations for including the patient • Agency expectations for patient roles to help prioritize research topics, voice and alter their processes experience data and utilization of it in evaluate proposals and study plans, accordingly. Here are a few of them: decisions are becoming ever clearer co-design study materials, interpret study findings, draft regulatory

22 Update Spring 2020 www.fdli.org Taking Stock of PFDD

• Companies translate a new patient of interest. These are often formed focus into internal training programs and managed by patient advocacy 2) To advance opportunities to and hiring and retention practices to organizations. support and reflect in the label de- expose PFDD concepts to functions terminations that are made based beyond those that have generally Recommendations in whole or in part on such patient paid the closest attention—patient From a policy perspective, we see the up- experience data; and advocacy, outcomes assessment, coming Prescription Drug User Fee Act and regulatory—bringing staff in (PDUFA) VII as an important opportu- 3) To recognize the value of and early from R&D, clinical operations, nity to strengthen PFDD both in terms advance patient-led, pre-compet- market access, and commercial. Even of its rigor and accountability. PDUFA itive platforms that allow a robust some legal and compliance team V and PDUFA VI, along with the 21st interchange among patient groups, members are taking note and helping Century Cures Act, laid the statutory regulators, academic researchers, colleagues structure contracting pro- cornerstones for PFDD upon which a and drug developers, predicated cesses to better support robust patient sustainable approach to the role of pa- on full transparency and recogni- engagement activities. tient experience can be built. Emerging tion of complementary contribu- • Recognizing that many legacy FDA draft guidances and other operations and goals. Patient Reported Outcome Measures tional steps provide structure for these (PROMs) were developed on the basis efforts. Our priorities for PDUFA VII fall Authenticity of physician or academic investi- into the following four topical areas. As noted above, initial PFDD projects gators’ observations, companies (e.g., FDA-led and externally-led PFDD Transparency explore and invest to develop novel meetings) and sustained commitments outcome measures that better align Our organizations, and various support- to develop and deliver patient experience with patient experience and leverage ers, are making significant investments data are fundamentally altering how we digital and telehealth tools that can in developing robust patient and caregiv- pursue our mission to confront serious provide more direct and continuous er data to support PFDD strategies. We diseases. This is happening because we measurement. need to continue to improve awareness possess unique working relationships • In diseases where severe disability is with sponsors of the need to incorporate with our communities built on trust present very early in life or where it patient perspectives early in target and unswerving dedication. At the same develops in the later stages of life, the identification and clinical trial design time, the drug development and regula- role of the caregiver as an engaged and for both sponsors and regulators to tory review processes are highly complex and reliable provider of observer appropriately share how they are using and prone to following longstanding reported outcomes is growing in this information. The Patient-Focused practices. We believe that there is a need acceptance as a critical and essential Impact Assessment Act, incorporated to ensure the role of patient organiza- clinical outcomes assessment tool. into the 21st Century Cures Act, was an tions in delivering authentic patient and • There are an expanding number of important step in this direction requir- caregiver perspectives is preserved as the pre-competitive arenas in which ing FDA to publish a brief, post-approval growth of PFDD attracts, predictably, companies participate alongside statement on how patient experience data new players, independent vendors, and patient advocates and academics was used in the review of the product. voices that may appear to speak for pa- to shape methods for the science of tients and caregivers but may have other patient input and streamline devel- Our goals here are several-fold: interests at stake. opment plans to reduce burdens for 1) To enhance this reporting with patients in clinical trials. Some of earlier awareness in the product Consistency these take place at the broad systems development cycle so that oppor- As the PFDD infrastructure matures and level such as the European Union’s tunities are captured across the becomes an increasingly reliable element Innovative Medicines Initiative PAR- product development continuum of product review, it will be important ADIGM project, while others address to ensure that what matters most to ensure that the science of patient shared opportunities and challenges to the patients is incorporated; input is used consistently across the in a single condition and community FDA’s centers, offices, and divisions. It is

FDLI Spring 2020 Update 23 Taking Stock of PFDD

understandable that any new paradigm essential, but obviously not sufficient, for Patient-focused drug development requires formal processes and education a new drug to demonstrate a clinically is one of the single-most profound to take root. Given the central role of meaningful impact on what matters to shifts in product development in PFDD in our future therapies, the neces- patients. It must also become available decades. PFDD now provides the sary resources must be made available by to the appropriate patients in a timely opportunity for patient advocacy Congress and the agency to implement manner. We encourage breaking down organizations of all sizes to signifi- these goals rapidly and consistently. the barriers between marketing approval cantly accelerate development and Without this, we risk a growing divide and market access—a gap which today is deliver novel and more effective between those areas where patient groups emerging as the second “valley of death” treatments to the people we serve. have resources to advance the field and in the lifecycle of therapeutic develop- Focused effort and collaboration those where these resources are lacking ment. This new evidentiary bridge from among stakeholder groups are and an unmet need becomes even greater approval to access must be erected swiftly required to ensure that it moves over time. and with support of Congress, regulators, forward in a transparent, authen- and payers. Payers must participate at an tic, consistent, and comprehensive Comprehensiveness earlier stage to inform determinations of manner—with patient organiza- Perhaps most importantly for the lon- patient-centered clinical-meaningfulness tions remaining at the core of this ger-term success of PFDD, its princi- in the context of regulatory review so area of regulatory science. We call ples for patient-centered, data-driven these data have a direct line of sight into on all stakeholders to join us in product development must be applied subsequent development of evidence of this commitment. FDLI across the entire new therapy discovery, beneficiary value. development, and access continuum. It is

24 Update Spring 2020 www.fdli.org GLOBAL FOCUS

You Can Smoke Tobacco, Sugarcane, or Newspapers, but You Cannot Vape by José Alberto Campos Vargas

Vaping, and its associated regulations and risks, is probably one same provision, including cigars, cigarettes, and tobacco. Each of the hottest topics being addressed by health authorities and includes the “Nicotiana tabacum” plant, whether in its natural industry specialists in diverse countries around the world. Mexico state or substitutes, and is used for smoking, chewing, or sniffing. is no exception to this trend. The upcoming vaping industry is Finally, among the diverse definitions, Section VII of this article being subjected to considerable scrutiny and, at times, outright establishes the concept of “trademark elements.” This concept is prohibition by the health authorities—just as dietary supplements, defined as names, commercial names, signals, marks, or any other herbal remedies, homeopathic medicine, piercings, and tattoos kind of visual or sound signal that relates to tobacco products, were examined in the past. As a general rule, the Mexican health such as cigarettes, cigars, chewing tobacco, etc. authorities have deemed that vaping, vapers, vaping liquids, acces- Under this provision, no product other than those specifically sories, flavors, and almost any other kind of product related to this included by the Tobacco Law should be deemed as subject to its industry must be considered as forbidden items under the Federal application. Law for Control of Tobacco Products (Tobacco Law). Furthermore, additional prohibitions in connection with The Tobacco Law was enacted on May 30, 2008, a time in which tobacco products are included in Articles 16 and 17 of the Tobacco vaping technology was virtually nonexistent. Thus, vaping was Law. Amongst these prohibitions are the sale of tobacco products not an issue even considered to be included under this law. Article on an individual basis; direct access to tobacco products in retail 5 established that the purpose of the law was the protection of activities; sale of tobacco products through vending machines; non-smokers as well as the regulation of the production, labeling, packaging, publicity, promotion, distribution, sale, and use of José Alberto Campos Vargas is a tobacco products. Likewise, this law established the obligation partner at Sánchez Devanny who leads for the authorities to implement plans and programs intended to the Life Sciences practice and co-heads the International Trade and Customs diminish the use and consumption of tobacco products. practice group. He has more than 15 Tobacco products are defined by Article 6, Section XIX, to years of experience advising clients include any product or substance that totally or partially uses operating in regulated sectors on tobacco leaves as raw material and is intended to be smoked, regulation and operational matters, and on international trade matters. chewed, or sniffed. Other related concepts are defined within this

FDLI Spring 2020 Update 25 GLOBAL FOCUS

promotion, distribution, or gratuitous delivery of tobacco prod- The Mexican authorities have argued that, although no con- ucts; sale of tobacco products in premises intended for educational clusive information regarding the use of vaping products and its purposes; and use of underage individuals in any kind of activity potential risks for human health have been determined, its use involving tobacco products (e.g., transportation, sale, distribution, and marketing should be forbidden. publicity, etc.). If the Mexican authorities’ position on the subject of human Amongst these prohibitions, Article 16, Section VI of the health derives from the potential risks arising from an activity Tobacco Law establishes that it is expressly forbidden to “market, where “damages to human health are unknown,” then it is pos- sell, distribute, or produce any kind of product that, although not sible other activities that could represent a risk to human health a Tobacco Product, contains any of the tobacco products trade- may soon be restricted or limited. If the reasoning being applied mark elements or any other kind of mark or signal whether visual to vaping was extended to other activities that represent a health or sound that can be directly identified with Tobacco Products1 risk for human population (according to some health officials), regulated by such Law.” The main purpose of this provision was to then certain activities regarding food products and transportation avoid the manufacturing, marketing, or distribution of products could be similarly prohibited. that in some manner included the trademarks or logos of tobacco For example, grilling and cooking with charcoal and barbecue products. Many of us may remember the diverse toy cars having smoke can be considered a significant source of air pollution. the “John Player Special” black and gold F1 paint or the yellow Consequently, the person doing the actual grilling would be Land Rover of the Camel Trophy. Other marketing products subjected to considerable exposure to noxious and toxic gas. The included the stuffed “Camel Joe” toys; the red and white Marlboro people around the grill would, to some extent, also inhale these ashtrays; or the Kent, “More Taste, Fine Tobacco” and All Togeth- substances or absorb them through the skin. Of course, those er jingles, which were precisely targeted by this total prohibition. people that are not exposed to the smoke or vapors from the grill Interestingly, the Tobacco Law does not forbid other prod- would still be subjected to pollution from the toxic materials that ucts that are not otherwise prohibited by law and which do not attach to the grilled foods, whether these are of animal or vegeta- include the trademark elements referred to by Article 16, Section ble origin. These cooking methods have been scientifically proven VI (such as marijuana or opium) that may be smoked. Examples to constitute a health risk and thus, under the current position of this include flavored sugar cane pulp and the use of hookahs, from the health authorities, could at some point in time become pipes, hitters (heaters), or other products in which tobacco or a restricted or forbidden activity. This could have a great effect on similar products may be smoked. Notwithstanding that the above individuals living in poverty-stricken areas or lacking cooking provision does not prohibit or restrict the use of products not methods other than charcoal or wood as they would face quite a specifically regulated by the Tobacco Law, the Mexican health challenge to be able to cook their food. authorities have taken the position that the above article must be Another recent health risk mentioned by some officials is the considered to include vapers, vaping liquids, and other similar possible prohibition of certain kinds of fat, particularly lard or fat technologies. The main argument used by the Mexican authori- from animal sources such as pork, poultry, and dairy products. ties is that the use of vaping products constitutes a health risk and, It is a well-known fact that saturated fats may increase the risk of to some extent, promotes the use of tobacco products by smokers cardiovascular disease. Furthermore, this is of particular impor- and nonsmokers alike, and thus promotes a legal activity whose tance in a country such as Mexico where obesity is considered a promotion is regulated.2 national health emergency. This position could of course have an Contrary to smoked tobacco products (e.g., cigarettes), vaping unfavorable effect on “world famous” Mexican food, which often implies the transformation of a liquid into vapor without burning depends on the particular flavors of a specific animal fat as an anything, and thus without the creation of certain harmful com- ingredient. pounds found in smoke. Irrespective of the possible scientific and Finally, one of the interesting “health risks” that has been raised medical consequences that vaping may be eventually determined as a potential area of interest to the Mexican health authorities to have, such potential consequences are very likely to be less, at is the rise of new mobility technologies, particularly electric least in regard to the “smoke” component. Hookahs and pipes, scooters. Scooters have become a major transportation means in which may or may not use tobacco, are neither forbidden nor re- some areas of the largest Mexican cities. In many cases, they have stricted in cases where they are used to “burn” vegetable materials been substituted for the use of private vehicles when traveling for a with flavoring and scents—provided that no tobacco is included short distance within the city. At a first look, this situation should in the mixture. appear to be a positive for the general health of the population,

