BioCentury
ARTICLE | Politics, Policy & Law

Christmas in July

Why user-fee reauthorization legislation won’t include major FDA reforms

April 7, 2017 9:39 PM UTC

Every reauthorization of PDUFA has been accompanied by legislation giving FDA new missions or powers, and Congress is gearing up to continue the tradition of treating this must-pass legislation as a Christmas tree to be hung with ornaments. Yet all signs point to a skinny bill this year.

Industry will be pleased that drug price controls will not be included. For FDA, which is just starting to digest reforms in the 21st Century Cures Act and is threatened by new White House restrictions on hiring and a proposed budget cut, less is definitely more. ...