As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
In interviews with former Fox News journalist Megyn Kelly and CNN’s Dana Bash, newly minted FDA Commissioner Marty Makary shared his thoughts on a variety of topics relating to his new role, including a new expedited approval pathway for rare disease drugs, “public distrust” in the FDA, his mission to reduce conflicts of interest within the agency and the potential causes of autism.
BioSpace strives for finely balanced reporting, equally considering the many voices currently weighing in on our fractured political reality—within which the biopharma space is caught squarely in the crosshairs. Above all, we aim to report what is true. In this vein, we sought clarification on a few key points made by the new commissioner and unpacked the particulars of others.
Statement: “All the [FDA workforce] cuts were limited to communications staff. . . . There were no layoffs to scientists or food inspectors.”
There is no debate over the massive layoffs made to the communications teams across the Department of Health and Human Services, including all of the employees at the FDA’s main communications office, but there have been reports of culls beyond those staffers. Some of these non-communications staff were given the option for reassignment.
“I am extremely disappointed in his leadership as the new FDA commissioner as he continues to spread falsehoods about the scope of layoffs at the FDA,” Chanapa Tantibanchachai, a former press officer at the agency, wrote in a LinkedIn post alongside a link to the CNN interview, adding that FOIA staff and travel arrangers who helped inspectors travel overseas were also let go, “among many other roles.”
After laying off around 1,000 FDA employees in February, the agency planned to ask some of its “recently fired scientists” to return, including some who were reviewing Elon Musk’s brain implant outfit Neuralink, Reuters reported.
A much larger cull of 10,000 staff across HHS—including 3,500 FDA employees—on April 1 included Peter Stein, director of the Center for Drug Evaluation and Research’s Office of New Drugs. Stein told Endpoints News that he was offered a “reassignment” in patient affairs but turned it down. “I declined the offer (as ridiculous) so am on administrative leave,” Stein told the publication.
Center for Biologics Evaluation and Research Director Peter Marks was also reportedly forced to choose between retirement and being fired.
Even if no direct cuts were made to scientists and inspectors, as Makary claimed, it’s misleading to suggest that this wouldn’t affect the overall operations at FDA, Genevieve Kanter, an associate professor of public policy at the University of Southern California Price School of Public Policy, told BioSpace earlier this month. She likened the layoffs of FDA support staff to a clinic that keeps only the doctors. “The idea that FDA reviews won’t be adversely affected after such a draconian staffing cut is like firing all the staff at a clinic and saying that patient care won’t be affected because we haven’t fired the doctors,” she said.
Statement: “I don’t think VAERS [the Vaccines Adverse Event Reporting System] is a good database because it is self-reported and not rates.”
Jefferies’ Andrew Tsai agreed with Makary’s comments. “His point about VAERS, or self-reported data, seemed valid, because on our side, we don’t really give too much credence on self-reported data,” he told BioSpace.
Earlier this month at a Make America Healthy Again event, Health and Human Services Secretary Kennedy revealed plans for a suite of changes to VAERS aimed at automating and boosting data collection to detect adverse events associated with immunization. “It’s outrageous that we don’t have a surveillance system that functions,” he said, according to STAT News.
Notably, VAERS was at the center of Marks’ departure. Marks said after he left the agency that he had denied Kennedy’s team access to the system.
“Why wouldn’t we [grant access]? Because frankly we don’t trust [them],” Marks said, according to the AP. “They’d write over it or erase the whole database.”
Statement: Speaking of Marks, Makary said the former CBER chief “resigned before I came to office.”
Marks resigned on March 28, and according to reporting by Politico, Makary was “quietly” sworn in as FDA commissioner the previous week and signed off on this forced removal shortly thereafter. The publication cited four unnamed people familiar with the matter. The Hill, citing Pink Sheet, reported the same sequence of events, adding that “Makary was briefed on the plan to oust Marks.” Pink Sheet cited “multiple sources,” including a former agency official.
