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 December. The selections feature topics ranging from approximating future entry dates of generic drugs; to a systematic review of trial-level meta-analyses measuring the strength of the association between surrogate end-points and overall survival in oncology, to the coverage of novel therapeutic agents by Medicare prescription drug plans following FDA approval. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RB, Darrow JJ, Kesselheim AS. A Method for Approximating Future Entry of Generic Drugs. Value Health. 2018 Dec;21(12):1382-1389.
  2. Danzon PM. Differential Pricing of Pharmaceuticals: Theory, Evidence and Emerging Issues. Pharmacoeconomics. 2018 Dec;36(12):1395-1405.
  3. Gagne JJ, Sarpatwari A, Desai RJ. Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products. Clin Pharmacol Ther. 2018 Dec 28. [Epub ahead of print]
  4. Haslam A, Hey SP, Gill J, Prasad V. A systematic review of trial-levelmeta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology. Eur J Cancer. 2019 Jan;106:196-211. Epub 2018 Dec 5.
  5. Shaw DL, Dhruva SS, Ross JS. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval. J Manag Care Spec Pharm. 2018 Dec;24(12):1230-1238.
  6. 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. 2018 Dec 12. [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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