FDA wants $7.2B for product safety, public health in Biden’s FY 2025 budget

The US Food and Drug Administration (FDA) has requested $7.2 billion from President Biden’s proposed fiscal year 2025 budget, an increase of $495 million from FY 2023 funding levels.

FDA’s request includes $3.5 billion in user fees as well as $157 million for a host of initiatives and programs, including medical product safety, public health and mission support, infrastructure modernization, and other modernization efforts. It also contains a list of legislative proposals the agency says will help facilitate competition, support innovation, enhance safety, address product shortages, and provide other services.

FDA also asked for $7.2 billion from President Biden’s FY 2024’s budget proposal, which also included requests for funds to address medical device supply chain enhancements and shortage programs as well as legislative proposals to expand FDA’s authority to address supply chain resiliency. (RELATED: FDA seeks 10% boost in Biden’s FY 2024 budget, Regulatory Focus 9 March 2023)

“The FDA continues to protect the health and well-being of millions of people,” Robert Califf, FDA Commissioner, stated in a press release. “This new funding request will help us build on our accomplishments and also modernize our agency and operations as we plan for the future. Our request for critical investments will help us address our most urgent priorities, strengthen our public health capacity, advance IT capabilities, and improve agency-wide infrastructure. The budget will also support the FDA’s ability to prepare for, build resilience to, and respond to shortages, support the implementation of expanded cosmetics regulation, and protect and promote a safe, nutritious U.S. food supply.”

Budget summary

FDA is requesting $114.8 million to shore up its employee workforce, which the agency says will go to cost-of-living adjustments and inflationary pay costs to keep existing staff and “minimize reductions to hiring capabilities.”

In a statement, the Alliance for a Stronger FDA said they support the FY 2025 budget increase, which is an increase of $168 million from FY 2024 based on FY final funding from 2024, which was recently completed. However, they noted the $114 million allocated for mandated salary increases leaves “very little to cover growing demands on the agency.”

“We will be asking Congress for additional FY [2025] FDA funding so that the agency can make essential investments in modernizing its information technology and data management infrastructure to support better informed decision-making, and programs that will keep the agency on pace with increasingly-sophisticated technologies and societal needs,” they said.

An additional $43.6 million would go to optimizing the function of the FDA’s offices and labs, including for emergency response and expansion of inspection operations at points of entry. “Optimally functioning facilities provide secure, modern, reliable, and cost-effective office and laboratory space that empowers the FDA’s workforce to protect and promote the safety and the public health,” the agency wrote in a budget summary fact sheet.

FDA is asking for $12.3 million to address disruptions in the supply chain as well as improving supply chain resiliency, which will be achieved with “an agency-wide crosscutting initiative” involving better analytics and regulatory approaches. The funds will also be used to hire more investigators for inspections of supply chain disruptions and product shortages, modernize systems to quickly address shortages, and “continue promoting manufacturing quality across the pharmaceutical industry.”

In terms of modernization, FDA requested $8.3 million to continue with centralized enterprise data modernization. The agency also asked for $2 million for other modernization activities across the agency such as centralizing planning, implementation, and business process improvement efforts. “These include the continuation of the critical inspections platform implementation and expansion effort to implement common business processes and data optimization across the agency,” they explained. FDA also proposed 2-year spending authorities to support both data and other agency modernization initiatives.

Additionally, FDA requested $1 million to expand their presence overseas in foreign offices as well as in oversight of imported products. “Funding will support the expansion of the agency’s foreign-office footprint, expanding agency resources to facilitate timely inspections of foreign facilities in specific countries. Additional deployed personnel would also improve oversight of imported products,” FDA wrote.

Legislative proposals

Also included within FDA’s FY 2025 budget proposal are more than 30 legislative proposals from the agency in areas of competition, innovation, safety, product shortages, and elsewhere.

FDA’s proposals to address product shortages include an expansion of FDA’s authority to require a manufacturer to create a label for a product that reflects the longest shelf-life data possible based on current data, an expansion of FDA’s recall authority for human and animal drugs, an expansion in FDA’s authority to require drug manufacturers to notify the agency of a demand increase for a drug, enhanced drug manufacturing amount reporting information, an expansion of FDA’s medical device shortage authority outside of public health emergencies, and the addition of a requirement to include a drug product’s original manufacturer and supply chain information on the label.

The agency has proposed the Hatch-Waxman 3-year exclusivity provisions be amended and limited to “situations where the new drug applicant is actually seeking such exclusivity and where the data supporting the exclusivity demonstrates the hypothesized effect of the drug, and to prevent information on new safety risks from blocking competition.”

“Under current law, new drugs can qualify for exclusivity that can block or delay competition from follow-on products even when the new drug applicant is not affirmatively seeking exclusivity, or when the new clinical investigation that is the basis of exclusivity fails to demonstrate the hypothesized effect of the drug,” FDA said.

FDA requested amendments to provisions of the Hatch-Waxman Amendments and the Generic Animal Drug and Patent Term Restoration Act to allow for protection of applicants who engage in so-called “skinny labeling” and are liable for patent infringement if they market a human or animal generic drugs “by excluding such labeling from the evidence that can be used to support a claim of patent infringement, and by clarifying that statements regarding therapeutic equivalence cannot be used as evidence to support an infringement claim.”

Other proposals proposed by FDA under the auspices of improving competition include a proposal to disclose the full ingredients of a brand drug to facilitate generic competition, an amendment to the 180-day failure to market forfeiture provision, a proposal to eliminate the distinction between biosimilars and interchangeable biosimilars, and a proposal to “explicitly address abbreviated new drug applications (ANDAs) for drug-device combination products.”

Concerning data, information, and postmarket safety, FDA is requesting authority to request applicants retain data and records for marketed products while the product is being legally marketed “and to ensure that FDA has appropriate tools to act on findings of fraudulent or unreliable data or information, including untrue statements of material fact.” Separately, FDA requested an amendment to the FD&C Act to require master files for drug manufacturing facilities, an expansion to its disclosing information authorities with states, an amendment that would allow the agency “a formal, designated opportunity to use a risk-based approach to determine if an inspection of the manufacturing facilities is necessary before [a non-application] drug is first distributed.”

The agency also proposed expanding its ability to disclose when a drug or biological product contains impurities that are a public health risk, and requested a requirement to destroy imported products if they pose a significant risk to public health, which would “prevent the potential re-importation of such products and would deter owners and consignees from offering products they know to pose a significant public health risk for import.”

Press release

FDA wants $7.2B for product safety, public health in Biden’s FY 2025 budget

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