By Patrick Wingrove
(Reuters) -The U.S. Food and Drug Administration is asking some of its recently fired staff responsible for critically important funding negotiations with drugmakers to return, three sources close to the matter said.
The staff being asked back are involved with renewing programs under which drugmakers provide user fees that pay for the agency’s drug review system.
The FDA last month fired most of its senior negotiators, as well as their project managers, Reuters previously reported.
Secretary of Health and Human Services Robert F. Kennedy Jr. directed the FDA to fire 3,500 employees as part of a massive restructuring of U.S. health agencies in March. HHS has said 20,000 employees have left the agency through layoffs, buyouts and early retirement offers spearheaded by billionaire Elon Musk’s Department of Government Efficiency.
At least one negotiator and nine other recently-fired staff who support negotiations were asked to come back, two sources said. They were asked if they wanted to return on or after Friday, or voluntarily resign.
The negotiator plans to return, two sources said, but it was unclear how many of the others asked back would do so.
HHS, which handles media enquiries for the FDA, said that any errors related to layoffs were a result of inaccurate data collected by human resources divisions across the department.
The move marks the second time this year that the FDA has sought the return of fired employees. It rehired some scientists in February following the first round of layoffs at the agency.
The subsequent mass FDA firings in April by the administration of President Donald Trump had begun to disrupt reviews of new medicines, according to FDA sources.
Under the current expiring user fee agreements, the FDA commits to complete new drug approval reviews within either 10 months or six months depending on whether it is a standard or priority application, according to experts.
Industry experts have said that the firings of most of the negotiators and their project managers threw into disarray the complex process of re-authorizing the agreements, overseen by Congress, under which pharmaceutical companies and makers of generic drugs pay for the FDA’s review of their products.
The staff are responsible for organizing its legally-required public meetings, which must be held before negotiations begin over the agreement renewals. The meeting for generic drugs was set for June, and the one for branded prescription medicines for July.
Around 200 biotech companies last month also penned a letter to Congress expressing their concerns with the firings at the FDA and asking that several staff be brought back, including user fee negotiators.
(Reporting by Patrick Wingrove in New York; editing by Caroline Humer and Bill Berkrot)
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