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Angie Drakulich was editorial director of Pharmaceutical Technology.
US Food and Drug Administration Commissioner Andrew von Eschenbach warned agency employees last Friday that 2,000 layoff notices could be coming as early as Sept. 21.
US Food and Drug Administration Commissioner Andrew von Eschenbach warned agency employees last Friday that 2000 layoff notices could be coming as early as Sept. 21. The layoffs depend on whether or not Congress renews user fees for drugs and medical devices, according to a Sept. 15 Associated Press (AP) article.
“All parties fully understand the importance of meeting the September 21st deadline because no one underestimates or fails to appreciate the disruption and demoralizing impact that even the threat of a RIF [reduction in force] is having on you and your families," von Eschenbach wrote in a letter delivered to employees at the end of the day, Sept. 14.
Both the House of Representatives and the Senate have passed legislation that renews the user-fee program, which goes toward supporting FDA’s work, through 2012 and are currently working to resolve differences between their respective bills (H.R.2900 and S.1082), according to the AP article. Von Eschenbach’s team has been working with Congress to finalize the legislation.
Pharmaceutical manufacturers started paying fees to FDA in 1992 after passage of the original Prescription Drug User Fee Act (PDUFA) for product applications and supplements, and other services. The funds support the review of these applications.
FDA proposed recommendations to Congress for the next reauthorization of PDUFA IV last March. If the user-fee legislation, which is bundled with other related bills, is not renewed, the pending layoffs would take effect within 60 days of given notice.