Robert F. Kennedy Jr. has pledged to reform the FDA, which oversees $3 trillion in products. This commitment, announced before his nomination as Health Secretary, sets him up for a showdown with the pharmaceutical industry, a major funder of the FDA.
Kennedy, an environmental activist critical of vaccine safety, could gain significant control over public health agencies. If confirmed, he would oversee health insurance for 140 million Americans and extensive medical research programs.
Criticism of FDA and Bold Claims
Kennedy has strongly criticized the FDA for its alleged ties to Big Pharma and Big Food. He claims the agency serves corporate interests, undermining public health. In late October, he posted on X (formerly Twitter): “The FDA’s war on public health is about to end. Preserve your records and pack your bags.”
The FDA did not comment on Kennedy’s nomination. His remarks have heightened tensions, signaling a major confrontation if he takes office.
Industry Reactions and Pushback
Pharma Market Responds to Nomination
News of Kennedy’s potential appointment caused shares of vaccine makers like Pfizer and Moderna to dip by 2% in after-hours trading. The pharmaceutical lobby group PhRMA emphasized the industry’s role in eradicating diseases like polio and smallpox. While not directly addressing Kennedy, the group stressed collaboration between government and industry to improve public health.
Kennedy ally Del Bigtree hinted at significant changes, including an investigation into FDA hiring practices and conflicts of interest. “You’ll see how these decisions were made, and it will all go public,” Bigtree said.
Hurdles to Implementing Changes
Kennedy’s vision for FDA reform faces structural and political challenges. The agency employs 18,000 people, many protected by federal labor laws. Additionally, nearly 46% of the FDA’s $7.2 billion budget comes from industry-paid “user fees.” Critics argue these fees create conflicts of interest, though the FDA denies such claims.
Dan Troy, former FDA chief counsel, questioned Kennedy’s ability to implement reforms. “Even if you fire staff, who has the expertise to rebuild the system?” Troy asked.
Pharma Leaders Highlight FDA’s Role
Industry executives praised the FDA’s achievements, especially in approving life-saving medications. AstraZeneca CEO Pascal Soriot described the FDA as a global leader in regulatory innovation. However, critics like Jeremy Levin, CEO of Ovid Therapeutics, warned that Kennedy’s vaccine skepticism could destabilize public health. “Vaccine denialism is as dangerous as anything you can imagine,” Levin stated.
Levin expressed confidence that any Trump administration appointees would ensure continuity at the FDA, citing successful COVID-19 vaccine oversight during Trump’s first term.
FDA Leadership Reassures Staff
FDA Commissioner Robert Califf sought to calm concerns among employees. In an internal email, he affirmed the agency’s mission to protect public health. “There will be changes, but the FDA’s core work will remain critical,” Califf wrote.
A Contentious Path Ahead
Kennedy’s promise to reform the FDA could reshape U.S. public health policy. However, he will face strong resistance from the pharmaceutical industry and the FDA’s entrenched structure. The battle ahead may determine the agency’s future and its relationship with Big Pharma. Whether Kennedy can fulfill his pledge remains uncertain, but his nomination has already sparked intense debate over the FDA’s role in American health care.
