DOCSLIB.ORG

Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics August 2019 LEADERSHIP William H

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics August 2019 LEADERSHIP William H. Frist, M.D. Mark McClellan, M.D., Ph.D. Former U.S. Senate Majority Leader Robert J. Margolis Professor of Business, Medicine, Senior Fellow, Bipartisan Policy Center and Policy, Duke University Founding Director, Duke-Margolis Center for Robert Califf, M.D., Ph.D. Health Policy Professor of Medicine, Donald F. Fortin, M.D., Former Administrator, Centers for Medicare and Professor of Cardiology, Duke School of Medicine Medicaid Services Member, Duke Clinical Research Institute Former Commissioner, Food and Drug Administration Former Commissioner, Food and Drug Administration Andrew von Eschenbach, M.D. President, Samaritan Health Initiatives Former Commissioner, Food and Drug Administration Former Director, National Cancer Institute Senior Fellow, Bipartisan Policy Center STAFF G. William Hoagland Janet M. Marchibroda Senior Vice President Fellow, Bipartisan Policy Center CONSULTANTS Gregory Daniel, Ph.D., R.Ph. Morgan Romine Deputy Director, Duke Margolis Center for Research Director, Duke Margolis Center for Health Policy Health Policy Clinical Professor, Fuqua School of Business, Mark Segal, Ph.D., FHIMSS Duke University Principal, Digital Health Policy Advisors ACKNOWLEDGMENTS The Bipartisan Policy Center would like to thank the Jayne Koskinas Ted Giovanis Foundation for Health and Policy for their generous support for this project. BPC would like to thank the leadership of this effort, including Senator Bill Frist, Dr. Rob Califf, Dr. Mark McClellan, and Dr. Andrew von Eschenbach, for their guidance, as well as Morgan Romine, Gregory Daniel, Mark Segal, and Ann Gordon who contributed to the development of this report. BPC would also like to thank several members of the BPC and Duke-Margolis Center for Health Policy staff, including Anand Parekh and Katherine Hayes of BPC and Marianne Hamilton-Lopez, Christina Silcox, and Nirosha Mahendraratnam Lederer of the Duke-Margolis Center for Health Policy, who reviewed and provided input to the report. Finally, BPC would like to extend its gratitude to the number of individuals—listed in the acknowledgments section—who participated in roundtable discussions, interviews, and meetings, to inform the development of report. DISCLAIMER The findings and recommendations expressed herein do not necessarily represent the views or opinions of the Bipartisan Policy Center’s founders or its board of directors. 2 bipartisanpolicy.org Letter from the Former FDA Commissioners Exciting progress has been made in recent years in the discovery and development of new therapies and treatments, particularly for patients fighting diseases thought to be incurable just a generation ago. Scientific breakthroughs coupled with a faster, more streamlined process for the development of novel drugs and biologics is accelerating the pace at which patients are receiving new, more effective treatments. But this acceleration is also enabling market entry based on biomarkers and surrogates rather than definitive information about risks and benefits in practice. These advances are set against the backdrop of continually rising health care costs, declining life expectancy, and ongoing concerns about affordability and disparities in the U.S. health care system. Efforts to shift from volume-based to value-based payment for care delivery are showing promise and providing lessons that can inform new models of payment for medical products that can help address these concerns. Just as the life cycle of drug development is being modernized through the use of real-world data and real-world evidence, so too can new models of value-based payment benefit from data generated through care processes and by patients themselves. Real-world data and evidence can improve regulatory and payment decision-making. It can also provide generalizable knowledge to support clinician and patient decision-making. We have already made significant progress in creating a framework for the use of real-world evidence in regulatory decision-making, but there is more work to do. This report examines both the progress so far and the barriers we must address if we are to meaningfully expand the role of real- world data and evidence to inform the discovery, development, and delivery of new therapies for patients, provide high-quality evidence about risks and benefits in practice, and inform which therapies are best for which patients. The report’s recommendations focus on clearing barriers to the access and use of real-world data to provide an evidence base for regulatory evaluation and value-based payment programs, expanding opportunities to use new data sources and approaches, and advancing new models of collaboration among payers, manufacturers, regulators, clinicians, and—most importantly—patients. We are living in an age of remarkable scientific progress. We owe it to the patients we serve to support that progress by continually examining and improving our processes to deliver new, effective therapies to them as fast as is safely possible. We believe the recommendations in this report are important steps toward reaching that critical goal. Sincerely, Robert Califf, M.D., Ph.D. Andrew von Eschenbach, M.D. Mark McClellan, M.D., Ph.D. Professor of Medicine, Donald F. Fortin, M.D., President, Samaritan Health Initiatives Robert J. Margolis Professor of Business, Professor of Cardiology, Duke School of Medicine Former Commissioner, Food and Medicine, and Policy, Duke University Member, Duke Clinical Research Institute Drug Administration Founding Director, Duke-Margolis Center for Former Commissioner, Food and Former Director, National Cancer Institute Health Policy Drug Administration Former Administrator, Centers for Medicare and Medicaid Services Former Commissioner, Food and Drug Administration bipartisanpolicy.org 3 5 Executive Summary 10 Introduction 12 Using Real-World Evidence to Support Value-Based Payment 14 Using Real-World Evidence to Support Regulatory Evaluation 17 Policy Recommendations Assuring Adequate Funding of Real-World Evidence Activities Improving Regulatory Clarity Improving Access to Data Improving Reliability and Relevance of Data Leveraging Technology to Gain Input Directly from Patients Expanding Efforts to Leverage Artificial Intelligence Accelerating Pilots and Demonstration Projects for New Data Sources and Additional Medical Products Assuring Privacy and Confidentiality Advancing Innovative, New Models of Drug Development Addressing Regulatory Barriers Expanding CMS Workforce to Support Evaluation of New Emerging Therapies Promoting Cooperation and Collaboration 39 Conclusion 40 Acknowledgments 41 Endnotes 4 bipartisanpolicy.org Executive Summary The amount of electronic health care data is increasing at unprecedented rates, due to the now widespread adoption of electronic health records (EHRs) and other technology in health care, as well as the significant increase in the number of patients that are now using technologies—such as wearables, biosensors, apps, and other digital health tools—to track their activities and health status and connect with the health system. These real-world data sources provide the opportunity to improve the evidence base for the development of new drugs and biologics, regulatory evaluation by the Food and Drug Administration (FDA), and new value-based payment arrangements, which align pricing or payments with outcomes. Real-world data and evidence have significant bipartisan support. Several provisions related to real-world evidence were contained in the 21st Century Cures Act passed and signed into law in December 2016, as well as the FDA Reauthorization Act of 2017 and other user fee legislation passed in 2017. The FDA has taken several steps to advance the generation and use of real-world evidence for regulatory decision-making, including the publication of the Framework for FDA’s Real-World Evidence Program (FDA Framework) in December 2018. While there are many opportunities to leverage these new data sources as real-world evidence to support regulatory efforts and new value-based payment arrangements for drugs and biologics, there are also barriers to their use. The recommendations below are expected to advance the generation and use of real-world evidence for regulatory evaluation and value-based payment decision-making. 1. ASSURING ADEQUATE FUNDING OF REAL-WORLD EVIDENCE ACTIVITIES 1.1 Fully Fund the FDA’s FY2020 Budget Request for the Creation of a New Medical Data Enterprise to Advance the Use of Real-World Evidence As it finalizes appropriations for FY2020, Congress should fully fund the FDA’s $60 million budget request for a Medical Data Enterprise to advance the use of real-world evidence to evaluate both effectiveness and safety of drugs, biologics, and devices. 2. IMPROVING REGULATORY CLARITY 2.1 Continue and Expand Upon Efforts to Improve Regulatory Clarity The FDA should build on the recent momentum related to real-world evidence and develop and publish timely guidance—as required by the 21st Century Cures Act—regarding the circumstances under which sponsors and the FDA may rely on real-world evidence to help support the approval of a new indication for an existing drug, as well as to help support or satisfy post-approval study requirements. Such guidance should address key issues raised within the recently released FDA Framework. The guidance should be informed not only by the FDA Framework, but also by insights gained
Recommended publications
  • In an Ehr World

