Key Takeaways
- The centralization of some functions created by a Health and Human Services Department reorganization and layoffs may shift power from the FDA to HHS.
- Experts worry the changes could harm industry and patients by leaving HHS without the expertise to develop good medical product development policy.
- Stakeholders also were skeptical the cuts could be made at the FDA without harming the agency's productivity, despite HHS's claims that it is removing duplicitous and redundant roles.
The US Food and Drug Administration will lose about 3,500 full time employees as part of a Department of Health and Human Services restructuring that also will centralize human resources, information technology, procurement, external affairs and policy functions.
The changes announced early on 27 March mean that the FDA may not only be losing about 18% of its staff compared to fiscal year 2024 numbers, but also crucial authority and power over work like guidance and regulation development.
HHS did not respond to questions about the changes. The FDA directed all questions on the topic to HHS.
Sources said the FDA was blindsided by the reorganization. Many FDA staff first heard of the plans through news reports, not FDA or HHS-led communication.
Specifics of how the centralization will function and who may be laid off at the FDA could drastically impact how the end outcomes impact key stakeholders. Personal emails started to go out to specific agency staff losing their jobs after typical work hours on 27 March.
More Power at HHS Could Equal More Politics Influencing FDA
“We do have questions around the centralization, as it is not clear to us whether what is being envisioned is a centralizing of HR, IT procurement and communication functions within each agency, or if this is a larger centralization being undertaken, and the impact of those are very different, and so it’s very important that we begin to understand that in more detail,” said E. Cartier Esham, executive director of the Alliance For A Stronger FDA.
Many predict the goal is the latter: a larger concentration of power at HHS.
“It’s very hard to know what this means, except that one is left with a sneaking suspicion that they’re going to pull up more authority into HHS and out of the operating divisions like FDA,” said Peter Lurie, president of the Center for Science in the Public Interest and former FDA associate commissioner for public health strategy and analysis.
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“It is certainly a move consistent with the centralization of power that we have seen throughout the administration so far,” Lurie said. “All of the various moves bring more authority higher up the executive chain and/or away from the other branches of government.”
HHS already appears to have usurped power from the FDA’s legal work by reorganizing the HHS Office of General Counsel.
“In policy, I think I would be left with a concern that HHS will be meddling more in the affairs … and that would worry me because the further you get from FDA the more that politics seeps into the process,” Lurie said.
HHS does not have staff with the technical knowledge and skill set to write the kinds of policies pharmaceutical companies and other industries regulated by the FDA need to develop products, a former senior agency official said. The source also said many of the centralization moves were tried in the past by HHS Secretary Tommy Thompson during the George W. Bush administration and reversed due to perceived failure.
Staff May Be Missed More Than Kennedy Suggests
The 3,500 cuts at FDA will not include drug, medical device, or food reviewers, or inspectors, the HHS announcement said. However, the last time HHS carved out these groups to ensure key approval milestones and safety work could remain on track, experts said other positions that help keep systems moving, such as project managers, were not exempt.
The FDA also is expected to lose another 900 employees or so due to staff leaving due to Trump Administration incentives to reduce the size of the federal government, sources said. HHS and FDA have not released an official number or roles of the employees who took buyouts, early retirement or other departure incentives, making it difficult to track the expertise that has been lost.
HHS told the unions representing its employees the reduction in force is “primarily aimed at administration positions including human resources, information technology, procurement and finance,” but also would target roles in high-cost regions and employees in programmatic areas determined to be redundant or duplicative with other functions at HHS or in the federal government, according to an email seen by the Pink Sheet.
Stakeholders were not convinced the changes will be the “win-win for taxpayers” that Kennedy described in his official statement on the overhaul.
“I think there’s room for reorganizing and there’s always room to look for efficiencies,” said Jill Rosenthal, director of public health policy at the left-leaning Center for American Progress. “But by cutting in this way, I think we’re going to have agencies that are less prepared to do the work that they do, which is so important to our health.”
“So they’ve got a broad claim, right? We’re going to be efficient and we’re going to lose no service,” Lurie said. “The world usually doesn’t work that way. The truth is that no program department can function efficiently without an adequate operational support.”
Lurie was skeptical that 3,500 people at the FDA fall into the categories targeted for the cuts. He said the areas to be trimmed often are supporting work HHS has indicated it wants to continue to flourish.
