Robert Hahn Testimony
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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 -
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. -
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 . -
Masakazu Konishi
Masakazu Konishi BORN: Kyoto, Japan February 17, 1933 EDUCATION: Hokkaido University, Sapporo, Japan, B.S. (1956) Hokkaido University, Sapporo, Japan, M.S. (1958) University of California, Berkeley, Ph.D. (1963) APPOINTMENTS: Postdoctoral Fellow, University of Tübingen, Germany (1963–1964) Postdoctoral Fellow, Division of Experimental Neurophysiology, Max-Planck Institut, Munich, Germany (1964–1965) Assistant Professor of Biology, University of Wisconsin, Madison (1965–1966) Assistant Professor of Biology, Princeton University (1966–1970) Associate Professor of Biology, Princeton University (1970–1975) Professor of Biology, California Institute of Technology (1975– 1980) Bing Professor of Behavioral Biology, California Institute of Technology (1980– ) HONORS AND AWARDS (SELECTED): Member, American Academy of Arts and Sciences (1979) Member, National Academy of Sciences (1985) President, International Society for Neuroethology (1986—1989) F. O. Schmitt Prize (1987) International Prize for Biology (1990) The Lewis S. Rosenstiel Award, Brandeis University (2004) Edward M. Scolnick Prize in Neuroscience, MIT (2004) Gerard Prize, the Society for Neuroscience (2004) Karl Spencer Lashley Award, The American Philosophical Society (2004) The Peter and Patricia Gruber Prize in Neuroscience, The Society for Neuroscience (2005) Masakazu (Mark) Konishi has been one of the leaders in avian neuroethology since the early 1960’s. He is known for his idea that young birds initially remember a tutor song and use the memory as a template to guide the development of their own song. He was the fi rst to show that estrogen prevents programmed cell death in female zebra fi nches. He also pioneered work on the brain mechanisms of sound localization by barn owls. He has trained many students and postdoctoral fellows who became leading neuroethologists. -
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. -
JOSEPH P. NEWHOUSE January 27, 2020 Dr. Newhouse Is the John D
JOSEPH P. NEWHOUSE January 27, 2020 Dr. Newhouse is the John D. MacArthur Professor of Health Policy and Management at Harvard University, Director of the Division of Health Policy Research and Education, and Director of the Interfaculty Initiative in Health Policy. He is a member of the faculties of the Harvard Kennedy School, the Harvard Medical School, the Harvard T.H. Chan School of Public Health, and the Faculty of Arts and Sciences, as well as a Research Associate of the National Bureau of Economic Research. He received B.A. and Ph.D. degrees in Economics from Harvard University and an honorary doctoral degree from the Pardee RAND Graduate School. Following his Bachelors degree, he was a Fulbright Scholar in Germany. Dr. Newhouse spent the first twenty years of his career at RAND, where he designed and directed the RAND Health Insurance Experiment. From 1981 to 1985 he was Head of the RAND Economics Department. In 1981 he became the founding editor of the Journal of Health Economics, which he edited for 30 years. He is a member of the editorial board of the American Journal of Health Economics and a past member of the editorial boards of the New England Journal of Medicine and the Journal of Economic Perspectives. In 1977 he was elected to the National Academy of Medicine (formerly the Institute of Medicine) and has served two terms on its governing Council. In 1995 he was elected a Fellow of the American Academy of Arts and Sciences. He is a past President of the Association for Health Services Research (AHSR), now AcademyHealth, of the International Health Economics Association, and was the inaugural President of the American Society of Health Economists. -
The Need to Shorten the Prescription Drug Approval Process
