House Committee Advances FDA Funding Bill Amid Policy Disputes

The U.S. House Appropriations Committee on Tuesday approved legislation to fund FDA for fiscal year 2027, advancing the measure to the full House after a largely party-line vote.

The Agriculture/FDA spending bill cleared the committee 4/29 by a vote of 35–25, according to congressional materials. The package provides about $7.1 billion in total funding for the agency, including discretionary appropriations and user fees that support its regulatory activities — roughly $100 million below the president’s budget request released earlier this month (see story).

The measure must still pass the full House and Senate before being reconciled into a final spending package.

Debate during the markup underscored broader political divisions over the FDA’s role in areas including vaccines, food safety and oversight of emerging medical technologies. Lawmakers also clashed over overall funding levels and the scope of the agency’s regulatory authority.

Accompanying report language outlines a wide range of congressional priorities, urging the FDA to accelerate work on drug safety, rare disease therapies, food labeling and tobacco enforcement. The committee placed particular emphasis on improving patient access to information, modernizing regulatory frameworks and addressing gaps in care for underserved populations.

Among specific areas of concern, the panel pointed to limited treatment options for several conditions and encouraged the FDA to take steps to spur development, including:

• Pediatric diseases such as inflammatory bowel disease, where the committee backed greater use of real-world evidence and extrapolated data to address clinical trial challenges in children.
• Polycystic ovary syndrome, which affects roughly 10% of women, where lawmakers highlighted the lack of FDA-approved therapies and called for expedited pathways and incentives.
• Post-bariatric hypoglycemia, a serious complication of weight-loss surgery for which current treatments are often off-label and inadequate.

The report also highlights persistent gaps in data on drug safety in pregnant women, noting that most approved medicines lack sufficient human pregnancy data. The committee urged the FDA to finalize regulations to improve the inclusion of pregnant women in clinical research.

On rare diseases, lawmakers reiterated concerns about regulatory delays and called for greater flexibility in clinical trial design, including the use of single-arm studies when randomized trials are not feasible. The FDA was asked to provide briefings on steps to improve regulatory consistency and speed, particularly for cell and gene therapies.

The committee also flagged safety concerns tied to compounded medicines, especially GLP-1 products marketed as alternatives to approved diabetes and obesity drugs. Lawmakers cited reports of dosing errors and misleading marketing, directing the FDA to increase enforcement and work with other agencies to block substandard imports.

More broadly, the report calls for reforms to maintain U.S. competitiveness in biotechnology, including streamlining early-stage clinical trial requirements and exploring a pilot program modeled on Australia’s clinical trial notification system. It also encourages expanded use of real-world data in regulatory decision-making, alongside continued development of standards to ensure scientific rigor and patient privacy.