DOCSLIB.ORG

US FDA Commissioner Nominee on Fast Track with Nov. 20 Hearing

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
US FDA Commissioner Nominee on Fast Track with Nov. 20 Hearing Vol. 81 / No. 45 November 11, 2019 nation of replacement in almost 15 years. US FDA Commissioner Nominee (See chart below.) Among the potential nominees consid- ered were Ned Sharpless, then acting com- On Fast Track With Nov. 20 Hearing missioner and now back at NCI, and Brett M. NIELSEN HOBBS [email protected] Giroir, the Health and Human Services assistant secretary for health who is now tephen Hahn’s nomination to lead November, seven months after the pre- acting commissioner, as part of the Fed- the US Food and Drug Administra- vious confirmed commissioner, Scott eral Vacancies Reform Act shuffle that the S tion was a long time coming, but it Gottlieb, left the post. (Also see “Stephen administration performed on Friday. (Also appears that Senate leadership is hoping Hahn For US FDA Commissioner: Will Aca- see “Giroir Becomes Acting US FDA Commis- that his time as nominee will be pleasantly demic Experience Suffice For Confirma- sioner, Giving Agency Experienced Political short, with a hearing in the Health Com- tion?” p. 4.) Hand” - Pink Sheet, 1 Nov, 2019.) mittee now scheduled for 20 November. The lengthy process to pick Hahn result- Tapping the runner-up as the de facto Sen. Lamar Alexander, R-TN, an- ed in the longest gap between departure interim commissioner isn’t unusual (think nounced on 6 November that he was of a confirmed commissioner and nomi- CONTINUED ON PAGE 4 supporting the nomination. “I had an excellent meeting with Dr. Wait Times For New Commissioners Hahn and believe he is well-qualified Hahn was the longest gap between the resignation of the previous commissioner to lead the FDA. As an oncologist, Dr. and nomination in over a decade. Hahn knows firsthand the importance of bringing new, lifesaving drugs and David Kessler 9.8 .53 months devices quickly through the regulatory process as well as the need for innova- Jane Henney 15.86 3.93 months tion for patients with debilitating and Mark McClellan* 20.2 20.2 months chronic pain. As a successful chief exec- utive, he will bring a guiding hand to an Lester Crawford 10.63 5.13 months agency tasked with protecting the pub- Andrew von Eschenbach 5.67 8.73 months lic’s health,” Alexander, who chairs the 1.73 health committee, said in a statement. Margaret Hamburg* 2.13 months “This is a crucial perspective at a time Robert Califf 5.37 5.3 months when FDA is implementing the 21st Scott Gottlieb* 1.7 Century Cures Act, regulating tobacco 1.7 months and vaping products, addressing the Stephen Hahn 7 opioid crisis, and protecting our nation’s 0 2 4 6 8 10 12 14 16 18 20 food supply.” Months Hahn, currently the chief medical executive at the MD Anderson Cancer Time Between Resignation of Previous Commissioner and Nomination Center, was nominated by President Time from Nomination to Confirmation Trump to be FDA commissioner on 1 Note: * indicates nomination following presidential inauguration FOR THE LATEST INSIGHT ON BIOPHARMA REGULATION AND POLICY, VISIT: PINK.PHARMAINTELLIGENCE.INFORMA.COM UK NICE DRUG REVIEWS DRUG REVIEWS Everyone Wants A Piece Of The EMA Accepts First Diabetes Drug China Alzheimer’s Approval Raises UK’s NICE, p. 9 Onto PRIME, p. 10 Hope But Also Questions, p. 12 Open for Entries THE 25TH OTC MARKETING AWARDS Entry deadline: 6 December 2019 GALA DINNER & AWARDS PRESENTATION THURSDAY, 5 MARCH 2020 | ROYAL LANCASTER LONDON, UK https://pharmaintelligence.informa.com/otc FOR SPONSORSHIP OPPORTUNITIES CONTACT: Rob Coulson E: [email protected] T: +44 (0) 7825 845 666 FOR ALL OTHER ENQUIRIES: Natalie Cornwell E: [email protected] Sponsored by Supported by T: +44 (0) 7827 993 776 JN2265 OTC Awards 2020 Open for Entries Advert US Letter.indd 1 2019/09/20 20:02 7 11 12 exclusive online content inside: COVER US FDA Commissioner Nominee On Fast Track HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead With Nov. 20 Hearing https://pink.pharmaintelligence.informa.com/PS141154 Trump administration wants the HIV drug maker to license HHS US FDA patents related to pre-exposure prophylaxis. Lawsuit follows 5 Stephen Hahn For US FDA Commissioner: Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents. Will Academic Experience Suffice For Confirmation? 7 US FDA Expands ‘Cures’ Hiring Authority To Fill Variety Rx Pricing, Rebating Should Be Back To Business Of Open Positions As Usual In 2020, PBMs Say https://pink.pharmaintelligence.informa.com/PS141153 Political focus of drug pricing debate has shifted away from UK NICE pharmacy benefit managers, CVS Health’s Merlo suggests. 