    In an Ehr World

    10.5 IDEAS TO THRIVE IN AN EHR WORLD PUBLISHED BY “The future is already here - it’s just not evenly distributed.” William Gibson (in 1993) INTRODUCTION: Most of our industry’s attention thus far has gone towards implementing electronic health record systems (EHRs). While it seems to be end in itself, rolling out an EHR is one of the many building blocks towards a digital platform that can change how healthcare is delivered. This paper gives 10.5 ideas that can help doctors, clinicians and administrators save time and therefore money in an EHR world. These ideas exist as early signals in our industry. It’s only a matter of time when these signals amplify to become an accepted norm. ABOUT THE AUTHOR: Praveen Suthrum, (Twitter: @suthrum) Praveen Suthrum is the President and Co-founder of NextServices, a healthcare management and technology company. He works on product design and technology. He contributed to The New Age of Innovation (by C.K. Prahalad and M.S. Krishnan) that was named the best book on innovation by The Economist in 2008. He has an MBA from The Ross School of Business at University of Michigan and attended Singularity University. Praveen loves to trek and has most recently climbed Mt. Kilimanjaro. 1 Get your records through a mobile cloud. Look at patients, not a computer. Your bank account, trading account, email, family pictures are all on the cloud - you can even access them through your iPad. More than the money required to keep servers running, taking back-ups and engaging IT staff, server-based systems waste time that can be spent elsewhere.
  • The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

