Thanks @arnoldventures.bsky.social for supporting @yalecrrit.bsky.social - study builds on work nearly a decade ago published in @jama.com (jamanetwork.com/journals/jam...) - flagging for @alecgaffney.bsky.social @zacharybrennan.bsky.social @sarahkarlin-smith.bsky.social @lizzylawrence.bsky.social

Lots more detail in the paper (jamanetwork.com/journals/jam...), but our findings provide the first evaluation of FDAAA and its enhanced safety-related regulatory authorities, and its impact on drug safety and public health, and informs current PDUFA VII negotiations! @reshmagar.bsky.social (5/5)

... among therapeutics with postmarket safety-related actions within 5 years of approval, median time to first action was 1.3 years shorter post-FDAAA implementation, perhaps a consequence of FDAAA's conferring FDA new PMR authority and defined timelines for label changes (4/5)

Among these, FDA took postmarket safety-related actions for 23%, including actions within 5 years of approval for 21% approved pre-FDAAA and 14% approved post-FDAAA (p=.06). While FDAAA was not associated with differences in time to first postmarket safety-related action ... (3/5)

We wanted to understand whether FDAAA was associated with changes in FDA postmarket drug safety−related actions, and what characteristics were associated with a greater or lower likelihood of actions. To do this, we studied all 560 new drugs and biologics approved by FDA from 2001-2017 (2/5)

See recent articles in @jama.com, such as jamanetwork.com/journals/jam..., jamanetwork.com/journals/jam..., and jamanetwork.com/journals/jam... @lisamjarvis.bsky.social