The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent staffing exodus.
The FDA is asking key staff responsible for negotiations over its user fee programs—whom it had recently fired—to return to their jobs, according to a Saturday report from Reuters.
The agency is rehiring at least one user fee negotiator and nine other employees who supported user fee processes, according to two anonymous sources familiar with the matter. As per Reuters, the negotiator intends to return to the FDA, while it remains unclear how many of the support staff plan to do the same. These personnel were involved in the user fee renewal process.
The FDA’s user fee programs—which cover different product types, such as medical devices, generics and biosimilars and new drugs and biologics—are one of the agency’s biggest funding streams. Under these programs, the FDA can collect certain fees from companies whose products it reviews. This money, which last year accounted for just under half of the agency’s total budget, primarily helps pay for staffing salaries.
Importantly, user fees do not ensure a favorable review. Instead, in exchange for their payment, companies can hold the FDA accountable to certain standards and deliverables, which the industry can negotiate. The next cycle of the user fee program, which is renewed every five years, is set to start in 2027. But negotiations are expected to begin this September—a lead time large enough to accommodate the complexity of the negotiation process.
However, the recent mass exodus of employees from the FDA has imperiled the user fee program—so much so that policy expert Alexander Gaffney last month called the situation an impending “catastrophic collapse.”
In a subsequent interview with BioSpace, Gaffney warned that if staffing levels at the agency drop below a certain level, it will set off a “trigger mechanism,” where the FDA will no longer be able to collect user fees from the industry. There is some breathing room yet for the agency—“the actual trigger happens at the end of the fiscal year,” Gaffney explained—but if nothing is done to avert it, the loss of these funds could set the U.S. back by more than three decades.
Since Robert F. Kennedy Jr assumed his role as Secretary of Health and Human Services in February, some 3,500 employees at the FDA have been laid off, including several who were involved in negotiating and renewing the user fee programs.
To compound the problem, many also decided to leave the agency voluntarily—or semi-voluntarily, being forced to retire early or get fired—including some high-ranking officials, such as Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research and Peter Stein, ex-director of the Office of New Drugs.
