FDA warns of layoffs if Congress fails to renew PDUFA

WASHINGTON Food and Drug Administration Commissioner Andrew von Eschenbach has told the agency’s employees that 2,000 of them could get layoff notices as early as next week if Congress fails to renew user fees for drugs and medical devices, according to the Associated Press.

The FDA and lawmakers are working to finalize the Prescription Drug User Fee Act, legislation that would renew user fees that would help the agency’s work.  In a letter to the employees, Eschenbach wrote, “All parties fully understand the importance of meeting the Sept. 21st deadline because no one underestimates or fails to appreciate the disruption and demoralizing impact that even the threat of a RIF is having on you and your families.”

The layoffs would take effect 60 days after issuance of a notice.  Both chambers of Congress are working on legislation that would renew the PDUFA program through 2012.