A House panel later today is scheduled to mark up the FDA’s appropriations bill for fiscal year 2025, the beginning of Congress’ process for funding the agency in the upcoming year.
Under the proposal, the FDA would receive a total budget of $6.75 billion, the same amount it received in the prior fiscal year. That falls well short of the requested $7.2 billion that the agency proposed in its budget request earlier this year.
This year’s government funding process is beginning after legislators last year struggled to pass appropriations packages, bringing the government to the brink of a shutdown. The current FDA bill has a ways to go before it gets to a vote. Assuming it clears the subcommittee that oversees the FDA’s budget, the legislation will be taken up by the full House Committee on Appropriations next month before it can move to the House floor.
Steven Grossman, executive director of the Alliance for a Stronger FDA, predicted it could be a long process to get the appropriations packages to completion, warning in a blog post last week that it might not be until December that the process gets ironed out.
“Depending on the outcome of the elections, the FY 25 funding bills may not be settled until early next year,” he wrote.
Much of the agency’s budget comes from user fees paid by product sponsors to fund reviews. In the current proposal, that includes about $1.5 billion for the prescription drug user fee program and about $626 million for the generic drug user fee program, plus $370 million for medical device user fees and about $32 million for biosimilar user fees.
Under the bill, the FDA’s drug center would be allocated $2.4 billion, of which at least $10 million would be set aside specifically to establish pilots to conduct more unannounced foreign inspections of drug manufacturers.
Meanwhile, the agency’s biologics center would receive a total of $577 million to conduct its operations, including inspections and investigations.