The House Appropriations Committee on Wednesday began marking up the FDA’s 2025 funding bill, offering the agency about 1% less than 2024 and almost 10% less than what President Joe Biden requested.
Beyond the dip in funds, an accompanying report to the bill raises new concerns and seeks updates from the FDA on what the Republican-led committee cites as misalignment between the FDA’s centers for drugs and biologics on accelerated approvals and rare disease treatments.
“The Committee is concerned that the application of the Accelerated Approval Pathway is not uniform between CDER and CBER,” lawmakers said in the report, noting the appropriations committee is requesting that the FDA brief the committee on how accelerated approvals can be “administered equally in both CDER and CBER.”
CBER chief Peter Marks has been vocal about his center’s push to use accelerated approvals more frequently for rare disease drugs. But he’s also been in the middle of controversy around the approvals, after he single-handedly signed off on expanding the use of Sarepta’s gene therapy for Duchenne muscular dystrophy to a far wider group of patients.
Similarly, the report raised concerns about “disparate approaches to similar rare disease treatment applications between centers” and how these differences “pose risks to innovation.”
For CDER and CBER, “particularly in their restructuring efforts tailored to the products they review, the Committee underscores the necessity of a more aligned approach specifically for rare diseases,” the report says.
Overall, the House bill provides $3.5 billion in discretionary funding and $3.2 billion in user fees, which is slightly less than the $6.75 billion in the Senate. The Senate will see its own FDA appropriations committee markup on Thursday.
Manufacturing
The committee also threw its support behind an FDA pilot on unannounced foreign drug inspections, following similar critiques of the agency’s work, and sought new quarterly briefings from the FDA on the pilot.
The report also raises concerns on drug shortages, particularly for generic sterile injectable drugs, noting that “a key driver of these shortages is the lack of resilient supply chains.”
Citing an FDA pilot on quality drug manufacturing management, which began last August, the committee said that within six months of the appropriations being enacted, it’s “eager to learn the results of the current evaluation program and requests an update.”