Silke Mayr Robert F. Kennedy Jr. has made headlines by promising to overhaul the U.S. Food and Drug Administration (FDA) if confirmed as President-elect Donald Trump’s nominee for Health and Human Services Secretary. The FDA, which regulates nearly $3 trillion worth of medicines, food, and tobacco products, plays a crucial role in public health—and its relationship with the pharmaceutical industry has long been a subject of controversy. Kennedy’s pledge to reform the agency is setting up a direct confrontation with Big Pharma, which funds much of the FDA’s operations.
Kennedy, an environmental activist and outspoken critic of vaccine safety, has long questioned the FDA’s close ties to the pharmaceutical and food industries. If confirmed, he would oversee critical public health initiatives, including government-funded health insurance programs that serve over 140 million Americans, and influence medical research and policy. However, it is his stance on the FDA that has grabbed the most attention.
In a series of public statements and social media posts, Kennedy has accused the FDA of serving the interests of pharmaceutical companies at the expense of public health. In one of his October posts, he declared: “The FDA’s war on public health is about to end. 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.”
A Clash with Big Pharma’s Influence
The announcement of Kennedy’s potential nomination has prompted a mixed reaction from the pharmaceutical industry. Shares of vaccine manufacturers, including Pfizer and Moderna, fell in after-hours trading, reflecting investor concern over potential regulatory changes.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s leading lobby group, quickly issued a statement defending the value of the pharmaceutical sector. The statement highlighted achievements such as the eradication of polio and smallpox through vaccines. PhRMA did not address Kennedy directly, but reiterated the importance of collaboration between the pharmaceutical industry and government regulators to improve public health outcomes.
Supporters of Kennedy, like Del Bigtree, a former communications director for his presidential campaign, argue that the FDA needs greater transparency and accountability. “There will be a full vetting of FDA staff and their industry ties,” Bigtree said. “You’ll see a level of transparency that should have happened a long time ago, and it will be made public.”
Challenges to Reforming the FDA
Kennedy’s vision for the FDA faces several obstacles. The agency employs around 18,000 staff members who are protected by federal labor laws that make it difficult to remove them without cause. Moreover, a significant portion of the FDA’s budget—nearly half—comes from “user fees” paid by pharmaceutical companies to help fund the fast review and approval of new drugs and medical devices. These user fees are a point of contention, with critics arguing that they create a conflict of interest.
The FDA maintains that user fees do not influence its decision-making process and that its overall budget is still subject to Congressional oversight. Congress renews the user fee program every five years, with the most recent renewal lasting through September 2027.
Some experts, like Dan Troy, former FDA chief counsel under President George W. Bush, question whether Kennedy could make the sweeping changes he envisions. “Even if you were able to fire a significant portion of the FDA staff, who would replace them?” Troy asked. “Who has the technical expertise to rewrite the rules and really change the system?”
Industry Leaders Express Concerns Over Kennedy’s Vaccine Views
Industry leaders are particularly concerned about Kennedy’s long-standing opposition to vaccines. Jeremy Levin, CEO of biotech company Ovid Therapeutics, expressed concern that putting a vaccine skeptic in charge of public health could destabilize trust in vital health interventions. “Vaccine denialism, which is central to RFK Jr.’s platform, is perhaps as dangerous as anything you could imagine,” Levin said.
While some pharmaceutical executives, like AstraZeneca’s CEO Pascal Soriot, have defended the FDA’s role in regulating life-saving medicines, others worry that Kennedy’s views could undermine the agency’s credibility. “The FDA has been the gold standard in terms of regulatory authority,” Soriot said. “My hope is that the good work they are doing today will continue to be reinforced.”
FDA Leadership Reassures Staff Amid Transition
As the Trump administration prepares to take office, FDA Commissioner Robert Califf sought to reassure agency staff about the future of the FDA. In an email to employees, Califf acknowledged that changes were coming but emphasized that the FDA would remain focused on its core mission to protect public health. “Rest assured, the FDA will continue to do the job it was created to do,” Califf wrote. “The work you do will remain critical, and this agency will continue to protect the public, as it has for over a century.”
What’s Next for the FDA and Public Health Policy?
Kennedy’s pledge to reform the FDA promises to be one of the most contentious issues of the incoming Trump administration. If confirmed, Kennedy would likely push for significant changes to the agency’s structure and its relationship with the pharmaceutical industry. However, making these changes will not be easy, and his proposals will almost certainly face fierce opposition from both the pharmaceutical industry and public health experts.
The future of the FDA—and its role in regulating the nation’s drug and food industries—remains uncertain as the battle between reform and industry influence plays out. One thing is clear: if Kennedy moves forward with his plans, it could reshape the landscape of American public health for years to come.