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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, FDA, Generic Drugs, Health Law Policy, International, Medicare/Medicaid, Pharmaceuticals, PORTAL Round-Up

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, 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 commentaries on political pressures and questions of integrity facing the FDA, to a critique of the financial incentive structure for antibiotic development, to an estimation of how much NHS England would spend if it paid U.S. Medicare Part D prices. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Anderson TS, Gellad WF, Good CB. Characteristics Of Biomedical Industry Payments To Teaching Hospitals. Health Aff (Millwood). 2020 Sep;39(9):1583-1591.
  2. Avorn J, Kesselheim AS. Up Is Down – Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval. N Engl J Med. 2020 Sep 15. Epub ahead of print.
  3. Brito JP, Ross JS, Sangaralingham L, Dutcher SK, Graham DJ, Wang Z, Wu Y, Yao X, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels. JAMA Netw Open. 2020 Sep 1;3(9):e2017645.
  4. Liu M, MacKenna B, Feldman WB, Walker AJ, Avorn J, Kesselheim AS, Goldacre B. Projected spending for brand-name drugs in English primary care given US prices: a cross-sectional study. J R Soc Med. 2020 Sep;113(9):350-359.
  5. Marcus SC, Reilly ME, Zentgraf K, Volpp KG, Olfson M. Effect of Escalating and Deescalating Financial Incentives vs Usual Care to Improve Antidepressant Adherence: A Pilot Randomized Clinical Trial. JAMA Psychiatry. 2020 Sep 23:e203000. Epub ahead of print.
  6. Radomski TR, Feldman R, Huang Y, Sileanu FE, Thorpe CT, Thorpe JM, Fine MJ, Gellad WF. Evaluation of Low-Value Diagnostic Testing for 4 Common Conditions in the Veterans Health Administration. JAMA Netw Open. 2020 Sep 1;3(9):e2016445.
  7. Sharfstein J. How the FDA should protect its integrity from politics. 2020 Sep;585(7824):161.
  8. Sinha MS, Powers Iii JH, Kesselheim AS. The Wrong Cure: Financial Incentives for Unimpressive New Antibiotics. J Infect Dis. 2020 Aug 22:jiaa536. 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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