Senate Democrats press HHS over FDA firings

Lia DeGroot, CQ-Roll Call on Feb 21, 2025

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WASHINGTON — A pair of Democratic senators are pushing back against the Trump administration’s decision to terminate a host of positions at the Food and Drug Administration, raising concerns that the firings could affect drug and device approvals and food safety efforts.

In a two-page letter sent to Health and Human Services Secretary Robert F. Kennedy Jr. Friday, first shared with CQ Roll Call, Sens. Jeanne Shaheen, D-N.H., the ranking Democrat on the Appropriations Committee’s subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and Patty Murray, D-Wash., the ranking Democrat on Senate Appropriations, take issue with the potential ripple effects of firings on drug and device approval, food safety, and responding to emerging public health threats like the ongoing H5N1 outbreak.

House Appropriations ranking Democrat Rosa DeLauro, D-Conn., and Rep. Sanford Bishop, D-Ga., the ranking member on the Appropriations subcommittee on Agriculture, Rural Development, Food and Drug Administration and related agencies, also signed.

They wrote that despite promises of transparency from the Trump administration, HHS did not provide notice to the House or Senate Appropriations Committee, which they say is required under the fiscal 2024 spending law.

The senators also drew attention to the user fee system at the FDA, under which Congress authorizes the agency to collect fees from industry that submit applications for review. The user fee program funds half of the agency’s roughly $7 billion budget.

The senators are concerned that terminated probationary employees were in place through the user fee system. They underscore that the FDA’s drug, device and tobacco centers, and its generic drug office are funded through user fees. The current user fee authorizations are set to expire in 2027.

The senators also point to “trigger” rates in the user fee laws which require the FDA to spend a certain amount of appropriated funds before they can access user fee funds. The concern is that the Trump administration could eliminate enough positions that the FDA is cut off from accessing its user fee funds.

“Without adequate staff at each center that receives user fees, the FDA may not be able to collect or spend user fees for the upcoming fiscal year,” the senators wrote. “This would be seriously detrimental to our medical drug and device programs by slowing the premarket review process, stifling innovation and preventing patients from accessing potentially lifesaving products.”

In an interview earlier this month, Howard Sklamberg, a partner at the law firm Arnold & Porter and a former FDA official, said eliminating user fee funded positions wouldn’t actually save taxpayer money.

“It would be very strange if you had cuts to target the user fees, because the user fees do not come from appropriations, they come from the companies,” he said.

Kennedy has repeatedly raised issues with the influence of industry in the FDA. The fees are collected through a central payment system and don’t go directly to individual employees, but some experts, including former FDA Commissioner Robert Califf, have said they would prefer to do away with the user fee system if Congress would fund the agency’s entire budget through appropriations.

Eliminating or altering the use fee programs would require an act of Congress.

The senators also raised concerns about the future of the FDA’s Human Foods Program, which was established last year after an extensive agency reorganization following the infant formula shortage in 2022.

The program is funded entirely through appropriations. Jim Jones, the agency’s deputy commissioner for human foods, resigned from his position earlier this week, FoodFix was the first to report, citing cuts to staff.