WASHINGTON/NEW YORK, Nov 15 (Reuters) – Robert F. Kennedy Jr. has pledged to reform the U.S. Food and Drug Administration (FDA) shortly before being proposed as health secretary under President-elect Donald Trump. His proposed modifications are likely to face resistance from the pharmaceutical industry, which significantly subsidizes the FDA’s operations.

If confirmed as U.S. Secretary of Health and Human Services, Kennedy, an environmental activist known for challenging vaccine safety and efficacy, would oversee critical health agencies, government-funded health insurance for over 140 million people, including low-income individuals, seniors, and the disabled, as well as medical research initiatives.

Kennedy has been outspoken about the FDA, which regulates nearly $3 trillion worth of medicines, food, and tobacco. In various interviews and on social media, he has accused FDA officials of acting in the interests of large pharmaceutical and food corporations.

“The FDA’s war on public health is about to come to an end,” Kennedy stated on X in late October. “If you’re an FDA employee and part of this corrupt system, I have two warnings for you: 1. Keep your records safe, and 2. Start packing your belongings.”

FDA representatives were not immediately available for comment regarding Kennedy’s nomination.

Following the announcement of Kennedy’s appointment, shares of vaccine manufacturers like Pfizer Inc and Moderna Inc fell, dropping by as much as 2% in after-hours trading.

The Pharmaceutical Research and Manufacturers of America, the main lobbying group for the industry, referred to the drug sector as “a crown jewel of the American economy” and expressed its desire to collaborate with the Trump administration to enhance patient healthcare.

The organization highlighted accomplishments such as the eradication of polio and smallpox via vaccination but did not mention Kennedy directly in its statement issued after the announcement.

Del Bigtree, who was previously in charge of communications for Kennedy’s campaign and remains a close ally, suggested that a thorough review of any FDA employees with industry connections is expected.

“You will witness a process of examining how these employees gained their positions and any potential conflicts of interest… this transparency is something that should have already occurred,” he noted. “And it will all be made public.”

Kennedy initially ran as an independent in this year’s presidential election before withdrawing in August and supporting Trump in exchange for a position in the Republican administration.

Implementing his proposals could entail the Trump administration removing federal workers’ protections against arbitrary dismissal, which were established by legislators. The FDA’s 18,000 employees have additional safeguards as their salaries come from a variety of sources, not just Congressional funding.

In 2024, nearly 46% of the FDA’s $7.2 billion budget, or $3.3 billion, was derived from “user fees,” which are payments from pharmaceutical and medical device companies intended to cover the resources needed for quick product reviews, inspections, and safety monitoring of clinical trials.

The FDA maintains that user fees do not affect its product approval decisions, and its overall budget still requires Congressional endorsement. The user fee program is reauthorized by Congress every five years, with the latest extension valid through September 2027.

Dan Troy, who served as chief counsel at the FDA during George W. Bush’s first term, expressed skepticism about any significant changes occurring.

Even if Kennedy and other political appointees manage to dismiss a considerable number of FDA staff, the challenge will be finding replacements with the expertise needed to formulate regulations that will genuinely transform the agency, he remarked.

Strengthening positive practices

Pharmaceutical executives have attempted to address concerns regarding Kennedy’s potential impact, emphasizing the critical role of the FDA in evaluating the safety and effectiveness of essential medications for diseases such as cancer, diabetes, and heart conditions.

AstraZeneca CEO Pascal Soriot expressed, “I hope and believe that people will recognize the good work the FDA is currently doing and will continue to support it.” He highlighted that the FDA has long been a leading global regulatory authority and has been particularly innovative and efficient in approving groundbreaking medicines.

Some voiced more explicit concerns regarding Kennedy’s views. Jeremy Levin, CEO of biotech firm Ovid Therapeutics and a former chair of the biotech lobby group BIO, warned, “Appointing a vaccine skeptic to lead any public health organization undermines the nation’s overall stability. Vaccine skepticism, a key facet of RFK’s platform, poses one of the greatest risks imaginable.”

Levin referred to prior appointees from Trump at the FDA, citing their role in the successful rollout of COVID-19 vaccines during his first term as “exceptional selections.”

“We must maintain the optimism that anyone appointed as FDA director under a Trump administration will be equally qualified,” he expressed.

In the aftermath of Trump’s election last week, FDA Commissioner Robert Califf attempted to reassure employees.

“While changes are undoubtedly coming, please know that the FDA will persist in fulfilling its foundational mission,” Califf stated in an email obtained by Reuters. “Your contributions are vital, and this agency will continue to safeguard the public as it has over the past century.”