FDA Center Directors Urge Lawmakers to Advance User Fees

Three senior FDA officials urged the Senate HELP Committee hearing Tuesday to move forward on user fees for drugs and biologics or risk funding problems at the agency.

CDER Director Janet Woodcock, CBER Director Peter Marks, and CDRH Director Jeffrey Shuren highlighted the achievements of the current generation of user fee programs — such as clearing the backlog of generic drug applications and approving the first four biosimilars — and said the agency depends on user fees to fund essential programs.

Committee Chair Lamar Alexander (R-Tenn.) said if Congress does not reauthorize the FDA’s user fees before July 27, the agency would be forced to begin notifying more than 5,000 employees that they could lose their jobs come October, when the user fee programs expire.

The center directors unexpectedly found themselves in the middle of a partisan debate over repeal of the Affordable Care Act, with the committee’s Democrats arguing the time spent on user fees would be better spent debating the Republican bill scheduled for a House vote.