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

By Ameet Sarpatwari 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 the effect of pill mill laws on opioid overdose, to the changes in price of generic drugs over time, to the clinical benefit of cancer drugs receiving accelerated approval. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bollyky T, Kesselheim AS. Pharmaceutical Protections in U.S. Trade Deals – What Do Americans Get in Return? N Engl J Med. 2019 May 23;380(21):1993-1995. Epub 2019 May 1.
  2. Brighthaupt SC, Stone EM, Rutkow L, McGinty EE. Effect of pill mill laws on opioid overdose deaths in Ohio & Tennessee: A mixed-methods case study. Prev Med. 2019 May 29. pii: S0091-7435(19)30198-7. [Epub ahead of print]
  3. Chen EY, Raghunathan V, Prasad V. An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate. JAMA Intern Med. 2019 May 28.  [Epub ahead of print]
  4. Dave CV, Brill G, Kesselheim AS. Changes in Price for Generic Drugs in the USA, 2008-2016. J Gen Intern Med. 2019 May 7. [Epub ahead of print]
  5. Gyawali B, Hey SP, Kesselheim AS. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval. JAMA Intern Med. 2019 May 28. [Epub ahead of print]
  6. Hilal T, Sonbol MB, Prasad V. Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration. JAMA Oncol. 2019 May 2. [Epub ahead of print]
  7. Skydel JJ, Luxkaranayagam AT, Dhruva SS, Ross JS, Wallach JD. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments. JAMA Netw Open. 2019 May 3;2(5):e193410.
Ameet Sarpatwari

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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