26 Update Spring 2020 www.fdli.org GLOBAL FOCUS

due to a reduced use of vehicles and subsequent reduced pollutant considered tobacco products, may be considered to be related. In emissions. However, some of Mexico City’s local health author- reality, these are attempts by the law to protect the health of indi- ities have considered the use of scooters to be a potential health viduals from such products. This restriction thus violates diverse risk for the local population. The reason for this position is that it constitutional principles and human rights different than the is very likely a number of users have sustained injuries by virtue right for a healthy environment and the individual’s health.4 of the lack of proper protection equipment, excessive speed, use of Based on these precedents, it is very likely that attempted headphones while riding, lack of general care, and lack of driving restrictions on products and activities by the health authorities civility by automobiles, motorcycles, bicycles, and other vehicle will find grounds to obtain judicial and constitutional protection drivers. from the Mexican courts without a proper consideration of con- All of the limitations and prohibitions of these health risks are stitutional and human rights principles. Unfortunately, under the not only contrary to logic and common sense, but also to various Mexican legal system, the fact that certain precedents—and even constitutional principles recognized by our Supreme Court of jurisprudence in a determined sense—exist, does not prohibit the Justice in several precedents. authorities from implementing or applying legal provisions that Among these provisions are those related to the use of marijua- have been deemed as unconstitutional. This makes it important na in Mexico, which is totally forbidden under the Mexican Gen- for the affected parties to file the necessary legal remedies to chal- eral Health Law. In fact, it was not until 2017 that its use for even lenge such application of these provisions. FDLI medical purposes was accepted, as it was considered a narcotic and psychotropic substance. Prior to the 2017 amendments, the 1. Emphasis added. 2. https://www.gob.mx/cms/uploads/attachment/file/215738/7_Aler- Mexican Supreme Court issued several interesting rulings where- ta_Sanitaria_cigarrillo_electr_nico__21Abril2017.pdf. by it established that such a totalitarian restriction was contrary 3. The following is a translation of the cited document: “RIGHT to the main human rights contemplated in the Mexican Federal FOR THE FREE DEVELOPMENT OF PERSONALITY. THE PROHIBITION FOR THE SELF-CONSUMPTION OF MARI- Constitution. In these rulings, the Mexican Supreme Court of Jus- JUANA CONTAINED IN THE GENERAL HEALTH LAW HAS tice determined that the total prohibition for the use of marijuana A “PRIMA FACIE” IMPACT ON THE CONTENT OF THIS FUNDAMENTAL RIGHT. This First Chamber concludes that as a recreational product violates individuals’ “free development the prohibition contained in articles 235, last paragraph, 237, 245, of personality,” and thus the possibility to differentiate themselves section I, 247, last paragraph, and 248 of the General Health Law, from the rest of the society. effectively affects the “prima facie” content of the analyzed fundamental right, since it constitutes a legal obstacle that prevents the Based on such arguments and the fact that the Mexican Con- exercise of the right to decide what type of recreational activities stitution protects the individual’s right to be unique and indepen- an individual wishes to carry out, while also preventing one from dent, the state cannot violate that right irrespective of the fact that lawfully carrying out all the actions or activities necessary to be able to materialize that choice through the self-consumption of the use of marijuana may have negative effects on the individual’s marijuana: sowing, cultivation, harvesting, preparation, condi- health.3 The Mexican Supreme Court of Justice established that tioning, possession, transport, etc.” Available at https://www.scjn. it is against the Constitution for the state to impose a single gob.mx/sites/default/files/listas/documento_dos/2018-10/AR-547- 2018-181002.pdf. standard of “healthy living” in a state that allegedly recognizes the 4. The following is a translation of the conclusion of the text: “FREE- existence of human rights (including uniqueness and indepen- DOM OF COMMERCE OR PROFESSIONAL ACTIVITY. SCOPE OF THE PROVISIONS CONTAINED IN THE FEDERAL dence). Mexico recognizes the personal freedom for individuals CONSTITUTION ARTICLE 5. The Supreme Court of Justice has to determine the manner in which they wish to develop on their established that the Federal Constitution Article 5 guarantees the own, even if it is not in the best interest of “their health.” right for an individual’s or legal entity’s freedom of activity. How- ever, such guarantee should not be deemed as absolute, unrestrict- The Mexican Supreme Court of Justice established that the legal ed, and unlimited, but requires that the activity is legal; this is, that provision cited by the health authorities as the basis for consid- it is to be permitted by law or not specifically forbidden. Likewise, ering vaping and all related activities as forbidden violates the this provision establishes that this right can be limited in two cases: a. by judicial determination; b. when the rights of third parties constitutional principle of equal treatment and proportionality. In or social rights are violated. When the government limits the right recent months, the Court has issued several precedents where it of commerce or professional activity based on a potential violation establishes that the legal provisions of the Tobacco Law violate the to social rights, the resolution that limits such activities must always have a legitimate reason that effectively supports the social Federal Constitution’s Article 1, since the restriction to “vaping” is interest and protects its rights.” Available at https://suprema-corte. much more restrictive than that applicable to tobacco products. vlex.com.mx/vid/tesis-jurisprudencial-pleno-aislada-27202317. This violation derives from the total and restrictive prohibition on the sale and marketing of products which, although not

FDLI Spring 2020 Update 27 7th Annual Eric M. Blumberg Memorial Lecture

Under the FDCA, Deciding Whether to Prosecute

By Richard M. Cooper Senior Counsel, Williams & Connolly LLP December 12, 2019

Established in 2014, the Eric M. Blumberg Memorial Lecture is delivered every year at FDLI’s annual Enforcement, Litigation, and Compliance Conference. It serves to honor Blumberg’s many years of service with the FDA, his impact on the careers of numerous lawyers, and his legacy as a public servant.

I thank FDLI for the honor of being invited to give this lecture. I had the privilege and genuine pleasure of serving in the Office of Chief Counsel at the Food and Drug Administration (FDA) Richard Cooper delivering the Blumberg Memorial Lecture at FDLI's 2019 Enforcement, Litigation, and Compliance with Rick Blumberg in the late 1970s when he was still—argu- Conference. ably—a young lawyer. Even then, he was an ardent protector of the public health and was vigorous in discussions of possible and colleagues discussed FDA’s expanded investigative and approaches the agency could take to problems, from which criminal enforcement operations with respect to unapproved, discussions I was happy to learn, even at the end of his pointed counterfeit, potentially dangerous, or otherwise unlawful prod- index finger. ucts that originate abroad or are sold online.5 A common definition of “enforcement” is “[t]he act or pro- In addition, some actions in court to enforce the FDCA do cess of compelling compliance with a law, mandate, command, not originate with FDA. Under the False Claims Act,6 a civil decree or agreement . . . .”1 I would add that “enforcement” also enforcement action for violation of the FDCA that has led to includes the act of seeking or imposing a remedy or punish- the submission of a false claim to the federal government can ment for past, continuing, or prospective noncompliance with a be initiated as a qui tam action by a private party; and DOJ law, mandate, command, decree, or agreement. can decide whether to intervene in, and take control of, such Thus, the concept of “enforcement” is broad. In the context of an action, or to allow it to proceed without DOJ involvement, the Federal Food, Drug, and Cosmetic Act (FDCA),2 it includes or to seek dismissal.7 In addition, the investigation that DOJ not only court actions—for product seizure, injunction, or conducts in response to the filing of a qui tam action can lead criminal prosecution—but also a wide range of administrative to a criminal prosecution under the FDCA and/or one or more actions, such as FDA Form 483 inspectional observations, other statutes.8 warning letters, debarments, product bans, public warnings, FDA’s criteria for enforcement actions that are set forth in FDA-initiated recalls, import refusals, civil monetary penalties, enforcement policy statements are critically important to en- required changes in labeling, refusals to approve a product or forcement officials at FDA and to private lawyers who represent an indication or claim for a product, and suspensions or with- subjects or targets of enforcement actions and who seek to in- drawals of prior approvals.3 In his Blumberg Memorial Lecture fluence the decisions those officials make as to potential actions; in 2015, Howard Sklamberg, FDA’s Deputy Commissioner for and, of course, they are very important to organizational and Global Regulatory Operations and Policy, discussed a number individual subjects and targets. Those criteria also matter to all of FDA’s enforcement tools that do not involve going to court— of us, who consume the products FDA regulates. and, thus, do not involve the Department of Justice (DOJ).4 Last month, a statement by Acting Commissioner Ned Sharpless