9 Everyone Wants A Piece Of The UK’s NICE Gene And Cell Therapies In Asia: New Korean Law DRUG REVIEWS To Change Landscape Of Cutting Edge Biologics https://pink.pharmaintelligence.informa.com/PS141155 10 EMA Accepts First Diabetes Drug Onto PRIME South Korea will undergo many changes as it gears up for a new 12 China Alzheimer’s Approval Raises Hope law on cutting edge regenerative medicine and biologics, which But Also Questions will be implemented next year. Until then, further discussions will be needed to set details of the rules that can step up the industry’s competitiveness and bring the country more in line SUPPLY CHAIN with global standards. 11 UK Adds MMR Vaccine To Export Ban List Another Ebola Vaccine Among New Filings At EMA https://pink.pharmaintelligence.informa.com/PS141156 ADVISORY COMMITTEES The European Medicines Agency has received 11 new marketing 14 Recent And Upcoming FDA Advisory Committee Meetings authorization applications, including three for orphan products from Vertex, MYR Pharmaceuticals and AstraZeneca. ONLINE ONLY! join the conversation FDA PERFORMANCE We are tweeting, liking and sharing the latest industry TRACKER news and insights from our global team of editors and analysts — join us! Regularly updated information about new submissions, pending applications and FDA actions, online-only interactive content at your fingertips 24/7 at @PharmaPinksheet pink.pharmaintelligence.informa.com/product- reviews-and-approvals/fda-performance-tracker pink.pharmaintelligence.informa.com November 11, 2019 | Pink Sheet | 3 US FDA Time To Senate Hearings For FDA Nominees CONTINUED FROM PAGE 1 Joshua Sharfstein or Lester Crawford) For the last three commissioners, time to hearing corresponded with time and putting Giroir at FDA could actually to confirmation. help speed Hahn’s nomination along. Democrats have expressed concern about Girior’s policy work on abortion 54 Margaret Hamburg and on reproductive issues, so they may 64 be disinclined to try to hold up Hahn’s confirmation since it would mean keep- 63 ing Girior at the head of the agency. Robert Califf 159 Hahn doesn’t appear to have any indus- try conflicts that have held up previous 26 nominees. (Also see “Hahn May Not Run Scott Gottlieb 56 Into Questions About Industry Ties Like His Predecessors” - Pink Sheet, 1 Nov, 2019.) But senators could always try to hold Stephen Hahn 19 up the nomination because of concerns they have about policy issues within the 0 20 40 60 80 100 120 140 160 FDA’s orbit, be they drug pricing, vap- ing, or CBD. So while a quickly scheduled Days from Nomination to Hearing Days from Nomination to Confirmation Scheduled hearing hearing is a good sign, it’s no guarantee of a smooth confirmation. Hamburg and Califf had the disadvantage of needing to go through the Senate Still, a long wait for a nominee fol- while it was controlled by the opposition party. lowed by a quickly scheduled hearing could signal a quick confirmation. Mark FDA Commissioner Confirmation Votes McClellan’s 2002 nomination was the longest waited for at 20.2 months, but Gottlieb got the fewest. the second-quickest time from nomi- nation to confirmation, 22 days, with a David Kessler 100 hearing coming after just 12 days – while the Senate was controlled by Democrats. Jane Henney 100 (See top chart left.) Mark McClellan 100 Quick doesn’t always mean pleasant, though. While McClellan passed the Sen- Lester Crawford 78 16 ate by voice vote, Scott Gottlieb, who had the third-quickest nomination at 56 days Andrew von Eschenbach 80 11 and got a hearing in 26 days, ended up with the fewest votes of any FDA nomi- Margaret Hamburg 100 nee ever, a tally that probably reflected Robert Califf 89 4 resistance politics at the beginning of the Trump administration as much as any Scott Gottlieb 57 42 concerns with him in particular. (See bot- 0 10 20 30 40 50 60 70 80 90 100 tom chart left.) Yes No Passed by Voice Vote Passed by Unanimous Consent Published online 6 November 2019 LET’S GET We are tweeting, liking and sharing the latest industry news and insights from our global team of editors and analysts, join us! SOCIAL @PharmaPinksheet 4 | Pink Sheet | November 11, 2019 © Informa UK Ltd 2019 US FDA Stephen Hahn For US FDA Commissioner: Will Academic Experience Suffice For Confirmation? DERRICK GINGERY [email protected] ne of Stephen Hahn’s best as- eral administrative experience. Kessler sets as the nominee for commis- served from November 1990 until late O sioner of the US Food and Drug February 1997. Administration may also be his biggest Hahn was a senior investigator at the cause for concern. NCI for about a year, but since July 1995 From an administrative perspective, Hahn he has practiced medicine in the private is a government neophyte. The chief medi- sector at the University of Pennsylvania cal executive of MD Anderson Cancer Cen- and MD Anderson Cancer Center. ter has never held a significant leadership Like Hahn, Kessler also came to FDA position at a government agency, let alone from an academic hospital setting.
