Large pile of amber prescription pill bottles

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

By Ameet SarpatwariCharlie LeeFrazer Tessema, 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 pharmaceutical law and policy.

Below are links to the papers identified from the month of May. The selections feature topics ranging from the association between clinical benefit of approved cancer drugs and their prices in the U.S. and Europe, to an assessment of how commercial health plans cover biosimilars relative to their reference products, to a commentary on how children should be included in clinical trials evaluating COVID-19 therapies. A full posting of abstracts/summaries of these articles can be found on our website.

  1. ’t Hoen E. Protect against market exclusivity in the fight against COVID-19. Nat Med. 2020 May 7. [Epub ahead of print].
  2. Bollyky TJ, Gostin LO, Hamburg MA. The Equitable Distribution of COVID-19 Therapeutics and Vaccines. JAMA. 2020 May 7. [Epub ahead of print].
  3. Chambers JD, Lai RC, Margaretos NM, et al. Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans. JAMA. 2020 May 19;323(19):1972-1973.
  4. Cohen BR, Mahoney KM, Baro E, et al. FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone. N Engl J Med. 2020 May 28;382(22):2129-2136.
  5. DeJong C, Chen AH, Lo B. An Ethical Framework for Allocating Scarce Inpatient Medications for COVID-19 in the US. JAMA. 2020 May 15. [Epub ahead of print].
  6. Hwang TJ, Randolph AG, Bourgeois FT. Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019  (COVID-19). JAMA Pediatr. 2020 May 7. [Epub ahead print].
  7. London AJ, Kimmelman J. Against pandemic research exceptionalism. Science. 2020;368(6490):476-477.
  8. Tessema FA, Kesselheim AS, Sinha MS. Generic but Expensive: Why Prices Can Remain High for Off-Patent Drugs. Hastings Law Journal. 2020 May 10;71(4): 1019-1052.
  9. Vokinger KN, Hwang TJ, Grischott T, et al. Prices and clinical benefit of cancer drugs in the USA and Europe: a cost-benefit analysis. Lancet Oncol. 2020;21(5):664-670.
  10. Zhai MZ, Lye CT, Kesselheim AS. Need for Transparency and Reliable Evidence in Emergency Use Authorizations for  Coronavirus Disease 2019 (COVID-19) Therapies. JAMA Intern Med. 2020 May 19.

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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