Program On Regulation, Therapeutics, And Law (PORTAL)

Division of Pharmacoepidemiology and Pharmacoeconomics

Department of Medicine, Brigham & Women’s Hospital and Harvard Medical School

Overview

Prescription medications and medical devices are the commonest health care interventions and have a major impact on the health of individual patients as well as populations. Law and regulation play an integral role ensuring their safety and efficacy, as well as access to these treatments. This legal-therapeutic interface sometimes works well, and sometimes less optimally. This program engages in research and training in these domains to consider how laws and regulations influence the development, utilization, and affordability of therapeutics, as well as the ethical questions these issues raise for patients, physicians, policymakers, and payors. Our primary goal is to evaluate what policies and practices best promote effective, safe, and equitable health care delivery. Follow us on Twitter: @PORTAL_Research

PORTAL offers the Harvard Medical School/Brigham and Women’s Hospital Fellowship in Pharmaceutical Law and Health Services Research. Current PORTAL fellows are Michael Fralick, M.D., F.R.C.P.C., HSPH 2018; Spencer Phillips Hey, Ph.D (also affiliated with HMS Center for Bioethics); Chana A. Sacks, M.D., HSPH 2018; Michael S. Sinha, M.D., J.D., M.P.H.; Kerstin N. Vokinger, M.D., J.D., Ph.D., LL.M., and Reed Beall, M.S., Ph.D. (beginning January 2017). To learn more information about the Fellowship in Pharmaceutical Law and Health Services Research, please click here.

Activities

  • Empirical and normative research in legal, ethical, and policy issues regarding the development, approval, and evidence-based use of drugs, devices, vaccines, procedures, and diagnostics. Particular areas of focus include regulation, intellectual property, and comparative effectiveness.  These topics are addressed through a variety of descriptive, qualitative, and quantitative methodologies.
  • Publication of this research in major medical, legal, and health policy journals.
  • Dissemination of this work through the lay media and international, national, regional, and local professional meetings.
  • Education of medical students and trainees in law and public health research.
  • Mentorship of trainees who are interested in pursuing careers in law, policy, or public health research.
  • Regular meetings and seminars to discuss ongoing research, emerging areas of interest and potential scholarship, and current issues in related fields.
  • Program Leadership

    Director: Aaron S. Kesselheim, M.D., J.D., M.P.H.
    Associate Professor of Medicine, Harvard Medical School
    Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital

    Co-Director: Jerry Avorn, M.D.
    Professor of Medicine, Harvard Medical School
    Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital

    Assistant Director: Ameet Sarpatwari, J.D., Ph.D.
    Instructor in Medicine, Harvard Medical School
    Associate Epidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital

    Affiliated Faculty

    Niteesh K. Choudhry, M.D., Ph.D.
    Professor of Medicine, Harvard Medical School
    Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics and the Hospitalist Program, Brigham and Women’s Hospital

    Joshua J. Gagne, Pharm.D., Sc.D.
    Assistant Professor of Medicine, Harvard Medical School
    Associate Epidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital

    Daniel B. Kramer, M.D.
    Assistant Professor of Medicine, Harvard Medical School
    Cardiac Electrophysiologist, Division of Cardiovascular Medicine and the CardioVascular Institute, Beth Israel Deaconess Medical Center

    Kevin Outterson, J.D., LL.M.
    Professor of Law, Boston University School of Law
    Professor of Health Law, Bioethics, and Human Rights, Boston University School of Public Health

    Benjamin Roin, J.D.
    Assistant Professor of Technological Innovation, Entrepreneurship, and Strategic Management, Sloan School of Management, MIT

    Sebastian Schneeweiss, M.D., Sc.D.
    Professor of Medicine, Harvard Medical School
    Vice-Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital

    Heidi Williams, Ph.D.
    Assistant Professor, Department of Economics, MIT

    Expert Roundtable

    PORTAL has recently launched an expert roundtable, in which public health, medical, and legal scholars discuss their research with the PORTAL team and offer insight on ongoing PORTAL projects. For more information, click here.

    Current Trainees

    Past Trainees

    Literature Scans

    Each month, members PORTAL review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

    Selected Peer-Reviewed Publications (since 2012)

    Select Blog Posts and Lay Media Articles

    National Conferences

    2014: What Evidence is Essential for New Medical Products? Implications for Patients and Health Policy
    2013: When Less Information is Better: Blinding as a Solution to Institutional Corruption

    Amicus Briefs

    PORTAL’s Ameet Sarpatwari and Aaron Kesselheim help compose an amicus brief for a Supreme Court case on all-payer claims databases

    PORTAL’s Aaron Kesselheim and Jerry Avorn help compose an amicus brief for a Supreme Court case on drug labeling liability

    PORTAL’s Aaron Kesselheim helps compose an amicus brief to the 11th Circuit on the constitutional validity of the Medicaid expansion

    Congressional Testimony

    Kesselheim, AS. Role of public funding in the development of transformative drugs. Middle Class Prosperity Project Forum, US Congress. 27 Jul 2015.

    Kesselheim, AS. 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.

    Kesselheim, AS. 21st Century Cures: Modernizing Clinical Trials. Subcommittee on Health, Committee on Energy and Commerce, US House of Representatives. 9 Jul 2014.

    Kesselheim, AS. Should FDA drug and device regulation bar liability claims? Committee on Oversight and Government Reform; US House of Representatives. 14 May 2008.