In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
“There literally should be nothing political about the FDA,” Marty Makary, the agency’s newly minted commissioner, declared during an interview earlier this month with former Fox News journalist Megyn Kelly. However, Makary has not shied away from political commentary, and there have been questions regarding possible political interference in FDA decisions—particularly those regarding vaccines—since Makary’s boss, Health and Human Services Secretary Robert F. Kennedy, Jr., took office in February.
On April 1, the FDA missed its PDUFA deadline for Novavax’s COVID-19 shot after reports that principal deputy commissioner Sara Brenner, who was acting commissioner prior to Makary taking office, directly intervened in the review.
According to Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, the FDA was ready to grant full approval of Novavax’s COVID-19 vaccine, which has been on the market under an emergency use authorization since July 2022. Then Center for Biologics Evaluation and Research (CBER) Director Peter Marks resigned and Scott Steele, a former CBER advisor, took the helm on an interim basis. The Novavax PDUFA was the first action item on Steele’s desk, Pitts told BioSpace. But rather than signing off on the approval, Steele sent it to Brenner, who then “bumped it up” to Kennedy’s office.
“Those were mistakes,” Pitts said. “This is especially sensitive because it’s an issue concerning vaccines, where we all know the secretary has very strong opinions.” In May 2021, for example, Kennedy petitioned the FDA to revoke emergency authorizations for COVID-19 vaccines and to refrain from issuing new ones, according to several news sources.
In Marks’ resignation letter, the former biologics boss wrote that Kennedy “wishes subservient confirmation of his misinformation and lies.” Truist Securities in a March 31 note to investors said this statement insinuates that the secretary may have plans for an anti-vax propaganda campaign.
Aside from the HHS secretary and FDA commissioner, who are appointed by the president and confirmed by the Senate, all FDA employees hold nonpolitical positions, Pitts clarified. “One of the commissioner’s most important jobs is to shield the agency professionals from political interference,” he said. The fact that Novavax’s application ended up in front of Kennedy is a clear sign that the agency is not shielded from the administration as it should be. “That is political interference.”
Makary Between a Rock and a Hard Place
While attempts have previously been made to draw the FDA into ideological battles, University of Minnesota professor Richard Painter, who served as chief ethics officer under President George W. Bush, said he has never heard of the FDA itself being a “political hot button.”
One area in which the agency has faced challenges to its decisions is with birth control pills and abortion-inducing drugs. Pitts highlighted one specific case during the Obama administration when then–HHS Secretary Kathleen Sebelius and then–FDA Commissioner Margaret Hamburg butted heads over patient access to the morning-after pill. In February 2011, Teva, the drug’s maker, filed an application for full over-the-counter status without age limits. After reviewing the application, the FDA’s Center for Drug Evaluation and Research (CDER) determined the drug was safe and effective for girls of any age, with Hamburg saying there was adequate evidence to support its use by “all females of child-bearing potential,” according to TIME. But the FDA rejected the application after a memorandum from Sebelius overruled the recommendation—backed up by President Barack Obama himself. In April 2013, Judge Edward Korman overturned Sebelius’ decision to place limits on Plan B, saying the ruling was made in “bad faith and improper political influence.”
At one point during this battle, Hamburg told Sebelius that if she overrode the FDA’s decision on this matter, she would resign, Pitts said.
In a recent post on his website, FDA Affairs, policy expert Steven Grossman called on Makary to make a similar stand against politicization of the FDA. “The integrity of FDA and of FDA decisionmaking are at risk,” he wrote. “It is up to Dr. Makary to either be the bulwark against politicization . . . or to defer to his boss and the prevailing ethos of the new Administration.”
Pitts, who served as associate commissioner for external relations at the FDA from 2003 to 2004, was responsible for briefing then–HHS Secretary Tommy Thompson on these types of “hot button issues” that came in front of the FDA. “We had heated discussions. The secretary had a lot of very strongly held beliefs, but he never asked me, not a single time, to change the agency’s action,” Pitts said.
He expressed a similar confidence in Makary: “Marty Makary is an honest guy. He’s intellectually strong, he’s nobody’s fool, and he’s not there to rubber stamp the secretary’s decisions full stop.”
BMO Capital Markets analyst Evan Seigerman told BioSpace that Makary is less extreme than Kennedy in his views on vaccines but cautioned that the commissioner may be a bit under the secretary’s thumb. “Clearly he knows who his boss is,” Seigerman said.
‘Negative for Biopharma’
Novavax and other vaccine-focused companies have already felt the reverberations of potential political influence or concern over such. Shares of key vaccine makers, including Pfizer, Eli Lilly and Novavax, fell in November 2024 after Trump announced his intention to nominate Kennedy.
“A more politicized FDA is negative for the biopharmaceutical industry, in our view,” Leerink Partners wrote in an April 25 note to investors in response to a recently published article by Pink Sheet.
This is a belief shared by Painter, who said that any company “working with a drug that is not ideologically favored” could be at risk. He specifically highlighted vaccines, immunology and reproductive health but said “there could be others as well, depending on the whims of the secretary of Health and Human Services.”
Cuts to NIH grants could also have long-term implications for biopharma pipelines. In an interview with BioSpace earlier this month, Audrey Greenberg, founder of the Center for Breakthrough Medicines, called NIH funding “the lifeblood of early-stage discovery” in cell and gene therapy.
For Pitts, the biggest impact to biopharma of a “political FDA” would be on Prescription Drug User Fee Act (PDUFA) dates. “The most important thing to sponsors isn’t speed, it’s predictability, and PDUFA provides predictability via user fee dates,” he said. “So when user fee dates become less predictable because of potential interference from outside the FDA review team, predictability suffers, the regulatory relationship between sponsor and agency suffers, the appetite for investing in riskier development programs suffers. It’s a cascade of bad things.”
Pitts noted that the Novavax PDUFA delay occurred before Makary was sworn in as FDA commissioner. As for whether the biopharma industry should be concerned about it setting a precedent, he said, “I hope not.”
Painter was more apprehensive. “Obviously, we have a whole different world now, because the Health and Human Services is run by Kennedy, who has his own agenda,” he said. “We may have increasing politicization over the FDA, and that’s a concern.”