28 Update Spring 2020 www.fdli.org 7th Annual Blumberg Lecture

In what follows, I will discuss one aspect of the overall FDA’s criteria for enforcement actions enforcement of the FDCA—the criteria applied by FDA and those applied by DOJ for initiating a criminal prosecution for that are set forth in enforcement policy violation of the FDCA. statements are critically important to The foundation for misdemeanor prosecutions of individu- enforcement officials at FDA and to private als under the FDCA consists of two Supreme Court decisions: lawyers who represent subjects or targets United States v. Dotterweich, decided in 1943,9 and United of enforcement actions and who seek to 10 States v. Park, decided in 1975. In Dotterweich, the Court held influence the decisions those officials make that the FDCA is of a type of legislation that “dispenses with as to potential actions; and, of course, they the conventional requirement for criminal conduct—awareness are very important to organizational and of some wrongdoing. In the interest of the larger good, it puts individual subjects and targets. the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger.”11 In its main brief in Park, DOJ stated FDA’s and the govern- In 1976, Sam Fine, FDA’s Associate Commissioner for ment’s enforcement policy under Dotterweich: Compliance, published in what was then the Food Drug Cos- metic Law Journal, a classic article entitled “The Philosophy [I]t has . . . been FDA policy to limit prosecutions of Enforcement.”14 He focused on enforcement through court to continuing violations, violations of an obvious or actions, and on criminal prosecutions in particular. He said: “I flagrant nature, and intentionally false or fraudulent am persuaded that prosecution of firms can have an important violations. and dramatic impact on their peers.”15 Thus, he emphasized the deterrent effect of criminal enforcement, in addition to its . . . . retributive effect. He identified five “interrelating factors” that FDA considers in deciding whether to recommend prosecution The standard for prosecution of individual corporate to DOJ: officials, as distinguished from prosecution of their corporations, is based on the reasonable [sic] relationship (1) the seriousness of the violation; criterion of Dotterweich. The government’s policy is to (2) evidence of knowledge or intent; prosecute only those individuals who are in a position (3) the probability of effecting future compliance by and who have an opportunity to prevent or correct the firm in question as well as others similarly violations, but fail to do so. Officials who lack authority situated as a result of the present action; to prevent or correct violations, or who were totally un- (4) the resources available to conduct investigations aware of any problem and could not have been expected necessary to consummate the case successfully; to be aware of it in the reasonable exercise of corporate and (underlying all of these) duties, are not the subject of criminal action. Even if (5) the extent to which the action will benefit con- the investigation discloses the elements of liability, and sumers in terms of preventing recurrences of the indicates that an official bears a responsible relationship violation throughout the industry.16 to them, the agency ordinarily will not recommend prosecution unless that official, after becoming aware Additional considerations he identified are whether the vi- of possible violations, often . . . as a result of notification olation is “of a continuing nature,” whether the violation is “so by FDA, has failed to correct them or to change his gross that any reasonable person would conclude management 12 managerial system so as to prevent further violations. must have known of the conditions,” whether the violation is “such that it is obvious that normal attention by management The Court inPark reaffirmed and further developedDot - could have prevented” it, whether the violation is “life-threat- terweich’s “responsible relation” standard. Thus, the Supreme ening or injuries have occurred,” and whether the violation Court set an extraordinarily low standard for a misdemeanor involves a “deliberate attempt[] to circumvent the law.”17 13 prosecution of a corporate officer for violation of the FDCA.

FDLI Spring 2020 Update 29 7th Annual Blumberg Lecture

Mr. Fine also noted that, in reviewing a prospective referral FDA needs to decide, in effect, whether for prosecution, the Office of Chief Counsel considers legal sufficiency, consistency, and “winnability.”18 Speaking a year suspected violative conduct warrants a after the Supreme Court’s decision inPark , Mr. Fine addressed referral to DOJ for a more comprehensive whether to recommend prosecution of individuals: investigation than FDA can conduct and for potential prosecution. The general Agency posture is to consider that individuals acting for and within the corporation are responsible for violations of the law, rather than to consider the Of course, to Mr. Fine’s criteria for recommending a crimi- corporation as acting alone. Therefore, as a rule, the nal prosecution to DOJ must be added DOJ’s own criteria for FDA does not recommend criminal prosecution against actually prosecuting corporations and corporate officers and a corporation without including charges against respon- other corporate employees. Although several of DOJ’s criteria sible individuals as well.19 are quite similar to the criteria articulated by Mr. Fine, as to matters beyond those he addressed, DOJ’s criteria have evolved The factors Mr. Fine identified generally remain in place over the last twenty years. today. In February 2011, FDA revised its Regulatory Procedures Two types of resolution of a criminal investigation that, in Manual (RPM) to state factors to be considered in deciding the mid-1990s, DOJ began applying to some business orga- whether to recommend to DOJ under Park a misdemeanor nization are a deferred prosecution agreement (DPA) and a prosecution of a corporate official. In addition to the official’s non-prosecution agreement (NPA). Generally, under a DPA or “position in the company and relationship to the violation” and an NPA, to avoid prosecution, an organization agrees to admit “whether the official had the authority to correct or prevent the wrongdoing, cooperate with DOJ, pay a financial penalty and/ violation,”—elements necessary for a conviction under Park— or otherwise remedy the harm its wrongdoing has caused, FDA enforcement personnel should consider: improve its corporate compliance programs, and hire an independent outside individual to monitor its compliance with (1) whether the violation involves actual or potential the agreement. In return, DOJ agrees to file charges in court but harm to the public; defer further proceedings in court for a specified time period (2) whether the violation is obvious; (under a DPA) or not to file charges at all (under an NPA); (3) whether the violation reflects a pattern of illegal and, at the end of the period, if the organization has complied behavior and/or failure to heed prior warnings; with all of its obligations under the agreement, DOJ declines to 22 (4) whether the violation is widespread; proceed with prosecution of the organization. A major reason (5) whether the violation is serious; why an organization regulated by FDA would seek such an (6) the quality of the legal and factual support for the agreement, or even a plea agreement in which the organization proposed prosecution; and could negotiate as to the entity that would be subject to crimi- (7) whether the proposed prosecution is a prudent use nal charges as well as other terms, is the risk of exclusion from of agency resources.20 federal healthcare programs under 42 U.S.C. § 1320a-7 (2017) if the organization is convicted of any of certain types of crimes. These factors do not differ significantly from those stated by In deciding whether to enter into a DPA or NPA, DOJ con- Sam Fine. siders principally an organization’s cooperation in DOJ’s inves- At this Conference two years ago, FDA Chief Counsel tigation, the collateral consequences of a criminal conviction of Rebecca Wood said that the agency was “exploring whether, the organization and effects on innocent third parties (such as consistent with the agency’s risk-based approach and public employees, communities, and possibly patients), and remedial health mission, there are additional ways that we can bring measures the organization has taken or plans to take, including 23 added clarity to [the] issue” of whether, and, if so, when, under with respect to its own compliance programs. Because, unlike Park, FDA should seek to impose criminal liability on “apex” plea agreements, DPAs and NPAs enable organizations to avoid corporate personnel “for serious acts or omissions done by criminal convictions and are not reviewed substantively by the subordinates at their firm.”21 courts, they have attracted criticism.24

30 Update Spring 2020 www.fdli.org 7th Annual Blumberg Lecture

The consideration of corporate cooperation, collateral con- (8) The adequacy of non-criminal remedies, such as sequences, and remedial measures are outside the scope of the civil or regulatory enforcement actions . . . .27 criteria identified by Sam Fine. They reflect the later stage of the process at which DOJ acts. FDA needs to decide, in effect, Mr. Holder commented that “prosecutors should ensure whether suspected violative conduct warrants a referral to DOJ that the general purposes of the criminal law—assurance of for a more comprehensive investigation than FDA can con- warranted punishment, deterrence of further criminal conduct, duct and for potential prosecution. Once DOJ has conducted protection of the public from dangerous and fraudulent con- its investigation, it needs to decide whether to proceed with a duct, rehabilitation of offenders, and restitution for victims and prosecution (and, if so, what its scope should be), to pursue one affected communities—are adequately met, taking into account or more non-criminal remedies, or to drop the matter altogeth- the special nature of the corporate ‘person.’”28 He also noted: er. Thus, these three elements—cooperation, collateral con- “Although acts of even low-level employees may result in sequences, and remedial measures—are more relevant to the criminal liability, a corporation is directed by its management decision facing DOJ than to the decision that faced FDA. and management is responsible for a corporate culture in which In 1999, Deputy Attorney General Eric Holder issued a mem- criminal conduct is either discouraged or tacitly encouraged.”29 orandum on federal prosecution of corporations.25 He empha- In FDCA cases, that sentiment links to the Park doctrine. Mr. sized the same general deterrent effect of criminal prosecution Holder further stated: “Prosecution of a corporation is not a of corporations that Sam Fine had emphasized.26 He stated substitute for the prosecution of criminally culpable individuals eight factors to be considered in deciding whether to prosecute, within or without the corporation.”30 Like Mr. Fine, Mr. Holder which overlapped with those asserted by Mr. Fine: also called for attention to “the sufficiency of the evidence, the likelihood of success at trial, the probable deterrent, rehabilita- (1) The nature and seriousness of the offense, includ- tive, and other consequences of conviction, and the adequacy of ing the risk of harm to the public, and applicable non-criminal approaches.”31 Thus, as to criminal prosecutions policies and priorities, if any, governing the prose- under the FDCA, the Holder Memorandum overlapped with cution of corporations for particular categories of Sam Fine’s criteria and added considerations that are addressed crime . . . ; more appropriately after DOJ’s full investigation. (2) The pervasiveness of wrongdoing within the corpo- Later Deputy Attorneys General have revised the Holder ration, including the complicity in, or condonation Memorandum in ways that have not changed the elements that of, the wrongdoing by corporate management . . . ; overlapped with Sam Fine’s elements. Rather, the revisions have (3) The corporation’s history of similar conduct, addressed the requirements for cooperation credit and other including prior criminal, civil, and regulatory factors that DOJ considers at the end of an investigation in enforcement actions against it . . . ; deciding how to proceed. (4) The corporation’s timely and voluntary disclosure In 2003, Deputy Attorney General Larry Thompson issued of wrongdoing and its willingness to cooperate in a revised version entitled “Principles of Federal Prosecution of the investigation of its agents, including, if neces- Business Organizations.”32 The most significant changes were sary, the waiver of the corporate attorney-client an “increased emphasis on and scrutiny of the authenticity of a and work product privileges . . . ; corporation’s cooperation” and on “the efficacy of the corporate (5) The existence and adequacy of the corporation’s governance mechanisms in place within a corporation.”33 compliance program . . . ; Mr. Thompson also added to the Holder Memorandum’s list (6) The corporation’s remedial actions, including any ef- of eight factors a ninth factor: “the adequacy of prosecution of forts to implement an effective corporate compliance program or to improve an existing one, to replace responsible management, to discipline or terminate Thus, as to criminal prosecutions under the wrongdoers, to pay restitution, and to cooperate FDCA, the Holder Memorandum overlapped with the relevant government agencies . . . ; with Sam Fine’s criteria and added (7) Collateral consequences, including dispropor- considerations that are addressed more tionate harm to shareholders and employees not appropriately after DOJ’s full investigation. proven personally culpable . . . ; and

