Representatives from the biotech, medical device and generic drug industry groups told members of the Senate Committee on Health, Education, Labor & Pensions that if the FDA user fee programs are not reauthorized, the agency would likely see more than 3,000 layoffs, reported RAPS.
The user fee programs allow the FDA to collect fees from drug manufacturers to fund the new drug approval process. The reauthorization proposals for PDUFA, MDUFA, GDUFA, and BSUFA were submitted to Congress in January, and now President Trump and Congress must take action on the already-agreed-to reauthorizations before August 1.
Senators on both sides agree that failed reauthorization will lead to cuts that harm new medical and drug product approvals and likely delay research.
Read the RAPS article