As budget reductions to the U.S. Food and Drug Administration (FDA) continue to take effect under the 2025 federal plan, the implications for patients, researchers, and biopharma companies are continuing to raise concern. These changes don’t just affect government operations, they impact lives.
In 2025 FDA’s budget encompassed $7.2 billion, including $3.5 billion from user fees.
At the May 22, 2025 FDA and Related Agencies subcommittee meeting, FDA Commissioner Martin Makary testified that the Agency is requesting a 2026 budget of $6.8 Billion. This would include $3.2 Billion in congressional appropriations and $3.6 billion from user fees, which would mean a decrease in funding for 2026.
Patients can’t afford delays in drug development. Yet with fewer resources available at the FDA, timelines for reviewing lifesaving therapies may be extended. Americans depend on the FDA’s scientific integrity, high quality and timeliness during their review, and oversight to evaluate safe and effective treatments. Resource challenges and disruptions at the agency risk slowing the pace of innovation and growth.
From Drug Reviews to Facility Inspections: Key Functions at RiskThe impact began accelerating earlier this year, when significant staffing reductions affected FDA personnel across key departments. Thousands of roles were eliminated at the federal level, including hundreds of FDA reviewers, inspectors, and scientific staff, individuals critical to evaluating drug applications, monitoring clinical trials, and inspecting manufacturing facilities. Although some staff focused on food and medical device regulation were later reinstated, the initial cuts created widespread concern. Regulatory processes were paused or delayed, placing grant applications, clinical trial reviews, and drug approvals in a state of uncertainty.
The result: patients awaiting treatment approvals and companies depending on predictable timelines are now grappling with potential delays and setbacks.
A Setback for Regulatory Efficiency
Budget and staffing cuts at the FDA, particularly in manufacturing facility inspections and drug evaluation and research, pose challenges for the agency’s ability to meet user fee commitments and review deadlines. Programs funded under the Prescription Drug User Fee Act (PDUFA), which expedite the review of critical therapies (including oncology and rare disease treatments), may now face slower response times.
This environment reinforces the importance of collaboration and clear communication between industry and the agency, especially when working with fewer resources.
Sustaining the Public-Private Model
For decades, the FDA’s work has been supported by user fees collected through programs like PDUFA. These fees enable the agency to hire skilled staff, maintain performance benchmarks, and provide timely regulatory feedback.
However, with constrained resources and evolving federal directives, particularly early in 2025, some questioned whether the same level of efficiency and reliability can be sustained. As time progressed, there were some delays, yet the Bracken regulatory team found that the FDA Review Teams were quite responsive, and timelines were upheld, despite FDA staffing constraints and uncertainties. The FDA Review and Inspection Teams that interface directly with industry are to be commended for their focus and dedication during these uncertain times.
The strength of the FDA’s public-private model depends on maintaining credibility, transparency, and responsiveness.
Now More Than Ever, Collaboration is Key
At Bracken, our regulatory and medical affairs experts serve as vital partners between industry sponsors and FDA reviewers. We focus on helping clients prepare complete, strategic, and clearly written submissions, ensuring each dossier supports the FDA’s work and avoids unnecessary delays. Every detail matters. Data must be presented clearly, risks must be contextualized thoughtfully, and communication must be precise and timely. In this landscape well-prepared submissions can make the difference between timely approval and costly holdups.
As regulatory challenges evolve, Bracken remains committed to guiding companies through this period of uncertainty. From smarter submission strategies to proactive agency engagement, our team helps clients stay aligned with FDA expectations, even when resources are constrained.
Ultimately, this moment is not just about agency structure: it’s about protecting the time, investment, and patient hopes behind every new therapy.
Need expert support for your FDA communications or regulatory strategy? Bracken is here to help. Contact us today to learn more.