FDA in Crisis: How Trump Administration Downsizing Is Slowing Medical Innovation and Endangering Public Health

By any measure, the Food and Drug Administration (FDA) is one of the most critical and ubiquitous institutions in American public life. It regulates products that account for over 20 cents of every consumer dollar, ensuring the safety of the food we eat, the drugs we take, and the medical devices that sustain and save lives.  Yet, in a time of rapid technological advancement and increasingly complex health threats, the FDA has been kneecapped by a sweeping wave of layoffs executed by Trump administration budget-cutters, casting a long shadow over the future of medical innovation and public health in the U.S.

In what officials touted as a bold effort to “shrink the size of government," the U.S. Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., carried out a reduction-in-force targeting nearly 3,500 FDA employees — roughly 20% of the agency’s workforce. Although frontline reviewers and inspectors were largely spared (at least according to Administration officials), the exodus of administrative, policy, technical support, laboratory, and communications staff has caused a ripple effect of disruption and dysfunction. Even the attempt to retain reviewers hasn't gone according to plan. As STAT News reported last week:

Health and Human Services Secretary Robert F. Kennedy Jr. has railed against what he sees as a “revolving door” between workers at drug companies and the Food and Drug Administration. But his department’s actions now seem to be causing that door to spin ever faster. 

Scores of FDA employees are searching for an exit from an agency in turmoil, particularly staff members tasked with reviewing drug applications, according to interviews with former employees and industry recruiters. Many of those joining the exodus were protected from the layoffs that hit the agency earlier this month, but their work environment has become morose, and cuts to other departments are making it more difficult to do their jobs.

Former FDA Commissioner Dr. Scott Gottlieb estimated during a recent appearance on CNBC's "Squawk Box" that as many as 600 reviewers have recused themselves from evaluations because they are interviewing with drug companies.

Nearly all of the scientists at food safety laboratories run by the FDA in the San Francisco and Chicago areas received layoff notices in April, according to four laid-off chemists and microbiologists quoted by CBS News. The San Francisco lab, opened during the first Trump administration, had been ramping up testing of infant formula, reducing by a quarter the Agency's baby formula testing capacity.

Also as reported by CBS:

Scientists in the San Francisco lab had been the only ones able to test for bird flu contamination in pet food in the agency's network, multiple FDA officials said. The lab's scientists were the only ones with the expertise and specialized "biocontainment infrastructure" to do the testing, a memo shared with CBS News circulated among agency officials said.

Scientists in that lab had also been responsible for major food safety investigations in recent years, given its proximity to major agricultural producers in the region. More than half of the fresh produce in the U.S. is grown in Northern and Central California. 

“We are underwater,” said one FDA device reviewer, speaking anonymously for fear of retaliation. “Innovation is slowed, and that means patients wait longer for life-saving treatments. This isn't theoretical — it’s happening now.”

Biotech companies developing drugs for hard-to-treat diseases and other ailments are already being forced to delay clinical trials and drug testing, according to the Wall Street Journal: 

Significant delays in the FDA’s core functions — such as approving amendments to clinical trials and guiding companies through processes for drug approval — are hindering the ability to develop drugs, say industry officials. Those setbacks are contributing to drugs taking longer to get through clinical trials and ultimately reach patients — and straining dollars for testing new possible treatments, say people familiar with the matter.

According to several employees, the agency is now missing deadlines mandated by the 1992 Prescription Drug User Fee Act (PDUFA) — a law enabling the FDA to collect user fees from drug manufacturers in exchange for timely evaluations. However, unless the agency receives a certain level of government funding, its ability to use these funds, which help expedite safety reviews for devices, drugs, and other products, would be curtailed.

The newly-appointed FDA Commissioner, Dr. Marty Makary, has publicly insisted the layoffs were part of an effort to increase efficiency and teamwork. Yet, for many FDA watchers and FDA staffers, those words ring hollow. Many of the decision-makers who approve final applications, some with decades of regulatory experience, were among those abruptly fired without time to transfer their responsibilities. Many of the remaining staff are struggling to perform highly technical tasks while also picking up the slack in areas like travel coordination, IT troubleshooting, and even accessing scientific literature. 

Among the damaging cuts were those to the FDA’s library and policy divisions. Reviewers once had access to expert librarians who secured medical and scientific journal articles critical to vetting drug safety and efficacy. Now, they must rely largely on materials provided by applicants, possibly allowing biased cherry-picking and weakening the accuracy of scientific assessments.

