Robert F. Kennedy Jr.’s Plan to Overhaul the FDA
Robert F. Kennedy Jr. has pledged to reform the U.S. Food and Drug Administration (FDA), which regulates nearly $3 trillion in medicines, food, and tobacco products. This promise, announced before being nominated as President-elect Donald Trump’s Health Secretary, signals a potential clash with the pharmaceutical industry, a powerful force within the FDA’s operations.
Kennedy, known for his outspoken views on vaccine safety, could control major health agencies if confirmed as Secretary of Health and Human Services. This role oversees health programs affecting over 140 million Americans. However, his primary focus appears to be the FDA, which he claims is too closely tied to Big Pharma and Big Food.
In late October, Kennedy posted on social media, “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 remarks sparked backlash from the pharmaceutical sector, which provides substantial funding to the FDA. After reports of Kennedy’s possible nomination, stock prices for Pfizer and Moderna dropped by up to 2% during after-hours trading.
Big Pharma Pushes Back
The Pharmaceutical Research and Manufacturers of America (PhRMA), a key industry lobby group, defended the sector’s role in public health. PhRMA emphasized the industry’s achievements, such as eradicating polio and smallpox through vaccination. While not naming Kennedy, the statement stressed the importance of government-industry collaboration to protect public health.
Kennedy’s allies, like Del Bigtree, a former campaign communications director, argue that Kennedy’s leadership would prioritize transparency and accountability at the FDA. Bigtree claims Kennedy aims to investigate FDA employees’ ties to the pharmaceutical industry, scrutinizing how they secured their positions and identifying possible conflicts of interest.
Challenges to Reforming the FDA
Reforming the FDA presents significant obstacles. The agency employs about 18,000 workers, many of whom are shielded by federal labor laws that protect against dismissal without cause. Additionally, the FDA’s funding depends heavily on “user fees” paid by pharmaceutical and medical device companies. In 2024, these fees totaled approximately $3.3 billion, supporting staff and resources for product reviews and clinical trial oversight. Critics argue this arrangement creates conflicts of interest, while the FDA insists these fees do not affect its decisions.
Dan Troy, a former FDA chief counsel under President George W. Bush, doubts Kennedy can make substantial changes without extensive regulatory expertise. “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 are working to reassure the public about the FDA’s role in safeguarding drug safety and efficacy. AstraZeneca CEO Pascal Soriot praised the FDA’s reputation as a global leader in drug regulation and its ability to expedite approvals for innovative treatments.
However, some industry leaders are troubled by Kennedy’s long-standing criticism of vaccines. Jeremy Levin, CEO of Ovid Therapeutics and former chairman of the biotech lobby group BIO, warns that placing a “vaccine denialist” in charge of health policy could harm public health. “Vaccine denialism, which is a central belief of RFK Jr., is as dangerous as anything you could imagine,” Levin stated.
Levin also pointed out that previous Trump appointees to the FDA were highly qualified, voicing hope that any future appointees would possess similar expertise.
FDA Leadership’s Response
Anticipating possible changes under Trump’s presidency, FDA Commissioner Robert Califf sought to reassure agency staff. In an internal email, Califf stated, “There will, no doubt, be changes ahead, but rest assured, the FDA will continue to do the job it was created to do. 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 vow to reform the FDA sets up a potential battle between the incoming Trump administration and the pharmaceutical industry. If confirmed as Health Secretary, Kennedy could wield significant influence to enact changes at the FDA. However, he will likely face strong opposition from industry stakeholders. The outcome will depend on how far Kennedy pushes for reform and the extent to which Big Pharma resists. The future of the FDA’s structure and its ties to the pharmaceutical sector hang in the balance.
