FDA’s Imperiled Funding Threatens Drug Approval Revamp, Staffing
Bloomberg Law
Bloomberg Law
Stacy Cline Amin spoke to Bloomberg Law about an impasse among congressional leaders on industry fees to the U.S. Food and Drug Administration (FDA), which could force the agency to let go of thousands of employees and lose out on changes to its fast-track drug pathway.
According to Stacy, the FDA will need to “start making decisions about what work they have the funding to continue to do,” adding that it “would be very devastating if it went past September 30” when the current user fee agreement expires. Nearly half of the FDA’s budget for the drug and device industries comes from user fees, with much of it going to employee salaries.
Stacy noted that there are a couple of possibilities for compromise, including agreeing to move forward with Senator Richard Burr’s proposal to ensure the user fees get authorized in time. The House package could also serve as a negotiation point, as it doesn’t include the Senate additions Burr voted against, Stacy said.
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