RFK

Donald Trump’s embrace of Robert F. Kennedy Jr. is forcing biotech and pharma leaders to grapple with having US life sciences policy influenced by a figure who has extensively criticized vaccines and the drug industry, routinely embraces many conspiracy theories, and has made threats to force out FDA staff. As Trump has made gains in his bid for the US presidency against Democrat nominee Kamala Harris, he’s embraced Kennedy, who was once considered a fringe candidate expected to gather at most a few percent of the vote in some states. “I’m gonna let him go wild on health,” Trump said of RFK Jr. on Sunday at a campaign event in Madison Square Garden in New York. “I’m gonna let him go wild on the food. I’m gonna let him go wild on the medicines.” While Kennedy would be an unlikely pick for an actual appointment in the administration given the difficulty he might face with a confirmation, he’s worked with Trump’s team to help plan for a new administration, particularly on healthcare issues. And last week, he gave a preview of what that would mean in a post on X, formerly known as Twitter, saying that “FDA’s war on public health is about to end,” and calling for stopping what he called the suppression of  “psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.” “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,” Kennedy said in the post. The remarks weren’t a one-off. Earlier this month , Kennedy made similar comments to television host Phil McGraw, better known as Dr. Phil, saying that the “principal objective of the FDA today is to serve the mercantile interests of pharmaceutical companies.” There would certainly be limits to what an unconventional, RFK Jr.-allied FDA leader could do, given the power of professional staff at the FDA. But Kennedy’s comments have forced the industry to contemplate a very different environment in Washington if Trump wins and embraces a new approach. And RFK Jr.’s planned reforms, like cutting funding or headcount at the FDA, would have to come from Congress. The FDA-pharma industry user fee deal, current through 2027, is renewed once every five years, and the FDA employees reviewing new and generic drugs or new evidence of existing drugs are typically not political appointees but physicians who are employed by the FDA via industry funds. One former Trump health official who has had conversations with the campaign and those preparing for a potential transition said there were aspects of RFK Jr.’s ideas that had merit, including a focus on wellness and health. But they expressed a hope that more mainstream figures in a Trump administration would put guardrails around more extreme concepts, like RFK Jr.’s well-documented anti-vaccine sentiments. The person spoke on condition of anonymity. The FDA and Trump campaign didn’t respond to requests for comment. Others are raising concerns that an RFK Jr.-run FDA might be antithetical to the agency’s mission. “If RFK has a significant influence on the next administration, that could further erode people’s willingness to get up to date with recommended vaccines, and I am worried about the impact that could have on our nation’s health, on our nation’s economy, on our global security,” former Surgeon General Jerome Adams said Monday at a conference in Minneapolis. Holly Fernandez Lynch, a lawyer and bioethicist at the University of Pennsylvania, told Endpoints News that RFK Jr.’s proposals would amount to “a dereliction of duty” by the agency. “FDA leadership cannot wholesale abandon the agency’s public health mission,” she said. “Unfortunately, I can’t imagine that the courts would come to the rescue given what we’ve seen lately. And whether Congress would or could depends on the elections too.” PhRMA, which represents large drugmakers, said in a statement to Endpoints that the US “leads the world in innovative new medicines, in part due to the strength and integrity of the FDA’s human drug review program. The FDA is the gold standard in evaluating the safety, efficacy and quality of medicines prior to and following approval, and its role is critical in providing certainty for patients, health care providers and manufacturers.”