Ambitious Priorities: Breaking Down FDA’s FY27 Budget

As the Fiscal Year 2027 (FY27) budget and appropriations process kicks into full swing this month, the release of the President’s budget and related congressional hearings provide opportunities to gain insight into both the Trump administration’s and congressional lawmakers’ areas of focus for the Department of Health and Human Services, including the Food and Drug Administration (FDA). How FDA is implementing its mission to protect and promote public health is a keen area of interest for Capitol Hill, regulated industries, patients, consumers and the American public as the agency is responsible for overseeing products that account for more than 20 percent of all consumer spending in the United States. On April 3, the White House rolled out its FY27 Presidential Budget Request and FDA’s section reflects priority areas of focus for the agency throughout Dr. Makary’s tenure as commissioner, including advancing various “Make America Healthy Again” (MAHA) initiatives, increasing the agency’s global competitiveness and inspection capabilities by funding opportunities for scientific advancement and streamlining activities related to accelerating review and approval and continuing efforts to modernize the agency. This client alert provides a high-level overview of key takeaways from FDA’s latest budget with respect to human medical products and food and next steps on Capitol Hill.

Topline Takeaways 

The President’s budget proposes a total of $7.2 billion for FDA, which is $232 million above the enacted FY26 funding level (a 3.3% increase). This total includes $3.3 billion in discretionary funding and $3.9 billion in user fee authority, including a newly proposed user fee that would provide $71 million to expand and collect fees from food facilities and importers under FDA’s human and animal foods program. Notably, the budget outlines a plan to combine FDA’s National Center of Toxicology Research with offices and programs under the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health to form a newly established National Center for Chemicals and Toxins within CDC. The proposed budget highlights requests in furtherance of the agency’s public health mission and to address “ambitious Administration priorities.” Highlighting an emphasis on operational imperatives, the budget emphasizes protecting user fee agreements, noting a request of $41.6 million to spend the minimum level of non-user-fee appropriated budget authority to obligate user fee revenues and an intent to use these funds to streamline applications, enable more timely approvals and deliver faster and cost-effective regulatory services. This is of note as Congress prepares to consider the upcoming reauthorizations of the human medical products programs set to expire on September 30, 2027—the Prescription Drug User Fee Program (PDUFA), the Medical Device User Fee Program (MDUFA), the Generic Drug User Fee Program (GDUFA) and the Biosimilar User Fee Program (BsUFA). The reduction to FDA’s workforce is also mentioned in the context of FDA working to implement “Simple Reform” with the stated goal of enabling programs to more efficiently address critical public health needs. The proposed budget also includes narratives outlining 27 legislative proposals.

Drug and Biologic Takeaways

In its FY27 budget request, FDA seeks $2.54 billion for the Human Drugs Program, reflecting both budget authority and drug user fees and an increase of roughly $39 million over FY26, while continuing to shift the program’s funding balance toward more user fees. The budget proposes reducing budget authority by $53 million to approximately $632 million and increasing user fee collections by $92.2 million to about $1.91 billion, framing the request as necessary to sustain core premarket review functions and to support a predictable, science-driven drug review program that ensures the safety, effectiveness, quality and availability of human drugs. Within its budget authority, FDA is prioritizing funding to preserve user fee agreements ($24.2 million) and enhance global competitiveness and inspection capacity ($14 million). These increases are offset by a $91.2 million reduction attributed to previously adopted agency-wide streamlining efforts. The budget frames the proposed user fee increase as necessary for the agency to maintain its public health mission by ensuring the safety and efficacy of regulated products.

Further, the FY27 FDA budget request seeks more than $574 million for the Biologics Program, comprised of both budget authority and user fees, representing a decrease of just over $27 million from the FY26 enacted level and continuing a trend of increasing user fees for the program. Specifically, the budget requests a reduction of more than $52 million in budget authority, offset in part by a $25 million increase in user fee collection, for a total of almost $207 million in budget authority and $367 million in user fees. The FY27 FDA budget notes that the requested level of funding would support advancing public health through thoughtful and innovative regulation that promotes the safety, purity, potency, effectiveness and timely delivery of biological products including vaccines, allergenics, blood and blood products and cell, tissue and gene therapies.

