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

Ameet Sarpatwari Aaron S. Kesselheim, Ameet Sarpatwari, Beatrice Brown, Clinical Research, Empirical, FDA, Health Law Policy, Medical devices, Opioid Crisis, Pharmaceuticals, PORTAL Round-Up

By Ameet Sarpatwari, Beatrice Brown, 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 August. The selections feature topics ranging from an overview on the evolution of medical device regulation in the United States, to an analysis of the impact of the disclosure of expanded access policies mandated by the 21st Century Cures Act, to an evaluation of how litigation has impacted the success of the Biologics Price Competition and Innovation Act.

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

  1. Beall RF, Hollis A, Kesselheim AS, Spackman E. Reimagining Pharmaceutical Market Exclusivities: Should the Duration of Guaranteed Monopoly Periods Be Value Based? Value Health. 2021 Sep;24(9):1328-1334. Epub 2021 Aug 8. PMID: 34452713.
  2. Bendicksen L, Rome BN, Avorn J, Kesselheim AS. Pursuing Value-Based Prices for Drugs: A Comprehensive Comparison of State Prescription Drug-Pricing Boards. Milbank Q. 2021 Aug 10. Epub ahead of print. PMID: 34375015.
  3. Bhasale AL, Sarpatwari A, Lipworth W, Møllebaek M, McEwin EJ, Gautam N, Santiago Ortiz A, Mintzes BJ. Regulatory authority and clinical acceptability: Physicians’ responses to regulatory drug safety warnings. Br J Clin Pharmacol. 2021 Aug 1. Epub ahead of print. PMID: 34337777.
  4. Chalasani R, Shinabery JM, Goetz CT, Chang CH, Yang Q, Suda KJ, Gellad WF. Buprenorphine Dispensing in Pennsylvania During the COVID-19 Pandemic, January to October 2020. J Gen Intern Med. 2021 Aug 10:1–3. Epub ahead of print. PMID: 34378112.
  5. Darrow JJ, Avorn J, Kesselheim AS. FDA Regulation and Approval of Medical Devices: 1976-2020. JAMA. 2021 Aug 3;326(5):420-432. PMID: 34342614.
  6. Jenei K, Meyers DE, Prasad V. The Inclusion of Women in Global Oncology Drug Trials Over the Past 20 Years. JAMA Oncol. 2021 Aug 26. Epub ahead of print. PMID: 34436541.
  7. Kang S, Chang S, Ross JS, Miller JE. Implementation of 21st Century Cures Act Expanded Access Policies Requirements. Clin Pharmacol Ther. 2021 Aug 24. Epub ahead of print. PMID: 34431083.
  8. Van de Wiele VL, Kesselheim AS, Sarpatwari A. Barriers To US Biosimilar Market Growth: Lessons From Biosimilar Patent Litigation. Health Aff (Millwood). 2021 Aug;40(8):1198-1205. PMID: 34339242.
  9. Walsh BS, Kesselheim AS. CAAP rule and prescription drug prices. Am J Manag Care. 2021 Aug;27(8):312-314. PMID: 34460172.

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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