Exclusive: US FDA asks some fired pharma user fee negotiation staff to return
Source: Reuters
May 2, 2025 6:22 PM EDT Updated 11 hours ago
May 2 (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.
Read more: https://www.reuters.com/business/world-at-work/us-fda-asks-some-fired-pharma-user-fee-negotiation-staff-return-2025-05-02/
That's utter BULLSHIT. Agencies do "data calls" all the time and there were most likely "few or no errors" but a fucking disregard for the processes that took many decades to put together - notably to work around the chronic underfunding of the regulatory agencies.
The whole point of what was a GOP-spearheaded "User Fee" model (put in place almost 35 years ago under Poppy) was to supplement "taxpayer funding" for the increasing workload, and introduce a "fee for service" business model, where firms "paid for" review of their new drug, and later new generic drug, or new medical device applications. The assigned employees (reviewers, Investigators, lab staff) for those applications, would have portions of their salaries (based on hours worked related to the application) essentially funded through that User Fee program (which is closely tracked). If the strict review process schedule is missed, then the agency must refund the applicant.
But the DOGE idiots didn't know or care and cavalierly "threw out" what private industry "paid for".
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