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

By Ameet Sarpatwari, Charlie Lee, Frazer 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 health law and policy issues relevant to current or potential future work in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School.

Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from the evolution of drug regulation in the US, to establishing a population health-based framework for value-based drug pricing, to the limited utilization of biosimilar infliximab in the US. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 Jan 14;323(2):164-176.
  2. Desai RJ, Sarpatwari A, Gautam N, Lii J, Fischer MA, Gagne JJ. Changes in Utilization of Generic Angiotensin Receptor Blockers Following Product Recalls in the United States. JAMA. 2020;323(1):87-89.
  3. Hu Y, Eynikel D, Boulet P, Krikorian G. Supplementary protection certificates and their impact on access to medicines in  Europe: case studies of sofosbuvir, trastuzumab and imatinib. J Pharm policy Pract. 2020 Jan 14;13:1.
  4. Jung EH, Sarpatwari A, Kesselheim AS. Novelty of Active Ingredients in High-Cost Brand-Name Drugs. J Gen Intern Med. 2020 Jan 2. [Epub ahead of print].
  5. Kaltenboeck A, Calsyn M, Frederix GWJ, Lowenthal J, Mitchell D, Rector B, Sarpatwari A. Grounding Value-Based Drug Pricing in Population Health. Clin Pharmacol Ther. 2020 Jan 17. [Epub ahead of print].
  6. Kim SC, Sarpatwari A, Landon JE, Desai RJ. Utilization and Treatment Costs of Tumor Necrosis Factor Inhibitors after the Introduction of Biosimilar Infliximab in the U.S. Arthritis Rheumatol (Hoboken, NJ). 2020 Jan 13. [Epub ahead of print].
  7. King AC, Schwartz LM, Woloshin S. A National Survey of the Frequency of Drug Company Detailing Visits and Free Sample Closets in Practices Delivering Primary Care. JAMA Intern Med. 2020 Jan 27. [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.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.