and its reliance on user fees from pharmaceutical and device manufacturers, which accounted for US $ 3.5bn of the FDA’ s US $ 7.2bn 2025 budget request. His calls for changes to the Prescription Drug User Fee Act( PDUFA) have placed the FDA’ s funding model under scrutiny, raising fears of weakened regulatory oversight.
Critics worry this approach prioritises cost-cutting over patient safety, potentially leaving the US healthcare system ill-prepared for future crises.
Despite these challenges, the FDA remains focused on its mission. The agency is actively advocating for expanded authorities to mandate early shortage reporting and additional funding to address systemic vulnerabilities.
The path to a resilient future While the FDA has made progress, long-term solutions require legislative and financial support.
The agency has called for amendments to Section 506J of the CARES Act to remove the limitation that ties shortage
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