FDA Seeks $372 Million (10%) Budget Boost for FY 2024
FDA’s just-released budget request for FY 2024 has the agency seeking a $372 million (10%) boost and a $150 million increase in user fees. The total funding being proposed for FDA, including $3.5 billion in total user fees, is $7.2 billion. “This funding will allow the agency to continue to leverage new and emerging technologies, recruit and support a highly skilled workforce, and adapt oversight to new production and business models,” an agency release says.
More than a quarter of the proposed increase, $98 million, would fund efforts to strengthen medical product safety and availability across FDA’s medical product Centers. “The budget includes funding to evaluate the performance, safety, and effectiveness of medical products, support resilience in the medical supply chain for devices, and funding to support public health programs to combat the opioid epidemic,” an agency budget document says.
The proposal would also provide $50 million for FDA to advance the Biden Administration’s Cancer Moonshot goals. “These funds will enhance FDA’s ability to improve evidence generation for underrepresented subgroups in oncology clinical trials, as well as to support pragmatic, decentralized trials and sources of evidence through patient-generated data and real-world evidence,” the agency says.
FDA says the $150 million user fee increase would come from increases in export certification fees and tobacco user fees. The budget proposal also accounts for the reauthorization of the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act later this year.
Accompanying FDA’s budget release is a summary of FY 2024 legislative proposals the agency is supporting. For example, FDA intends to seek authority to require retention of data and records supporting their applications and to act upon submissions containing fraudulent or unreliable data. “FDA is requesting express authority for the agency to ensure that data supporting application and non-application medical products are reliable and verifiable for as long as the product may be legally marketed, including throughout the lifetime of the application or market authorization, 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,” it explains.
FDA says the new authority will help it address increasing instances of fraudulent or unreliable data in premarket submissions for medical devices and marketing applications for drug and biological products. “In many instances, the fraudulent or unreliable nature of the data is not discovered until after marketing authorization is granted,” it says. “FDA believes these new or clarified authorities would encourage applicants and manufacturers to more closely examine and monitor the information and data they submit to FDA, and generate to support the marketing of FDA-regulated medical products, improving the reliability of their data.”
FDA is also seeking a legislative proposal to explicitly address generic drug-device combination products in the FD&C Act. Because the Act does not explicitly address ANDAs for drug-device combination products, it makes it difficult for companies to develop generic versions of these products and for FDA to efficiently approve them. “Among other things, FDA seeks amendments to clarify that FDA can request and review data for such applications, that certain differences between the device constituent parts of the reference listed drug (RLD) and the proposed generic are permissible, and that differences in labeling between the RLD and the proposed generic as a result of permissible differences in the device are also permissible,” the agency says.
Additionally, FDA says it will seek a safe harbor for generic drug “skinny labeling” which permit exceptions to the requirement that generic labeling be identical to the brand-name drug's labeling, allowing “carve outs” from the labeling on diseases or patient populations that remain protected by use patents. It says the proposal would exclude 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.
And FDA will seek a legislative proposal to amend the 180-day exclusivity provisions to encourage timely marketing of first generics. “FDA is proposing that the FD&C Act be revised to specify that 180-day patent challenge exclusivity for generic drugs does not block approval of subsequent applications from other generic drug manufacturers until a first applicant begins commercially marketing the drug,” the agency says, adding that “this revision should ensure that the exclusivity period lasts 180 days (i.e., from the date of first commercial marketing by a first applicant until 180 days later) rather than for multiple years, as can occur under current law (i.e., while the first applicant is eligible for 180-day exclusivity prior to commercial marketing in addition to the 180-day period itself).” This is intended to prevent first applicants from parking their eligibility for this exclusivity either by declining to begin marketing their product for extended periods of time after ANDA approval, or by delaying receipt of final approval of their ANDAs for extended periods of time, while avoiding a forfeiture, it says.
The Alliance for a Stronger FDA says it “endorses the President’s requested increase in FDA’s budget authority (BA) appropriations of approximately $372 million over the FY 2023 appropriated amounts for a proposed total of approximately $3.963 billion…We will be reviewing the detailed budget request (expected early next week) to provide additional information about the strengths of the request and any areas in which we think additional emphasis is needed.”