    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.
  • Artificial Intelligence: the Key to Unlocking Novel Real-World Data?

    Artificial Intelligence: the Key to Unlocking Novel Real-World Data?

    Artificial Intelligence: The Key to Unlocking Novel Real-World Data? While Artificial intelligence stands to make significant contributions to clinical research due to its unparalleled ability to translate unstructured data into real-world evidence (RWE), significant challenges remain in achieving regulatory-grade evidence. By Michele Cleary 16 | March/April 2019 Value & Outcomes Spotlight Artificial intelligence (AI) is revolutionizing healthcare services. From improving disease detection to supporting treatment decision making, AI has become ubiquitous in care delivery. Now AI is poised to transform the drug and device development process, helping researchers refine the approval process and significantly cutting both the time and the expense needed to bring products to market. While AI has long been used to facilitate recruitment of study subjects, optimize study design, and support patient adherence to study protocols, AI’s greatest contribution to clinical research may still be on the horizon— unlocking the data richness that lies within the mountains of novel real- world data (RWD) sources. This article explores how AI may improve clinical research through its ability to better translate RWD into real-world evidence (RWE), thus providing more valid evidence of clinical benefits and risks. Dan Riskin, MD, of Verantos, Rich Glinklich, MD of OM1, and Sebastian Schneeweiss, MD of Aetion all shared their valuable insights into how AI is transforming clinical research. THE SEARCH FOR REGULATORY-GRADE DATA With innovations in digital data, HEOR researchers are facing explosive growth in novel RWD sources. But as researchers move from traditional RWD sources (eg, registries and claims data) to these novel data sources, unstructured data present a significant opportunity and challenge.
  • Mark B. Mcclellan, M.D., Ph.D. Duke University 100 Fuqua Drive Box 90120 Durham N.C

    Mark B. Mcclellan, M.D., Ph.D. Duke University 100 Fuqua Drive Box 90120 Durham N.C

    CURRICULUM VITAE MARK B. MCCLELLAN, M.D., PH.D. DUKE UNIVERSITY 100 FUQUA DRIVE BOX 90120 DURHAM N.C. 27708 EDUCATION: 1993 Ph.D., Economics, Massachusetts Institute of Technology 1992 M.D., Harvard-MIT Division of Health Science and Technology, cum laude 1991 M.P.A., Regulatory Policy, Kennedy School of Government, Harvard University 1985 B.A., English/Biology, University of Texas, Austin, summa cum laude CLINICAL TRAINING: 1996 Diplomate, American Board of Internal Medicine 1993 – 1995 Resident in Internal Medicine, Department of Medicine, Brigham and Women's Hospital EMPLOYMENT: CURRENT POSTION 2015 - Present Director of the Duke-Margolis Center for Health Policy 2015 - Present Robert J. Margolis MD Professor of Business, Medicine and Health Policy 2015 - Present Faculty Member & Sr. Policy Advisor, University of Texas, Austin, Dell Medical School PREVIOUS POSITIONS 2007 – 2015 Senior Fellow in Economic Studies, Brookings Institution 2013 – 2015 Director, Initiatives on Value and Innovation in Health Care, Brookings Institution 2007 – 2013 Director, Engelberg Center for Health Care Reform, Brookings Institution 2006 – 2007 Visiting Senior Fellow, AEI-Brookings Joint Center for Regulatory Studies, American Enterprise Institute and the Brookings Institution 2004 – 2006 Administrator, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services 2002 – 2004 Commissioner, U. S. Food and Drug Administration 2001 – 2002 Member, Council of Economic Advisers, and Senior Director for Health Care Policy, White House
  • Ontario Biology Day 2014 Abstracts

