Pharmacist with a prescription looking at a medicine box on a pharmacy shelf.

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, 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 May. The selections feature topics ranging from an investigation of federal support for the development of expensive HIV drugs, to an analysis of COPD exacerbations and hospitalizations among new users of maintenance inhalers, to a comparison of sales for new drugs with and without an initial orphan drug designation. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Cliff ERS, Janakiram M, Kesselheim AS. Melflufen: post-hoc subgroup analyses and the US FDA Oncologic Drugs Advisory Committee. Lancet Haematol. 2023 May;10(5):e314-e317.
  2. Dhruva SS, Kesselheim AS, Woloshin S, Ji RZ, Lu Z, Darrow JJ, Redberg RF. Physician Perspectives on FDA’s Decision to Grant Accelerated Approval to Aducanumab for Alzheimer’s Disease. Clin Pharmacol Ther. 2023 May 23. Epub ahead of print.
  3. Feldman WB, Avorn J, Kesselheim AS, Gagne JJ. Chronic Obstructive Pulmonary Disease Exacerbations and Pneumonia Hospitalizations Among New Users of Combination Maintenance Inhalers. JAMA Intern Med. 2023 May 22:e231245. Epub ahead of print.
  4. Kranz P, McGauran N, Banzi R, Ünal C, Lotz F, Kaiser T. Reforming EU and national orphan drug regulations to improve outcomes for patients with rare diseases. BMJ. 2023 May 9;381:e072796.
  5. Michaeli T, Jürges H, Michaeli DT. FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis. BMJ. 2023 May 9;381:e073242.
  6. Olivier T, Haslam A, Prasad V. Post-progression treatment in cancer randomized trials: a cross-sectional study of trials leading to FDA approval and published trials between 2018 and 2020. BMC Cancer. 2023 May 17;23(1):448.
  7. Tessema FA, Barenie RE, Avorn J, Kesselheim AS. Federal Funding For Discovery And Development Of Costly HIV Drugs Was Far More Than Previously Estimated. Health Aff (Millwood). 2023 May;42(5):642-649.
  8. Tu SS, Nagar S, Kesselheim AS, Lu Z, Rome BN. Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation. JAMA. 2023 May 9;329(18):1607-1608.

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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