Robert F. Kennedy Jr. has vowed to reform the U.S. Food and Drug Administration (FDA). The agency oversees nearly $3 trillion in medicines, food, and tobacco products. This pledge, made just before his nomination as Secretary of Health and Human Services, sets up a potential showdown with Big Pharma. Pharmaceutical companies hold significant financial influence over FDA operations.
As an environmental activist and vocal vaccine safety critic, Kennedy could gain control of key health agencies. These agencies manage government-funded health programs for over 140 million Americans. If confirmed, he would oversee public health, medical research, and health insurance programs for vulnerable populations. However, his views on the FDA have drawn the most attention.
Kennedy has criticized the FDA for aligning too closely with Big Pharma and Big Food. He describes this alignment as a “war on public health.” In a social media post, Kennedy issued a stark warning to FDA staff: “Preserve your records, and pack your bags.”
Pharmaceutical Industry Pushback
Kennedy’s remarks have alarmed the pharmaceutical industry, which funds a large part of the FDA’s operations. Following news of his potential nomination, shares of vaccine manufacturers Pfizer and Moderna fell by up to 2% in after-hours trading.
The Pharmaceutical Research and Manufacturers of America (PhRMA), a leading industry lobby group, defended the sector’s contributions to public health. PhRMA highlighted how vaccines eradicated diseases like polio and smallpox. While not naming Kennedy directly, their statement emphasized government-industry cooperation for better health outcomes.
Kennedy’s allies argue his administration would bring transparency to the FDA. Del Bigtree, a former campaign communications director, said Kennedy plans a thorough review of FDA staff’s ties to the pharmaceutical industry. “Transparency that should have happened long ago will finally come,” Bigtree said.
Challenges to FDA Reform
Kennedy’s plans for the FDA face serious obstacles. The agency employs 18,000 workers protected by federal labor laws, making removals difficult. Nearly half of the FDA’s $7.2 billion budget comes from “user fees” paid by pharmaceutical companies. These fees support product reviews, inspections, and safety measures. Critics argue these financial ties create conflicts of interest.
The FDA denies that user fees influence its decisions. The agency’s overall budget still depends on Congressional approval. Congress renews the user fee program every five years, most recently extending it through September 2027.
Dan Troy, a former FDA chief counsel, doubts Kennedy can enact meaningful reforms. “If Kennedy removes staff, who replaces them?” Troy asked. “Who has the expertise to rewrite the rules?”
Concerns About Kennedy’s Vaccine Views
Pharmaceutical leaders have expressed concerns over Kennedy’s stance on vaccines. Jeremy Levin, CEO of Ovid Therapeutics, warned that Kennedy’s vaccine skepticism could erode trust in health interventions. “Vaccine denialism is as dangerous as anything you could imagine,” Levin said.
Levin also highlighted the achievements of previous Trump appointees in overseeing rapid COVID-19 vaccine development. He hopes future FDA leaders will be equally qualified.
Pascal Soriot, CEO of AstraZeneca, praised the FDA as a global leader in drug regulation. He emphasized its role in approving innovative treatments efficiently.
FDA Leadership Reassures Staff
FDA Commissioner Robert Califf has reassured staff about the agency’s future amid possible changes. In an email, Califf emphasized the FDA’s enduring mission to protect public health. “The FDA will continue doing the critical work it has done for over a century,” Califf wrote.
The Road Ahead: Reform or Stalemate?
Kennedy’s commitment to reforming the FDA signals a possible confrontation with Big Pharma. If confirmed, he may push for major changes, but strong industry opposition is likely. The future of the FDA—and its relationship with the pharmaceutical industry—rests on Kennedy’s ability to fulfill his reform promises.