Valparaiso University Law Review Volume 27 Number 1 Fall 1992 pp.95-137 Fall 1992 Getting There First With the Best: The Need to Shorten the Prescription Drug Approval Process Mark A. Kassel Follow this and additional works at: https://scholar.valpo.edu/vulr Part of the Law Commons Recommended Citation Mark A. Kassel, Getting There First With the Best: The Need to Shorten the Prescription Drug Approval Process, 27 Val. U. L. Rev. 95 (1992). Available at: https://scholar.valpo.edu/vulr/vol27/iss1/3 This Notes is brought to you for free and open access by the Valparaiso University Law School at ValpoScholar. It has been accepted for inclusion in Valparaiso University Law Review by an authorized administrator of ValpoScholar. For more information, please contact a ValpoScholar staff member at [email protected]. Kassel: Getting There First With the Best: The Need to Shorten the Presc Notes GETTING THERE FIRST WITH THE BEST: THE NEED TO SHORTEN THE PRESCRIPTION DRUG APPROVAL PROCESS I. INTRODUCTION Due to unnecessary time delays, high costs and safety concerns, drug regulation in the United States is in need of reform.' The United States consistently lags behind the rest of the developed world in the approval of new, innovative, and efficient medications.2 Therefore, the Food and Drug Administration (FDA) needs to implement creative and effective changes in the prescription drug approval process3 in order to protect the health of the American public. Most Americans think that the FDA's stringent process for approving new prescription drugs guarantees that prescription drugs are successfully monitored.4 The American public assumes that safe and innovative drugs are made available to the public as quickly' and cost effectively6 as possible, while unsafe7 products are kept off the market.' However, this confidence placed in the FDA is unwarranted. -
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 -
Congress of the United States House of Representatives COMMITTEE on ENERGY and COMMERCE 2125 RAYBURN HOUSE OFFICE BUILDING WASHINGTON, DC 20515-6115
FRANK PALLONE, JR., NEW JERSEY GREG WALDEN, OREGON CHAIRMAN RANKING MEMBER ONE HUNDRED SIXTEENTH CONGRESS Congress of the United States House of Representatives COMMITTEE ON ENERGY AND COMMERCE 2125 RAYBURN HOUSE OFFICE BUILDING WASHINGTON, DC 20515-6115 Majority (202) 225-2927 Minority (202) 225-3641 October 16, 2020 Mark McClellan, M.D., Ph.D. Founding Director Duke-Margolis Center for Health Policy Duke University 100 Fuqua Drive, Box 90120 Durham, NC 27708 Dear Dr. McClellan: Thank you for appearing before the Subcommittee on Oversight and Investigations on Wednesday, September 30, 2020, at the remote hearing entitled “Pathway to a Vaccine: Ensuring a Safe and Effective Vaccine People Will Trust.” We appreciate the time and effort you gave as a witness before the Subcommittee on Oversight and Investigations. Pursuant to Rule 3 of the Committee on Energy and Commerce, members are permitted to submit additional questions to the witnesses for their responses, which will be included in the hearing record. Attached are questions directed to you from me and other members of the Committee. In preparing your answers to these questions, please address your responses to the member who has submitted the questions using the Word document provided with this letter. To facilitate the publication of the hearing record, please submit your responses to these questions by no later than the close of business on Friday, October 30, 2020. As previously noted, your responses to the questions in this letter, as well as the responses from the other witnesses appearing at the hearing, will all be included in the hearing record. -
Donald Griffin Was Able to Affect a Major Revolution in What Scien- Tists Do and Think About the Cognition of Nonhuman Ani- Mals
NATIONAL ACADEMY OF SCIENCES DONALD R. GRIFFIN 1915– 2003 A Biographical Memoir by CHARLES G. GROSS Any opinions expressed in this memoir are those of the author and do not necessarily reflect the views of the National Academy of Sciences. Biographical Memoirs, VOLUME 86 PUBLISHED 2005 BY THE NATIONAL ACADEMIES PRESS WASHINGTON, D.C. DONALD R. GRIFFIN August 3, 1915–November 7, 2003 BY CHARLES G. GROSS OST SCIENTISTS SEEK—but never attain—two goals. The M first is to discover something so new as to have been previously inconceivable. The second is to radically change the way the natural world is viewed. Don Griffin did both. He discovered (with Robert Galambos) a new and unique sensory world, echolocation, in which bats can perceive their surroundings by listening to echoes of ultrasonic sounds that they produce. In addition, he brought the study of animal consciousness back from the limbo of forbidden topics to make it a central subject in the contemporary study of brain and behavior. EARLY YEARS Donald R. (Redfield) Griffin was born in Southampton, New York, but spent his early childhood in an eighteenth- century farmhouse in a rural area near Scarsdale, New York. His father, Henry Farrand Griffin, was a serious amateur historian and novelist, who worked as a reporter and in advertising before retiring early to pursue his literary inter- ests. His mother, Mary Whitney Redfield, read to him so much that his father feared for his ability to learn to read. His favorite books were Ernest Thompson Seton’s animal 3 4 BIOGRAPHICAL MEMOIRS stories and the National Geographic Magazine’s Mammals of North America. -