Load more

Recommended publications
  • Masks Off: Officials Reevaluating Mandates for Indoor Mask Use by Leandra Bernstein Monday, May 10Th 2021
    Masks off: Officials reevaluating mandates for indoor mask use by Leandra Bernstein Monday, May 10th 2021 WASHINGTON (Sinclair Broadcast Group) — Leading public health figures suggested over the weekend that it was time to reevaluate requirements for wearing masks indoors as COVID-19 cases continue to decline and more than half of all American adults have received at least one dose of a vaccine. On CBS's "Face the Nation" Sunday, former commissioner of the Food and Drug Administration Dr. Scott Gottlieb, encouraged jurisdictions with low rates of infection to begin relaxing mask mandates. "I think we're at the point in time when we can start lifting these ordinances in a wholesale fashion," he said, noting that half the states in the country are seeing daily infections at just 10 per 100,000 and almost a quarter have infection rates of 5 in 100,000. The former FDA chief advocated lifting restrictions on outdoor gatherings entirely and eliminating other required mitigation measures under certain criteria. "The states where prevalence is low, vaccination rates are high, and we have good testing in place—we're identifying infections—I think we could start lifting these restrictions indoors as well, on a broad basis," he said. It's possible that mask ordinances may have to be reimplemented if there are outbreaks or if there is a decline in immunity, Gottlieb advised. "But that's a long ways off. We'll worry about that in the fall and the winter," he said. "We're at the point right now where we could start lifting these ordinances and allowing people to resume normal activity." Asked about Dr.
    [Show full text]
  • Developing and Scaling COVID-19 Vaccines May 13, 2020 at 12:30 – 2:30 Pm ET a Webinar by the Duke-Margolis Center for Health Policy and the Alexandria Summit
    Developing and Scaling COVID-19 Vaccines May 13, 2020 at 12:30 – 2:30 pm ET A webinar by the Duke-Margolis Center for Health Policy and the Alexandria Summit Objective: To explore issues, strategies, and policies for developing and scaling COVID-19 vaccines. 12:30 pm Welcome and Overview Mark McClellan, Duke-Margolis Center for Health Policy 12:45 pm Fireside Chat Mark McClellan, Duke-Margolis Center for Health Policy Anthony Fauci, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services 1:00 pm Envisioning a Path Forward Remarks from Scott Gottlieb, American Enterprise Institute and former Food and Drug Administration, U.S. Department of Health and Human Services 1:05 pm Session One: Vaccine Development This session will explore vaccine development under an accelerated timeline, including strategies to develop or modify technologies, participate in cross-sector collaborations, conduct clinical trials, and achieve approval – all during an active pandemic. Peter Marks, Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services Tal Zaks, Moderna Therapeutics Adrian Hill, Jenner Institute and Oxford Martin Programme on Vaccines John Reed, Sanofi 1:45 pm Session Two: Vaccine Production and Access at Scale This session will explore the scope and scale of manufacturing needs, once a vaccine has been developed and approved, to prepare for demand and ensure appropriate access. Luciana Borio, In-Q-Tel and former National Security Council Director, Medical and Biodefense Preparedness Paul Stoffels, Johnson & Johnson Richard J. Hatchett, Coalition for Epidemic Preparedness Innovation Victor Dzau, National Academy of Medicine 2:25 pm Closing Remarks Joel Marcus, Alexandria Summit; Alexandria Real Estate Equities, Inc./Alexandria Venture Investments Lynne Zydowsky, Alexandria Summit; Alexandria Real Estate Equities, Inc./Alexandria Venture Investments Mark McClellan, Duke-Margolis Center for Health Policy 2:30 pm Adjourn .