Many offices at the FDA “are actually starving” for the kinds of operational staff FDA is aiming to cut, particularly those staff that support food and drug inspectors, Lurie said. The dietary supplement and food additives areas, both pet projects of Kennedy, are under-resourced, Lurie said.
“Its very hard for me to see how a set of cuts as deep as these are going to advance his declared priorities,” Lurie said.
“We are concerned about the numbers,” said Esham, adding that the FDA should release transparent plans for managing its workload efficiently and effectively going forward.
“What are the details and the plan to ensure that the FDA will still be able to not only effectively protect our food supply, keep pace with scientific advancements and ensure our country has first access to next generation animal and health medical interventions?” she asked.
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The Biotechnology Innovation Organization also raised concerns about disruptions at the FDA.
“As changes are implemented, it is critical to retain top-tier talent across government agencies, that safety monitoring and reviews continue without disruption, and that we continue to uphold the scientific rigor that makes American institutions the gold standard that is emulated around the world,” a BIO spokesperson said. “We also urge the administration to be as transparent as possible to ensure that there are not disruptions to critical government operations that could impede our industry’s ability to serve the American people.”
The Pharmaceutical Researchers and Manufacturers of America declined to comment.
Makary Backtracking On Congressional Promises?
The Senate confirmed FDA Commissioner Martin Makary 25 March. Initially, the FDA told Pink Sheet he would be sworn in on the 26 March and report to White Oak the next day.
But Makary was not at White Oak on 27 March. The agency would not confirm that he had been sworn in and working.
Sources outside the agency said Makary was expected to be sworn in on 28 March, forcing Acting Commissioner Sara Brenner to handle staff communication about the layoffs.
“I firmly believe the changes for the FDA, as outlined by Secretary Kennedy, will position the agency for the future and empower us to maximally deliver on our regulatory mission,” Brenner wrote in a memo to staff obtained by the Pink Sheet. Brenner will become Principal Deputy Commissioner once Makary takes office.
The timing may not bode well for Makary, who promised Senators he would lead the personnel review, adding that any layoffs would be “surgical.”
Initial reactions from Congress seemed to fall along party lines.
Sen. Bill Cassidy of Louisiana, the top Republican on the Senate committee overseeing the FDA, had breakfast with Kennedy before the reorganization and cuts were announced, his office said.
“I am interested in HHS working better, such as lifesaving drug approval more rapidly, and Medicare service improved. I look forward to hearing how this reorganization furthers these goals,” Cassidy wrote on X.
House Energy and Commerce Committee Chair Brett Guthrie, R-KY, and Energy and Commerce Health Subcommittee Chair Buddy Carter, R-GA, issued a supportive joint statement that echoed HHS’s claims that the department has grown and created redundancies, and in some cases, conflicting objectives over the years.
Their Democratic counterparts on the Energy and Commerce Committee said the cuts should be stopped.
“The massive layoffs will have a devastating impact on our nation’s health care system and the health of the American people,” said Reps. Frank Pallone, D-NJ, and Diana DeGette, D-CO.
Many patient organizations also worried about the changes.
“Eliminating positions in [the FDA], even non-review staff, could impact the development and approval of new drugs, leading the U.S. to lose its position as the country where cancer drugs are approved the fastest and made available first,” said Wayne A. I. Frederick, interim CEO of the American Cancer Society and the American Cancer Society Cancer Action Network. “Loss of staff will also undoubtedly impact the ability to respond to the drug shortages we are experiencing.”
“Hasty decisions made in secret that disrupt funding and remove experienced staff at key health agencies like the NIH, FDA, and CDC hinder the progress we have fought so hard to achieve,” US Against Alzheimer’s said.
CMS Gets Smaller Cuts
The impact of the reorganization on the US Centers for Medicare and Medicaid Services appears more minor than at the FDA. About 300 employees are expected to be lost, which HHS said will not impact Medicare and Medicaid Services.
Former President Joe Biden’s CMS Administrator Chiquita Brooks La-Sure criticized the move.
“When you take a wrecking ball to an agency like CMS, you’re taking a wrecking ball to the people who are out across the country ensuring our parents and grandparents can get safe, affordable care as they age,” said Brooks-LaSure, now a senior fellow at The Century Foundation. “You’re taking a wrecking ball to cancer patients who need a new, innovative treatment to be covered. You’re taking a wrecking ball to mothers and newborns who are both at the most critical points of their lives.”
Derrick Gingery contributed to this report.
