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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, 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 December. The selections feature topics ranging from a discussion of the challenges in confirming drug effectiveness after early approval, to an analysis of potential savings from a proposed policy requiring manufacturers of drugs receiving accelerated approval to pay higher rebates to Medicaid until efficacy is demonstrated, to an evaluation of the racial and ethnic representation in clinical trials supporting FDA approval of new drugs and biologics. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Barber M, Sarpatwari A, Cepuch C. COVID-19 antivirals must not affect HIV drug supply. Lancet HIV. 2021 Dec 8. Epub ahead of print.
  2. Cherkaoui S, Pinnow E, Bulatao I, Day B, Kalaria M, Brajovic S, Dal Pan G. The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes. Clin Pharmacol Ther. 2021 Dec;110(6):1512-1525.
  3. Hwang TJ, Vokinger KN, Kesselheim AS. New Treatments for Migraine-Therapeutic Ratings and Comparative Coverage in the US, Canada, and Europe. JAMA Intern Med. 2021 Dec 13. Epub ahead of print.
  4. Jiang JX, Polsky D, Littlejohn J, Wang Y, Zare H, Bai G. Factors Associated with Compliance to the Hospital Price Transparency Final Rule: a National Landscape Study. J Gen Intern Med. 2021 Dec 13:1–8. Epub ahead of print.
  5. Lolic M, Araojo R, Okeke M, Woodcock J. Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019. 2021 Dec 7;326(21):2201-2203.
  6. Lynch HF, Robertson CT. Challenges in confirming drug effectiveness after early approval. 2021 Dec 3;374(6572):1205-1207.
  7. Olivier T, Haslam A, Prasad V. Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action. JAMA Netw Open. 2021 Dec 1;4(12):e2138793.
  8. Rome BN, Kesselheim AS. Raising Medicaid Rebates For Drugs With Accelerated Approval. Health Aff (Millwood). 2021 Dec;40(12):1935-1942.
  9. Timbie JW, Kim AY, Concannon TW. Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices: A Landscape Assessment. Value Health. 2021 Dec;24(12):1792-1798.

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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