    [Show full text]
  • The Spreading Cancer of Counterfeit Drugs
    The Spreading Cancer of Counterfeit Drugs The Spreading Cancer of Counterfeit Drugs Pharmaceutical Fakery Metastasizes from Lifestyle to Lifesaving Medicines Pharmaceutical Fakery Metastasizes from LifestyleBy: to Peter Lifesaving J. Pitts Medicines Former FDA Associate Commissioner President, Center By:for MedicinePeter J. Pitts in the Public Interest Former FDA Associate Commissioner President, Center for JulyMedicine 2020 in the Public Interest OctoberJuly 2020 2020 Introduction Just as the coronavirus mutates to survive and thrive, so to do the purveyors of counterfeit medicines – with their high-speed “host” being the digitization of patient care. The future is now. So, how do we balance moving forward with user-friendly digitization, telemedicine and virtual healthcare delivery while simultaneously recognizing the unintended consequences of the innovative criminal mind? The first step is to recognize there’s a problem. Counterfeit Medicines: A Moveable Feast Once upon a time, at the beginning of the new millennium, counterfeit medicines in the United States were largely “lifestyle” products such as erectile dysfunction drugs – Viagra being the poster child of the problem.i Other categories of fake pills included treatments for depression.ii The common denominator was patient shame and embarrassment. Ordering from seemingly benign (i.e., “from Canada”) websites seemed like a safe and anonymous way to address their conditions without having to visit either a physician, mental health professional or pharmacist. A second category of counterfeit prey were people seeking higher risk drugs (opioids, steroids, etc.) to facilitate a more dangerous lifestyle. The rationale for this second group was easier access to more dangerous (often controlled) substances.iii To respond to this emerging threat, the FDA formed a Counterfeit Drug Task Force in July 2003.iv As a former FDA Associate Commissioner, I was proud to serve as a member of that task force.
    [Show full text]
  • Download Open Letter
    1 Supply projections include vaccines produced by Pfizer/BioNTech, Moderna, AstraZeneca/Oxford, Johnson & Johnson, Novavax, and CureVac. Amanda Glassman J. Stephen Morrison Gary Edson Mark McClellan Executive Vice President, Senior Vice President and President, COVID Director, Duke-Margolis Center for Global Director, Global Health Collaborative Center for Health Policy, Development; CEO of CGD Policy Center, Center for Duke University Europe; and Senior Fellow Strategic and International John Bridgeland Studies CEO, COVID Krishna Udayakumar Rachel Silverman Collaborative Director, Duke Global Policy Fellow, Center for Katherine Bliss Health Innovation Center, Global Development Senior Fellow, Global Anjali Balakrishna Duke University Health Policy Center, Program Director, COVID Prashant Yadav Center for Strategic and Collaborative Michael Merson International Studies Senior Fellow, Center for Wolfgang Joklik Professor Global Development of Global Health, Duke Anna McCaffrey Global Health Institute, Fellow, Global Health Duke University Policy Center, Center for Strategic and International Studies Thomas Bollyky Helene Gayle William H. Frist Senior Fellow, Council on Foreign President and Chief Executive Former U.S. Senate Majority Relations Officer, The Chicago Community Leader Trust Scott Gottlieb Margaret (Peggy) Hamburg Amb [ret] Jimmy Kolker Resident Fellow, American Former Commissioner of the US Former Assistant Secretary, Enterprise Institute, and former Food and Drug Administration, Global Affairs, Department Health Commissioner
    [Show full text]
  • Participant Bios
