FDA Budget Under The Microscope

Senators challenge Commissioner Makary on staff cuts, drug approvals, rare diseases research, and more

May 22, 2025

⚡️ NIMITZ HEALTH NEWS FLASH ⚡️ 

“A Review of the President’s FY26 Budget Request for the Food and Drug Administration”

Senate Appropriations Agriculture, Rural Development & FDA Subcommittee

May 22nd, 2025 (recording linked here)

Source: Politico

WITNESS & TESTIMONY

HEARING HIGHLIGHTS

👩‍⚕️ FDA Staffing Reductions and Functional Impact

FDA leadership confirmed roughly 1,900 staff were cut—primarily from HR, communications, and procurement—not scientific reviewers or inspectors. While core functions like drug review and food lab operations are reportedly on track, concerns remain over the loss of technical staff in food safety and infant formula, and inconsistent public messaging raised doubts about internal clarity and operational resilience.

🦠 COVID-19 Booster Policy Shift

The FDA is limiting COVID-19 boosters to high-risk groups, citing a lack of updated clinical trial data for broader use. Leadership emphasized the need for age-stratified, evidence-based approvals and published a regulatory framework to guide future decisions. The agency positioned this shift as a correction from blanket annual booster strategies and aligned it with international norms.

💊 Delays in Rare Disease and Biosimilar Drug Access

Persistent delays in rare disease drug reviews prompted scrutiny, despite FDA assurances that PDUFA timelines are intact. Officials cited case complexity, not staffing, as the cause, but acknowledged broader reforms are needed. The agency is also evaluating ways to streamline biosimilar approvals—such as removing duplicative trial requirements—to lower drug costs and boost market competition.

MEMBER OPENING STATEMENTS

  • Chair Hoeven (R-ND) highlighted the importance of American farmers and ranchers in producing the highest quality, lowest-cost food supply in the world, noting that this must not be taken for granted. Hoeven praised Dr. McCary’s background in both medicine and business, specifically commending his work at Johns Hopkins. He urged the FDA to pursue innovation and efficiency while staying grounded in the real-world challenges faced by agricultural producers, including rising costs and market instability.

  • Ranking Member Shaheen (D-NH) shifted focus to the FDA’s role in supporting biomedical innovation, highlighting the growth of biotech industries in her state and the need for regulatory stability. Shaheen expressed grave concern over the FDA workforce reductions under the current administration, warning that firings have disrupted critical medical product reviews and harmed agency effectiveness. She criticized the lack of transparency surrounding the FY2026 budget request and underscored the FDA’s hopeful mission to bring life-saving treatments to Americans.

WITNESS OPENING STATEMENT

  • FDA Commissioner Makary presented the Trump administration’s proposed $6.8 billion FDA budget and outlined several initiatives taken during his first seven weeks in office, including eliminating petroleum-based food dyes and reducing animal testing. He emphasized a shift to surprise inspections of overseas pharmaceutical manufacturers and highlighted enforcement actions such as the seizure of nearly two million illegal Chinese vaping products. Makary announced new efforts in AI-assisted scientific reviews to streamline drug approvals, citing a recent case where AI reduced a multi-day review to six minutes. He outlined ambitious goals for the agency, including faster drug approvals, novel PTSD treatments, and cost reductions through generics and biosimilars, pledging to bring “gold standard science and common sense” back to the FDA.

QUESTION AND ANSWER SUMMARY

  • Sen. Collins (R-ME) expressed concern about FDA delays in approving treatments for rare diseases and urged faster action under accelerated pathways. Commissioner Makary responded that FDA was still meeting all PDUFA timelines, and that staffing cuts did not affect scientific reviewers, explaining delays as tied to complex cases rather than workforce changes.

    Sen. Collins pushed back, citing patient frustration with repeated postponements, and said she would follow up directly to address unmet needs. Commissioner Makary defended the new CBER leadership, asserting the incoming scientist's qualifications and commitment to continuity in rare disease review.