    Ontario Biology Day 2014 Abstracts

    Ontario Biology Day 2014 University of Toronto Mississauga March 22-23, 2014 Abstracts We would like to thank our sponsors Titanium Sponsor Platinum Sponsors Office of the VP Research, UTM Office of the Dean University of Toronto Mississauga Fluid Surveys 2 Gold Sponsors Canadian Society of Zoologists 3 Ontario Biology Day 2014 March 22-23 University of Toronto Mississauga Conference Organizing Committee Daniel Almeida Lisa Cheung Yen Du Sanja Hinic-Frlog Aaron LeBlanc Fiona Rawle Audrey Reid Christoph Richter Published by: University of Toronto Mississauga Department of Biology 3359 Mississauga Road Mississauga, ON L5L 1C6 http://www.utm.utoronto.ca/biology Twitter: @UTMBiology Copyright 2014 Logo Design by Scott Winrow 4 Welcome to Ontario Biology Day 2014 at the University of Toronto Mississauga! We are thrilled to welcome you to the 27th annual Ontario sponsors by signing the “Thank you to our sponsors” card at the Biology Day (OBD) undergraduate student research conference. registration desk. And importantly, we would like to extend a On behalf of the Department of Biology at the University of thank you to all of the supervisors and students that have Toronto Mississauga, we wish you the best of success in travelled to the conference this weekend to present their work presenting your research to your peers this weekend, and and share in this conference experience. This conference is a congratulate you on your achievement in undergraduate biology celebration of your research, and we congratulate you on your research. hard work and research achievements. OBD is an annual event that showcases and celebrates biology Sincerely, research conducted by undergraduate students across Ontario.
  • Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics July 2019 LEADERSHIP William H

    Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics July 2019 LEADERSHIP William H

    Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics July 2019 LEADERSHIP William H. Frist, M.D. Mark McClellan, M.D., Ph.D. Former U.S. Senate Majority Leader Robert J. Margolis Professor of Business, Medicine, Senior Fellow, Bipartisan Policy Center and Policy, Duke University Founding Director, Duke-Margolis Center for Robert Califf, M.D., Ph.D. Health Policy Professor of Medicine, Donald F. Fortin, M.D., Former Administrator, Centers for Medicare and Professor of Cardiology, Duke School of Medicine Medicaid Services Member, Duke Clinical Research Institute Former Commissioner, Food and Drug Administration Former Commissioner, Food and Drug Administration Andrew von Eschenbach, M.D. President, Samaritan Health Initiatives Former Commissioner, Food and Drug Administration Former Director, National Cancer Institute Senior Fellow, Bipartisan Policy Center STAFF G. William Hoagland Janet M. Marchibroda Senior Vice President Fellow, Bipartisan Policy Center CONSULTANTS Gregory Daniel, Ph.D., R.Ph. Morgan Romine Deputy Director, Duke Margolis Center for Research Director, Duke Margolis Center for Health Policy Health Policy Clinical Professor, Fuqua School of Business, Mark Segal, Ph.D., FHIMSS Duke University Principal, Digital Health Policy Advisors ACKNOWLEDGMENTS The Bipartisan Policy Center would like to thank the Jayne Koskinas Ted Giovanis Foundation for Health and Policy for their generous support for this project. BPC would like to thank the leadership of this effort, including Senator Bill Frist, Dr. Rob Califf, Dr. Mark McClellan, and Dr. Andrew von Eschenbach, for their guidance, as well as Morgan Romine, Gregory Daniel, Mark Segal, and Ann Gordon who contributed to the development of this report.
  • FDA Regulatory and Compliance Monthly Recap

    FDA Regulatory and Compliance Monthly Recap

    FDA Regulatory and Compliance Monthly Recap FEBRUARY 2016 KEY FINDINGS FDA publishes guidance on human factors review for devices, combination products FDA publishes guidance on human factors review for devices, The FDA published two draft guidance documents and one final combination products . 1 guidance document to address the incorporation of human factors FDA enforcement statistics for FY 2015 point to more enforcement by studies in the development of medical products and combination CDRH than by CDER . 2 products. The guidance documents add to two existing documents on FDA publishes updated guidance on human factors: one on human device factors in medical device design selective safety data collection for and one on safety considerations to minimize medication errors. late-stage premarket, postapproval clinical studies . 4 The first draft guidance, called List of Highest Priority Devices for Dr. Robert Califf to lead FDA Human Factors Review, addresses what devices require human following confirmation as commissioner . 5 factors data to be included in premarket submissions. The medical devices the FDA says require human factors data are those that it believes have the potential to cause serious harm if used improperly, such as anesthesia machines, duodenoscopes, automated external defibrillators, infusion pumps, robotic surgery devices and ventilators, among others. Premarket submissions for devices listed in the draft guidance should include a human factors test report and data, or a detailed rationale for not including such information. The second draft guidance document addresses the incorporation of human factors studies in the development of combination products, which include any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device and a biological product.
  • Programs Director for IT Services Research and Where He Created the Global IT Service Research and Innovation Institute, SRII (