    Sentinel Initiative Public Workshop Participant Biographies Mark McClellan, MD, PhD is director of the Engelberg Center for Health Care Reform and Leonard D. Schaeffer Chair in Health Policy Studies at the Brookings Institution. At the Center, his work focuses on promoting high-quality, innovative and affordable health care. A doctor and economist by training, he also has a highly distinguished record in public service and in academic research. Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services (CMS) and former commissioner of the Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy. These include the Medicare prescription drug benefit, the FDA’s Critical Path Initiative, and public-private initiatives to develop better information on the quality and cost of care. Dr. McClellan chairs the FDA’s Reagan-Udall Foundation, is co-chair of the Quality Alliance Steering Committee, sits on the National Quality Forum’s Board of Directors, is a member of the Institute of Medicine, and is a research associate at the National Bureau of Economic Research. He previously served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House, and was an associate professor of economics and medicine at Stanford University. Margaret Hamburg, MD is Commissioner of Food and Drugs, confirmed on May 18, 2009, by a unanimous Senate vote. The second woman to be nominated for the position, Dr. Hamburg is exceptionally qualified to serve with her training and experience as a medical doctor, scientist, and public health executive.
    [Show full text]
  • Overruling the Food and Drug Administration
    Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Alisha Crovetto, Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action (May 2012). Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:10985168 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action Alisha Crovetto Harvard Law School J.D. Candidate, 2013 May 2012 Food & Drug Law Course Paper Abstract On December 7, 2011, newspaper headlines from coast to coast announced that Plan B One-Step, a form of emergency contraception, would not be made available to females under seventeen without a prescription. The denial of over-the-counter (“OTC”) status, though newsworthy itself, drew particular attention because of the unusual nature of the decision. As the New York Times announced, “[f]or the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration .
    [Show full text]
  • The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007
    The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 -name redacted-, Coordinator Specialist in Biomedical Policy -name redacted- Specialist in Nutrition and Food Safety -name redacted- Specialist in Drug Safety and Effectiveness -name redacted- Specialist in Public Health and Bioethics January 29, 2008 Congressional Research Service 7-.... www.crs.gov RL34334 CRS Report for Congress Prepared for Members and Committees of Congress The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 Summary Considerable attention has been focused on the ability of the Food and Drug Administration (FDA) to accomplish its mission with the funds provided by congressional appropriations and user fees. FDA regulates a wide range of products valued at more than $1 trillion in the U.S. economy. The agency plays a key public health role. FDA is responsible for the safety of most foods (human and animal) and cosmetics, and it regulates both the safety and the effectiveness of human drugs, biologics (e.g., vaccines), medical devices, and animal drugs. In congressional hearing testimony and at other public venues, former FDA Commissioners, interest group representatives, and former high-ranking individuals in the agency or in the Department of Health and Human Services have argued that FDA is underfunded and at risk of being unable to fulfill all the statutory responsibilities assigned by Congress. Reports by the Institute of Medicine, the Government Accountability Office, and the FDA Science Board have made similar observations. The main voices in support of FDA budget levels, past and present, have been representatives of the various presidential administrations. Calls for cutting the FDA budget or maintaining it at the current level come from organizations, such as CATO and the Hoover Institute, that propose limitations on the agency’s authority and, therefore, its need for funding.
