Shortly after Robert F. Kennedy Jr. was confirmed to be secretary of HHS, thousands of government scientists, technical advisors, and staff across federal public health agencies were dismissed. This was not without warning. Before being confirmed, Kennedy had ominously tweeted that FDA employees should “pack [their] bags” and voiced his intention to terminate 600 current NIH staff. When asked during the confirmation process if he would fire career staff who disagreed with him or the president on scientific decision-making, he responded that he looked “forward to following the law, including relevant employment and labor relations laws.”
The sudden mass loss of scientific and technical expertise across the government is only part of the first wave of gutting the federal public health workforce. Under an executive order, agency heads are to work with the Department of Government Efficiency (DOGE) to develop and institute plans “to initiate large-scale reductions in force” and identify components of agencies that could be “eliminated or consolidated.” Such efforts are expected to result in the dismissal or resignation of thousands of employees.
The impact on the country will be disastrous, severely hampering our capacity to manage, much less improve, the health and healthcare of all Americans. Without immediate action by Congress or the courts, the future of HHS and the health of the nation are at risk.
FDA’s Expansive and Essential Purview
FDA’s role in protecting the health of all Americans cannot be underestimated. The agency regulates 20 cents of every dollar spent on consumer products in the U.S. Most of us think of drugs, vaccines, and medical devices when we think of FDA. But FDA also regulates most food, infant formula, cosmetics, pet food and veterinary drugs, laboratory tests, and tobacco products. FDA even regulates bottled water.
While the agency’s annual budget of over $7 billion may seem large, nearly half the funds are paid by regulated industries (i.e. “users”) as a fee to support adequate staffing, ensure timely approvals, and pay for other agency initiatives, such as surveillance efforts. Last year, Congress appropriated $3.5 billion to fund FDA, which means that every American is paying an average of only $10 per year to live in a country where we can trust that the medicines we take work and the food we eat is safe.
As physicians and researchers, we are especially aware of the critical role FDA plays in overseeing the medical product industry. Before a drug, vaccine, or medical device is made available to the public (to be administered or prescribed), manufacturers must prove its safety and effectiveness. FDA staff with varied scientific, clinical, and technical expertise, including doctors, scientists, and engineers, review extensive patient-level data, oversee the clinical trials manufacturers conduct, and inspect production facilities in the U.S. and around the world. And FDA’s regulatory role continues even after approval in monitoring safety to take timely action, including withdrawing the product from the market should significant harms be found, or warning physicians like us about serious side effects.
Necessary Growth at the FDA
FDA’s remit in health innovation has only grown. Applications for new medical products to FDA have only increased over the past two decades, breakthroughs have yielded novel cell and gene therapies for diseases once considered fatal, and medical devices leveraging artificial intelligence are now used routinely. Consequently, FDA has had to expand its regulatory capacity and its workforce. In 1990, FDA had just under 8,000 employees; as of last year, the agency comprised nearly 20,000.
With such growth, it is no surprise that the agency has been singled out with criticisms of bloat and inefficiency. But FDA has already taken steps to improve efficiencies and embrace public accountability. Over the past 5 years, the agency has undergone an extensive modernization effort for all of its core programs, improving data infrastructure and aligning initiatives within the agency. This culminated most recently in the creation of a Unified Human Foods Program with restructured field operations.
Moreover, perhaps uniquely among federal agencies, the “user fee” funding agreements include timelines for key agency actions, such as how much time the FDA is allowed to review a new drug application, and deadlines for issuing new guidance documents or implementing pilot programs, with opportunities for public comment to ensure accountability. And finally, the FDA is a leader in transparency efforts, making its reasoning and rationale behind all decisions public, convening public meetings with advisory committees to solicit expert advice, and publicly posting numerous data sources relevant to public health and safety.
Reform Is Good When Done Right
Nevertheless, as we have studied, written, and spoken about, further reforms at the FDA are indeed needed to win back public trust, both among physicians and patients. But firing or forcing the resignation of thousands of FDA employees will only be antithetical to Kennedy’s goals of rigorously evaluating safety and enhancing transparency. Without sufficient staffing, these goals are improbable, if not impossible. Among those that were fired are biostatisticians within drug and medical device review teams that ensure manufacturers’ claims of efficacy are reflected within the data; pharmacologists who evaluate safety of drugs before and after approval; and scientific staff responsible for reviewing new medical devices, including software-based products leveraging artificial intelligence, to prevent patient harm.
These actions do, however, fit the administration’s view that regulatory costs harm the economy, delay access to medicines, and thereby hurt patients. They have outlined aspirations for an agency that approves medical products only on the basis of safety, essentially letting the market decide which products to use. For an administration so focused on efficiency, this approach may seem penny-wise but it is actually pound-foolish. Most products are not miraculously effective, so clinical trials are needed to discern true benefits, and many safety issues are only appreciated after approval through use in large populations. This approach to regulation would lead to massive amounts of wasteful spending on ineffective, and potentially unsafe, products.
Cutting FDA staff as a cost-saving measure could also have a compound effect. In establishing the “user fee” approach, Congress stipulated that FDA must spend a specific amount of appropriated funds in order to accept, and spend, user fees from regulated industries. Because staffing is FDA’s largest budget item by far, significant cuts may lead to an agency spending too little to accept the funding that makes up half its budget, further weakening FDA and possibly endangering patients and the public who rely on the agency’s efforts.
A Threat to Health and Safety
Historically, the FDA has gained regulatory authority after officials became aware of pervasive risks posed to the public by health, medical, cosmetic, and food products. Corn and wheat being sold after adulteration with alum and clay. Unsanitary conditions in the meatpacking industry. More than a hundred deaths, including in children, from toxic Elixir Sulfanilamide. Thousands of birth defects from thalidomide.
It would be naïve to think that the same harms won’t happen today as the current administration pursues a deregulatory agenda that decimates the federal public health workforce under the guise of government efficiency. At this week’s confirmation hearing, Congress should ask the FDA commissioner nominee how he intends maintain the agency’s critical mission of promoting public health and protecting public safety amid efforts to diminish its capacity to do so.
Reshma Ramachandran, MD, MPP, MHS, is an assistant professor at the Yale School of Medicine. Joseph S. Ross, MD, MHS, is a professor at the Yale Schools of Medicine and Public Health. Ramachandran and Ross co-direct the Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT) at Yale in New Haven, Connecticut.
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