Ahead of Robert F. Kennedy Jr.’s confirmation hearings, experts—and RFK’s own family—expressed concerns about his vaccine-related views, though the same experts are largely unfazed by the level of power he and Marty Makary could ultimately wield over the FDA.
Just one day after being sworn in as the 47th president of the United States, Donald Trump ordered the Department of Health and Human Services to go dark, potentially halting communication of information critical to public health. The directive is ostensibly to enable the new administration to get settled, but already disruptions are being felt across the FDA, CDC and NIH.
The new administration’s healthcare team could be helmed by Robert F. Kennedy, Jr. as Department of Health and Human Services (HHS) secretary, Marty Makary as FDA commissioner and Mehmet Oz as head of the Centers for Medicare & Medicaid Services (CMS). For two months, speculation has been swirling as to how these three—characters all—could change the near-term shape of U.S. healthcare.
Experts who spoke with BioSpace downplayed the potential for sweeping changes while positing various policy shifts that could eventuate under the new administration. Mostly, though, the consensus is that the industry must now play the waiting game.
“Right now, we have rhetoric and the rhetoric is contradictory, and so we just have to wait and see,” outgoing FDA Commissioner Robert Califf told BioSpace during a media roundtable before leaving office.
“Some of the people who have been nominated in the positions have been very critical . . . sort of implying that there are nefarious motives of people working in the public health agencies,” Califf said. “Historically—and I think it’ll be the case here—it feels a lot different when you have to make the decision and be accountable for it, as opposed to criticizing the decision.” He added that the heads of FDA and HHS don’t have carte blanche authority to make large-scale changes to their organizations.
Ethan Siegal, founder and policy analyst at The Washington Exchange, was similarly undaunted, telling BioSpace that life in the biopharma sector “is not going to be as worrisome or risky as everyone has initially postulated.”
The U.S. Senate Finance Committee will convene Wednesday to discuss RFK’s nomination. A date has not yet been set regarding Makary. Siegal said he believes that both will ultimately be confirmed. Republicans have a slim majority in the Senate. “Republicans got their political win when [Matt] Gaetz had to withdraw [as nominated attorney general] . . . and so I don’t see any of the remaining healthcare biopharma nominees as being worth a big Republican Senate fight.”
In an investor note Tuesday, however, Jefferies analysts shared a different opinion. “RFK could also lose the confirmation vote (we think it will be close) and if replaced would be a major near-term (+) upside catalyst for biotech,” they wrote.
Later in the day, RFK’s niece, Kerry Kennedy Meltzer, provided STAT News with private email exchanges between her uncle and herself detailing false claims made by the nominee about COVID-19 vaccines during the pandemic and citing articles by other vaccine critics linking childhood immunizations to vaccines.
RFK Jr.’s hearings are scheduled to begin at 10 am Eastern time on Wednesday morning and continue into Thursday.
RFK and Makary: Bad for Vaccines, Good for Cell Therapy?
When it comes to Makary, in comparison with some of Trump’s other HHS nominees, there is a general consensus in the biopharma sector that “the industry has landed in a good spot with regard to FDA oversight of drugs and devices and potential reforms within the FDA,” Siegal said. “I do think he appreciates the history of the FDA, appreciates what his role is to be as the head of the FDA, and I think all of that is a fundamental positive.”
Makary will focus on the number one issue for biopharma in any given year, Siegal continued, which is the number of novel drugs approved, and the number of new indications approved for currently marketed medicines. The biggest challenge for Makary—as with the other main healthcare nominees—will be a lack of significant managerial experience, he said.
Siegal added that if confirmed, RFK Jr. will be an “overhang” for Makary, “depending upon how he behaves, publicly, optically, rhetorically, because I think RFK is a politician who likes to talk, and therefore politicians who like to talk are always problematic in general.” However, Siegal acknowledged that “we won’t know until [RFK Jr.] actually interferes with something.”