Per an FDA news release, Makary was confirmed as commissioner by the U.S. Senate on March 25 and had taken the oath of office as of April 1. BioSpace has reached out to HHS for further details on this timing.
Statement: “We are removing industry members, pharma members, from FDA advisory committees. . . . We’re going to be replacing them, whenever statutorily possible, with patients and family caregivers.”
Coinciding with this interview, on April 17, the FDA announced a policy directive limiting pharmaceutical company employees from serving as members on its independent advisory committees.
The possibility of conflicts of interest—or so-called “regulatory capture” of the FDA by the pharma industry—has been debated for decades and was alluded to by Kennedy at a recent visit to the FDA’s White Oaks, Maryland campus where he called staffers the industry’s “sock puppet.”
This directive would appear to be the administration’s opening salvo toward addressing this issue. However, experts who spoke with BioSpace this week said the impact of this initiative would be minimal. This is partly because of the words “statutorily possible.” A provision in the Food and Drug Administration Modernization Act of 1997 “has been interpreted to mean that newly created advisory committees must include an industry representative,” Kanter told BioSpace in an email. Kanter suspects that RFK and Makary will only be able to remove industry representatives from adcomms established prior to this law.
Statement: Makary said President Donald Trump and HHS Secretary Robert F. Kennedy Jr. are the two most popular politicians in America right now, citing polling data.
According to multiple outlets, Trump’s approval ratings are on the decline. A Pew survey conducted between April 7 and 13 revealed that 59% of 3,589 respondents disapprove of Trump’s job performance, compared to 40% who approve.
Citing the same survey, Forbes reported last week that amid ever-changing tariff policies, Trump has “the worst economic reviews in years,” at 37% favorable to 51% unfavorable.
While recent national polling data for Kennedy does not appear to be available, analysts at Cantor Fitzgerald—a firm formerly led by current Secretary of Commerce Howard Lutnick—last month called for Kennedy’s dismissal, saying in a March 31 note that the HHS Secretary was “undermining the trusted leadership of health care in this country,” per Reuters.
Meanwhile, an informal poll conducted by BioSpace in the wake of Kennedy’s massive job cuts at HHS showed that 82% of 804 respondents believed he himself should get the axe.
BioSpace has reached out to HHS to obtain the polling data mentioned by Makary.
Statement: When asked by Kelly about reports that some people walked out of Kennedy’s recent speech to FDA employees, Makary said this was not true. “I was in that room. Nobody got up and walked out.”
It was during this speech that Kennedy accused FDA staffers of being a “sock puppet” to the pharma industry. According to reporting by Politico, “several FDA staffers had walked out of the rooms where the speech was being broadcast at the agency’s headquarters in White Oak, Maryland”—possibly eluding Makary’s eye?
Additionally, an FDA insider told BioSpace that they went to the ceremony for “about 15 minutes” before leaving.
Statement: When asked by Kelly about the causes of autism, Makary said, “If I had to make a hypothesis . . . as a scientist . . . I think it is the cumulative burden of all of these exposures, environmental and dietary, that alter the microbiome.”
Kennedy has said that he will find a cause for autism by September, tapping discredited scientist David Geier to lead the research effort. The Secretary has long touted a link between autism and vaccines—a connection that has repeatedly been debunked.
As for Makary’s environmental hypothesis, one study published in Psychological Medicine in 2014 found that there was little regional variation in the prevalence of autism spectrum disorder (ASD), casting doubt on an environmental hypothesis. Meanwhile, the advocacy group Autism Speaks said research shows that ASD develops from a combination of genetic influences and environmental influences, including social determinants.
“More than 100 genes on different chromosomes may be involved in causing ASD, to different degrees,” according to the National Institutes of Health. If someone is susceptible to ASD because of genetic mutations, “an infection or contact with chemicals in the environment could cause autism in someone who is susceptible because of genetic mutations,” the agency states. “However, someone who is genetically susceptible might not get an ASD even if he or she has the same experiences.”
