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

Ameet Sarpatwari PORTAL Round-Up

By Ameet Sarpatwari,  Liam Bendicksen, 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 August. The selections feature topics ranging from a review of the regulatory consequences of the FDA’s accelerated approval of eteplirsen, to a comparison of the safety and effectiveness of generic and brand-name fluticasone-salmeterol for COPD, to an analysis of free speech challenges to Medicare drug price negotiation under the Inflation Reduction Act. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bendicksen L, Zuckerman DM, Avorn J, Phillips S, Kesselheim AS. The Regulatory Repercussions of Approving Muscular Dystrophy Medications on the Basis of Limited Evidence. Ann Intern Med. 2023 Aug 22. Epub ahead of print.
  2. Bhat S, Ross JS, Ramachandran R. Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership. JAMA Intern Med. 2023 Aug 21:e232842. Epub ahead of print.
  3. Dhruva SS, Ross JS, Wilson NA. Unique Device Identifiers for Medical Devices at 10 Years. JAMA Intern Med. 2023 Aug 21. Epub ahead of print.
  4. Feldman WB, Kesselheim AS, Avorn J, Russo M, Wang SV. Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone-Salmeterol to Treat Chronic Obstructive Pulmonary Disease. Ann Intern Med. 2023 Aug;176(8):1047-1056. Epub ahead of print.
  5. Lu A, Ji RZ, Ge AY, Ross JS, Ramachandran R, Redberg RF, Dhruva SS. Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices. JAMA. 2023 Aug 17:e2314414. Epub ahead of print.
  6. Neumann PJ, Tunis SR. Turning CMS into a Health Technology Assessment Organization. N Engl J Med. 2023 Aug 24;389(8):682-684. Epub ahead of print.
  7. Purohit U, Sacks CA, Raissi A, Hughes E, Boctor M, Manzoor S, Hodzic-Santor B, Zhu K, Raudanskis A, Ross JS, Fralick M. Press Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study. J Gen Intern Med. 2023 Aug 2. Epub ahead of print.
  8. Tu SS, Kesselheim AS, Wetherbee K, Feldman WB. Changes in the Number of Continuation Patents on Drugs Approved by the FDA. JAMA. 2023 Aug 1;330(5):469-470.
  9. Tu SS, Tushnet R. Free Speech Challenges to the Inflation Reduction Act. JAMA. 2023 Aug 29. 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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