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# Makary Will Face Political Interference Soon: Gottlieb
- URL: https://www.fdaweb.com/makary-will-face-political-interference-soon-gottlieb/
- Published: 2025-04-03T12:00:00.000Z
- Updated: 2026-09-14T14:57:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158948

Former FDA commissioner **Scott Gottlieb** says FDA commissioner **Marty Makary** will likely face political interference from the Trump administration attempting to impact decision-making at the agency, especially due to HHS secretary **Robert F. Kennedy Jr.**’s vaccine skepticism. Speaking at Politico’s 2025 Health Care Summit in Washington, DC 4/2 ([see Youtube video](https://youtu.be/sAV-d5Z8DoQ?si=u6bmqHmeeZHnyutm&ref=fdaweb.com)), Gottlieb, who acknowledged he and Makary are friends, said the new commissioner will be facing some early tests soon as there are user fee action dates that are on the horizon. These will “give us an indication of how much he is going to establish independence about the decision making there, not just on the policy, but on product-specific things related to vaccines, or how much he’s going to be pressured by the secretary to do certain things that are clear evidence of some sort of political decision making in the scientific review process.”

Gottlieb acknowledged that every commissioner is faced with political pressure, although he said he was fortunate because then-HHS secretary **Alex Azar** was “exceptional and he understood that it was important to maintain the independence of FDA, and he guarded that. But, I’ve been in and around FDA for 25 years, and there’s always secretaries who think that they can get involved in certain decisions, but you have to educate them about the importance of maintaining that firewall and independence, because it serves them well… I think we’re going to see some really visible tests of that very soon.”

Based on the dramatic level of FDA staff cuts this week, Gottlieb said product reviews will be deeply impacted. He said many cuts made to components of the review process were likely because whoever was deciding on the terminations didn’t fully realize what role they played in actual drug reviews. “It seems that anything that had the word ‘policy’ in it as an office was eliminated, and perhaps there was a proliferation of the title of policy,” according to Gottlieb.

The directive to make the staff reductions came from the administration’s Department of Government Efficiency and Gottlieb believed that the “actual adjudication” of the cuts was made by a small group of mostly political leadership inside the Office of the Commissioner, and without Makary’s input. While the Center directors were in a position to know which components would impact a review or core function, they unfortunately were not consulted, he said.

Across the Office of New Drugs there were a number of “policy” offices and the staff in these would help “adjudicate cross-cutting scientific issues that transcended different drug reviews,” Gottlieb explained. “So if you had an endpoint that was used in multiple clinical trials, and you had to make a determination about the comparability of the results across different drug reviews, or if you had a side effect associated with one drug, and you wanted to determine whether or not it was a class-wide side effect or specific to a particular molecule, that office made those adjudications and did those evaluations.” He noted that this was just one example of the offices that were eliminated that will directly impact drug reviews.

The policy people who were cut also worked on good review management practices, which is “basically a recipe for what reviewers should do, what rules they should follow when they’re reviewing applications, particularly in areas of novel technology or breaking new ground, like a novel generic approval,” Gottlieb said. “That apparatus is what’s gone, and so that is going to have a very tangible effect.”

Reminiscing on his tenure under president Trump’s first administration, Gottlieb noted that Trump was the one who championed the Right to Try Act. “He believed in the power of pharmaceutical innovation, and particularly these new paradigms, to transform people's lives,” he said. “So I don’t know that this is consistent with his ethos about how innovation can impact patients.”

Based on all that has happened this week from the cuts, Gottlieb was asked if confirming HHS secretary **Robert F. Kennedy Jr.** was a mistake. He responded that he would have expected there to be chaotic issues, especially when considering the lack of thoughtfulness that went into the decisions and the cuts were not gradual. What concerns Gottlieb more about Kennedy is his position around vaccines. “And my concern is, which I think has been borne out, that he would interfere very directly in the vaccine approval process, which I think we’re going to, unfortunately, see, but also in terms of the infrastructure that we rely on this country to get children vaccinated for things like polio and diphtheria and measles, mumps and rubella,” he said. “And I think we’re seeing that as well.

“They’ve canceled grants on new vaccine production,” Gottlieb continued. “We’ve seen him take down front-facing patient pages on the CDC Web site that encouraged people to get vaccinated. Probably the most tangible step that we’ve seen in recent weeks was during what is the biggest flu epidemic that we’ve had in 20 years in the U.S., they took down a campaign that was encouraging people to go out and get vaccinated for flu… So these are all very tangible things, because I think his career has been dedicated to these sort of anti-vax efforts. I don't think he’s made a mystery about it. I don't think we should be surprised. He's been very clear. You can't fault him for not being very clear about his intentions here. I think the people who thought, ‘Well, maybe he won't follow through on it.’ I think they are the ones who probably have some buyer’s remorse. I don’t.”