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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, FDA, Health Law Policy, Intellectual Property, Judicial Opinions, Pharmaceuticals, PORTAL Round-Up, Vaccines

By Ameet Sarpatwari, Alexander Egilman, and Aaron 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 March. The selections feature topics ranging from an analysis of patent challenges by generic manufacturers on brand-name inhalers, a discussion of the Alliance for Hippocratic Medicine v. FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. public investment in the development of mRNA COVID-19 vaccines. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Brown BL, Kesselheim AS, Sarpatwari A. Analysis of Risk Evaluation and Mitigation Strategies for Teratogenic Drugs: Variation in Primary and Secondary Prevention Measures. PLoS Med. 2023 Mar 6;20(3):e1004190.
  2. Daval CJR, Bendicksen L, Kesselheim AS. Eroding Judicial Deference to the FDA – Consequences for Public Health. N Engl J Med. 2023 Mar 16;388(11):963-966. Epub ahead of print.
  3. Deshmukh AD, Kesselheim AS, Rome BN. Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021. JAMA Health Forum. 2023 Mar 3;4(3):e230217.
  4. Fontrier AM, Kanavos P. Do Reimbursement Recommendations by the Canadian Agency for Drugs and Technology in Health Translate into Coverage Decisions for Orphan Drugs in the Canadian Province of Ontario? Value Health. 2023 Mar 6:S1098-3015(23)00062-1. Epub ahead of print.
  5. Lalani HS, Nagar S, Sarpatwari A, Barenie RE, Avorn J, Rome BN, Kesselheim AS. US Public Investment in Development of mRNA Covid-19 Vaccines: Retrospective Cohort Study. BMJ. 2023 Mar 1;380:e073747.
  6. Patel NG, Kesselheim AS, Darrow JJ. Trust and Regulation: Assuring Scientific Independence in the FDA’s Emergency Use Authorization Process. J Health Polit Policy Law. 2023 Mar 24:10637726. Epub ahead of print.
  7. Reddy S, Beall RF, Tu SS, Kesselheim AS, Feldman WB. Patent Challenges And Litigation On Inhalers For Asthma And COPD. Health Aff (Millwood). 2023 Mar;42(3):398-406.
  8. Sarayani A, Donahoo WT, Hampp C, Brown JD, Winterstein AG. Assessment of the Risk Evaluation and Mitigation Strategy (REMS) for Phentermine-Topiramate to Prevent Exposure During Pregnancy. Ann Intern Med. 2023 Mar 21. Epub ahead of print.
  9. Shahzad M, Naci H, Wagner AK. Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway. JAMA. 2023 Mar 7;329(9):760-761.
  10. Tu SS, Nagar S, Van de Wiele VL. Broad Patent Claims Come Before the Supreme Court in Amgen v Sanofi. JAMA. 2023 Mar 27. Epub ahead of print.
  11. Zettler PJ, Adashi EY, Cohen IG. Alliance for Hippocratic Medicine v. FDA– Dobbs’s Collateral Consequences for Pharmaceutical Regulation. N Engl J Med. 2023 Mar 9;388(10):e29. Epub ahead of print.

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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