Dr. Martin Makary has taken the stage.
The Johns Hopkins surgeon and President Donald Trump’s nominee for FDA commissioner faced his first Senate hearing this week, answering lawmakers’ questions about his political views and how he’ll deal with challenges at the agency.
Makary is among Trump’s more conventional picks to lead a federal agency, and unlike Robert F. Kennedy Jr., who was confirmed as secretary of HHS last month, has a medical background.
Compared to Kennedy’s Senate hearings, Makary faced a lighter gantlet of combative questions from lawmakers on Thursday. But Democrats raised concerns over how Makary could be influenced by some of Kennedy’s more fringe theories related to vaccines, including vaccine assessments and expert panels.
As head of FDA, Makary would have oversight over new vaccine reviews, post-market surveillance of shots already on the market, and the power to revisit approval decisions.
Makary is expected to ultimately be confirmed by the Senate and, once in office, is likely to face a number of immediate tests hanging over the agency.
A depleted workforce
Last month, the Trump administration made good on a promise to drastically cut the federal workforce, firing thousands of staff at health agencies. While some staffers have reportedly been hired back, including many who work in the medical device review office, it’s still unclear if the FDA will function as normal with a reduced workforce.
Some pharma companies, including Eli Lilly and Johnson & Johnson, have acknowledged the cuts’ possible impact on the drug review process, Bloomberg Law reported. So far though, there haven’t been major upsets in the review process or communication with the agency, according to David Rosen, who served14 years at the FDA and now works with pharma companies on regulatory submissions as a partner at Foley & Larder.
But while the new leadership gets settled in, delays could be on the way.
“This has been the most disruptive [situation] I've seen in terms of the change at the top,” Rosen said. “We don't know what's going to happen at the commissioner’s level. Everybody's still being taught the administration's priorities here.”
Makary stated during the hearing Thursday he will do an “assessment” of the workforce and ensure scientists have the resources they need to do their jobs, but noted that more agency cuts are still on the table. And Kennedy has stated in the past that “entire departments” at the agency should be gutted.
“I don't think there [are] any guardrails to stop anything going on at this point,” Rosen noted.
However, it’s unlikely the administration would make changes that significantly disrupt the drug review process, Rosen predicted.
“Maybe they're going to look at some of the spending and contracts, but I think what they want is to make sure the review process functions appropriately,” he said.
RFK Jr.’s influence
With Kennedy leading the HHS, health agencies’ attitudes towards vaccines could be shifting.Kennedy is currently facing his first infectious disease response test with the current measles outbreak and recent death of an unvaccinated child in Texas. While Kennedy published an op-ed this week noting that vaccines protect children and said he’s directed the CDC to work with Texas health officials on the outbreak, he also pushed vitamins as a treatment — a focus that’s worried other health experts.
On the vaccine front, Senators asked Makary whether he would follow the science.
“I have never been afraid to speak my scientific opinion,” Makary said.
But Makary did not commit to immediately reconvene a flu vaccine advisory committee meeting that was recently canceled — a move that came after another advisory panel of vaccine experts scheduled for late February was postponed.
With Kennedy shifting some of the public discourse from a push for immunizations to vaccine safety and efficacy, vaccine makers are likely to face more regulatory scrutiny, Rosen predicted. And it’s unclear if Makary would take a stand against an approach that is also in line with the Trump administration’s point of view.
“This administration is different. You've got everybody playing cards with the president, and everybody doesn't want to challenge him at this point,” Rosen said.
GLP-1 copycats
Makary will also take his position as the FDA remains locked in a battle with compound pharmacies and Big Pharma companies over GLP-1s. The FDA removed semaglutide, the active ingredient in Novo Nordisk’s blockbuster weight loss and diabetes drugs, from its shortage list at the end of February.
A number of compounded pharmacies moved into the GLP-1 space when the medications were in shortage — the only time they’re allowed to sell their versions of the top-selling drugs. Now, removing them from the shortage list has started the timer for companies selling compounded versions to end their operations.
The agency had previously removed tirzepatide, used in Eli Lilly’s GLP-1 drugs, from the shortage list and has since faced lawsuits from compounders. The compounders sued the FDA again last week following the semaglutide decision.
According to Rosen, the timing of semaglutide’s removal from the list was surprising given the vacant leadership roles and ongoing litigation.
“There's no commissioner and there's an acting director for the Center for Drug Evaluation and Research,” he said. “I was a little surprised that they did this.”
Makary has also had past conflicts of interest in the matter, previously serving as chief medical officer for Sesame Health, a telehealth company that offered compounded GLP-1 medications. While Makary has resigned from the position, as well as other pharma industry roles, his history in the space could complicate his decision-making approach to the situation, Rosen said..
“I don't think FDA would have taken action to pull these things off the drug shortage list if they weren't comfortable,” Rosen said. “I would expect that [Makary] is either going to follow the law or recuse himself, because he's been a shareholder or principal on some of these things, so he might want to not be involved in the decision-making process.”