    Programs Director for IT Services Research and Where He Created the Global IT Service Research and Innovation Institute, SRII (

    SRII China Summit 2015 Theme: Innovating Digital Economy — Advancing Industry 4.0 Transformation Time： March 4-6, 2015 Venue: Shanghai, China Background Advanced Industrial Technology Research Institute in Shanghai Jiao Tong University(AITRI) is excited to team up with Service Research & Innovation Institute (SRII) to host 2015 SRII China Summit：Innovating Digital Economy— Advancing Industry 4.0 Transformation from March 4th to 6th, 2015 in Shanghai Lingang New City. Senior leaders from key industry sectors, academia, research, government and professional organizations in India, Asia, Europe and USA will be invited to discuss IOT, big data, Industry 4.0, Smart-Healthcare, Education and other related topics. The summit is well aligned with innovation agenda for industry upgrade and emerging market in Shanghai as well as in China. SRII (Service Research & Innovation Institute) is a global ICT Research & Innovation Institute with a mission to drive ICT Innovation (Cloud computing, Mobile Services, Big data analytics, Security, Social) for major sectors of service economy (government, education, healthcare, transportation, manufacturing, agriculture & food safety, and etc) around the world. SRII member include senior leaders from industry, academia, research and government organizations from around the world. Advanced Industrial Research Institute (AITRI) promotes the emerging pillar industries transferred from the high-tech research findings by maximizing the market value of the industrial technologies. AITRI is building an international
  • Obituary: Thomas Henry Kunz (1938–2020)

    Obituary: Thomas Henry Kunz (1938–2020)

    applyparastyle "fig//caption/p[1]" parastyle "FigCapt" applyparastyle "fig" parastyle "Figure" Journal of Mammalogy, 101(6):1752–1780, 2020 DOI:10.1093/jmammal/gyaa100 Published online November 20, 2020 Obituary: Thomas Henry Kunz (1938–2020) Dr. Thomas Henry Kunz (Fig. 1), an internationally rec- Tom’s early interest in science was sparked by a fifth-grade ognized expert on the ecology and behavior of bats and teacher who had her students undertake a project raising silk- Professor at Boston University, passed away on 13 April 2020 worms. Tom commented in his autobiography that, “This ex- in Dedham, Massachusetts, at the age of 81 as the result of perience left an indelible impression on me, and highlights the complications from COVID-19. Tragically, Dr. Kunz’s career power of observational learning” (197:150). Tom also had an was cut short when he was the victim of a pedestrian–auto- early experience with a bat colony inside a stove in a fishing mobile accident on 26 October 2011. He was struck crossing cabin. After chasing and removing the bats from the cabin, a street in Toronto, Canada, while participating in his favorite Tom recalled, “being fascinated by these little winged ‘crit- annual meeting, that of the North American Society for Bat ters’” (197:150). Tom became an Eagle Scout and remembered Research (NASBR). He never fully recovered from the head taking great pride in earning his nature merit badge, which re- trauma suffered and was not able to live independently, but quired learning the names of local plants and animals. When he enjoyed daily visits from his wife and frequent visits from Tom graduated from high school, he was planning to attend his children and grandchildren as well as friends.
  • Appendix A-1 UNITED STATES COURT of APPEALS for the DISTRICT of COLUMBIA CIRCUIT ___Argued Sept. 23, 2020 Decided Dec

    Appendix A-1 UNITED STATES COURT of APPEALS for the DISTRICT of COLUMBIA CIRCUIT ___Argued Sept. 23, 2020 Decided Dec

