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 November. The selections feature topics ranging from pricing and competition policies for generic drugs; to the effects of health insurance on prescription drug use among low-income adults, to a review of the US biosimilar market. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Federico CA, Wang T, Doussau A, Mogil JS, Fergusson D, Kimmelman J. Assessment of Pregabalin Postapproval Trials and the Suggestion of Efficacy for New Indications; A Systematic Review. JAMA Intern Med. 2018 Nov 26. [Epub ahead of print]
  2. Ghosh A, Simon K, Sommers BD. The Effect of Health Insurance on Prescription Drug Use Among Low-Income Adults: Evidence from Recent Medicaid Expansions. J Health Econ. 2018 Nov 6;63:64-80. [Epub ahead of print]
  3. Gupta R, Shah ND, Ross JS. Generic Drugs in the United States: Policies to Address Pricing and Competition. Clin Pharmacol Ther. 2018 Nov 24. [Epub ahead of print].
  4. Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT. Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act. JAMA Pediatric. 2018 Nov 19. [Epub ahead of print].
  5. Sarpatwari A, Barenie R, Curfman G, Kesselheim AS. The US Biosimilar Market: Stunted Growth and Possible Reforms. Clin Pharmacol Ther. 2018 Nov 11. [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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