Posted by Michael Wonder on 10 Mar 2022
Legislation would set expiration for FDA’s accelerated approvals
9 March 2022 - New legislation, introduced by a top Democrat in the House of Representatives, would codify the U.S. FDA’s authority to require that drug sponsors complete post-marketing studies on drugs that receive accelerated approval.
The Accelerated Approval Integrity Act (H.R. 6963) would also set a five year limit for how long a drug can stay on the market without confirmation of clinical benefit or significant progress toward that goal.
The bill was introduced on 7 March 2022 by Representative Frank Pallone (D-NJ), chairman of the House Energy and Commerce Committee.
