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 July. The selections feature topics ranging from the change in industry relationships among members of academic institutional review boards over the past decade, to manufacturer delays in reporting serious and unexpected adverse events to the FDA, to drug patenting in India. A full posting of abstracts/summaries of these articles may be found on our website.
- Campbell EG, Vogeli C, Rao SR, Abraham M, Pierson R, Applebaum S. Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014. JAMA Intern Med. 2015 Jul 13. [Epub ahead of print].
- Eichler HG, Thomson A, Eichler I, Schneeweiss S. Assessing the relative efficacy of new drugs: an emerging opportunity. Nat Rev Drug Discov. 2015 Jul 1; 14(7):443-4.
- Flacco ME, Manzoli L, Boccia S, et al. Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor. J Clin Epidemiol. 2015 Jul; 68(7):811-20.
- Gellad WF, Flynn KE, Alexander GC. Evaluation of Flibanserin: Science and Advocacy at the FDA. JAMA. 2015 Jul 6. [Epub ahead of print].
- Ma P, Marinovic I, Karaca-Mandic P. Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration. JAMA Intern Med. 2015 Jul 27. [Epub ahead of print].
- Sampat BN, Shadlen KC. Patent watch: Drug patenting in India: looking back and looking forward. Nat Rev Drug Discov. 2015 Jul 17. [Epub ahead of print].
- Sharfstein JM, Kesselheim AS. The Safety of Prescription Drugs. JAMA. 2015 Jul 21; 314(3):233-4.
