RFK Jr. Says He Wants To Untie Links Between Industry And FDA

“FDA’s war on public health is about to end,” Robert F. Kennedy Jr. wrote on X just prior to the November election. “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 is President-elect Trump’s nominee for Secretary of the Department of Health and Human Services. He told the Washington Post that “the president has asked me to clean up corruption and conflicts at the agencies.”

It’s not clear which specific corruption Kennedy is alluding to. But it’s known that the Make America Healthy Again movement, which Kennedy heads, favors independence between the public health agencies and the pharmaceutical and food industries. Some in the MAHA movement want to end what they view is a revolving door between industry and the government: For example, instances in which officials at the Food and Drug Administration had previous pharmaceutical industry ties or companies hire agency staffers who were responsible at FDA for the reviews of drugs prior to approval for marketing.

Kennedy says one of his mandates is to return public health agencies to the gold standard of scientific review. But this raises the question, what do President-elect Trump and HHS secretary nominee Kennedy mean by reverting, say, the FDA’s drug review process to a gold standard?

While it’s speculative at this point, it could imply retreating from the use of approaches that have been adopted in recent decades to speed up the review process. Perhaps there will be less use, for instance, of the accelerated approval mechanism that allows for earlier marketing authorization of certain drugs that treat serious or life-threatening conditions, based on a surrogate endpoint if it is thought to predict clinical benefit. Kennedy may wish to also abandon emergency use authorizations that were used during COVID to fast-track people’s access to vaccines.

It could be that Kennedy wants FDA to always require at least two randomized controlled trials prior to approval. RCTs are frequently referred to as the gold standard of evidence generation. And in fact, two significant pivotal trials are usually already required for a novel pharmaceutical to be approved by FDA. But exceptions to the rule exist, for the purpose of allowing for more flexibility, especially where there’s a high degree of unmet need. It’s these exceptions which Kennedy could target.

Ironically, though, Kennedy touts certain drugs, supplements and other therapies, some of which lack an RCT evidence base. In October, Kennedy lashed out at the FDA in a post on X for “suppressing” a wide range of items, including “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.”

Together with Kennedy, the next FDA commissioner will give direction to the agency. On the day that Trump nominated Marty Makary to be in charge of the FDA, he wrote on Truth Social: “FDA has lost the trust of Americans, and has lost sight of its primary goal as a regulator. He [Makary] will work under the leadership of Robert F. Kennedy Jr. to, among other things, properly evaluate harmful chemicals poisoning our Nation’s food supply and drugs and biologics being given to our Nation’s youth, so that we can finally address the Childhood Chronic Disease Epidemic.”

Makary and Kennedy have a shared enthusiasm for examining the root causes of rising rates of chronic diseases, including obesity, and increases in the incidence of cancer among young people.

And Makary has criticized and researched various flaws in the United States healthcare system throughout his career, from investigating deaths due to medical errors to calling out drug makers for exploiting the FDA’s rare disease drug program. He has also questioned the evidence base for certain treatments and established clinical practices.

Moreover, the New York Times reports that Makary has aired concerns that Americans are too reliant on drugs, saying the nation has the most overmedicated and sickest population in the world. “The best way to lower drug costs in the U.S. are to stop taking drugs we don’t need,” Makary said.

While Makary also emerged during the COVID pandemic as a critic of the FDA, it’s less clear whether he would examine ties with the industry, related, for instance, to the Prescription Drug User Fee Act. Expected HHS Secretary nominee Robert F. Kennedy Jr.’s dislike of user fees could reach a critical point in the 2027 PDUFA reauthorization, according to Pink Sheet.

In 1992, Congress passed and President George H.W. Bush signed PDUFA, a law that provides FDA with resources to make the drug review and approval process more efficient. Beyond creating the user fee program, PDUFA legislation has instituted a broad range of changes to FDA policy, including the abovementioned accelerated pathways for approval, but also industry involvement in FDA decision-making and increased communication between FDA and industry during the drug application process.

Neither Kennedy nor Makary can unilaterally rescind PDUFA. Congress would have to repeal the law. But, prior to Congress’s next reauthorization of PDUFA in 2027, they could look to insert changes that reduce FDA’s dependence on the industry.

In 2024, $3.3 billion, or almost 46% of the agency’s $7.2 billion budget, came from user fees, payments made by pharmaceutical and medical device manufacturers to fund the staff resources required to review products expeditiously regarding their safety and efficacy.

PDUFA was initially motivated in the early 1990s by lengthy drug review timelines at FDA. Researchers at the Tufts Center for the Study of Drug Development observed a drug lag between newly approved pharmaceuticals in the United Kingdom and in the U.S. in the years leading up to the PDUFA law. In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. As a result, U.S. patients often faced delays in access compared to their British counterparts.

PDUFA and other lower regulatory barriers led to an increase in the speed of FDA reviews and the increased the likelihood of earlier U.S. drug launches.

Within approximately ten to 15 years of enactment of PDUFA, for drugs approved in both the U.S. and Europe, approximately 64% were first available in the U.S., a median of 90 days sooner than in Europe.

The U.S. is now a leader in bringing “novel, life-improving, and life-saving therapies from the researcher’s bench to a patient’s bedside,” according to the Center for International and Strategic Studies. And this applies to annual numbers of drug approvals by the FDA as well as the pace of the review process. In addition, the FDA’s regulatory framework for drug development is often considered an archetype around the globe.

The question then becomes to what extent Kennedy and Makary would want to disrupt a process which has given the U.S. a comparative advantage, albeit at the expense of industry dependency.