BioCentury
ARTICLE | Politics & Policy

FDA user fees fall short

June 19, 2017 9:49 PM UTC

Medical product user fees will not cover the full expense of fulfilling the commitments in pending medical product user fee reauthorization legislation, according to a Congressional Budget Office report. CBO estimates that there will be a $1.2 billion gap between the $9 billion in user fee revenues FDA is slated to receive from 2018-2022 and the cost associated with new commitments outlined in agreements negotiated with industry and included in the FDA Reauthorization Act of 2017 (S. 934).

FDA activities included in S. 934 that will not be fully funded through user fees include provisions intended to expedite generic drug reviews, and to stimulate pediatric drug and device development...