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 April. The selections feature topics ranging from the study time reduction of using surrogate endpoints instead of overall survival in oncology trials, to the association of pharmaceutical manufacturer payments to physicians and opioid prescribing doses, to the timeliness of post-approval studies for new drugs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chen EY, Joshi SK, Tran A, Prasad V. Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials. JAMA Intern Med. 2019 Apr 1.
  2. D’Andrea E, Hey SP, Ramirez CL, Kesselheim AS. Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Apr 5;2(4):e192224.
  3. Fleischman W, Agrawal S, Gross CP, Ross JS. Association of Pharmaceutical Manufacturer Payments to Physicians and Prescribing Dosage of Opioids. J Gen Intern Med. 2019 Apr 22.[Epub ahead of print].
  4. Liu S, Kesselheim AS. Experiences With and Challenges Afforded by Expedited Regulatory Pathways. Clin Pharmacol Ther. 2019 Apr;105(4):795-797.
  5. Vijay A, Ross JS, Shah ND, Jeffery MM, Dhruva SS. Medicare Formulary Coverage and Restrictions for Opioid Potentiators from 2013 to 2017. J Gen Intern Med. 2019 Apr;34(4):518-520.  Wallach JD, Egilman AC, Ross JS, Woloshin S, Schwartz LM. Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis. J Gen Intern Med. 2019 Apr;34(4):492-495.
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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