Last month, President-elect Donald Trump announced Robert F. Kennedy Jr. as his choice to be the next secretary of the Department of Health and Human Services (HHS). Kennedy, a former Democrat who ran for president as an independent, endorsed Trump after suspending his own campaign in August. He has pledged to take on Big Pharma in the role, and he’s one step closer to doing so if the US Senate confirms his nomination early next year.
An environmental lawyer with no medical or public health training, Kennedy is an unconventional pick to lead the vast agency, which comprises the Food and Drug Administration, Centers for Disease Control and Prevention, National Institutes of Health, and Centers for Medicare and Medicaid Services.
Kennedy has been a vocal opponent of the pharmaceutical industry over the years, while also promoting alternative health practices, spreading vaccine misinformation, and embracing conspiracy theories such as the claim that HIV does not cause AIDS. This week, more than 75 Nobel Laureates signed a letter urging the Senate to oppose Kennedy’s nomination, saying he would “put the public’s health in jeopardy.” Yet Kennedy has also made some common-sense health proposals that cut across party lines, such as cracking down on ultraprocessed foods and promoting preventive health care.
After endorsing Trump, Kennedy launched the Make America Healthy Again campaign, which focuses on combatting chronic diseases—such as diabetes and heart disease—and laid out a handful of policy ideas to do that in a September Wall Street Journal editorial. Some of those policy proposals take direct aim at the pharmaceutical industry, including reforming the Prescription Drug User Fee Act, or PDUFA, and reviewing direct-to-consumer pharmaceutical ad guidelines.
Enacted by Congress in 1992, PDUFA authorizes the FDA to collect fees from pharma companies when they submit new drug applications to the agency. In fiscal year 2022, user fees represented 46 percent of the FDA’s total budget of $6.2 billion. In his WSJ editorial, Kennedy said the practice “creates a barrier to entry to smaller firms and puts bureaucrats’ purse strings in the hands of the pharmaceutical industry.”
PDUFA was created in response to a bottleneck in new medicine approvals due to what the industry saw as an understaffed and underfunded FDA. User fees were adopted as a way to boost the FDA’s ability to review new drug applications. While a PDUFA payment doesn’t guarantee the approval of a new drug, it does set a timeframe for the FDA to review a drug application, which critics say may result in rushed approvals.
“The underlying theory was, the FDA spends a ton of money doing drug approvals. That actually benefits the drug companies by giving a seal of approval in the marketplace, and so the drug companies should pay,” says Robert Weissman, copresident of Public Citizen, a left-leaning consumer rights advocacy group based in Washington, DC, that has been critical of PDUFA. “What it means is that the FDA has actually come to view the drug companies too frequently as their clients, and so it has absolutely compromised the independence of the agency.”
PDUFA must be reauthorized by Congress every five years, and fees have been increased over the years. It’s set to come up for renewal in 2027, halfway through Trump’s second term, which will provide an opening for changing the law.
“You could lower the fees, but it will require legislative action, and legislators already have a lot on their plates,” says Jeromie Ballreich, a health economist at Johns Hopkins University who specializes in pharmaceutical policy.
Even if that happens, he doesn’t see lower PDUFA fees as magically leveling the playing field for smaller drug firms, as RFK envisions. Ballreich says the biggest barrier for drug development is not PDUFA fees but the cost of carrying out large clinical trials needed to prove the safety and efficacy of a drug. Those trials can cost tens of millions of dollars.
If RFK does succeed in influencing Congress to reduce PDUFA fees, it would mean a huge hit to the FDA’s budget. Unless Congress appropriated more money to run the agency, the FDA would likely face major cuts.
Kennedy has also threatened to ban direct-to-consumer pharmaceutical advertising. “One of the things I’m going to advise Donald Trump to do in order to correct the chronic disease epidemic is to ban pharmaceutical advertising on TV,” Kennedy said in a video from a campaign rally he posted on X in early November.
The FDA has the ability to set new rules for pharmaceutical advertising, and in fact, the agency spent more than a decade working on new guidelines aimed at increasing transparency around drug risks and side effects. The new rules, which require drugmakers to present information in “consumer-friendly language” in a neutral manner without distractions, took effect on November 20.
But the administration would likely face legal challenges if it proposed additional restrictions or an outright ban on pharma ads, says Jim Potter, executive director of the nonpartisan Coalition for Healthcare Communications. “The courts view advertising as a form of commercial speech, and they’ve ruled in a series of cases dating back to the 1970s that banning advertising violates First Amendment protections of freedom of speech,” he says. “If the administration wanted to unilaterally impose new rules, they would be on shakier legal ground today than in past years.”
That’s because the US Supreme Court last summer overturned the longstanding Chevron doctrine, which allowed federal agencies some latitude in how they interpreted ambiguous laws. The Supreme Court ruling shifts power from agencies like the FDA to the courts.
Ballreich and Weissman worry that Kennedy’s support of raw milk, vitamins, and disproven treatments for Covid-19, including ivermectin and hydroxychloroquine, could lead to the agency approving medicines that lack scientific evidence.
“I think when Robert Kennedy talks about fighting corruption and Big Pharma monopolies, that is going to translate into reducing standards at FDA to enable the authorization and promotion of ineffective and dubious therapies, drugs, herbs, whatever,” Weissman says.
As HHS secretary, Kennedy would not be directly responsible for approving new drugs or treatments. That job falls to the FDA’s Center for Drug Evaluation and Research, which more often than not approves drugs based on the recommendations of independent advisory committees. But in a handful of controversial cases, the agency has approved drugs against this expert advice, such as when it greenlit Exondys 51, a drug for Duchenne muscular dystrophy, in 2016. FDA advisers said there was not enough evidence to show that the drug had actual clinical benefits.
RFK has also called for more scrutiny of vaccines, which already must be tested on thousands of healthy volunteers for several years before being licensed. This skepticism could play out in fewer vaccines making it to the market and more postmarket monitoring of approved vaccines.
Working with Mehmet Oz, Trump’s pick to lead the Centers for Medicare and Medicaid Services, Kennedy could push to get questionable treatments or medical devices covered by Medicare, the federal health insurance program for people aged 65 or older and those with disabilities.
But Kennedy’s anti-pharma stance could be tempered by congressional Republicans, who have been historically reticent about more regulation, and Trump’s other appointees. The incoming president has made a more conventional pick for FDA commissioner in Marty Makary, a pancreatic surgeon and public policy researcher at Johns Hopkins. Meanwhile, Vivek Ramaswamy, founder of the pharmaceutical company Roivant Sciences and a Republican presidential candidate, has been tapped to lead the Department of Government Efficiency, or DOGE, a planned presidential advisory commission under the second Trump administration.
“There are huge question marks with the Trump administration and its approach to pharmaceuticals in general,” Ballreich says. “It’s hard to know how this is really going to shake out.”