    [Show full text]
  • Reducing Global COVID Vaccine Shortages
    Reducing Global COVID Vaccine Shortages: New Research and Recommendations for US Leadership April 15, 2021 Mark McClellan, MD, PhD Krishna Udayakumar, MD, MBA Michael Merson, MD Gary Edson, JD, MBA Authors Mark McClellan, Duke-Margolis Center for Michael Merson, Duke Global Health Health Policy Institute Krishna Udayakumar, Duke Global Health Gary Edson, COVID Collaborative Innovation Center Acknowledgements We thank Beth Boyer and Adam Kroetsch for assistance with our analyses and editing, and Morgan Romine and Patricia Green for editing and design support. We also thank Mark Dybul and Steve Morrison for helpful feedback on various aspects of this report. Disclosures Mark McClellan, MD, PhD, directs the Duke-Margolis Center for Health Policy, was Commissioner of the Food and Drug Administration from 2002-04 and Administrator of the Centers for Medicare and Medicaid Services from 2004-06. He is an independent director on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and receives fees for serving as an advisor for Arsenal Capital Partners, Blackstone Life Sciences, and MITRE. Krishna Udayakumar, MD, MBA, reports that the following organizations have provided research and operational support (funding and/or in-kind) through Duke-affiliated non-profit, Innovations in Healthcare, and/or Duke University in the past 12 months, or direct fees/honoraria, or represent equity holdings: Amazon, Amgen, AstraZeneca, Bayer, Bill and Melinda Gates Foundation, Grand Challenges Canada, McKinsey & Company, Medtronic, Pfizer, Pfizer Foundation, Takeda, USAID, Vynamic, WeberShandwick, World Economic Forum. Michael H Merson, MD, reports in the past 12 months fees/honoraria for serving as an advisor to Weber Shandwick and the National Basketball Association.
    [Show full text]
  • Crawford E-Transcript.Ptx
    VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D. CONDUCTED ON WEDNESDAY, MAY 24, 2006 Page 1 1 UNITED STATES DISTRICT COURT 2 EASTERN DISTRICT OF NEW YORK 3 - - - - - - - - - - - - - - X 4 ANNIE TUMMINO, et al., : 5 Plaintiffs, : 6 v. : No. 05-CV-366(ERK/VVP) 7 ANDREW C. VON ESCHENBACH, : (Korman, C.J.) 8 as Acting Commissioner of : (Pohorelsky, M.J. 9 The Food & Drug : 10 Administration, : 11 Defendant. : 12 - - - - - - - - - - - - - - X 13 14 Videotaped Deposition Of 15 LESTER M. CRAWFORD, D.V.M., Ph.D. 16 Washington, D.C. 17 Wednesday, May 24, 2006 18 9:11 a.m. 19 20 Job No. 1-78974 21 Pages 1 - 244 22 Reported by: Jacquelyn C. Jarboe L.A.D. REPORTING & DIGITAL VIDEOGRAPHY - (800) 292-4789 (202) 861-3410 (800) 292-4789 (301) 762-8282 (703) 288-0026 (410) 539-3664 VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D. CONDUCTED ON WEDNESDAY, MAY 24, 2006 Page 2 1 Videotaped deposition of LESTER M. CRAWFORD, 2 D.V.M., Ph.D., held at the offices of: 3 4 5 Arnold & Porter LLP 6 555 Twelfth Street, Northwest 7 Washington, D.C. 20004 8 (202) 827-1152 9 10 11 12 13 14 Pursuant to agreement, before Jacquelyn C. 15 Jarboe, Notary Public in and for the District of 16 Columbia. 17 18 19 20 21 22 L.A.D. REPORTING & DIGITAL VIDEOGRAPHY - (800) 292-4789 (202) 861-3410 (800) 292-4789 (301) 762-8282 (703) 288-0026 (410) 539-3664 VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D.
    [Show full text]
  • FDA Finally Approves Plan B—But with Restrictions
    FDA finally approves Plan B—but with restrictions New York Janice Hopkins Tanne The US Food and Drug Administration has finally approved the emergency contraceptive Plan B for sale over the counter to women aged 18 or over. Plan B is a two pill, high dose regimen of the oral contraceptive levonorgestrel. It is about 90% effective in preventing pregnancy when taken within 72 hours of unprotected sex. Plan B will be available towards the end of the year at a cost of $25 (£13; €20) to $40. Women will have to request it from a pharmacist in a pharmacy that is licensed to sell it or from a health clinic. They will have to show government issued identification, such as a driver’s licence, proving they are aged 18 or older. Younger women will need a doctor’s prescription. Men aged 18 or older will also be able to buy the drug for their partner, a move that has raised concern that they may buy it for women under 18. It will not be sold at petrol stations or in convenience stores. The manufacturer, Barr Pharmaceuticals, will survey pharmacies to see that they follow the rules. The FDA’s acting commissioner, Andrew von Eschenbach, approved Plan B three days after President Bush said that he supported approval of the drug for women aged over 18, with prescription only access for younger women. In his approval letter Dr von Eschenbach noted that buyers of nicotine patches and some other drugs already had to prove they were at least 18. The approval came nearly three years after the FDA’s own expert advisory committees and professional staff recommended that the drug be available over the counter for women of all ages.