Equally devastating were cuts to the agency’s information technology (IT) teams. Former FDA Chief Information Officer Vid Desai, who was laid off, warned in a farewell letter that “nothing within the FDA operates without IT and data.” He noted that the team had been vital in managing the vast amounts of clinical trial data, real-world evidence, and pharmacovigilance reports underpinning regulatory decision-making. Without this infrastructure, the efficiency of reviewers suffers, and the risk of errors increases — potentially allowing unsafe or ineffective drugs to slip through the cracks. At the very least, reviews will proceed more slowly.

The fallout extends beyond the FDA itself. The Association for Accessible Medicines, which represents generic drug manufacturers, expressed alarm at the dismissal of key personnel overseeing biosimilar and generics programs, and the Pharmaceutical Research and Manufacturers of America (PhRMA) voiced serious concerns about whether the agency could still fulfill its basic mission.

One particularly alarming consequence is the interference with the ability of the FDA to renew and negotiate user fee agreements with the pharmaceutical industry. These agreements, renegotiated every five years, are essential to funding the agency’s operations and setting future priorities. However, according to Reuters, both the head and deputy head negotiators for at least one of the agreements were terminated, as were the staff coordinating the public meetings required by law.

Steven Grossman, a regulatory expert and author of the FDA Matters blog, warned that “the loss of the user fee teams is just one of many important functions that have become unstaffed or understaffed. That’s not good for the American people, consumers, patients, and industry.”

Even a seemingly mundane function like employee travel has become a logistical headache. Foreign inspections are a core function of FDA oversight of foreign factories that manufacture drugs and their chemical precursors, especially given the global nature of pharmaceutical manufacturing and the questionable practices in some countries. But with the elimination of the travel office, inspectors must now spend hours booking their flights, handling visa issues, and preparing documentation — precious time taken away from ensuring drug safety and compliance abroad. 

The layoffs have also decimated the communications offices across the Agency. These teams play a vital role in translating complex scientific and regulatory findings into plain language, keeping the public – including healthcare providers -- informed in a timely way about safety issues, product recalls, and approval of new products. 

What was once a functioning system of scientific review and oversight has become a quagmire.

Critics of the cuts note that they appear ideologically driven rather than rooted in performance metrics or operational necessity. The Trump administration has long advocated shrinking the federal bureaucracy under the banners of “efficiency” and “draining the swamp.” But the new decision-makers seem not to understand that some government agencies – of which the FDA is the prototype -- must make affirmative decisions before products can be marketed. Thus, in practice, relentless, largely indiscriminate firings and the toxic atmosphere have left critical agencies hollowed out, riddled with inefficiencies, and unable to serve the people they are tasked with protecting.

What is unfolding at the FDA should concern every American. New drug approvals may be delayed or derailed entirely. Life-saving treatments may be slower to reach the market. And as mentioned above, oversight of foreign drug manufacturing — already under strain — will likely suffer. The aggregate effect will be a public health system that is less resilient, less agile, and less trustworthy.

If the goal of these cuts was to make government leaner, the result, instead, has been to make it weaker. And in the realm of public health, weakness can be deadly. Two highly respected scientists who recently left senior positions at the FDA have suggested several priorities for strengthening the Agency. Among them:

1. Strengthen the scientific review teams — the agency’s beating heart

FDA’s review divisions are staffed by multidisciplinary teams of scientists, physicians, biostatisticians, and regulatory experts who are deeply committed to the public good.

         2.   Respect -- don't override -- scientific judgement

In recent years, top-down overruling of review teams has become more frequent. This trend is dangerous. If a single official is overturning expert recommendations, either that person is yielding to political pressure or the review teams are getting it wrong. Neither scenario bodes well for public trust or biomedical innovation. The commissioner must make it clear that decisions will be science-based, transparent, and consistent with statutory standards.

These are already at risk in the new regime, so the solutions must come from Congress, whose oversight role is more critical than ever. Lawmakers must not only investigate the scope and impact of these layoffs but also move swiftly to restore staffing levels and the FDA’s ability to perform its mission. That includes expanding funding for essential support services, reinstating critical management personnel, and ensuring that scientific integrity, not ideology, guides decisions.

At stake is not just the efficiency of a federal agency but the health and safety of millions of Americans. In a world facing increasingly complex medical challenges — from pandemics to greater application of personalized medicine and artificial intelligence — the FDA must be empowered, not gutted. The recent changes have done significant damage. It is now up to the government to begin to repair it.