FDLI Spring 2020 Update 31 7th Annual Blumberg Lecture

individuals responsible for the corporation’s malfeasance.”34 He that the proper parties are held responsible for their actions, stated: “Only rarely should provable individual culpability not and it promotes the public’s confidence in our justice system.”43 be pursued, even in the face of offers of corporate guilty pleas.”35 She made clear that the guidance provided by her memoran- He also stated that, although his “guidelines” referred to corpo- dum applied “in any investigation of corporate misconduct,” rations, they also applied to “consideration of the prosecution civil as well as criminal.44 She identified “six key steps to of all types of business organizations, including partnerships, strengthen [DOJ’s] pursuit of individual corporate sole proprietorships, government entities, and unincorporated wrongdoing”: associations.”36 In 2006, a further revision was made by Deputy Attor- (l) in order to qualify for any cooperation credit, ney General Paul McNulty.37 His revision imposed on DOJ corporations must provide to the Department all prosecutors new restrictions on seeking, as part of coopera- relevant facts relating to the individuals responsi- tion, waivers of the attorney-client and attorney-work-product ble for the misconduct; privileges by business organizations under investigation. It also (2) criminal and civil corporate investigations should barred prosecutors from considering as a lack of cooperation focus on individuals from the inception of the a corporation’s advancement of legal fees to employees, except investigation; where the advancement of fees and other significant facts show (3) criminal and civil attorneys handling corporate that the corporation intended to impede DOJ’s investigation.38 investigations should be in routine communication In 2008, Deputy Attorney General Mark Filip made another with one another; revision and placed DOJ’s Principles of Federal Prosecution of (4) absent extraordinary circumstances or approved Business Organizations in the United States Attorneys’ Manual departmental policy, the Department will not (USAM), thereby confirming that they are mandatory for DOJ release culpable individuals from civil or criminal attorneys.39 To respond to widespread criticisms that previous liability when resolving a matter with a corpora- DOJ policy had led federal prosecutors to exert undue pressure tion; on target organizations to waive privileges and to mistreat em- (5) Department attorneys should not resolve matters ployees who were subjects or targets of an investigations,40 the with a corporation without a clear plan to resolve revised Principles changed DOJ’s approach to such aspects of related individual cases, and should memorialize prosecutors’ evaluation of a subject or target organization’s co- any declinations as to individuals in such cases; operation and remediation as waiver of privileges, payment of and employees’ legal fees, joint-defense agreements, and disciplining and termination of employees. Mr. Filip otherwise maintained (6) civil attorneys should consistently focus on individ- the nine factors as set forth in the Thompson Memorandum, uals as well as the company and evaluate whether and they have become known as “the Filip Factors.” to bring suit against an individual based on con- In a speech in 2014, Marshall L. Miller, the Principal Deputy siderations beyond that individual’s ability to pay.45 Assistant Attorney General for the Criminal Division, strongly emphasized that cooperation credit for a business organiza- This emphasis on proceeding against individuals accorded tion under investigation would depend on providing evidence with Sam Fine’s statement that, “as a rule, the FDA does not relating to culpable individuals.41 Mr. Miller’s remarks did not recommend criminal prosecution against a corporation with- cover criminal investigations or prosecutions under the FDCA, out including charges against responsible individuals as well.”46 which are overseen by the Consumer Protection Branch of the It also accorded with the Filip Factors, as originally stated by Civil Division rather than by the Criminal Division; but they Eric Holder and as revised by his successors. What was new in presaged what would soon become DOJ-wide policy. the Yates Memorandum was the strengthening of the incentive In 2015, Deputy Attorney General Sally Yates issued a mem- for companies under investigation by DOJ to conduct their orandum entitled “Individual Accountability for Corporate own investigations to identify all corporate wrongdoers and to Wrongdoing.”42 Ms. Yates asserted that individual “account- provide to DOJ the information about the culpability of indi- ability is important for several reasons: it deters future illegal viduals that was developed in those investigations. activity, it incentivizes changes in corporate behavior, it ensures

32 Update Spring 2020 www.fdli.org 7th Annual Blumberg Lecture

and prosecutors will not request it. But to earn coop- What was new in the Yates Memorandum eration credit, the corporation does need to produce all was the strengthening of the incentive for relevant facts—including the facts learned through those companies under investigation by DOJ to interviews—unless identical information has already conduct their own investigations to identify been provided.48 all corporate wrongdoers and to provide to DOJ the information about the culpability In that speech, Ms. Yates also announced three sets of of individuals that was developed in those changes to the USAM to implement the new policy on charging investigations. individuals and on when organizations will receive credit for cooperation: (i) revisions of the Filip Factors; (ii) a new section applying the revised Filip Factors to civil as well as criminal In a speech the day after issuing her Memorandum, Ms. cases; and (iii) a revision of the USAM’s section on parallel pro- Yates stated: ceedings.49 The revised Filip Factors “emphasize the primacy in any corporate case of holding individual wrongdoers account- No more partial credit for cooperation that doesn’t able and list a variety of steps that prosecutors are expected to include information about individuals. . . . The rules take to maximize the opportunity to achieve that goal.”50 have just changed. Effective today, if a company wants The Yates Memorandum’s emphasis on proceeding against any consideration for its cooperation, it must give up the individuals and to apply pressure to business organizations to individuals, no matter where they sit within the compa- contribute to the prosecution of individuals has continued un- ny. And we’re not going to let corporations plead igno- der the current administration. In April 2017, Attorney General rance. If they don’t know who is responsible, they will Jeff Sessions stated: “The Department of Justice will continue to need to find out. If they want any cooperation credit, emphasize the importance of holding individuals accountable they will need to investigate and identify the responsible for corporate misconduct. It is not merely companies, but spe- parties, then provide all non-privileged evidence impli- cific individuals, who break the law. We will work closely with 47 cating those individuals. our law enforcement partners, both here and abroad, to bring these persons to justice.”51 In a speech in October 2017, Deputy In a speech in November 2015, Ms. Yates further elaborated Attorney General Rod Rosenstein said: on this policy: In recent years, experts have debated the question, “Can [T]here is nothing in the new policy that requires com- a company be too big to jail?” That question focuses on panies to waive attorney-client privilege or in any way the wrong issue. We will seek appropriate corporate pen- rolls back the protections that were built into the prior alties when justified by the facts and the law. The pri- factors. The policy specifically provides that it requires mary question should be, “Who made the decision to only that companies turn over all relevant non-privi- set the company on a course of criminal conduct?” Our leged information and our revisions to the USAM— investigations will continue to focus on those people.52 which left the sections on the attorney-client privilege intact—underscore that point. In a February 2018 speech, Ethan Davis, Deputy Assistant Attorney General for the Consumer Protection Branch, dis- But let’s be clear about what exactly the attorney-client cussed his Branch’s enforcement priorities.53 He referred to off- privilege means. As we all know, legal advice is privi- label promotion (the subject of the conference he was address- leged. Facts are not. If a law firm interviews a corporate ing) and, in particular, whether the promotional speech at issue employee during an investigation, the notes and memos was false or misleading and whether it led to harm to patients.54 generated from that interview may be protected, at least He also referred to the opioid crisis, and, in particular, to in part, by attorney-client privilege or as attorney work non-compliance with Risk Evaluation and Mitigation Strategies product. The corporation need not produce the pro- or good manufacturing practice requirements.55 He added, tected material in order to receive cooperation credit in accordance with established FDA and DOJ policy: “Where

FDLI Spring 2020 Update 33 7th Annual Blumberg Lecture

appropriate, we will seek to hold accountable those individuals [Deputy Attorney General Rosenstein’s who are responsible for the wrongful conduct.”56 changes] maintained, but softened In November 2018, Deputy Attorney General Rosenstein announced further refinements of DOJ’s policies as to enforce- somewhat in light of practical experience, ment actions against business organizations and individuals. the Yates Memorandum’s focus on The changes maintained, but softened somewhat in light pressuring companies for information about of practical experience, the Yates Memorandum’s focus on possibly culpable individuals. pressuring companies for information about possibly culpable individuals. Mr. Rosenstein’s summary of the changes included . . . the following elements:

[W]e are revising the policy to restore some of the dis- Under our revised policy, pursuing individuals respon- cretion that civil attorneys traditionally exercised—with sible for wrongdoing will be a top priority in every supervisory review. corporate investigation.

The most important aspect of our policy is that a com- . . . pany must identify all wrongdoing by senior officials, including members of senior management or the board [A]bsent extraordinary circumstances, a corporate of directors, if it wants to earn any credit for cooperating resolution should not protect individuals from criminal in a civil case. liability.

If a corporation wants to earn maximum credit, it must Our revised policy also makes clear that any company identify every individual person who was substantially seeking cooperation credit in criminal cases must iden- involved in or responsible for the misconduct. tify every individual who was substantially involved in or responsible for the criminal conduct. . . . In response to concerns raised about the inefficiency I want to emphasize that our policy does not allow cor- of requiring companies to identify every employee porations to conceal wrongdoing by senior officials. To involved regardless of relative culpability, however, the contrary, it prohibits our attorneys from awarding we now make clear that investigations should not be any credit whatsoever to any corporation that conceals delayed merely to collect information about individuals misconduct by members of senior management or the whose involvement was not substantial, and who are board of directors, or otherwise demonstrates a lack of not likely to be prosecuted. good faith in its representations.57 . . . These comments leave some uncertainties, including the following: how the Park doctrine affects the assessment of Civil cases are different. The primary goal of affirmative which individuals are “substantially involved in or responsible civil enforcement cases is to recover money, and we for the criminal conduct” and what kinds of “extraordinary have a responsibility to use the resources entrusted to us circumstances” would warrant protecting individuals as part efficiently. Based on the experience of our civil lawyers of a corporate settlement. Because the facts considered in such over the past three years, the “all or nothing” approach assessments generally are not publicly disclosed, it will be to cooperation introduced a few years ago was counter- impossible or very difficult for people outside DOJ to develop productive in civil cases. When criminal liability is not an understanding of how these assessments are being made by at issue, our attorneys need flexibility to accept settle- DOJ prosecutors generally. ments that remedy the harm and deter future violations, so they can move on to other important cases.

