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

By Ameet Sarpatwari, Michael S. Sinha, 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 September. The selections feature topics ranging from changes in misuse and abuse of prescription opioids following implementation of REMS programs, to the determinants of market exclusivity for prescription drugs, to the fate of FDA post-approval studies. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bucher Bartelson B, Le Lait MC, Green JL, Cepeda MS, Coplan PM, Maziere JY, Wedin GP, Dart RC. Changes in misuse and abuse of prescription opioids following implementation of Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy. Pharmacoepidemiol Drug Saf. 2017;26(9):1061-1070.
  2. Hey SP, Cohen IG, Adashi EY, Kesselheim AS. Influence, integrity, and the FDA: An ethical framework. Science. 2017;357(6354):876-877.
  3. Kashoki M, Lee C, Stein P. FDA Oversight of Postmarketing Studies. N Engl J Med. 2017;377(12):1201-1202.
  4. Kesselheim AS, Sinha MS, Avorn J. Determinants of Market Exclusivity for Prescription Drugs in the United States. JAMA Intern Med. 2017 Sep 11. [Epub ahead of print]
  5. Mostaghim SR, Gagne JJ, Kesselheim AS. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study. BMJ. 2017;358:j3837.
  6. Woloshin S, Schwartz LM, White B, Moore TJ. The Fate of FDA Postapproval Studies. N Engl J Med. 2017;377(12):1114-1117.
  7. Zeitoun JD, Baron G, Vivot A, Atal I, Downing NS, Ross JS, Ravaud P. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study. Int J Cancer. 2017 Sep 20. [Epub ahead of print]
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About asarpatwari

Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School and an Associate Epidemiologist at Brigham and Women’s Hospital based in 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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