Donald Trump’s victory in the United States presidential election signals potential changes ahead for federal health agencies and the industries under their watch.
Though the extent of these changes remains uncertain, Trump has committed to a vision of “making America healthy again,” and his association with Robert F. Kennedy Jr.—a prominent critic of vaccines and the pharmaceutical industry—suggests this agenda may involve unconventional or disruptive policies.
“I’m going to let him go wild on health,” Trump said in a campaign speech in New York last month. “I’m going to let him go wild on the food. I’m going to let him go wild on medicines.”
That sounds ominous, but will changes be so radical?
Kennedy's potential involvement in overseeing or advising on healthcare policy is drawing the drug industry’s scrutiny, particularly concerning Trump’s approach to the Food and Drug Administration (FDA).
Traditional or radical options?
In his previous term, Trump appointed traditional choices, including Scott Gottlieb and later Stephen Hahn, to lead the FDA. Although his administration sometimes pressured the agency toward approving unproven COVID-19 treatments, such as hydroxychloroquine, it also spearheaded "Operation Warp Speed," facilitating the rapid development of safe and effective coronavirus vaccines.
“I think a Trump administration will pay a lot of attention to the FDA,” Holly Fernandez Lynch, an associate professor of medical ethics and health policy at the University of Pennsylvania told BiopharmaDive. “Obviously, the FDA was high on President Trump’s radar screen last time around because of COVID.”
A drug policy agenda shaped by Robert F. Kennedy Jr. in Trump’s second term could take a distinct direction. In a recent interview with NPR, Kennedy stated he has been tasked with eliminating “corruption” in regulatory agencies, restoring a foundation of evidence-based science, and addressing what he describes as a chronic disease epidemic.
He has also shared on X that he aims to promote areas of medical science that some physicians view as unconventional, including stem cell injections and “nutraceuticals.”
“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 wrote.
While it’s not yet decided what Kennedy’s role might be, other candidates might be favoured for FDA and HHS and even if it is Kennedy, he may still have difficulty winning Senate confirmation for everything or anything he wants to do.
“None of us know who’s going to be appointed,” Jeffrey Jonas, the former CEO of Sage Therapeutics and currently a partner at Cure Ventures told BiopharmaDive.
“So the question is going to be: Is [Kennedy] going to be the only voice in the room? Or is he going to be brought in to represent a particular point of view on health and drugs?”
“The drug industry is arguably the most highly regulated industry in the world. It’s really not a job for amateurs or politicians,” Jonas added. “We have to hope that this administration, and every administration, appoints people who are familiar with the science in an apolitical manner.”
Good for M&A?
While biotech leaders may hold some reservations about Kennedy, they are cautiously optimistic about the potential impact of a Trump administration on federal oversight of mergers and acquisitions (M&A).
Dealmaking within the pharmaceutical sector is crucial for biotech, as acquisitions generate returns for investors and channel both capital and expertise into startups driving innovation. However, critics argue that these consolidations can also amplify market power and stifle competition.
The Federal Trade Commission (FTC), led by Biden-appointed chair Lina Khan, has heightened its focus on industry M&A. Notably, the FTC scrutinised Amgen’s US$28 billion acquisition of Horizon Pharmaceuticals, imposed stricter merger guidelines, and, in a move that has raised concern among biotech stakeholders, took the unusual step of blocking an early-stage licensing deal.
“With regard to FTC, there’s a good chance that changing leadership there will be a positive for biotech,” Daphne Zohar, the CEO of Seaport Therapeutics and previously head of PureTech Health (LSE:PRTC, NASDAQ:PRTC, OTC:PTCHF), wrote in an email.
Federal Trade Commission (FTC) chair Lina Khan’s term is set to run through 2028, though the president has the authority to appoint the chair and will have the opportunity to replace Commissioner Rebecca Kelly Slaughter when her term expires in May 2025.
Beyond reshaping agency leadership, a Trump administration could alter federal approaches to drug pricing.
During his first term, Trump proposed several policies aimed at reducing drug costs, though many were stalled or blocked in court. Among these was a “favoured nations” policy intended to tie Medicare reimbursements to international drug prices.
This approach, according to industry expert Jonas, offers “one way to control prices on a macro level,” marking an area of high interest.
However, Trump appears to have stepped back from this idea, with his campaign indicating to Stat in October that there is “no push” to revive the policy.