The Food and Drug Administration is one of the most consequential institutions in American public life. It regulates products that account for over 20 cents of every consumer dollar. It ensures 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 wave of layoffs executed by Trump administration budget-cutters that cast a long shadow over the future of America’s medical innovation and public health.
In what officials touted as a bold move to “shrink the size of government,” the Department of Health and Human Services, 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 front-line reviewers and inspectors were mainly spared, the exodus of administrative, policy, technical, and communications staff has caused a ripple effect of disruption and dysfunction.
“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 delaying clinical trials and drug testing in the wake of the massive FDA layoffs.
A related challenge facing the agency is that 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.
The recently appointed head of the FDA, Dr. Marty Makary, has publicly insisted the layoffs were part of an effort to increase efficiency and teamwork. But for many FDA watchers and staffers, those words rang hollow. Staffers are struggling to perform highly technical tasks while also picking up the slack in areas such as travel coordination, IT troubleshooting, and even accessing scientific articles.
Among the most 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 evaluating drug safety and efficacy. Now, they must rely mainly on materials provided by applicants, allowing biased cherry-picking and weakening the integrity of scientific assessments.
Equally devastating were cuts to the agency’s information technology professionals, who were vital in managing the vast amounts of clinical trial data, real-world evidence, and pharmacovigilance reports underpinning regulatory decision-making.
Without all this infrastructure, reviewers’ efficiency 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.
One particularly alarming consequence is the paralysis in the FDA’s ability 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, 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.
Even a seemingly mundane function such as employee travel has become a logistical headache. Foreign inspections are a core function of FDA oversight, especially given the global nature of pharmaceutical manufacturing. But with the elimination of the travel office, inspectors now spend hours booking their flights, handling visa matters, and preparing documentation, taking precious time away from their primary jobs.
The layoffs have also decimated the FDA’s 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 about safety matters, product recalls, and approval of new products.
The Trump administration has long advocated shrinking the federal bureaucracy under the banners of “efficiency” and “draining the swamp.” However, 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 have left critical agencies hollowed out, riddled with inefficiencies, and unable to serve the people they are tasked with protecting.
FDA: FOOD INDUSTRY WILL PHASE OUT PETROLEUM-BASED DYES
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. Oversight of foreign drug manufacturing, already under strain, will likely suffer. The aggregate effect is a public health system that is less resilient, agile, and trustworthy.
If the goal of these cuts was to make the government leaner, the result has been to make it weaker. And in the realm of public health, weakness can be deadly.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger distinguished fellow at the American Council on Science and Health. A 15-year veteran of the FDA, he was the founding director of the agency’s Office of Biotechnology.