    [Show full text]
  • COVID-19: a Weekly Health Care Update from Washington May 4-8, 2020 in BRIEF DEEP DIVE
    COVID-19: A Weekly Health Care Update from Washington May 4-8, 2020 IN BRIEF What Happened This Week: The Senate returned to Washington this week and conducted a handful of COVID-related hearings – all with modified layouts in an effort to adhere to social distancing guidelines. The Trump Administration posted several resources online for providers and facilities seeking clarification on the distribution of Provider Relief Funds. The Department also announced the distribution of over $500 million in funding under the recently enacted Paycheck Protection Program and Health Care Enhancement Act to expand COVID-19 testing nationwide. Members of the House of Representatives still have not returned, but the Democratic majority continues to put the finishing touches on another round of legislation to respond to the pandemic. What to Expect Next Week: Expect the Senate to reconvene in Washington next week. The House schedule is still fluid, although it’s possible that Members could be called on to return to Washington as well. It’s also possible that House Democratic Leadership will reveal the details of their next COVID-19 legislative response proposal (CARES Act “2.0”). DEEP DIVE Senate Returns to Washington After Five Weeks of Working Remotely Senators returned to Washington on Monday, May 4 after working remotely for weeks due to the coronavirus. In an effort to pick up with business as usual, the chamber conducted a handful of hearings this week, including one held by members of the Senate HELP Committee to examine new coronavirus tests. Witnesses included NIH Director Dr. Francis Collins and BARDA Acting Director Dr.
    [Show full text]
  • The Opioid Epidemic and Emerging Public Health Policy Priorities
    OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH THE OPIOID EPIDEMIC AND EMERGING PUBLIC HEALTH POLICY PRIORITIES PRESENTED TO THE AMA NATIONAL ADVOCACY CONFERENCE February 13, 2019 ADMIRAL BRETT P. GIROIR, M.D. Assistant Secretary for Health and Senior Advisor for Opioid Policy THE STATE OF OPIOID MISUSE IN AMERICA (2017) 11.4 million 2.1 million 53.1% people misused opioids people had an opioid obtained the last in the past year use disorder pain reliever they - 11.1 million misused pain relievers - 1.7 million people with a prescription misused from a pain reliever use disorder - 886,000 used heroin friend or relative - 652,000 people with a heroin use - 562,000 both misused pain disorder relievers and heroin - 252,000 had both pain reliever and 36% heroin use disorders from a prescription from a healthcare Main reasons for opioid misuse: Pain 62.6% provider OFFICE OF THE NSDUH, 2017 Data; published Sept. 2018 ASSISTANT SECRETARY FOR HEALTH 2 U.S. DRUG OVERDOSE DEATHS THE MOST CRITICAL PUBLIC HEALTH CHALLENGE OF OUR TIME 80,000 70,000 70,237 All Drug 60,000 Overdoses 50,000 47,600 40,000 Opioid 30,000 Overdoses 20,000 10,000 0 OFFICE OF THE SOURCE: NCHS, National Vital Statics System, Mortality ASSISTANT SECRETARY FOR HEALTH 3 OVERDOSE MORTALITY BY CLASS OF DRUG ADAPTED FROM CDC STATISTICS, JANUARY 2019 NAT & SEMI – SYNTHETIC PSYCHO- HEROIN METHADONE COCAINE SYNTHETIC OPIOIDS STIMULANTS JUNE 2017 * 16,622 15,546 3,357 26,057 13,367 9,446 JUNE 2018 * 15,283 13,929 3,283 31,551 15,095 11,741 Change -8.06% -10.04% -2.20% 21.08% 12.93% 24.30% https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm >70% of Cocaine Deaths also have Opioids Detected OFFICE OF THE • Number of predicted deaths for the 12 months ending in June of the indicated year ASSISTANT SECRETARY FOR HEALTH 4 4 SHOCKING LEVELS OF ILLICIT DRUG SMUGGLING Feds make largest fentanyl bust in U.S.
    [Show full text]