President-elect Donald Trump has nominated Robert F. Kennedy Jr. as his choice for Secretary of Health and Human Services, a decision that could lead to significant changes within the U.S. Food and Drug Administration (FDA). Kennedy, an environmental activist known for his skepticism about vaccines, would oversee agencies responsible for public health, government-funded health insurance programs for over 140 million Americans—including the poor, elderly, and disabled—as well as medical research and more.
Kennedy has been particularly vocal about the FDA, an agency that regulates nearly $3 trillion worth of medicines, food, and tobacco products. In interviews and on social media, he has accused agency staff of being influenced by large pharmaceutical and food companies.
“FDA’s war on public health is about to end,” Kennedy wrote on X (formerly Twitter) in late October. “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.”
FDA officials were not immediately available to comment on Kennedy’s nomination.
Following the announcement, shares of vaccine manufacturers, including Pfizer Inc. and Moderna, fell by as much as 2% in after-hours trading. The Pharmaceutical Research and Manufacturers of America, a leading industry lobby group, released a statement expressing a willingness to work with the Trump administration to improve patient health. The statement highlighted achievements like the elimination of polio and smallpox through vaccination but did not mention Kennedy by name.
Del Bigtree, former communications director for Kennedy’s election campaign and a close associate, said he expects a thorough examination of FDA employees’ ties to industry. “You’re going to see a vetting process of how people got their jobs and what their conflicts of interest are,” he said. “Transparency that should have happened is going to be made public.”
Kennedy had run for president as an independent earlier this year before dropping out in August and endorsing Trump in exchange for a role in the administration.
Implementing Kennedy’s proposed changes would require the new Trump administration to alter protections that prevent federal employees from being fired arbitrarily. The FDA’s 18,000 staff members are further protected because their salaries are not solely funded by Congress.
In 2024, about $3.3 billion—or nearly 46% of the FDA’s $7.2 billion budget—came from “user fees,” which are payments made by pharmaceutical and medical device manufacturers. These fees fund the resources needed to quickly review products, conduct inspections, and ensure the safety of clinical trials.
The FDA maintains that user fees do not influence its approval decisions and that its overall budget remains subject to Congressional approval. Congress renews the user fee program every five years, with the most recent extension valid through September 2027.
Dan Troy, former chief counsel at the FDA under President George W. Bush, expressed skepticism about significant changes occurring. “Even if Kennedy and other political appointees were able to fire a substantial number of staff, who are you going to put in place? Who has the technical expertise to write these rules that are going to really change the paradigm?” he said.
Pharmaceutical executives have sought to ease concerns about Kennedy’s potential impact, emphasizing the importance of the FDA’s role in ensuring the safety and efficacy of life-saving medications for diseases like cancer, diabetes, and heart disease.
“My hope, my belief, is people will see the good work the FDA is doing today and continue to reinforce this,” Pascal Soriot, Chief Executive of AstraZeneca Plc, said earlier this week. “The FDA has been not only a global reference in regulatory authority but also the most innovative and fastest in approving differentiated medicines.”
Others were more direct about their apprehensions regarding Kennedy’s views. “Putting somebody in charge of any public health service who is a vaccine skeptic puts at risk the stability of the nation at large,” Jeremy Levin, CEO of Ovid Therapeutics and former chairman of biotech lobby group BIO, told Reuters late last month. “Vaccine skepticism, which is a central aspect of RFK’s stance, is perhaps as dangerous as anything you could imagine.”
Levin praised previous Trump appointees at the FDA and the successful development of COVID-19 vaccines during his first term as “exceptional choices.” He added, “We have to hold on to the hope that anyone appointed as FDA director in a Trump administration would be of the same quality.”
Meanwhile, FDA Commissioner Robert Califf sought to reassure staff following Trump’s election last week. “There will, no doubt, be changes ahead, but rest assured, the FDA will continue to do the job it was created to do,” he wrote in an email viewed by Reuters. “The work you do will remain critical, and this agency will continue to protect the public, as it has for over a century.”