Former FDA officials, experts decry HHS staff cuts

The recent announcement by the Department of Health and Human Services (HHS) regarding the layoff of 3,500 US Food and Drug Administration (FDA) employees is expected to affect staff that develop policies related to real-world data and artificial intelligence. Additionally, these cuts could impact consumer safety offices and the personnel who initially review applications before they are sent for full reviews. If these positions are eliminated, it may adversely affect the review process for new drugs and medical devices.

Some have expressed concerns about the dearth information regarding the cuts. This concern is shared by two former FDA commissioners, two additional experts, and the Alliance for a Stronger FDA, all of whom spoke to Focus about the implications of the reduction-in-force announcement.

Last week, Robert Kennedy Jr., secretary of the US Department of Health and Human Services (HHS), announced plans to reorganize the department and terminate another 10,000 workers, including 3,500 from FDA. He described HHS as a sprawling bureaucracy with tremendous waste and duplication, and said job cuts and restructuring would make it more efficient. (RELATED: This Week at FDA: HHS reorg features deep FDA staff cuts; Makary, Bhattacharya confirmed for FDA and NIH, Regulatory Focus 28 March 2025)

The reduction will not affect drug, medical device or food reviews, nor will it impact inspectors, according to an HHS fact sheet. Rather, its focus will be on streamlining operations and centralizing administrative functions

Former FDA Commissioner Robert Califf decried the cuts in a recent email to Focus. He noted that its “hard to imagine getting the work done if another 3,500 people are cut in addition to attrition that has already happened or is planned. The demoralization of the workforce also makes it more difficult to get things done.”

Califf added that “a reorganization and down-sizing of this magnitude, if not done carefully, will result in death and disability our population. New treatments, safe food, tobacco use reduction, etc. — these all take people.”

Califf also rejected Secretary Kennedy’s complaints alleging that the FDA has become inefficient in recent years.

“No, I do not agree that the agency is inefficient. Having said that the federal HR system makes it very difficult to be agile and to move out people who are not able or willing to do a good job,” he said. “This is a minor factor compared with what I consider to be massive underfunding for an agency responsible for regulation of one-fifth of the economy. So, there is room for pruning people having a difficult time doing their work—this would be good for productive employees, but there has been an inexcusable failure to treat people with respect and to support them if they have to transition to a job in the private sector.”

‘Hard to imagine’ Makary signing pink slips

Peter Pitts, president of the Center for Medicine in the Public Interest and former FDA associate commissioner, was similarly critical of HHS’s announcement.

In an interview, he told Focus that “it is hard to imagine a man of Dr. Markary’s intelligence and character is going to come in and blithely sign 3,500 pink slips that someone puts on his desk.”

Makary previously claimed during his Senate confirmation hearing that he would conduct a thorough evaluation of the agency's personnel needs.

Pitts and others expressed concerns that the cuts would particularly impact the policy and communications areas. He noted that since the cuts cannot affect staff funded by user fees, “the only remaining area full of non-user fee personnel is in the Office of the Commissioner.” Additionally, it would affect a “very small number” of staff within the review centers.

Pitts emphasized that eliminating the specialized communications offices within HHS would be a mistake. He explained that the staff in these offices possess a deep understanding of complex and nuanced topics that are grasped by very few people. Centralizing these functions would imply that a single office in the Humphrey Building can comprehend the intricacies of all the various HHS agencies and divisions. Additionally, the job cuts are expected to affect legal staff as well.

The cuts will also affect employees in regulatory science, including staff engaged in real-world evidence, artificial intelligence, or the evaluation of new medical device technologies.

Pitts said that “you don’t get data by pushing a button and reaching a regulatory decision.”

Pitts stated that these budget cuts contradict Secretary Kennedy's goal of focusing on chronic diseases. He emphasized, "If the Secretary wants to prioritize chronic diseases, you don’t cut staffing; you increase it."

Cuts could affect consumer safety officers

Robert Pollock, a senior advisor at Lachman Consultants, mentioned that project managers and consumer safety officers may be affected by the budget cuts, although the details are still unclear. These individuals serve as the primary point of contact for applicants regarding their applications.

Pollock stated that for sponsors submitting new drug applications or new generic drug applications, these individuals are their first and only point of contact regarding their applications. He also noted that if this occurs, the review process could be significantly impacted.

Steven Grossman, an FDA regulatory consultant and author of "FDA Matters," recently noted in a blog post that the policy, compliance, data collection, and regulatory staff are the most at risk of cuts, as well as those whose positions may be centralized at HHS.

Grossman added that the Commissioner’s office staff is at “particularly high-risk, as well as their counterparts in each of the Centers.”

Grossman also noted that he is “concerned about the potential for misunderstanding if anyone other than the Commissioner’s office makes the decisions. For example, there are a large number of vital cross-cutting initiatives that are not self-explanatory, such as IT systems development, AI, regulatory science, the Agency for Toxicological Research, cosmetics regulation, and antibiotic resistance.

Announcement is ‘kind of irresponsible’

Experts also decried the lack of specific information on what offices and personnel would be affected by the staffing cuts. Pitts said that “this administration has been very good at keeping its own secrets. This is why I think it’s kind of irresponsible to announce a huge action with few details.”

Cartier Esham, executive director of the Alliance for a Stronger FDA, concurred. “The announcement of the decrease of the 3,500 employees in addition to the employees who were targeted previously, is concerning. We think it's really important that we begin to see details of what positions have been terminated versus positions that have vacancies that could be refilled. We also want to see the details regarding the plans for centralization, specifically which functions are being streamlined and moved to HHS. We need to see those details.”

Esham said that the Alliance recently wrote to legislators in the House and Senate expressing its concerns and asking for more information about the cuts.

Former FDA officials, experts decry HHS staff cuts

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