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# FDA Budget Request Seeks 3% Increase
- URL: https://www.fdaweb.com/fda-budget-request-seeks-3-increase/
- Published: 2026-04-06T12:00:00.000Z
- Updated: 2026-09-14T13:36:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160932

While many government agencies will have to deal with significant budget cuts next year, FDA’s just-released proposed fiscal year [2027 budget](https://www.fda.gov/media/191778/download?attachment&ref=fdaweb.com) seeks a 3.3% increase or about $200 million to fund the agency’s operations. As proposed, the budget would total $7.2 billion, which includes $3.3 billion in budget authority, a decrease of 1.4% or $47.8 million below the FY 2026 enacted level. It also includes $3.92 billion in user fees, an increase of 7.7% or $280.1 million above the FY 2026 level. “These requests will help FDA address its most urgent public health priorities, Make America Healthy Again, and increase America’s global competitiveness,” the request says.

FDA’s budget request says the agency is in the “process of transitioning its routine domestic food safety inspections to states and establishing an integrated framework that focuses FDA expertise on high-risk, complex, or emerging public health issues both domestically and abroad. At the same time, FDA intends to improve its existing capabilities to meet ever-growing inspectional demands. To support this work, FDA’s foreign offices require additional resources to expand the agency’s global footprint. Within this initiative, FDA will fund efforts to accelerate the establishment of new or advanced pharmaceutical manufacturing facilities in the United States, which will strengthen our supply chains and reduce our dependence on foreign pharmaceutical manufacturing.”

Under legislative proposals that FDA would support is an effort to curb misleading advertising to consumers. “This proposal would update FDA’s authorities with respect to direct-to-consumer (DTC) advertising," the agency say. "Specifically, this proposal would deem a drug to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352) if a DTC drug advertisement lacks fair balance and creates a misleading impression regarding FDA approval, the scope of the FDA-approved indication(s) and the limitations of use, or the drug’s efficacy and benefits, including by making or suggesting overstated representations that are not supported.” FDA says it needs additional authorities to more effectively address DTC advertising that lacks fair balance.

The proposal also seeks to update the FD&C Act to clarify that a compounded drug is deemed to be misbranded if an advertisement’s representation is false or misleading or creates a misleading impression by failing to clearly and prominently disclose that FDA has not approved or evaluated these products prior to marketing. The would also be misleading if the ads make misleading comparative claims to a particular FDA-approved drug or class of drugs; misrepresent the data available about the compounded drug or its active ingredients for particular indications based on clinical trials of FDA-approved drugs containing the same active ingredients; or omit risk information or fail to provide fair balance.

FDA says it would also support legislation to “create an optional risk-based expedited IND pathway for certain Phase 1 clinical trials where there is existing preclinical data that can potentially satisfy the regulatory standard with validated NAMS \[new approach methodologies\] methods.” This new pathway, aims to reduce duplicative and time-consuming requirements while maintaining safety and ethical standards. “This policy would be particularly important for smaller biotechnology firms that face greater barriers to entry under the current paradigm, which has fueled the increase in early stage preclinical, and Phase 1 activity in China and Australia,” it says. “The U.S. has longer timelines and a greater regulatory burden because of the preclinical work and investigational process – this policy would create an accelerated path to initiate U.S.-based Phase 1 clinical programs, drive market competition by reducing the regulatory burden for drugs with adequate preclinical data to support first-in-human studies, and lower drug development costs in support of the president’s goals on reshoring industry.”

The proposal indicates FDA would support legislation to amend current law to allow domestic generic drug manufacturers to submit generic drug applications earlier than foreign manufacturers in certain circumstances, “which may help repatriate the U.S. pharmaceutical supply chain by making domestic generic drug manufacturers more likely to be eligible for 180-day exclusivity.”

Regarding complete response letters (CRLs), FDA’s document notes it would support legislation to enhance FDA’s authority to publicly disclose information on deficiencies in safety and efficacy data provided to a sponsor in such letters. “The disclosure of certain information in CRLs may make drug development more efficient for multiple stakeholders, as it could help others prevent similar deficiencies in their own development programs and marketing applications,” it says.