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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of April. The selections feature topics ranging from the FDA’s plan to help tackle prescription opioid misuse, to physicians’ knowledge about FDA drug approval standards and breakthrough therapy designation, to a proposal to delink antibiotic reimbursement from sales “using a graded array of benchmarked rewards.” A full posting of abstracts/summaries of these articles may be found on our website.

1. Califf RM, Woodcock J, Ostroff S. A Proactive Response to Prescription Opioid Abuse. N Engl J Med. 2016 Apr 14;374(15):1480-5.
2. Goldacre B, Gray J. OpenTrials: towards a collaborative open database of all available information on all clinical trials. 2016 Apr 8;17(1):164.
3. Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM. Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation. 2016 Apr 12;315(14):1516-8.
4. Rex JH, Outterson K. Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach. Lancet Infect Dis. 2016 Apr;16(4):500-5.
5. Woloshin S, Schwartz LM. US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up. JAMA Intern Med. 2016 Apr 1;176(4):439-42.