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

By Ameet SarpatwariAviva 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from a discussion of antitrust as a tool to address patent thickets, to an analysis of the relationship between price and efficacy for recently approved cancer drugs, to an examination of the viability and implications of preemption challenges to state laws restricting medication abortion.

A full posting of abstracts/summaries of these articles may be found on our website.

  1. Jaksa A, Louder A, Maksymiuk C, Vondeling GT, Martin L, Gatto N, Richards E, Yver A, Rosenlund M. A Comparison of Seven Oncology External Control Arm Case Studies: Critiques From Regulatory and Health Technology Assessment Agencies. Value Health. 2022 Dec;25(12):1967-1976. [Epub 2022 Jun 25]. (PMID: 35760714).
  2. Knox R, Curfman G. The Humira patent thicket, the Noerr-Pennington doctrine and antitrust’s patent problem. Nat Biotechnol. 2022 Dec;40(12):1761-1763. (PMID: 36477501).
  3. Miljkovic MD, Tuia JE, Olivier T, Haslam A, Prasad V. Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020. JAMA Intern Med. 2022 Dec 1;182(12):1319-1320. (PMID: 36315136).
  4. Rand LZ, Melendez-Torres GJ, Kesselheim AS. Alternatives to the quality-adjusted life year: How well do they address common criticisms? Health Serv Res. 2022 Dec 20. [Epub ahead of print]. (PMID: 36537647).
  5. Richie C, Kesselheim AS, Jones DS. Climate change and the prescription pad. Lancet. 2022 Dec 22:S0140-6736(22)02545-4. [Epub ahead of print]. (PMID: 36566765).
  6. Zettler PJ, Beckmeyer A, Brown BL, Sarpatwari A. Mifepristone, preemption, and public health federalism. J Law Biosci. 2022 Dec 21;9(2):lsac037. (PMID: 36568649).

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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