JAMA
February 14, 2017, Vol 317, No. 6, Pages 555-656
http://www.jama.jamanetwork.com/issue.aspx
Viewpoint
New “21st Century Cures” Legislation: Speed and Ease vs Science
Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD
JAMA. 2017;317(6):581-582. doi:10.1001/jama.2016.20640
This Viewpoint discusses potential threats to public health that arise from provisions of the 2016 21st Century Cures Act that allow drug manufacturers to use surrogate measures of safety and that encourage the US Food and Drug Administration to emphasize speed over science in the drug approval process.