Posted by December 3, 2015 at 9:19 AM
Written by Eileen Cronin, Ph.D. and Lisa Plymate, M.D.
The 21st Century Cures Act, which sailed through the House and is now in the Senate, calls into question the FDA’s current regulatory process. Its supporters claim the FDA process prevents innovation in pharmaceutical products. As someone injured by thalidomide in 1960, I (Cronin) am concerned that we’ll go too far in weakening the FDA approval process. My co-author (Plymate) has similar concerns. As a prescriber she may lose trust in the label “FDA approved.” Together we explored the history of the FDA as an agency, its purpose, why its regulations were instituted, and what could happen if we went back in time.
Read more in The Hill.