34 Update Spring 2020 www.fdli.org 7th Annual Blumberg Lecture

In December 2018, James Burnham, Deputy Assistant Attor- appropriateness of the criteria I have been discussing. With one ney General for the Consumer Protection Branch, summarized significant exception, I think those criteria generally are appro- his Branch’s approach to enforcement of the FDCA: priate. The exception relates to what is required for cooperation credit. Sally Yates expressed the requirement as to “turn over So let me tell you what kind of conduct will get the all relevant non-privileged information” and “to produce all Consumer Protection Branch’s attention. We focus on relevant facts—including the facts learned in [privileged] inter- practices that hurt people—practices like marketing a views.” Mr. Rosen stein expressed it as “identifying every indi- product for a potentially dangerous or untested pur- vidual substantially involved in or responsible for the criminal pose. Even if no one has been hurt, we look for activity conduct.” Even though cooperation credit is a special benefit, that poses an unacceptable risk of harm if it continues, this outsourcing of parts of the traditional prosecutorial roles like maintaining insanitary conditions. We also target of investigating facts and assessing whether individuals were fraud, like lying to the public about what diseases a prod- substantially involved in or responsible for wrongdoing places uct is effective in treating.58 inappropriate burdens on organizations under investigation. An adequate discussion of the benefits and costs of cooperation The particular areas of current FDCA enforcement he em- under DOJ’s policy would require another talk. phasized largely overlapped with those previously identified by Unless you are an enforcement official or a criminal defense 59 his predecessor, Ethan Davis. lawyer, may you never have to consider this subject again. FDLI So, that is where we are. I will end by commenting on how the version of the Filip Factors that currently appears in the With one significant exception, I think those 60 Justice Manual has changed from the original formulation in criteria generally are appropriate. The the Holder Memorandum. exception relates to what is required for Whereas the Holder Memorandum listed eight factors, the current Justice Manual lists ten. The first three current fac- cooperation credit. tors—the nature and seriousness of the wrongdoing, its pervasiveness within the corporation and complicity in it or con- 1. Black’s Law Dictionary 669 (11th ed., Bryan A. Garner, editor in doning of it by management, and the corporation’s history of chief 2019). misconduct and prior enforcement actions against it—remain 2. 21 U.S.C. §§ 301–399d (2018). the same as in the Holder Memorandum. The fourth factor— 3. For descriptions of some types of FDA enforcement actions, see, e.g., FDA, Types of Enforcement Actions (Nov. 6, 2017), https:// timely and voluntary disclosure of wrongdoing and willingness www.fda.gov/animal-veterinary/resources-you/types-fda-en- to cooperate—has been revised to delete the reference to waiver forcement-actions. For statistics relating to FDA’s non-criminal of privileges and to move the element of disclosure to a sepa- enforcement actions during fiscal 2017,see FDA Enforcement Statistics Summary Fiscal Year 2017, https://www.fda.gov/ rate, sixth factor. The fifth factor—the corporation’s compliance media/110196/download. See also Vernessa T. Pollard & Anisa program—has been revised to make clear that the focus is on Mohanty, FDA Enforcement: How It Works, in A Practical Guide to both the compliance program at the time of the offense and FDA’s Food and Drug Law and Regulation 505, 507, 509 (6th ed., Kenneth R. Piña & Wayne L. Pines. eds. 2017). 61 the compliance program at the time of the charging decision. 4. Howard Sklamberg, Third Annual Eric M. Blumberg Memorial The sixth factor—timely and voluntary disclosure—was Luncheon Address (Dec. 10, 2015). part of the Holder Memorandum’s fourth factor. The seventh 5. Ned Sharpless, M.D., Melinda K. Plaisier, & Catherine A. Hemsen, Expanding Criminal Enforcement Operations Globally to Protect factor—remedial actions by the corporation—is substantively Public Health (Oct. 17, 2019), https://www.fda.gov/news-events/ the same as the Holder Memorandum’s sixth factor. The eighth fda-voices-perspectives-fda-leadership-and-experts/expand- factor—collateral consequences of a criminal conviction—re- ing-criminal-enforcement-operations-globally-protect-public-health. fers to additional types of collateral consequences. The ninth 6. 31 U.S.C. §§ 3729-3733 (2017). See generally, DOJ, The False factor—non-criminal remedies—is a little more detailed than Claims Act: A Primer (undated), https://www.justice.gov/sites/ the Holder Memorandum’s eighth factor. The tenth factor—the default/files/civil/legacy/2011/04/22/C-FRAUDS_FCA_Primer. pdf; Press Release, DOJ, Department of Justice Issues Guidance adequacy of prosecution of responsible individuals—is new. on False Claims Act Matters and Updates Justice Manual (May 7, I have spent many more years as a defense lawyer than 2019) (with link to new guidance), https://www.justice.gov/opa/ pr/department-justice-issues-guidance-false-claims-act-matters- as an enforcer of the FDCA, so I may have a bias as to the and-updates-justice-manual; Gibson Dunn, 2019 Mid-Year False

FDLI Spring 2020 Update 35 7th Annual Blumberg Lecture

Claims Act Update (July 16, 2019), https://www.gibsondunn. see, respectively, RPM Chapters 4 (Apr. 2019), 5 (Dec. 2017), and com/2019-mid-year-false-claims-act-update/. 6 (Aug. 2018), https://www.fda.gov/inspections-compliance-en- 7. As to DOJ’s power to dismiss a qui tam action under the False forcement-and-criminal-investigations/compliance-manuals/ Claims Act, see Memorandum from Michael D. Granston, Direc- regulatory-procedures-manual; Compliance Policy Guide § tor, Commercial Litigation Branch, Fraud Section, Civil Division, 101.100: FDA Considerations for Recommending Charges Under DOJ to Attorneys, Commercial Litigation Branch, Fraud Section, 21 U.S.C. § 331(a) or (d) for Causing the Introduction of Violative and Assistant U.S. Attorneys Handling False Claims Act Cases, Products into Interstate Commerce[;] Guidance for FDA Staff Offices of the U.S. Attorneys re Factors for Evaluating Dismissal (Oct. 2016), https://www.fda.gov/inspections-compliance-en- Pursuant to 31 U.S.C. 3730(c)(2)(A) (Jan. 10, 2018), https://www. forcement-and-criminal-investigations/manual-compliance-poli- fcadefenselawblog.com/wp-content/uploads/sites/561/2018/01/ cy-guides/chapter-1-general. Memo-for-Evaluating-Dismissal-Pursuant-to-31-U-S.pdf; See 21. Rebecca K. Wood, Remarks at the FDLI Enforcement, Litigation, also, e.g., Newsletter and Letter from Sen. Charles E. Grassley, and Compliance Conference 5 (Dec. 6, 2017), https://www.fda.gov/ Chairman, Sen. Comm. on Finance, to Hon. William Barr, news-events/speeches-fda-officials/remarks-fdli-enforcement-liti- Attorney General (Sept. 4, 2019), https://www.grassley.senate.gov/ gation-and-compliance-conference-12062017. news/news-releases/grassley-questions-use-doj-memo-limit-re- 22. “[A] deferred prosecution agreement is typically predicated upon covery-tax-dollars-lost-fraud; Serra J. Schlanger, The End May be the filing of a formal charging document by the government, and Here: Court Grants DOJ Motion to Dismiss Whistleblowers’ FCA the agreement is filed with the appropriate court. In the non-pros- Suit (Nov. 15, 2019), http://www.fdalawblog.net/2019/11/the-end- ecution agreement context, formal charges are not filed and the may-be-here-court-grants-doj-motion-to-dismiss-whistleblowers- agreement is maintained by the parties rather than being filed fca-suit/; Jeff Overley, 5 Takeaways As DOJ Finds Footing in FCA with a court.” Craig S. Morford, Acting Deputy Attorney General, Dismissal, https://www.law360.com/articles/1217347/5-takeaways- Memorandum for Heads of Department Components and United as-doj-finds-footing-in-fca-dismissal-crusade; Sam Bolstad, The States Attorneys re Selection and Use of Monitors in Deferred Granston Memo in Tension: Third Circuit Allows DOJ’s Dismissal of Prosecution Agreements and Non-Prosecution Agreements with FCA Claim without a Hearing; Sen. Grassley Wants DOJ to Pump Corporations [and Other Business Organizations] 1, n.2 (Mar. the Brakes (Oct. 8, 2019), https://www.jdsupra.com/legalnews/the- 7, 2008), https://www.justice.gov/sites/default/files/dag/lega- granston-memo-in-tension-third-81442/. cy/2008/03/20/morford-useofmonitorsmemo-03072008.pdf. See 8. See, e.g., Press Release, DOJ, GlaxoSmithKline to Plead Guilty generally, e.g., Justice Manual §§ 9.28.200(B) (“In certain instances, & Pay $750 Million to Resolve Criminal and Civil Liability it may be appropriate to resolve a corporate criminal case by means Regarding Manufacturing Deficiencies at Puerto Rico Plant other than indictment. Non-prosecution and deferred prosecution (Oct. 26, 2010), https://www.justice.gov/opa/pr/glaxosmith- agreements, for example, occupy an important middle ground kline-plead-guilty-pay-750-million-resolve-criminal-and-civil-li- between declining prosecution and obtaining the conviction of a ability-regarding. corporation.”), 9-28-1100(B) (“Where the collateral consequences 9. 320 U.S. 277, 281 (1943). of a corporate conviction for innocent third parties would be 10. 421 U.S. 658 (1975). significant, it may be appropriate to consider a non-prosecution or 11. 320 U.S. at 281. deferred prosecution agreement with conditions designed, among 12. Brief for the United States at 16, 31–32, United States v. Park, 421 other things, to promote compliance with applicable law and to U.S. 658 (1975) (No. 74-215) (footnote omitted). prevent recidivism. Declining prosecution may allow a corporate 13. The imposition of sentences of imprisonment for three months un- criminal to escape without consequences. Obtaining a conviction der the Park doctrine was affirmed, over a dissent, inUnited States may produce a result that seriously harms innocent third parties v. DeCoster, 828 F.3d 626 (8th Cir. 2016), cert. denied, 581 U.S. who played no role in the criminal conduct. Under appropriate ___, 137 S. Ct. 2160 (2017). There is a large literature on thePark circumstances, a deferred prosecution or non-prosecution agree- doctrine. For a discussion of FDA’s and DOJ’s application of the ment can help restore the integrity of a company’s operations and doctrine, see Jennifer Bragg, John Bentivoglio, & Andrew Collins, preserve the financial viability of a corporation that has engaged Onus of Responsibility: The Changing Responsible Corporate Officer in criminal conduct, while preserving the government’s ability to Doctrine, 65 Food & Drug L.J. 525 (2010). prosecute a recalcitrant corporation that materially breaches the 14. Sam D. Fine, The Philosophy of Enforcement, 31 Food Drug Cos- agreement. Such agreements achieve other important objectives metic L.J. 324 (1976). as well, like prompt restitution for victims.”) (footnote omitted), 15. Id. at 325. https://www.justice.gov/jm/jm-9-28000-principles-federal-pros- 16. Id. at 328. ecution-business-organizations. See also, e.g., Peter R. Reilly, 17. Id. at 329–31. Sweetheart Deals, Deferred Prosecution, and Making a Mockery of 18. Id. at 327. the Criminal Justice System: U.S. Corporate DPAs Rejected on Many 19. Id. at 329. Fronts, 50 Ariz. St. L.J. 1113 (2018). 20. RPM § 6-5-3, Special Procedures and Considerations for Park 23. See U.S. Gov’t Accountability Office, GAO-09-636T, Doctrine Prosecutions (Aug. 2018), https://www.fda.gov/inspec- Testimony Before the Subcommittee on Commercial and tions-compliance-enforcement-and-criminal-investigations/ Administrative Law, Committee on the Judiciary, House of compliance-manuals/regulatory-procedures-manual. The Representatives, Corporate Crime[:] Preliminary Obser- promulgation of this set of factors in 2011 is discussed in Anne vations on DOJ’s Use and Oversight of Deferred Prose- K. Walsh, FDA Finally Releases “Non-Binding” Park Doctrine cution and Non-Prosecution Agreements 9 (June 25, 2009) Criteria, FDA Law Blog (Feb. 7, 2011), http://www.fdalawblog. (Statement of Eileen R. Larence, Director, Homeland Security and net/2011/02/fda-finally-releases-non-binding-park-doctrine-cri- Justice), https://www.gao.gov/assets/gao-09-636t.pdf. teria/. For detailed presentations of FDA’s enforcement policies 24. See, e.g., Reilly, supra note 22, at 1119, n.22; Julie R. O’Sullivan, and procedures with respect to advisory actions (warning letters How Prosecutors Apply the “Federal Prosecutions of Corporations” and untitled letters), administrative actions, and judicial actions, Charging Policy in the Era of Deferred Prosecutions, and What That

