By Ameet Sarpatwari, Michael S. Sinha, 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 May. The selections feature topics ranging from post-approval safety events among novel drugs approved between 2001 and 2010, to the failure of the Alzheimer’s drug Solanezumab, to the three-year impacts of the Affordable Care Act among low-income adults. A full posting of abstracts/summaries of these articles may be found on our website.
- Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017 May 9;317(18):1854-1863.
- Gellad WF, Kesselheim AS. Accelerated approval and expensive drugs – a challenging combination. N Engl J Med. 2017 May 25;376(21):2001-2004.
- Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017 May 3;357:j1680.
- Sacks CA, Avorn J, Kesselheim AS. The failure of Solanezumab – how the FDA saved taxpayers billions. N Engl J Med. 2017 May 4;376(18):1706-1708.
- Sommers BD, Maylone B, Blendon RJ, Orav EJ, Epstein AM. Three-year impacts of the Affordable Care Act: improved medical care and health among low-income adults. Health Aff (Millwood). 2017 Jun 1;36(6):1119-1128.