    Appendix A-1 UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT ________ Argued Sept. 23, 2020 Decided Dec. 1, 2020 No. 20-5048 MOOSE JOOCE, ET AL., APPELLANTS v. FOOD & DRUG ADMINISTRATION, ET AL., APPELLEES ________ Consolidated with 20-5049, 20-5050 ________ Appeals from the United States District Court for the District of Columbia (No. 1:18-cv-00203) (No. 1:18-cv-01615) (No. 1:19-cv-00372) ________ Jonathan Wood argued the cause for appellants. With him on the briefs were Damien M. Schiff and Oliver Dunford. Lindsey Powell, Attorney, U.S. Department of Justice, argued the cause for appellees. With her on the brief were Mark B. Stern and Joshua Revesz, Attorneys, Robert P. Charrow, General Counsel, U.S. Department of Health and Human Services, and Peter G. Dickos, Associate Chief Counsel, Food and Drug Administration. Appendix A-2 Before: ROGERS and PILLARD, Circuit Judges, and SENTELLE, Senior Circuit Judge. Opinion of the Court by Circuit Judge ROGERS. ROGERS, Circuit Judge: Less than a year ago, the court rejected three challenges by an e-cigarette manufacturer and distributor, and an e-cigarette industry group to a rule deeming e-cigarettes to be “tobacco products” subject to regulation under the Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (“the Act”). In Nicopure Labs, LLC v. FDA, 944 F.3d 267, 271 (D.C. Cir. 2019), the court held that it was “entirely rational and nonarbitrary [for the Food and Drug Administration (“FDA”)] to apply to e-cigarettes the Act’s baseline requirement that, before any new tobacco product may be marketed, its manufacturer show the FDA that selling it is consistent with the public health.” The court also rejected First Amendment objections to the Act’s barring of claims that e-cigarettes are safer than existing products absent such a demonstration and ban on the distribution of free e-cigarette samples.
  • Congressional Record United States Th of America PROCEEDINGS and DEBATES of the 114 CONGRESS, SECOND SESSION

    Congressional Record United States Th of America PROCEEDINGS and DEBATES of the 114 CONGRESS, SECOND SESSION

    E PL UR UM IB N U U S Congressional Record United States th of America PROCEEDINGS AND DEBATES OF THE 114 CONGRESS, SECOND SESSION Vol. 162 WASHINGTON, MONDAY, FEBRUARY 22, 2016 No. 27 House of Representatives The House was not in session today. Its next meeting will be held on Tuesday, February 23, 2016, at 2 p.m. Senate MONDAY, FEBRUARY 22, 2016 The Senate met at 3 p.m. and was READING OF WASHINGTON’S been a uniform sacrifice of inclination called to order by the President pro FAREWELL ADDRESS to the opinion of duty and to a def- tempore (Mr. HATCH). The PRESIDING OFFICER. Pursuant erence for what appeared to be your de- f to the order of the Senate of January sire. I constantly hoped that it would have been much earlier in my power, PRAYER 24, 1901, the Senator from Delaware, Mr. COONS, will now read Washington’s consistently with motives which I was The Chaplain, Dr. Barry C. Black, of- Farewell Address. not at liberty to disregard, to return to fered the following prayer: that retirement from which I had been Let us pray. Mr. COONS, at the rostrum, read the Farewell Address, as follows: reluctantly drawn. The strength of my Our Father in Heaven, Your counsel inclination to do this, previous to the stands firm and sure. Fashion the To the people of the United States last election, had even led to the prepa- hearts of our lawmakers so that they FRIENDS AND FELLOW-CITIZENS: The ration of an address to declare it to desire to do Your will.
  • Department of Health & Human Services (HHS) Records Provided To

    Department of Health & Human Services (HHS) Records Provided To

    Description of document: Department of Health & Human Services (HHS) records provided to Chairman Darrell Issa, House Oversight and Government Reform Committee, concerning the administration of the Freedom of Information Act (FOIA), 2010-2011 Requested: 10-December-2011 Released date: 07-August-2014 Posted date: 12-October-2015 Source of document: FOIA Request Department of Health and Human Services (HHS) Freedom of Information Officer Hubert H. Humphrey Building, Room 729H 200 Independence Avenue, SW Washington, DC, 20201 Fax: 202-690-8320 Email: [email protected] Note: This is one of several files on the same subject for various agencies available on governmentattic.org. See: http://www.governmentattic.org/5docs/chairmanIssa.htm The governmentattic.org web site (“the site”) is noncommercial and free to the public. The site and materials made available on the site, such as this file, are for reference only. The governmentattic.org web site and its principals have made every effort to make this information as complete and as accurate as possible, however, there may be mistakes and omissions, both typographical and in content. The governmentattic.org web site and its principals shall have neither liability nor responsibility to any person or entity with respect to any loss or damage caused, or alleged to have been caused, directly or indirectly, by the information provided on the governmentattic.org web site or in this file. The public records published on the site were obtained from government agencies using proper legal channels. Each document is identified as to the source. Any concerns about the contents of the site should be directed to the agency originating the document in question.