36 Update Spring 2020 www.fdli.org 7th Annual Blumberg Lecture

Means for the Purposes of the Federal Criminal Sanction, 51 Am. Department of Justice Announces the Rollout of an Updated United Crim. L. Rev. 29 (2014). States Attorneys’ Manual, U.S. Dep’t of Justice (Sept. 25, 2018), 25. Memorandum from Deputy Attorney General to All Component https://www.justice.gov/opa/pr/department-justice-announc- Heads and United States Attorneys on Bringing Criminal Charges es-rollout-updated-united-states-attorneys-manual. For a com- Against Corporations (June 16, 1999), https://www.justice.gov/ mentary on the new version of the Manual, see, e.g., Amandeep S. sites/default/files/criminal-fraud/legacy/2010/04/11/charging- Sidhu et al., The New Justice Manual: DOJ Updates US Attorney’s corps.PDF. [sic] Manual for the First Time in Decades, McDermott Will & 26. Id. at first and second unnumbered pages. Emery (Oct. 12, 2018), https://www.mwe.com/insights/new-jus- 27. Id. at third unnumbered page. tice-manual-doj-attorney/. 28. Id. 40. See, e.g., McNulty Memo Out, Filip Memo In: DOJ Makes 29. Id. at fourth unnumbered page. Revisions to Corporate Charging Guidelines, McGuireWoods 30. Id. at second unnumbered page. (Sept. 4, 2008), https://www.mcguirewoods.com/client-resources/ 31. Id. at third unnumbered page. Alerts/2008/9/mcnultymemooutfilipmemoindojmakesrevi- 32. Memorandum from Larry D. Thompson, Deputy Attorney sionstocorporatechargingguidelines; Mark J. Stein & Joshua General, to Heads of Department Components and United States A. Levine, The Filip Memorandum: Does It Go Far Enough?, Attorneys on Principles of Federal Prosecution of Business Orga- Law.com (Sept. 11, 2008), https://www.law.com/corpcounsel/ nizations (Jan. 20, 2003), https://www.americanbar.org/content/ almID/1202424426861/. dam/aba/migrated/poladv/priorities/privilegewaiver/2003jan20_ 41. Principal Deputy Assistant Attorney General for the Criminal Divi- privwaiv_dojthomp.authcheckdam.pdf. sion Marshall L. Miller, Remarks at the Global Investigation Review 33. Id. at cover page. Program, U.S. Dept. of Justice (Sept. 17, 2014), https://www. 34. Id. at 3. This factor was inserted as the eighth factor, and adequacy justice.gov/opa/speech/remarks-principal-deputy-assistant-attor- of non-criminal remedies was re-numbered as the ninth factor, ney-general-criminal-division-marshall-l-miller. See also Remarks and its text was slightly revised. by Assistant Attorney General for the Criminal Division Leslie R. 35. Id. at 2. Caldwell at the 22nd Annual Ethics and Compliance Conference 36. Id. at 2, n.1. U.S. Dept. of Justice (Oct. 1, 2014), https://www.justice.gov/opa/ 37. Memorandum from Paul J. McNulty, Deputy Attorney General, to speech/remarks-assistant-attorney-general-criminal-division-les- Heads of Department Components and United States Attorneys, lie-r-caldwell-22nd-annual-ethics. on Principles of Federal Prosecution of Business Organizations 42. Memorandum from Sally Quillian Yates, Deputy Attorney (undated, but Dec. 11, 2006; released Dec. 12, 2006, https://www. General, to the Assistant Attorney General, Antitrust Division, justice.gov/archive/opa/pr/2006/December/06_odag_828.html), the Assistant Attorney General, Civil Division, et al. on Individual https://www.justice.gov/sites/default/files/dag/legacy/2007/07/05/ Accountability for Corporate Wrongdoing (Sept. 9, 2015), https:// mcnulty_memo.pdf [hereinafter McNulty Mem.]. The McNulty www.justice.gov/archives/dag/file/769036/download. Memorandum also superseded the Memorandum from Acting 43. Id. at 1. Deputy Attorney General Robert D. McCallum on Waiver of 44. Id. at 2. Corporate Attorney-Client and Work Product Protections (Oct. 45. Id. at 2–3 (footnote omitted). Ms. Yates further stated that she had 21, 2005), discussed in Elkan Abramowitz & Barry A. Bohrer, “directed that certain criminal and civil provisions in the United Waiver of Corporate Attorney-Client and Work-Product Pro- States Attorney’s [sic] Manual, more specifically the Princi- tection, 234 N.Y.L.J. (Nov. 1, 2005), https://www.maglaw.com/ ples of Federal Prosecution of Business Organizations (USAM publications/articles/2005-11-01-waiver-of-corporate-attorney-cli- 9-28.000 et seq.) and the commercial litigation provisions in Title ent-and-work-product-protection/_res/id=Attachments/index- 4 (USAM 4-4.000 et seq.), be revised to reflect these changes.” Id. =0/07011050001Morvillo.pdf. at 3. For commentary on the six steps, see, e.g., Deputy Attorney 38. The McNulty Memorandum also clarified that the corporate General Sally Q. Yates Delivers Remarks at the New York City Bar compliance program to be evaluated under the fifth factor is the Association White Collar Crime Conference, U.S. Dept. of Justice corporation’s pre-existing program. McNulty Mem. supra note (May 10, 2016), https://www.justice.gov/opa/speech/deputy-attor- 37, at 4. ney-general-sally-q-yates-delivers-remarks-new-york-city-bar-as- 39. Memorandum from Mark Filip, Deputy Attorney General, to sociation; Laura G. Hoey et al., The Yates Memo: Have the Rules Heads of Department Components and United States Attorneys Really Changed? Ropes & Gray LLP (Mar. 29, 2016), https://www. on Principles of Federal Prosecution of Business Organizations ropesgray.com/en/newsroom/news/2016/03/Attorneys-Exam- (Aug. 28, 2008), https://www.justice.gov/sites/default/files/dag/ ine-The-Yates-Memo-and-Changes-to-Individual-Prosecutions. legacy/2008/11/03/dag-memo-08282008.pdf. The Manual applies 46. Fine, supra note 14, at 324. Nevertheless, prior to the Yates not only to all U.S. Attorneys’ Offices, but also to all components of Memorandum, there had been criticism that FDA and DOJ were DOJ. Deputy Attorney General Rod J. Rosenstein Keynote Address not prosecuting individuals frequently enough to deter criminal on Corporate Enforcement Policy (Oct. 6, 2017), https://wp.nyu. conduct. See, e.g., Marc A. Rodwin, Do We Need Stronger Sanctions edu/compliance_enforcement/2017/10/06/nyu-program-on-cor- to Ensure Legal Compliance By Pharmaceutical Firms?, 70 Food & porate-compliance-enforcement-keynote-address-october-6-2017/ Drug L.J. 435 (2015). [hereinafter Rosenstein Keynote]. “[U]nless the statements are 47. Deputy Attorney General Sally Quillian Yates Delivers Remarks incorporated into the U.S. Attorneys’ Manual or issued through at New York University School of Law Announcing New Policy a formal Department memorandum, they are not necessarily on Individual Liability in Matters of Corporate Wrongdoing U.S. policies that govern Department employees.” Id. On September 25, Dept. of Justice (Sept. 10, 2015), https://www.justice.gov/opa/ 2018, DOJ announced the issuance of a new version of the USAM, speech/deputy-attorney-general-sally-quillian-yates-delivers-re- to be known thereafter as the Justice Manual. Press Release, marks-new-york-university-school.