The National Academies Committee on a New Government-University
NOTE: This is an unedited verbatim transcript of the Workshop on a New Government-University Partnership for Science and Security held at Stanford University on September 27-28, 2006. It was prepared by CASET Associates and is not an official report of The National Academies. Opinions and statements included in the transcript are solely those of the individual persons or participants at the workshop, and are not necessarily adopted or endorsed or verified as accurate by The National Academies. The National Academies Committee on a New Government-University Partnership for Science and Security September 28, 2006 Stanford University Bechtel Conference Center 616 Serra Mall, Encina Hall Stanford, CA Proceedings by: CASET Associates, Ltd. 10201 Lee Highway, suite 180 Fairfax, Virginia 22030 (703) 352-0091 NOTE: This is an unedited verbatim transcript of the Workshop on a New Government-University Partnership for Science and Security held at Stanford University on September 27-28, 2006. It was prepared by CASET Associates and is not an official report of The National Academies. Opinions and statements included in the transcript are solely those of the individual persons or participants at the workshop, and are not necessarily adopted or endorsed or verified as accurate by The National Academies. TABLE OF CONTENTS Page Introductions and Purpose of Meeting Jacques S. Gansler and Alice P. Gast 1 Security Concerns at National and University Laboratories Siegfried S. Hecker 3 Discussion 26 International Collaborations Jonathan Dorfan 40 Discussion 56 National Security and Academic Publishing Donald Kennedy 64 Discussion 77 Open Discussion: Moving Forward 86 NOTE: This is an unedited verbatim transcript of the Workshop on a New Government-University Partnership for Science and Security held at Stanford University on September 27-28, 2006. -
The Honorable Orrin Hatch Senator of Utah Senate Finance Committee, Chairman 104 Hart Senate Office Building Washington, DC 20510
The Honorable Orrin Hatch Senator of Utah Senate Finance Committee, Chairman 104 Hart Senate Office Building Washington, DC 20510 July 14, 2015 Dear Senator Hatch, While the undersigned often hold policy views which differ from those currently espoused by the Centers for Medicare & Medicaid Services (CMS), we write collectively to urge the confirmation of Andy Slavitt as CMS Administrator. Mr. Slavitt’s previous professional roles provide the required understanding of health markets and mechanisms, which CMS desperately needs at this time. Absent that perspective, the agency could naturally lean toward an overly prescriptive regulatory construct. Mr. Slavitt is well respected by both ideological camps and can play a constructive role in solving problems. CMS spends more tax payer money than any other federal government agency. The Administrator’s role requires a strong, seasoned executive able to make sound policy and operational judgments. Mr. Slavitt has demonstrated that ability in and out of government, in times of crisis and calm. Congress requires a relationship with the CMS Administrator characterized by civil dialog and candor. Each of us has worked with Mr. Slavitt and believes he is able to communicate and work with Congress constructively. Each of us has served either as Secretary of the United States Department of Health and Human Services, to whom the Administrator of CMS reports, or as Administrator of CMS (acting or confirmed). As former high-level officials at the Department of Health and Human Services, we are uniquely positioned to understand the Administrator’s role. Thank you for considering our views. Each of us is available to members of the Senate or their staffs who wish to have personal conversations related to this confirmation.