One area where this could happen is with vaccines. Although RFK Jr. began to walk back his rhetoric on vaccines this week—stating in prepared testimony for the Senate Health, Education, Labor and Pensions Committee that he is not “anti-vaccine or anti-industry,” according to Bloomberg—Siegal predicted he could still meddle in the sector. While he is not likely to interfere with a vaccine’s approval by the FDA or CDC, Siegal continued, RFK Jr. could have the most “specific and egregious” impact on this sector by producing “the type of statements to inhibit the uptake of vaccines.”
Sonia Nath, partner and chair of the global life sciences and healthcare regulatory practice group at Cooley, agreed that vaccines will be a focus for RFK Jr. She noted that vaccine skepticism also applies to Makary and CDC Director nominee Dave Weldon. “If confirmed, they likely will work together to make big changes in vaccine policies,” Nath told BioSpace over email.
While acknowledging that “because [Makary] has not served in government before, his precise policy goals are unknown,” Nath listed potential shifts including how vaccine recommendations are made and the addition of a requirement for more evidence prior to approval. He may also focus on the ways in which FDA policies can impact pricing, Nath added, “whether that is by reviewing enforcement discretion policies related to compounding or companies’ use of market exclusivities to block competition.” Notably, Makary is chief medical officer at telehealth company Sesame, a health service market that offers compounded semaglutide.
While vaccine makers may face headwinds under the new administration, Nath added that other sectors could benefit from a general openness to novel treatments, with “a potential shift in policy in favor of certain products such as stem cell therapies and nutraceuticals.” Indeed, RFK Jr. has previously accused the FDA of “suppressing” stem cell therapies, according to Pharmaphorum. RFK Jr.’s current investments in gene editing biotech CRISPR Therapeutics also support this notion—though he vowed last week to divest his interests in CRISPR as well as immunotherapy-focused Dragonfly Therapeutics if he is confirmed as health secretary.
An RFK Jr. confirmation could also be a boon for the fledgling therapeutic psychedelics industry, as he has also pointed to psychedelic drugs as a class of therapeutic the FDA has obstructed, Pharmaphorum reported. In a highly-watched decision, the FDA in August rejected Lykos Therapeutics’ New Drug Application for a midomafetamine (MDMA)-assisted therapy for post-traumatic stress disorder. The sector got a win last week, however, when J&J’s esketamine nasal spray Spravato won approval as a monotherapy.
Makary has himself hinted at the need to lessen the agency’s roadblocks. In an opinion piece published by Fox News in October 2021, he wrote, “COVID has given us a clear-eyed look at a broken Food and Drug Administration that’s mired in politics and red tape. Americans can now see why medical advances often move at turtle speed. We need fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.”
The Bottom Line
Beyond any policies that could support or hinder specific sectors, an overarching issue that could be influenced by the new administration is the Prescription Drug User Fee Act (PDUFA), renegotiations for which begin this year. Under PDUFA, the pharma industry pays user fees to the FDA in exchange for the agency’s commitment to review potential drugs. RFK Jr., in particular, has been a vocal critic of this user fee program due to its potential to create a conflict of interest between the two parties.
However, “if user fee programs were abolished, FDA’s work would slow, or Congress would have to fund the agency to continue its important public health mission, which may not be a popular position with the incoming administration or the current Congress,” Nath said.
Wherever RFK Jr., Makary and the other nominees come down on this and other issues, Califf emphasized that the power they wield will not be absolute. The FDA, he said, has “a lot of bosses,” including HHS, the executive branch and Congress, “which also thinks it’s your boss.”
“It’s interesting to me that people think the FDA could just declare this and that. It usually can’t,” Califf said, pointing to “a whole series of [recent] Supreme Court decisions that constrain the agency even more.” Here, Califf may have been referring in part to the overturning of Chevron deference, which had given federal agencies the authority to interpret ambiguous statutes but was overturned by the U.S. Supreme Court in July 2024. “I would say, if the administration gets activist and goes beyond the boundaries of the rule book, if the courts are true to what they’ve already ruled, that will get reined in fairly quickly.”
