Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Liam Bendicksen, Alexander Egilman, andAaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of August. The selections feature topics ranging from a discussion of opportunities for improving the use of U.S. Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bendicksen L, Kesselheim AS, Rome BN. The Vexing Voyage of Vasopressin: The Consequences of Granting Market Exclusivity to Unapproved Drugs. Chest. 2022 Aug;162(2):433-435.
  2. Daval CJR, Kesselheim AS, Sarpatwari A. Improving the Use of FDA Advisory Committees. N Engl J Med. 2022 Aug 25;387(8):675-677. Epub ahead of print.
  3. Hanna J, Nargesi AA, Essien UR, Sangha V, Lin Z, Krumholz HM, Khera R. County-level variation in cardioprotective antihyperglycemic prescribing among medicare beneficiaries. Am J Prev Cardiol. 2022 Aug 2;11:100370.
  4. Hwang TJ, Bourgeois FT. New legislation to promote paediatric studies for new cancer medicines. Lancet Oncol. 2022 Aug;23(8):e368-e369.
  5. Hwang TJ, Kesselheim AS, Dusetzina SB. Reforming Patient Cost Sharing for Cancer Medications in Medicare Part D. JAMA Oncol. 2022 Aug 4. Epub ahead of print.
  6. Hwang TJ, Kesselheim AS, Rome BN. New Reforms to Prescription Drug Pricing in the US: Opportunities and Challenges. JAMA. 2022 Aug 19. Epub ahead of print.
  7. Lumpkin MM, Hamburg MA, Schultz WB, Sharfstein JM. Transparency practices at the FDA: A barrier to global health. Science. 2022 Aug 5;377(6606):572-574. Epub ahead of print.
  8. Trapani D, Tay-Teo K, Tesch ME, Roitberg F, Sengar M, Altuna SC, Hassett MJ, Genazzani AA, Kesselheim AS, Curigliano G. Implications of Oncology Trial Design and Uncertainties in Efficacy-Safety Data on Health Technology Assessments. Curr Oncol. 2022 Aug 16;29(8):5774-5791.
  9. Van de Wiele VL, Torrance AW, Kesselheim AS. Characteristics Of Key Patents Covering Recent FDA-Approved Drugs. Health Aff (Millwood). 2022 Aug;41(8):1117-1124.
  10. Wunnava S, Miller TA, Narang C, Nathan M, Bourgeois FT. US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021. JAMA. 2022 Aug 9;328(6):580-582.

Ameet Sarpatwari

Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

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