US Food and Drug Administration Commissioner Dr. Marty Makary suggested in a new interview that autism is caused by a range of environmental and dietary exposures, echoing some comments made by US Health and Human Services Secretary Robert F. Kennedy Jr. but stopping short of referencing vaccines.
“I think it is the cumulative burden of all of these exposures, environmental and dietary, that alter the microbiome,” he told Megyn Kelly in an hourlong interview that spanned issues such as societal distrust of federal health agencies, industry influence and food policy.
He also insisted that Kennedy’s criticism of vaccines — and push to study links between immunizations and autism, although research has found no proof of any ties — has been misconstrued. “That’s not what he’s saying at all,” Makary said before referencing a study at the US National Institutes of Health using electronic health records to find potential autism drivers. Kennedy has said the agency is involved in a “massive” testing and research effort that will find some of the causes of autism by September.
Makary’s interview on “The Megyn Kelly Show,” published Thursday, marks his first sit-down discussion since starting in the commissioner role 17 days earlier. It came nearly a week after a visit from the HHS secretary to the FDA campus that unleashed controversy over Kennedy’s allegations of “deep state” corruption within the agency.
Makary appeared to defend Kennedy’s remarks, citing the opioid crisis as “the quintessential example of what’s wrong with a cozy relationship, when the regulator agency is captured by the industry.”
But he also told Kelly that “there are no plans for any mass cuts” at the FDA after roughly 3,500 employees were laid off this month in restructuring led by the Department of Government Efficiency.
“If somebody is doing a good job doing [a drug or device] review, we want to encourage them and support it. It’s hard work,” Makary said. “We want to do other things here at the FDA to support a great culture.”
Makary said the FDA would remove industry representatives from advisory committees that discuss reviews of drugs, vaccines and medical devices.
“We’re going to be replacing them, whenever statutorily possible, with patients and … family caregivers,” he said. “We are going to be inviting pharma companies to send representatives to the advisory committees, but they can sit with the rest of the public and watch and pose questions as the rest of the American public can.”
Although these advisory committees typically include an industry representative, they do not have voting power on the committees’ questions.
Kelly asked Makary about Dr. Peter Marks, the former director of the FDA’s Center for Biologics Evaluation and Research, who was forced out last month. Marks, who had been instrumental in shaping the first Trump administration’s Operation Warp Speed effort to rapidly develop Covid-19 vaccines and treatments, wrote in his resignation letter that Kennedy is undermining vaccine confidence.
Makary distanced himself from Marks and his comments.
“I never knew the guy. I never met him. He resigned before I came to office,” he said. “There’s a lot of talented people who can do that job well, a lot of very smart people who are right now … applying for that job.”