The US Food and Drug Administration (FDA) is asking some of its recently fired staff to return, three sources close to the matter said. The staff, who were responsible for critical funding negotiations with drugmakers, are involved in renewing programs that pay for the FDA’s drug review system.
In March, Secretary of Health and Human Services Robert F. Kennedy Jr. directed the FDA to fire 3,500 employees as part of a restructuring effort. However, at least one negotiator and nine other recently-fired staff were asked to come back, according to two sources.
The move marks the second time this year that the FDA has sought the return of fired employees. The agency rehired some scientists in February following the first round of layoffs.
Industry experts say that the firings have thrown into disarray the complex process of re-authorizing user fee agreements, which oversee pharmaceutical companies and makers of generic drugs paying for the FDA’s review of their products. These agreements are set to expire soon, and the FDA must complete reviews within 10 months or six months depending on the type of application.
Around 200 biotech companies expressed concerns to Congress about the firings at the FDA and asked that several staff be brought back, including user fee negotiators. The FDA’s return of some fired staff may help restore stability to this critical process.
Source: https://www.usnews.com/news/top-news/articles/2025-05-02/exclusive-us-fda-asks-some-fired-pharma-user-fee-negotiation-staff-to-return