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 industry funding of cancer patient advocacy organizations, to the shared responsibility between the FDA and CMS, to active surveillance of follow-on biologics. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Abola MV, Prasad V. Industry Funding of Cancer Patient Advocacy Organizations. Mayo Clin Proc. 2016;91(11):1668-1670.
  2. Bauer SR, Redberg RF. Improving the Accelerated Pathway to Cancer Drug Approvals. JAMA Intern Med. 2016 Nov. [Epub ahead of print]
  3. Califf RM, Sherman RE, Slavitt A. Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS. JAMA. 2016 Nov 29. [Epub ahead of print]
  4. Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016 Nov 2. [Epub ahead of print]
  5. Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS. Active Surveillance of Follow-on Biologics: A Prescription for Uptake. Drug Saf. 2016 Nov 12. [Epub ahead of print]
  6. Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended-Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016;170(11):1103-1104.
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This entry was posted in Aaron S. Kesselheim, Ameet Sarpatwari, Health Law Policy by asarpatwari. Bookmark the permalink.

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.