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 June. The selections feature topics ranging from the merits of the proposed 21st Century Cures Act and Trans-Pacific Partnership, to discrepancies between non-public FDA complete response letters and sponsor press releases, to the status of pediatric post-approval safety systems in North America. A full posting of abstracts/summaries of these articles may be found on our website.
- Avorn J. In Opposition to Liberty: We Need a “Sovereign” to Govern Drug Claims. Ann Intern Med. 2015 June 30. [Epub ahead of print]
- Avorn J and Kesselheim AS. The 21st Century Cures Act – Will It Take Us Back in Time? New Engl J Med. 2015 June 25;372(26):2473-2475.
- Doshi P. FDA drug summaries: a simplification too far? 2015 June 12; 350:h3135.
- Kapczynski, A. (2015). The Trans-Pacific Partnership – Is It Bad for Your Health? N Engl J Med.2015 June 10. [Epub ahead of print]
- Lanini S, Zumla A, Ioannidis JPA, et al. Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa? The Lancet Infectious Diseases. 2015 June;15(6):738-745.
- Lurie P, Chahal HS, Sigelman DW, Stacy S, Sclar J, Ddamulira B.Comparison of content of FDA letters not approving applications for new drugs and associated public announcement from sponsors: cross sectional study. 2015 June 10;350:h2758.
- McMahon AW, Wharton GT, Bonnel R, et al. Pediatric post-marketing safety systems in North America: assessment of the current status. Pharmacoepidemiol Drug Saf. 2015 June 22. [Epub ahead of print]
- Ruger JP, Ruger TW, Annas GJ. The Elusive Right to Health Care under U.S. Law. New Engl J Med. 2015 June 25;372(26):2558-2563.