FDLI Spring 2020 Update 37 48. Deputy Attorney General Sally Quillian Yates Delivers Remarks 57. Deputy Attorney General Rod J. Rosenstein Delivers Remarks at the at American Banking Association and American Bar Association American Conference Institute’s 35th International Conference on Money Laundering Enforcement Conference U.S. Dept. of Justice the Foreign Corrupt Practices Act, U.S. Dept. of Justice (Nov. 29, (Nov.16, 2015), https://www.justice.gov/opa/speech/deputy-attor- 2018), https://www.justice.gov/opa/speech/deputy-attorney-gen- ney-general-sally-quillian-yates-delivers-remarks-american-bank- eral-rod-j-rosenstein-delivers-remarks-american-conference-in- ing-0. stitute-0. A link to a redlined version of the provisions in the 49. Id. Justice Manual showing the changes announced by Mr. Rosenstein 50. Id. The revisions are discussed inDOJ Revises USAM “Filip appears in the first paragraph of John C. Richter, Brandt Leibe, Factors”–Focus on Prosecuting Individuals, Cooperation Credit, & William S. McClintock, Insight: Individuals Remain Focus Privilege and Coordination, DLA Piper (Nov. 19, 2015), https:// After DOJ Revisions to Yates Memo on Individual Accountability, www.dlapiper.com/en/us/insights/publications/2015/11/doj-revis- Bloomberg Law (Jan. 24, 2019), https://news.bloomberglaw.com/ es-usam-filip-factors/. white-collar-and-criminal-law/insight-individuals-remain-fo- 51. Attorney General Jeff Sessions Delivers Remarks at Ethics and cus-after-doj-revisions-to-yates-memo-on-individual-account- Compliance Initiative Annual Conference, U.S. Dept. of Justice ability. See also, e.g., Gejaa T. Gobena et al., DOJ Embraces a More (Apr. 24, 2017), https://www.justice.gov/opa/speech/attorney-gen- Realistic Position on Corporate Cooperation, Hogan Lovells US eral-jeff-sessions-delivers-remarks-ethics-and-compliance-initia- LLP (Jan 18, 2019), https://www.hoganlovells.com/en/publications/ tive-annual. doj-embraces-a-more-realistic-position-on-corporate-cooper- 52. Rosenstein Keynote, supra note 39, at 9. See also Deputy Assistant ation. Attorney General Matthew S. Miner Delivers Remarks at the 6th 58. Deputy Assistant Attorney General James M. Burnham Delivers Annual Government Enforcement Institute, U.S. Dept. of Justice Remarks to the 2018 Food and Drug Law Institute Conference, U.S. (Sept. 12, 2019), https://www.justice.gov/opa/speech/deputy-assis- Dept. of Justice (Dec. 13, 2018), https://www.justice.gov/opa/ tant-attorney-general-matthew-s-miner-delivers-remarks-6th-an- speech/deputy-assistant-attorney-general-james-m-burnham-de- nual-government. See also Thomas L. Kirsch II & David E. Hollar, livers-remarks-2018-food-and-drug-law. Prosecution of Individuals in Corporate Criminal Investigations, 59. Id. 66 Dep’t of Just. J. of Fed. Law & Prac. 5, 3 (Oct. 2018), https:// 60. Justice Manual § 9-28.300 (updated Nov. 2018), https://www. www.justice.gov/usao/page/file/1106771/download. justice.gov/jm/jm-9-28000-principles-federal-prosecution-busi- 53. Deputy Assistant Attorney General Ethan P. Davis Delivers ness-organizations#9-28.300. Remarks to the FDAnews Off-Label Communication: Top Tips for 61. See also, e.g., Criminal Division Announces Publication of Guidance Compliance Conference, U.S. Dept. of Justice (Feb. 28, 2018), on Evaluating Corporate Compliance Programs, U.S. Dept. of https://www.justice.gov/opa/speech/deputy-assistant-attor- Justice (Updated April 2019), https://www.justice.gov/opa/pr/ ney-general-ethan-p-davis-delivers-remarks-fdanews-label. criminal-division-announces-publication-guidance-evaluat- 54. Id. The emphasis on false or misleading statements reflectsUnited ing-corporate-compliance-programs; John Nassikas, John Tan, & States v. Caronia, 703 F.3d 149 (2d Cir. 2012), where truthful, Lindsey Carson, New DOJ Compliance Program Guidance, Harv. non-misleading off-label promotion was held protected by the L. Sch. F. on Corporate Governance & Fin. Reg. (June 10, First Amendment. 2019), https://corpgov.law.harvard.edu/2019/06/10/new-doj-com- 55. Id. at 4–5. pliance-program-guidance/; OIG Compliance Program Guidance 56. Id. at 6. for Pharmaceutical Manufacturers, 68 Fed. Reg. 23,731 (May 5, 2003).

38 Update Spring 2020 www.fdli.org Unrivaled As the leading Quality, Compliance and experience Regulatory consulting firm, we partner with healthcare companies to ensure safe and reliable access to the world’s Skilled life-saving healthcare products. Our track execution record of success has earned us the trust of 20 of the top 30 Global Pharmaceutical firms, 25 of the top 30 Medical Device Demonstrated firms, and 7 of the top 10 Biotechnology results firms in the world.

1.844.VALIDANT [email protected] www.validant.com FDLI News

FDLI Welcomes New Board Members

2020 Board of Directors Executive Committee We are pleased to announce that Daniel A. Kracov, Partner, Arnold & Porter, has been named Vice Chair, and that Freddy A. Jimenez, Vice President, Law and Compliance, Celldex Therapeutics has been named Sec- retary and General Counsel. Frederick R. Ball, Partner, Duane Morris LLP, has been named Treasurer for a second term. Also serving on the Executive Committee are Chair Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Amy Comstock Rick, President and CEO, FDLI.

Joining the Board FDLI welcomed four new members to the Board of Directors in January. Each has been significantly involved with FDLI in the past, and they all come with impressive backgrounds in the legal and regulatory fields.

Dean R. Cirrota is the President of EAS Consulting Group, which provides regulatory consulting to all FDA-regulated industries. He is a lead trainer at his firm and regularly speaks on FDA compliance and initiatives.

Amy Norris is Executive Counsel and Senior Vice President, Legal for Clif Bar & Company. She advises the company on legal and operational matters and man- ages her company’s risk management and regulatory compliance groups.

Cynthia Schnedar is Executive Vice President of Regulatory Compliance at Greenleaf Health Inc., where she advises clients in the life sciences industry. She brings significant experience from the public and non-profit sectors, where she has focused on compliance and enforcement issues.

Rachel Turow is Executive Counsel, Regulatory Law at TEVA Pharmaceuticals USA, Inc. She provides legal support and helps manage her company’s drug- device combination products and digital health projects.

40 Update Spring 2020 www.fdli.org FDLI News

FDLI Welcomes the 2020 Committees

Board of Directors Annual Conference Planning Committee: * denotes Board Member is also a member of the Wade Ackerman, Covington & Burling LLP Executive Committee David Bloch, Medtronic Jeff Chasnow, Pfizer, Inc. Frederick R. Ball*, Duane Morris LLP James N. Czaban, DLA Piper LLP (US) Jennifer L. Bragg*, Skadden, Arps, Slate, Meagher Sandra Eskin, The Pew Charitable Trusts & Flom LLP Azim Chowdhury, Keller and Heckman LLP Cathy L. Burgess, Alston & Bird LLP Kathleen Hoke, University of Maryland Carey Carla Cartwright, Johnson & Johnson School of Law Dean R. Cirotta, EAS Consulting Group Jonathan Havens, Saul Ewing Arnstein & Lehr LLP Jeffrey Francer, Association for Accessible Medicines Erika Lietzan, University of Missouri-Columbia Miriam Guggenheim, Covington & Burling LLP School of Law Freddy A. Jimenez*, Celldex Therapeutics John A. Murphy, Biotechnology Innovation Organization Sandra Cohen Kalter, Medtronic Adora Ndu, BioMarin Pharmaceutical Inc. Daniel Kracov*, Arnold & Porter LLP Meredith Olearchik, Campbell Soup Company Amy Norris, Clif Bar & Company Suzan Onel, Kleinfeld, Kaplan & Becker LLP Francis B. Palumbo, University of Maryland, Stuart Pape, Polsinelli PC School of Pharmacy Lauren Roth, FDA - OC Amy Comstock Rick*, Food and Drug Law Institute Deborah Shelton, Arent Fox LLP Margaret F. Riley, University of Virginia, Schools of David Spangler, Consumer Healthcare Products Law and Medicine Association (CHPA) Cynthia Schnedar, Greenleaf Health, Inc. Marta Villaraga, Exponent, Inc. Rachel Turow, TEVA Pharmaceuticals USA, Inc. Armando Zamora, FDA - ORA

Advertising and Promotion Conference Enforcement, Litigation, and Compliance Conference Planning Committee Planning Committee Fadwa Almanakly, Bayer Healthcare Pharmaceuticals Hannah Bornstein, Nixon Peabody LLP Heather Banuelos, King & Spalding LLP Adrienne Franco Busby, Faegre Drinker Madhavi Bellamkonda, Abbott Vascular Biddle & Reath LLP Blythe Buchanan, Biogen, Inc. Maya P. Florence, Skadden, Arps, Slate, Rebecca Burnett, Framework Solutions Meagher & Flom LLP Dale Cooke, PhillyCooke Consulting Sonali P. Gunawardhana, Shook, Hardy & Bacon LLP Mary Ellen Dronitsky, Northeastern University Stephanie Haggarty, Pfizer, Inc. Virginia Foley, Opus Regulatory Inc Dan G. Jarcho, Alston & Bird LLP Mark Garsombke, Hall, Render, Killian, Heath Steven A. Johnson, Zogenix, Inc. & Lyman P.C. Charles N. Jolly, Baker Donelson Bryant M. Godfrey, Arnold & Porter LLP Pete J. Leininger, King & Spalding LLP Mark C. Levy, Eckert Seamans Cherin & Mellott, LLC Anne K. Miller, Medtronic Lauren A. Miller, Otsuka America Pharmaceutical, Inc. Sun “Sandra” Park, Genentech, Inc. Cassie Scherer, Medtronic Bob A. Rhoades, Validant Dolores M. Shank-Samiec, Merck & Co., Inc. Suzie Loonam Trigg, Haynes and Boone LLP Michael Francis Smith, PDL BioPharma, Inc. Anne K. Walsh, Hyman, Phelps & McNamara, PC Beth P. Weinman, Ropes & Gray LLP Fran Zipp, Lachman Consultants

