Robert F. Kennedy Jr. has vowed to overhaul the U.S. Food and Drug Administration (FDA), an agency responsible for regulating nearly $3 trillion in medicines, food, and tobacco products. This ambitious promise, made shortly before being named President-elect Donald Trump’s nominee for health secretary, is already setting the stage for a clash with the pharmaceutical industry, which has significant influence over the FDA’s operations.
Kennedy, an environmental activist known for his outspoken views on vaccine safety, could gain control over key health-related agencies, including those that manage government-funded health programs for more than 140 million Americans, if confirmed as Secretary of Health and Human Services. However, it is the FDA that has drawn the most attention from Kennedy, who has frequently accused the agency of being too closely aligned with Big Pharma and Big Food.
In a social media post in late October, Kennedy 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.”
Kennedy’s comments were met with resistance from the pharmaceutical industry, which provides a significant portion of the FDA’s funding. Following news of Kennedy’s potential nomination, stocks of major vaccine makers, including Pfizer and Moderna, saw a decline of as much as 2% in after-hours trading.
Big Pharma Pushes Back
The Pharmaceutical Research and Manufacturers of America (PhRMA), a major industry lobby group, issued a statement defending the pharmaceutical sector’s contributions to public health. PhRMA highlighted the achievements of the industry, including the eradication of polio and smallpox through vaccination. Although the statement did not name Kennedy, it underscored the importance of collaboration between the government and the pharmaceutical industry to ensure public health.
Kennedy’s allies, including Del Bigtree, a former communications director for his presidential campaign, believe that Kennedy’s administration would prioritize transparency and accountability within the FDA. Bigtree suggested that Kennedy would push for a thorough examination of FDA employees’ ties to the pharmaceutical industry, questioning how they obtained their positions and whether conflicts of interest existed.
Challenges to Reforming the FDA
Reforming the FDA will not be an easy task. The agency employs around 18,000 people, many of whom are protected by federal labor laws that make it difficult to dismiss employees without cause. Additionally, a significant portion of the FDA’s budget comes from “user fees” paid by pharmaceutical and medical device manufacturers. These fees, which totaled approximately $3.3 billion in 2024, fund the staff and resources needed to review products quickly and ensure safety in clinical trials. Critics argue that these financial ties to the industry could lead to conflicts of interest, but the FDA maintains that these fees do not influence its decisions.
Dan Troy, who served as FDA chief counsel under President George W. Bush, expressed doubt that significant reforms could be implemented without substantial expertise in the regulatory process. “Even if Kennedy and other political appointees were able to remove a significant portion of the FDA staff, who would you replace them with?” Troy asked. “Who has the technical expertise to rewrite the rules and change the system?”
Industry Concerns About Kennedy’s Views on Vaccines
Pharmaceutical executives have attempted to reassure the public about the FDA’s role in ensuring the safety and efficacy of critical medications. Pascal Soriot, CEO of AstraZeneca, praised the FDA for its long-standing reputation as a global leader in drug regulation and its ability to approve innovative treatments quickly.
However, some industry figures are more concerned about Kennedy’s long-standing views on vaccines. Jeremy Levin, CEO of Ovid Therapeutics and former chairman of the biotech industry lobby group BIO, expressed concerns that appointing someone who denies the safety of vaccines could have dangerous consequences for public health. “Vaccine denialism, which is a central belief of RFK Jr., is as dangerous as anything you could imagine,” Levin said.
Levin also emphasized that previous Trump appointees to the FDA were highly qualified and capable of managing the agency. He expressed hope that any future FDA leadership would have similar expertise.
FDA Leadership’s Response
In anticipation of potential changes following Trump’s election, FDA Commissioner Robert Califf reassured staff that the agency would continue its mission to protect public health. “There will, no doubt, be changes ahead, but rest assured, the FDA will continue to do the job it was created to do,” Califf wrote in an email to staff. “The work you do will remain critical, and this agency will continue to protect the public, as it has for over a century.”
Looking Ahead
Kennedy’s pledge to reform the FDA is creating a rift between the incoming Trump administration and the pharmaceutical industry. If confirmed as Health Secretary, Kennedy would have the power to implement significant changes at the FDA, but this would likely face considerable opposition from industry stakeholders. The future of the FDA and its relationship with Big Pharma may depend on how far Kennedy is able to push for reforms — and how much resistance he faces from a sector that plays a major role in funding the agency’s operations.
