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Analysis-RFK Jr vow to purge FDA sets up collision with Big Pharma
By Ahmed Aboulenein and Michael Erman - 11/15/2024
By Ahmed Aboulenein and Michael Erman
WASHINGTON/NEW YORK (Reuters) - Robert F. Kennedy Jr. vowed to purge the U.S. Food and Drug Administration shortly before being chosen as President-elect Donald Trump's nominee for health secretary. Any changes he wants to make will come up against a pharmaceutical industry that pays much of the regulator's bills.
Kennedy, an environmental activist who has helped sow doubts about the safety and efficacy of vaccines, would have authority over the nation's agencies responsible for public health, government-funded health insurance plans for more than 140 million including the poor, those 65 and older, and the disabled, medical research and more if confirmed as U.S. Secretary of Health and Human Services.
Kennedy has been most vocal about the FDA, an agency that oversees nearly $3 trillion in medicines, food and tobacco products. In interviews and on social media, Kennedy has accused agency staff of doing the bidding of Big Pharma and Big Food. "FDA's war on public health is about to end," Kennedy wrote on X in late October. "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." FDA officials were not immediately available to comment on the Kennedy nomination.
Shares of vaccine makers including Pfizer Inc, and Moderna, fell after news of Kennedy's appointment and were down in after-hours trading by as much as 2%.
Calling the drug industry "a crown jewel of the American economy," the Pharmaceutical Research and Manufacturers of America, the leading industry lobby group, said in a statement it wanted to work with the Trump administration to improve health for patients.
The group stressed achievements such as the elimination of polio and smallpox, both of which were accomplished through vaccination. It did not mention Kennedy by name in the statement, released after the announcement.
Del Bigtree, who was director of communications for Kennedy's election campaign and remains close to the former candidate, said he expected a careful look at any FDA employee ties to industry. "You're going to see a vetting process of, how do the people have the jobs here? What were their conflicts of interest ... you're going to watch a transparency that should have happened," he said. "And it's all going to be made public."
Kennedy ran for president in this year's election as an independent before dropping out in August and endorsing Trump in exchange for a role in the Republican's administration.
Making good on such pledges would require the new Trump administration to strip federal employees of protections against arbitrary firing put in place by lawmakers. The 18,000 FDA staff are further shielded because their salaries are not exclusively funded by Congress. In 2024, $3.3 billion, almost 46% of the agency's $7.2 billion budget, came from so-called "user fees," or payments made by pharmaceutical and medical device manufacturers to fund the staff resources needed to review their products quickly, conduct inspections, and ensure the safety of clinical trials. The FDA says user fees do not influence its decisions to approve products, and its overall budget is still subject to Congressional approval. Congress renews the user fee program every five years and most recently extended its use through September 2027.
Dan Troy, former chief counsel at the FDA under Republican President George W. Bush's first administration, said he did not expect any "seismic changes."
Even if Kennedy and other political appointees were able to fire a substantial number of staff, "who are you going to put in place? Who has the technical expertise to write these rules that are going to really change the paradigm?" he said.
REINFORCE THE GOOD Pharmaceutical executives have tried to mitigate concerns over Kennedy's potential influence, and stressed the importance of the agency's scrutiny of the safety and efficacy of life-saving medications for everything from cancer to diabetes and heart disease. "My hope, my belief, is people will see the good work the FDA is doing today and continue to reinforce this," AstraZeneca Plc Chief Executive Pascal Soriot said earlier this week. "The FDA has really been for many years not only the reference in terms of regulatory authority in the world, but also the most innovative and the fastest in approving medicines that really are differentiated." Others were more blunt about their concerns about Kennedy's long-held views. "Putting somebody in charge of any public health service who is a vaccine denier puts at risk the stability of the nation at large," Jeremy Levin, CEO of biotech company Ovid Therapeutics and a former chairman of biotech lobby group BIO told Reuters late last month. "Vaccine denialism, which is a central plank of RFK's, is perhaps as dangerous as anything as you could imagine." Levin described previous Trump appointees at the FDA and a project overseeing the successful development of COVID-19 vaccines during his first term as "exceptional choices." "We have to hold on to the hope that anybody who gets put into the position of the FDA director in a Trump administration would be of the same quality," he said. In the meantime, FDA Commissioner Robert Califf sought to reassure staff members following Trump's election last week. "There will, no doubt, be changes ahead, but rest assured, the FDA will continue to do the job it was created to do," he wrote in an email viewed by Reuters. "The work you do will remain critical and this agency will continue to protect the public, as it has for over a century."
(Reporting by Ahmed Aboulenein in Washington and Michael Erman in New York; Additonal reporting by Stephanie Kelly in New York and Maggie Fick in London; Editing by Michele Gershberg and Diane Craft)