  • Chair Hoeven (R-ND) asked for a status update on workforce reductions and how to ensure safety amid reorganizations. Commissioner Makary stated that nearly 1,900 staff were affected by RIFs, mostly from admin and support roles, and emphasized the FDA’s historic expansion since 2007 as justification for streamlining.
    Chair Hoeven stressed that fee-supported staffing must be preserved to maintain drug review timelines and patient safety. Commissioner Makary reassured that FDA was on track with user fee targets, had rehired some staff, and was ensuring scientific teams remained fully supported.

    Chair Hoeven asked about the MAHA Commission’s forthcoming report and how FDA would balance scientific findings with practical impacts on agriculture. Commissioner Makary explained the report would focus on root causes of chronic disease—such as food additives like talc—and insisted it would not target any one chemical, but would elevate overlooked scientific conversations.

  • Ranking Member Shaheen (D-NH) pressed on the FDA’s decision to limit COVID-19 boosters to high-risk individuals, questioning the timeline and transparency of that change. Commissioner Makary defended the policy shift as science-based, emphasizing a lack of randomized trials and public demand, and stated that companies had time and funding to present clinical trial data by fall.

  • Sen. Hyde-Smith (R-MS) cited new data suggesting high complication rates from mifepristone and asked whether FDA would consider reinstating prior safety protocols. Commissioner Makary said he had reviewed the top-line results and committed to evaluating the study in full once peer-reviewed data were available.

  • Sen. Ossoff (D-GA) asked whether FDA scientists working on food and infant formula safety were fired, citing contradictory statements and a resignation letter. Commissioner Makary responded that scientific reviewers were not cut, but acknowledged that some research scientists were slated for RIF before his tenure and were later rehired after internal review.

  • Sen. Murray (D-WA) criticized the FDA’s staffing cuts, questioned their efficiency, and asked if firing staff funded by user fees saved taxpayer money. Commissioner Makary said support staff, not core scientific reviewers, were cut and that the cuts targeted bloated administrative areas, like HR and communications.
    Sen. Murray asked whether critical inspections had been missed post-layoffs. Commissioner Makary claimed food labs were operating at 100% and denied backlogs in inspections or drug approvals.

    Sen. Murray also raised concerns over the FDA appearing to respond to a politically motivated anti-abortion study. Commissioner Makary said he had not reviewed the full study and would base future action only on sound science.

  • Sen. Peters (D-MI) urged action on drug supply chain resilience and asked for support on the bipartisan MAPS Act. Commissioner Makary strongly supported domestic manufacturing, cited FDA’s alignment with this goal, and endorsed public-private solutions to reduce dependence on China.

    Sen. Peters followed up on reports that bird flu monitoring had been paused due to staff cuts. Commissioner Makary said the pause was a routine equipment recalibration unrelated to staffing, emphasized efforts to develop a universal flu shot, and said any preemptive poultry vaccination would be premature.

  • Chair Hoeven echoed the complexity of bird flu policy and asked about FDA’s coordination with USDA and HHS on the issue. Commissioner Makary affirmed close coordination and shared concerns about unintended consequences of preemptive poultry inoculation, advocating for data-driven vaccine planning.

    Chair Hoeven then asked about FDA’s use of AI in inspections and drug reviews. Commissioner Makary explained that AI was being securely deployed to assist scientific reviewers and food inspection prioritization, always with human oversight.

  • Ranking Member Shaheen revisited biosimilars and pushed for greater competition in insulin and diabetes-related drugs. Commissioner Makary agreed the approval process was too slow, expressed openness to reducing confirmatory trial requirements, and praised emerging bipartisan legislative fixes.

    Ranking Member Shaheen raised concern over youth vaping, asking for details on FDA enforcement. Commissioner Makary described illegal Chinese imports targeting children, emphasized new DOJ partnerships, and announced a $34 million vape seizure that day.