As he wraps stormy FDA tenure, Hahn admits 'there was a substantial amount of pressure' from White House — report
Last summer, as drugmakers rushed to test and deliver the first Covid-19 vaccines in hopes of taming a raging pandemic, FDA commissioner Stephen Hahn repeatedly reassured the public that he will fight for science and fend off any politicization. At one point in August — just before he would appear alongside President Donald Trump in a controversial event announcing the emergency use authorization of convalescent plasma — he told a reporter that “I’ve had absolutely no pressure from anyone.”
But as his brief, tumultuous tenure at the agency comes to an end, Hahn is looking back and casting that time in a much different light.
In exit interviews with Politico and Bloomberg on Tuesday, Hahn described a “clash of cultures” with the Trump administration, which he described as “deregulatory.” The influence of the election year weighed heavier than expected, he noted.
“I heard loud and clear from the White House — President Trump and others — that they wanted FDA to move faster,” he told Politico.
Trump made his impatience with the FDA amply clear, decrying a “deep state” within the agency that he said was slowing down a Covid-19 vaccine, insinuating that the reason no vaccine was authorized before the election was because “politics gets involved,” and boasting “no president’s ever pushed them like I’ve pushed them.” As late as December, he lambasted the FDA was a “big, old, slow turtle” and called on Hahn to “stop playing games.”
“With time, particularly over mid- to last summer and then into fall, there was a substantial amount of pressure,” Hahn admitted.
After coming under attack from the scientific community for citing inaccurate numbers on the effectiveness of convalescent plasma, Hahn earned plaudits for standing his ground on safety follow-up from clinical trials. Despite the Department of Health and Human Services’ assertion of authority and the White House’s initial rejection of the updated guidance (it later relented) — which asked for two-month follow-up and thus precluded any hope of having a vaccine ready for review in early November — the FDA managed to push it through by framing it as recommendations and communicating early with the companies.
But the HHS’ attempted power grab didn’t stop there, with Secretary Alex Azar issuing new policies right down to the twilight of the new government, including a push to conduct regular reviews on career staffers and set term limits — an idea Hahn said he was not consulted on.
From his Q&A with Bloomberg:
My major concern about that was that it has such far-reaching implications on public health and our mission, but also by the way, the mission of CDC, CMS, etc. That required a discussion. What would industry think about this? What would stakeholder groups, what would patient groups think?
If, for example, an FDA center director knew his or her term was up, and it was a situation like this past year, would there be even subconscious pressure to make a decision one way or the other — knowing that the ultimate authority allowing you to stay in your position rested with the secretary of Health and Human Services?
The experience in Washington DC has left Hahn, who came into the job with a résumé spanning top research institutions but virtually no political background, an advocate for more FDA independence — although he stopped short of completely endorsing calls for the agency to be a standalone entity separate from HHS.
“There’s a lot of different models out there, but I think given what we’ve seen over the last year, particularly in the public health emergency, really bring this issue into the fore,” Hahn said to Politico, adding in his Bloomberg interview: “I would be in favor of that if there was the appropriate balance between oversight and independence.”
Biden, who is set to be inaugurated this morning, has tapped veteran FDA official Janet Woodcock as Hahn’s interim successor. Hahn said he will be taking some time off before deciding on next steps.