In letter to RFK Jr., Democrats flag threats to drug review process from FDA firings

In letter to RFK Jr., Democrats flag threats to drug review process from FDA firings

It hasn’t yet been two weeks since Robert F. Kennedy Jr. took his post as Department of Health and Human Services (HHS) secretary, but letters from lawmakers outlining their concerns about the agency's recent actions are piling up.

One of the first controversial moves made since the Trump administration took office was the mass firing of civil workers through an executive order permitting Elon Musk’s new Department of Government Efficiency (DOGE) to initiate “workforce optimization” procedures. 

While these layoffs have hit governmental agencies across the board, the workforce changes at the FDA have raised particular concern for a group of Democratic lawmakers due to the nature of the agency’s funding.

Sens. Jeanne Shaheen and Patty Murray, plus Reps. Sanford Bishop and Rosa DeLauro, wrote to RFK Jr. on Friday with “grave concerns” about mass firings of probationary staff at the FDA. They cited cuts in the agency's Center for Devices and Radiological Health, the Center for Tobacco Products (CTP) and the Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), specifically.

"We are concerned that the mass firings of probationary staff at the FDA, many of whom with scientific backgrounds, will prevent us from staying on the cutting edge of drug and device approvals, maintaining food safety and responding to new threats, like avian flu," the lawmakers wrote.

Roll Call first reported on the lawmakers' letter late last week.

The FDA is funded in part by user fees, a program that allows the agency to collect money from companies that submit applications for review. Employee salaries at the CTP are paid entirely through user fees, according to the letter. 

The user fee program framework includes trigger rates that must be met in order for the FDA to access the funding. Without enough staff at the CDER, which receives user fees, the FDA could find itself in a position where it's not able to use access its fees, according to the lawmakers.

“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,” the lawmakers said in the letter.

User fees are intended to "supplement congressional appropriations, not replace them," according to a Congressional Research Service document (PDF) explaining the program. With this in mind, the "triggers" are designed to ensure that the agency's public funding remains in place.

Outside of concerns with the FDA's user fee system, the DOGE activities have raised concern among Democrats regarding the issue of government-funded medical research. In a Feb. 19 letter (PDF) to RFK Jr., all of the Senate's sitting Democrats—and its two independent members—raised concern that Americans could see fewer new drugs as a potential consequence of cuts at the National Institutes of Health.

“The Trump Administration has already executed targeted firings and forced resignations of key scientific leadership, and the loss of talent, knowledge, and experience caused by mass firings and forced resignations at our nation’s health agencies is sowing chaos at HHS and putting American lives at risk,” the senators wrote in that letter.

During his confirmation hearings, RFK Jr. repeatedly pledged to lead the HHS with “radical transparency.” Given this promise, the senators requested that he disclose the specific number of HHS workers who were fired and on what grounds, plus any analysis performed prior to the layoffs and information on the directives given by the DOGE.

“As HHS Secretary, the consequences of epidemics, lost treatments, and lack of access to care are your responsibility,” the letter reads. “These firings represent the abdication of your sworn duty to ensure the health and well-being of America’s families.”