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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Pharmaceuticals, PORTAL Round-Up

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 September. The selections feature topics ranging from an examination of Park doctrine prosecutions of executives of pharmaceutical and medical device companies, an analysis of patent thickets covering biologic drugs, and a discussion of product hopping strategies among manufacturers of inhalers. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Daval CJR, Avorn J, Kesselheim AS. Holding Pharmaceutical and Medical Device Executives Accountable as Responsible Corporate Officers. JAMA Intern Med. 2022 Sep 19. Epub ahead of print.
  2. Feldman WB, Bloomfield D, Beall RF, Kesselheim AS. Brand-name market exclusivity for nebulizer therapy to treat asthma and COPD. Nat Biotechnol. 2022 Sep;40(9):1319-1325.
  3. Goode R, Chao B. Biological patent thickets and delayed access to biosimilars, an American problem. J Law Biosci. 2022 Sep 1;9(2):lsac022.
  4. Kapczynski A. The Political Economy of Market Power in Pharmaceuticals. J Health Polit Policy Law. 2022 Sep 27:10234184. Epub ahead of print.
  5. Messinger JC, Kesselheim AS, Vine SM, Fischer MA, Barenie RE. Associations Between Copays, Coverage Limits for Naloxone, and Prescribing in Medicaid. Subst Abuse. 2022 Sep 29;16:11782218221126972.
  6. Olivier T, Haslam A, Prasad V. Dose modification rules and availability of growth factor support: A cross-sectional study of head-to-head cancer trials used for US FDA approval from 2009 to 2021. Eur J Cancer. 2022 Sep;172:349-356. Epub ahead of print.
  7. Walia A, Haslam A, Prasad V. FDA validation of surrogate endpoints in oncology: 2005-2022. J Cancer Policy. 2022 Sep 22;34:100364. Epub ahead of print.
  8. Wouters OJ, Feldman WB, Tu SS. Product Hopping in the Drug Industry – Lessons from Albuterol. N Engl J Med. 2022 Sep 29;387(13):1153-1156. 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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