Drug and biologic policy play a prominent role in FDA’s legislative proposals, with the agency outlining a broad set of recommendations to strengthen FDA’s oversight of human drugs and biologics, accelerate competition and product development and modernize regulatory processes. Various legislative narratives included in the budget request propose expanding FDA authority over direct-to-consumer drug advertising and compounded drug promotion, clarifying and modernizing New Drug Application (NDA), Biologics License Application (BLA) and Abbreviated New Drug Application (ANDA) review timelines and appeals processes and allowing limited public disclosure of deficiencies identified in complete response letters (CRLs) for NDAs and BLAs. Several proposals aim to bolster supply-chain integrity and enforcement, including authority to require destruction (rather than export) of refused imports posing significant public health risks, mandatory disclosure of active pharmaceutical ingredient sourcing data and corresponding civil penalties, enforcement authority over unapproved manufacturing changes, enhanced record retention and anti-fraud authorities and explicit authority to disclose and use impurity-related safety information in the public health interest. Other proposals reflect the administration’s focus on streamlining FDA processes and are designed to speed access and streamline development, such as creating an expedited, risk-based alternative to the current investigational new drug (IND) pathway for certain Phase 1 trials, permitting earlier Paragraph IV certifications for U.S.-based generic drug manufacturers, changes to the Orange Book patent listing rules that trigger 30-month stays and changes to generic drug-device combination product provisions in the Food, Drug & Cosmetic (FD&C) Act. Changes are also proposed to the Public Health Service Act, including eliminating a separate statutory standard for a determination of interchangeability and deeming all approved biosimilars interchangeable with their respective reference products and, separately, creating an additional abbreviated licensure pathway for biological products.

Device Takeaways

The FY27 FDA budget proposes $1.005 billion for FDA’s Device and Radiological Health Program, reflecting both budget authority and medical device user fee funding. This funding level represents a 10% increase from the FY26 enacted level and is intended to allow the Devices Program to continue to make advances in diagnosing, monitoring and treatment provided by new devices while enhancing safeguards for patients. The budget notes a focus on efforts to improve predictability, efficiency and transparency of FDA regulatory systems so manufacturers can bring novel products to market in a timely manner. Increases to the Device Program budget also reflect efforts to protect user fee agreements, increase FDA’s inspectional capacity, strengthen post-market surveillance and promote and protect public health. The budget also includes device-related legislative proposals, including giving the agency the same importer destruction authority as proposed for drugs, changes to drug-device combination product statutory provisions, requiring retention of data and records supporting marketed medical products and marketed medical product applications to address fraudulent data and giving FDA additional authority to ensure that foreign firms manufacturing devices intended for import into the U.S. are in compliance with quality system requirements and to disrupt the flow of problematic imported medical devices.

Food Takeaways

FDA’s FY27 budget request signals that food policy remains a central pillar of the agency’s broader MAHA agenda. The proposal would increase the Human Foods Program to roughly $1.293 billion (up from $1.185 billion in FY26), pairing that funding boost with a MAHA-oriented focus on food chemical safety, nutrition and infant health and new full-time equivalents to support these activities. It includes $57 million for MAHA initiatives aimed at removing unsafe chemicals from the food supply and ensuring foods are “safe and nutritious,” including expansion of the Closer to Zero program to address toxic elements in children’s foods and efforts to overhaul the “Generally Recognized as Safe” (GRAS) designation as key components of the agency’s food-policy agenda. Notably, the budget requests funding to explore opportunities for legislative changes related to closing the GRAS loophole, signaling the agency may seek to pursue statutory changes on this issue in addition to any potential administrative actions.

The request also points to a structural shift in FDA’s food oversight model. In addition to seeking greater inspection capacity, the agency notes it will expand routine domestic food safety inspections in states while concentrating federal resources on high-risk, complex or emerging public health issues, underscoring a shift toward a more targeted, risk-based approach. The budget further promotes a MAHA agenda through a suite of legislative proposals that would expand FDA’s post-market oversight of food chemicals, including new requirements for food manufacturers to conduct post-market safety evaluations, meet minimum data standards and submit results to FDA—marking a significant evolution from a historically more reactive posture. The proposal also includes new tools aimed at strengthening food oversight, including expanded information-sharing authority with state, local, Tribal and territorial authorities, new infant formula oversight requirements such as mandatory pathogen reporting and environmental monitoring, as well as a proposal to establish a biennial registration fee for foreign human and animal food facilities, which is projected to generate $71 million in additional revenue intended to support oversight of imported foods and food program work abroad. Taken together, the FY27 proposal reflects not simply increased funding, but an increasingly assertive and ambitious food policy posture—one that combines expanded ingredient scrutiny, inspection realignment and new tools to oversee an increasingly complex and global food supply.

Next Steps

As the name suggests, the White House’s budget submission is a request, not a directive. FDA’s current appropriated funding runs through September 30, 2026. With less than six months until the end of FY26, in the weeks and months ahead, the House and Senate will hold hearings and markups as the FY27 budget and appropriations process moves forward. FDA will continue to be an area of focus for both Republican and Democratic members of Congress as they work to figure out a path forward on FY27 appropriations. Congressional leaders will use these hearings and subsequent markups to engage on various aspects of FDA’s budget request, assessing the proposed funding and corresponding legislative proposals while also looking to highlight their own work on a range of FDA policy issues and potential areas on which the agency might work with Congress, which could culminate in future statutory changes. However, the path to final FY27 funding will not be linear as this work will be playing out against the backdrop of this year’s midterm elections and preparations for FDA’s user fee reauthorizations next year. FDA funding and policy proposals will continue to be an area to watch as an already active year continues to unfold on FDA fronts.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.