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 October. The selections feature topics ranging from the trajectories of injectable cancer drug costs after launch in the United States, to the FDA Unapproved Drugs Initiative, to registries supporting new drug applications. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Gordon N, Stemmer SM, Greenberg D, Goldstein DA. Trajectories of Injectable Cancer Drug Costs After Launch in the United States. J Clin Oncol. 2017 Oct 10. [Epud ahead of print]
  2. Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. J Manag Care Spec Pharm. 2017 Oct;23(10):1066-1076.
  3. Jonker CJ, van der Berg HM, Kwa MSG, Hoes AW, Mol PGM. Registries supporting new drug applications. Pharmacoepidemiol Drug Saf. 2017 Oct 6.
  4. Sarpatwari A, Choudhry NK. Recalibrating Privacy Protections to Promote Patient Engagement. N Engl J Med. 2017 Oct 19;377(16):1509-1511.
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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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