FDLI Spring 2020 Update 41 FDLI News

Publications and Academic Programs Committee Daniel McGee, Solari Hemp Joanne Hawana, Mintz, Levin, Cohn, Ferris, Glovsky Douglas MacKay, CV Sciences and Popeo, P.C. Debby Miran, Entourage Therapeutics, LLC Mark Hendrickson, Leavitt Partners Megan L. Olsen, Council for Responsible Nutrition Laurie Lenkel, FDA - OC Christopher Van Gundy, Sheppard Mullin Richter Elizabeth Richards, Latham & Watkins LLP & Hampton LLP Sarah Roache, Georgetown University Deborah Walter, Greenwich Biosciences Lynn C. Tyler, Barnes & Thornburg LLP Daniel Wang, Pinney Associates, Inc. Jessica Anne Wasserman, Greenspoon Marder LLP Audit Committee Cathy Burgess, Alston & Bird LLP Finance Committee Neil P. Di Spirito, Epstein Becker & Green, PC Frederick R. Ball, Duane Morris LLP Jonathan Havens, Saul Ewing Arnstein & Lehr LLP Jeffrey Francer, Association for Accessible Medicines Stuart Pape, Polsinelli PC Jeffery Gibbs, Hyman, Phelps & McNamara, PC Elizabeth Oestreich, Greenleaf Health, Inc. Austern Writing Awards Committee Peter Pitts, Center for Medicine in the Public Interest Alena M. Allen, University of Memphis Stuart TenHoor, Stuart TenHoor Legal Search Nathan Beaton, Latham & Watkins LLP Barbara A. Binzak Blumenfeld, Buchanan Ingersoll Food Advertising, Labeling, and Litigation Conference & Rooney PC Planning Committee Christine E. Kirk, Peterson Wilmarth and José Alberto Campos Vargas, Sanchez Devanny Robertson, LLP Jonathan M. Cohen, K&L Gates LLP Donnelly McDowell, Kelley Drye & Warren LLP Stefanie Jill Fogel, DLA Piper LLP (US) Joshua Oyster, Ropes & Gray LLP Lorie S. Foster, Abbott Nutrition Melissa B. Runsten, Debevoise & Plimpton, LLP August T. Horvath, Foley Hoag LLP Maia Kats, Kaplan Fox & Kilsheimer, LLP California Programs Planning Committee Cynthia L. Meyer, Kleinfeld, Kaplan & Becker, LLP Afia Asamoah, Google Health Eve Pelonis, Keller and Heckman LLP Michele L. Buenafe, Morgan, Lewis & Bockius LLP Michael Roberts, UCLA School of Law Scott L. Cunningham, Covington & Burling LLP Lanny Schimel, Kerry, Inc Allison Fulton, Sheppard Mullin Richter & Kurt D. Weaver, Womble Bond Dickinson (US) LLP Hampton LLP Vinita Kailasanath, Arnold & Porter LLP Food and Drug Law Journal Editorial Advisory Board Angela Meyer, Exponent Nigel Barrella, The Good Food Institute Amy Speros, Latham & Watkins LLP Laurie J. Beyranevand, Vermont Law School Deborah E. Tolomeo, Genentech, Inc. Jennifer Black, FDA - OC Daron Watts, The Watts Group, PLLC Marie Boyd, University of South Carolina Nury Yoo, Keller and Heckman LLP Nathan Brown, Akin Gump Strauss Hauer & Feld LLP Bridget C.E. Dooling, George Washington University Cannabis Derived Products Committee Carl Fischer, Becton Dickinson (BD) Libby Baney, Faegre Drinker Biddle & Reath LLP Peter Barton Hutt, Covington & Burling LLP Linda D. Bentley, Mintz, Levin, Cohn, Ferris, John Johnson III, Benjamin L. England & Associates Glovsky and Popeo, P.C. LLC/FDAImports.com, LLC Kelly Fair, Canopy Growth Corporation Alan C. Katz, toXcel, LLC William A. Garvin, Buchanan Ingersoll & Rooney PC Dinesh Kumar, FDA - OC Steven N. Levine, Husch Blackwell LLP Marian J. Lee, Gibson Dunn & Crutcher LLP Brian J. Malkin, Arent Fox LLP Priya Malavika Mannan, Novartis Pharmaceuticals Keith Matthews, Wiley LLP Corporation

42 Update Spring 2020 www.fdli.org FDLI News

J. R. McNair, Winston & Strawn LLP New to Food and Drug Law Planning Committee Alan G. Minsk, Arnall Golden Gregory LLP Alexander V. Alfano, Axinn, Veltrop & Harkrider LLP Anne Marie Murphy, Consumer Healthcare Brigid Bondoc, Sidley Austin LLP Products Association (CHPA) Delia A. Deschaine, Hogan Lovells US LLP Nicole Negowetti, Harvard Law School Lauren A. Farruggia, Saul Ewing Arnstein & Lehr LLP James T. O’Reilly, University of Cincinnati Dina Gayanova, Buchanan Ingersoll & Rooney PC Joseph A. Page (Academic Advisor), Georgetown Steven Gonzalez, Ropes & Gray LLP University Elizabeth Mulkey, Goodwin Procter LLP Sung Park, Reed Smith LLP Marc Wagner, BakerHostetler Jessica Ringel, King & Spalding LLP Marc J. Scheineson, Alston & Bird LLP Patient Organization Engagement Committee Shy Shorer, National Institutes of Health Ryan Hohman, Friends of Cancer Research Anna Sims, FDA - OC Brenda Huneycutt, FasterCures Eric Solowey, Parexel International Corporation Maureen M. Japha, Peterson Wilmarth and Andrew Wasson, Haug Partners LLP Robertson, LLP (PWR) Emily Wright, Pfizer, Inc. Debra Lappin, Faegre Drinker Biddle & Reath LLP Patti Zettler, The Ohio State University Lisa Pieretti, International Hyperhidrosis Society Ami E. Simunovich, Becton Dickinson (BD) Food Enforcement and Compliance Conference James Valentine, Hyman, Phelps & McNamara, PC Planning Committee Laura D. Wingate, Crohn’s & Colitis Foundation Elizabeth Fawell, Hogan Lovells John Packman, DLA Piper Publications Peer Review Committee Sarah Roller, Kelley Drye & Warren Kenita Barrow, Otsuka America Pharmaceutical, Inc. Steve Armstrong, Haynes & Boon, LLP Royce B. DuBiner, McGuireWoods LLP Ricardo Carvajal, Hyman Phelps & McNamara Emily Hussey, Reed Smith LLP Andrea Ferrenz, Campbell Soup Sara Wexler Koblitz, Hyman, Phelps & McNamara, PC Dana Graber, FMI Areta L. Kupchyk, Foley Hoag LLP Heili Kim, Faegre Drinker Biddle & Reath LLP Dan Logan, Kleinfeld, Kaplan & Becker, LLP Trevor Findley, USDA Eileen M. McMahon, Torys LLP Elizabeth Oestreich, Greenleaf Health, Inc. Medical Products Committee Beth G. Oliva, Fox Rothschild LLP Shelby Buettner, FDA - OC Neha Patel, Arnold & Porter LLP Melanie Katrice Gross, Genentech, Inc. Tyler Scandalios, Benjamin L. England & Ralph F. Hall, University of Minnesota Associates LLC/FDAImports.com Colleen M. Heisey, Jones Day Carmine Jabri, E.M.M.A. International Tobacco and Nicotine Products Committee Consulting Group, Inc. * denotes committee member is a member of the Public Health Subcommittee Monaya M. Krause, Medtronic Chad A. Landmon, Axinn, Veltrop & Harkrider LLP Issa Abuaita, Al Fakher USA Scott M. Lassman, Lassman Law + Policy Scott D. Ballin, Public Health Consultant Gregory H. Levine, Ropes & Gray LLP James Baumberger*, American Academy of Pediatrics Veleka Peeples-Dyer, Baker McKenzie Aruni Bhatnagar*, American Heart Association Schevon Gaylord Salmon, Otsuka America Tara Lin Couch, EAS Consulting Group, LLC Pharmaceutical, Inc. Michael Cummings, Medical University of South Kathleen M. Sanzo, Morgan, Lewis & Bockius LLP Carolina Brittani Cushman, Turning Point Brands, Inc. Cliff Douglas*, American Cancer Institute Stacey Younger Gagosian*, Truth Initiative

FDLI Spring 2020 Update 43 FDLI News

Thomas Glynn, Stanford University School of Medicine Webinar Programs Committee Robyn Gougelet, Pinney Associates, Inc. Benjamin Abel, McGuireWoods LLP Ben Haas, Latham & Watkins LLP Kalah Auchincloss, Greenleaf Health, Inc. Bryan M. Haynes, Troutman Sanders LLP Nathan Beaver, Foley & Lardner LLP Dennis Henigan*, Campaign for Tobacco-Free Kids Mitchell Berger, FDA - CBER Desmond Jenson*, Public Health Law Center – Vanessa K. Burrows, Simpson Thacher & Bartlett Tobacco Control Legal Consortium Karen Corallo, Skadden, Arps, Slate, Meagher Eshael Johnson, FDA - CTP & Flom LLP Ondrej Koumal, Philip Morris International Jack Garvey, Compliance Architects LLC Eric N. Lindblom, O’Neill Institute for Abraham Gitterman, Arnold & Porter LLP National and Global Health Law, Georgetown Law Elizabeth Guo, Covington & Burling LLP Joe Murillo, JUUL Labs Kendra A. Martello, Mallinckrodt Pharmaceuticals John Marshall, Altria Client Services LLC Rebecca Jones McKnight, DLA Piper LLP (US) Kelley Coleman Nduom, FDA - CDER Elise Paeffgen, Alston & Bird LLP Henry Roemer, Specialty Tobacco Council, Inc. Serra J. Schlanger, Hyman, Phelps & McNamara, PC Barry Schaevitz, Fox Rothschild LLP Cicely Vaughn, Walmart Inc. Jim M. Solyst, Swedish Match North America Carolina Wirth, Arnall Golden Gregory LLP Mark J. Vaders, Womble Bond Dickinson (US) LLP

44 Update Spring 2020 www.fdli.org Academic Programs University of Maryland Annual Health Law Regulatory and Compliance Competition

FDLI was pleased to be a sponsor of the University of from law firms, government agencies, commercial corpora- Maryland Francis King Carey School of Law’s 9th Annual tions, and health care entities. This year’s competition was Health Law Regulatory and Compliance Competition. The held on February 22, 2020 and saw nearly forty students competition was founded by Abraham Gitterman of Arnold from twelve law schools competing. & Porter LLP, a long-time FDLI member. Topics focus on First place was awarded to the team of Sophie Beutel, compliance with health care regulations and health law and Marissa Fritz, and Simone Hussussian from the University help students prepare to enter health care legal practice. of Pennsylvania Law School. Meghan Browder and Da- This year's topics included fraud and abuse issues; patient vid Cohen, a team from American University Washington assistance programs; reimbursement issues; and health, College of Law, received second place. A fellow American technology, data, and privacy related to telehealth. Teams University Washington College of Law team, Brittney Hall of two or three students have ninety minutes to analyze and Lauren Sager, received third. a hypothetical fact pattern and present their findings and FDLI would like to extend its congratulations to all the recommendations to a panel of regulatory and compliance winners and looks forward to each of them joining the attorneys. Judges (including many FDLI members) come health law community. FDLI

Judges, students, and community members gather for the 9th Annual Health Sophie Beutel, Marissa Fritz, and Simone Hussussian (University of Pennsyl- Law Regulatory and Compliance Competition. vania) took the top prize at the annual competition.

Meghan Browder and David Cohen (American University) placed second. Brittney Hall and Lauren Sager (American University) placed third.

FDLI Spring 2020 Update 45 FDLI’s H. Thomas Austern Writing Competition Accepting Submissions Through June 19, 2020

The Austern Writing Competition is intended to encourage law students interested in the areas of law affecting FDA-regulated industries: food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices, veterinary devices, cannabis, or tobacco.

Deadline: June 19th, 2020

Eligibility Requirements: Students currently enrolled in a JD Program at any of the nation’s ABA-accredited law schools or a 2019-2020 academic year graduate.

1st Place 2nd Place 3rd Place $750 $500 $250

Award Winners Are: • Awarded a complimentary one-year FDLI membership • Considered for publication in the Food and Drug Law Journal • Recognized for their excellence in scholarship

fdli.org/austern