PORTAL faculty have the opportunity to contribute to state and national policy discussions. Our faculty often attend meetings at the Food and Drug Administration and has been invited to give Congressional Testimony on a number of occasions. We have also collaborated in the preparation of Amicus Briefs for the U.S. Supreme Court on cases of particular relevance to our work. Selected examples provided below.
National governmenT
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Designing cancer drug development to promote innovation and enhance access.
Meeting of the President’s Cancer Panel. 9 Dec 2016. |
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Options for lowering drug prices. Invited session with Sen. Amy Klobuchar. 22 Sept 2016. Lessons for Follow-On Biologics from Generic Small Molecules. Federal Trade Commission Follow-On Biologics Workshop. 4 Feb 2014 FDA Safety and Innovation Act (FDASIA) and the breakthrough drug designation: the risks of approving drugs on the basis of limited supporting data. Briefings for Senate and House of Representative Congressional Staff 2013. |
FDA testimony
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Ensuring Timely Availability and Use of Low-Cost, High-Quality Generic Drugs
Food and Drug Administration. Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access Public Meeting. 18 Jul 2017. (Video here starting at 58:21) Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products. Food and Drug Administration. Public Hearing. 10 Nov 2016. (Video here starting at 44:56) Assessing PDUFA 2012: breakthrough therapy and other expedited review and approval designations. Food and Drug Administration, Center for Drug Evaluation and Research. PDUFA Reauthorization Public Meeting. 15 Jul 2015. (Video here starting at 24:00) Studying the post-market safety and rational use of generic drugs Food and Drug Administration, Office of Generic Drugs. Generic Drug User Fee Act (GDUFA) Regulatory Science Initiatives Public Meeting. 5 June 2015. (Video here starting at 1:21:40) Does controversy during generic drug approval affect outcomes? Results from observational data, a systematic review, and surveys of patients and physicians Food and Drug Administration, Office of Generic Drugs and Office of Research & Standards 28 April 2015. Tackling generic drug safety Food and Drug Administration, Office of Generic Drugs. Generic Drug User Fee Act Regulatory Science Initiatives Public Meeting. 16 May 2014. (Video here starting at 54:40) High Priority Research Topics in Regulatory Science Related to Generic Drugs Food and Drug Administration, Office of Generic Drugs. Generic Drug User Fee Act (GDUFA) Regulatory Science Initiatives Public Meeting. 21 Jun 2013. |
Congressional testimony
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Promoting Competition to Lower Medicare Drug Prices.
US House of Representatives, Committee on Ways & Means, Subcommittee on Health. 7 Mar 2019. |
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Examining the Actions of Drug Companies in Raising Prescription Drug Prices.
US House of Representatives, Committee on Oversight and Reform. 29 Jan 2019. |
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Strategies that Delay Timely Entry of Generic Drugs and Potential Policy Solutions: The CREATES Act and Beyond. Antitrust Concerns and the FDA Approval Process, US House of Representatives, Judiciary Committee. 27 Jul 2017. |
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The Public Health Risks of Expanding Off-Label Promotion of Prescription Drugs and Devices. Examining Medical Product Manufacturer Communications, US House of Representatives, Energy & Commerce Committee. 12 Jul 2017. |
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Role of Public Funding in the Development of Transformative Drugs. Middle Class Prosperity Project Forum, US Congress. 27 Jul 2015. |
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Why are Some Generic Drugs Skyrocketing in Price? Subcommittee on Primary Health and Aging; Committee on Health, Education, Labor, and Pensions; US Senate. 20 Nov 2014. |
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21st Century Cures: Modernizing Clinical Trials. Subcommittee on Health, Committee on Energy and Commerce, US House of Representatives. 9 Jul 2014. |
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Reauthorization of MDUFA: What it Means for Jobs, Innovation, and Patients. Energy & Commerce Committee, Subcommittee on Health. 15 Feb 2012. |
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Should FDA drug and device regulation bar liability claims? Committee on Oversight and Government Reform; US House of Representatives. 14 May 2008. |
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amicus briefs
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Dr. Aaron Kesselheim part of an amicus brief to the U.S. Supreme Court in Expressions Hair Design v. Schneiderman, oral argument scheduled for January 2017.
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Dr. Ameet Sarpatwari and Dr. Aaron Kesselheim help compose an amicus brief for Gobeille v. Liberty Mutual, a U.S. Supreme Court case on all-payer claims databases
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Dr. Aaron Kesselheim and Dr. Jerry Avorn help compose an amicus brief for Wyeth v. Levine, a U.S. Supreme Court case on drug labeling liability
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Dr. Aaron Kesselheim helps compose an amicus brief to the 11th Circuit on State of Florida vs. Department of Health & Human Services, a case on the constitutional validity of the Medicaid expansion that eventually reached the U.S. Supreme Court.
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state government
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States and Rising Prescription Drug Costs: Origins and Prospects for Reform. (Testimony, Connecticut Health Care Cabinet). 10 January 2017.
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Impact of S.1048: A Bill to Improve Transparency of Drug Research and Development Costs. (Testimony, Massachusetts Legislature Joint Committee on Health Care Financing.) 11 April 2016. |
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A Prescription for Insight: Understanding the Cost and Value of Pharmaceutical Drugs. (Testimony, Joint Committee on Health Care Financing, Massachusetts General Assembly). 1 April 2016. |
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Prescription Drug Prices (Testimony, House Committee on Health Care, Vermont General Assembly). 21 January 2016. 2013 Overdose Response Program-Senate Bill 610 / Invited Testimony, Maryland General Assembly, Annapolis, MD |
professional societies
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States and Rising Prescription Drug Costs: Origins and Prospects for Reform. Massachusetts Bar Association Annual Health Law Symposium. 7 Apr 2017.
Prescription Drug Costs (Panel). American Medical Association National Advocacy Conference. 1 Mar 2017. States and the Rising Cost of Pharmaceuticals: A Call to Action. National Academy for State Health Policy. 11 Jan 2017. (webinar, video here). Should Drug Costs be Controlled by Regulating Industry as a Public Utility? National Academy for State Health Policy. 15 Oct 2016. (report here). High Drug Prices: Sources and Solutions. American Medical Association Board of Delegates. 10 Jun 2016. Hospital Administration and Prescription Drug Prices. American Hospital Association Annual Meeting. 3 May 2016. Big Data Ethics in Comparative Effectiveness Research. Ethics Forum, Massachusetts Medical Society. 4 Dec 2015. (video here) Expanded Access to Investigational Drugs and Other Current Health Policy Topics. National Physician’s Alliance FDA task force. 16 Mar 2015. Regulation of New Technologies: Vaccines for Non-Communicable Diseases. Emerging Issues and New Frontiers in FDA Regulation. Food and Drug Law Institute/Petrie-Flom Center Symposium. 20 Oct 2014. The Practices and Perils of “Non-Traditional” Drug Promotion. Food and Drug Law Institute. Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries. 17 Sep 2013. Health Care Costs and Biomedical Innovation. Brookings Institution, Engelberg Center for Health Care Reform. 22 Apr 2011. (Video here) |
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Program On Regulation, Therapeutics And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics 1620 Tremont Street, Suite 3030 Boston, MA 02120 |