50 Shades Of Regulatory Gray: More Flexible FDA?
This article was originally published in Scrip
Executive Summary
The FDA's approval on Aug. 18 of Sprout Pharmaceuticals' libido-boosting pill Addyi (flibanserin) had some Americans scratching their heads about why the agency would give its blessing to a twice-rejected, side-effect-ridden drug and wondering if US regulators had simply crumbled under pressure from a politically charged public relations campaign.