WASHINGTON/NEW YORK, Nov 15 (Reuters) – Robert F. Kennedy Jr. has pledged to overhaul the U.S. Food and Drug Administration (FDA) shortly before he was nominated by President-elect Donald Trump to serve as the health secretary. The changes he aims to implement will confront a pharmaceutical industry that significantly funds the agency’s operations.

Kennedy, known for his environmental activism and skepticism about the safety and effectiveness of vaccines, would oversee the national health agencies, Medicare and Medicaid plans which serve over 140 million Americans including low-income individuals, senior citizens, and people with disabilities, if he is confirmed as Secretary of Health and Human Services.

Kennedy has been particularly critical of the FDA, an agency that regulates nearly $3 trillion worth of drugs, food, and tobacco products. In various interviews and on social media platforms, he has accused the agency’s employees of being influenced by major pharmaceutical and food companies.

“The FDA’s detrimental impact on public health will soon come to an end,” Kennedy stated on X (formerly Twitter) in late October. “To those employed at the FDA who are part of this corrupt system, I have two messages for you: 1. Safeguard your records, and 2. Start packing your bags.”

The FDA has yet to respond to inquiries regarding Kennedy’s nomination.

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

The Pharmaceutical Research and Manufacturers of America, the main trade group for the drug industry, called the pharmaceutical sector “a crown jewel of the American economy” in a statement, expressing a desire to collaborate with the Trump administration to enhance patient health.

The group highlighted achievements such as eradicating polio and smallpox through vaccinations but did not specifically mention Kennedy in their post-announcement statement.

Del Bigtree, former communication director for Kennedy’s campaign and an associate of the ex-candidate, anticipated a thorough review of any FDA employees with industry connections.

“There will be a vetting process for how people got their positions and their potential conflicts of interest… expect to see a level of transparency that should have been implemented previously,” he stated. “All of this will be made public.”

Kennedy initially ran for president this year as an independent but withdrew in August to support Trump in exchange for a position in his administration.

Following through on his commitments would require the new Trump administration to revoke federal employee protections that guard against arbitrary dismissals, which were established by legislators. The FDA’s 18,000 employees also benefit from additional safeguards because their salaries are not solely funded by federal allocations.

This year, the FDA’s budget included $3.3 billion from “user fees,” which are payments from pharmaceutical and medical device companies to fast-track product reviews, conduct inspections, and ensure clinical trials’ safety. This amounted to nearly 46% of the agency’s total $7.2 billion budget.

The FDA claims that these user fees do not affect their product approval process, and that their overall budget is still subject to Congressional oversight. The user fee program is reviewed and renewed by Congress every five years, with the latest extension lasting until September 2027.

Dan Troy, who previously served as chief counsel at the FDA during President George W. Bush’s first term, expressed skepticism about significant shifts occurring. He noted, “Even if Kennedy and other political appointees were to dismiss a considerable number of staff, where will you find replacements? Who possesses the technical skills to draft regulations that will actually reshape the system?”

Uphold the Positive

Executives from the pharmaceutical industry have sought to calm fears regarding Kennedy’s possible influence, emphasizing the vital role of the FDA in assessing the safety and effectiveness of crucial treatments for ailments such as cancer, diabetes, and heart disease.

“My hope and belief is that people recognize the commendable work the FDA is doing currently and will continue to support this,” stated Pascal Soriot, CEO of AstraZeneca Plc. “For many years, the FDA has not only been a global benchmark for regulatory authority but also the most innovative and swiftest at approving groundbreaking medications.”

Some industry leaders have voiced more direct concerns regarding Kennedy’s long-standing beliefs.

“Having someone who denies vaccine efficacy in charge of any public health agency endangers the nation’s stability,” Jeremy Levin, CEO of Ovid Therapeutics and former leader of the biotech lobby group BIO, told Reuters last month. “Vaccine skepticism, which is a key part of RFK’s platform, poses significant risks as serious as it gets.”

Levin referred to former Trump appointees at the FDA and a project that successfully managed the development of COVID-19 vaccines during his initial term as “outstanding selections.”

“We must maintain our optimism that anyone appointed as FDA director in a Trump administration will match that high standard,” he remarked.

Meanwhile, FDA Commissioner Robert Califf aimed to calm employees following Trump’s election last week.

“Changes are inevitable, but you can be confident that the FDA will keep fulfilling its fundamental mission,” he stated in an email obtained by Reuters. “The work you do remains vital, and this agency will persist in safeguarding public health, as it has done for over a century.”