Stephen Hahn Calls for Independent FDA to Protect Against Political Interference

Former FDA Commissioner Stephen Hahn is voicing support for making the FDA its own federal agency independent of HHS and for enacting protective measures against political interference.

Hahn, whose tenure as agency chief during the COVID-19 pandemic was punctuated with reports of intense pressure by the Trump administration to accelerate vaccine authorization, said during a Monday appearance on the In the Bubble podcast, that the FDA would be stronger as its own agency.

“A serious conversation needs to take place about an independent FDA because I think we’ve learned from [the previous administration] that, given the importance that the FDA has in the regulation of medical products and consumer products, that really, there need to be more safeguards in place around these issues,” he said.

The former commissioner was candid about his time as head of the FDA, which lasted a little over a year, calling the experience “very difficult, [with] … substantial pressures to make decisions” but noting that the agency was ultimately able to stick to the science because its experts took a unified approach on decisions. Hahn said the previous administration was focused on delivering results during the pandemic and did not fully understand why the agency operates as cautiously as it does.

“At FDA, there’s a reason for the processes we use. There’s a reason for the cross-disciplinary approach that we use to review medical products,” he said. “Understanding the data and slicing and dicing it will allow you to come to the absolute best decision.”

Hahn previously claimed near the end of the Trump presidency that the administration had applied increasing pressure on the FDA to deliver a coronavirus vaccine before Trump left office.

His concerns over potential interference against the agency mirror those of seven fellow ex-commissioners who believe the FDA should be taken out from under HHS and turned into an independent government agency. The former agency heads — Robert Califf, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan, Andrew von Eschenbach and Frank Young — contended in January 2019 that doing so “would promote reliance on consistent science-based regulation and ensure that the American public has access to the best that science and industry can offer.”

During the interview, Hahn also recalled the challenging period during which he oversaw the FDA’s response to the pandemic and noted the unprecedented partnership between government, academia and private industry to accelerate vaccine and therapeutic research.

One of the most important lessons learned from the pandemic, he said, was how to efficiently conduct rolling reviews of COVID-19 medical products to get them to the public as quickly as possible.

“The thought was we would create this sort of matrix around platforms around preclinical studies that need to be done and create an approach that allowed us to move seamlessly from one step to the next,” he said.

The rolling review approach that the FDA has taken during the pandemic, which enables it to evaluate data and give feedback in real-time and accelerate its regulatory processes, is one Hahn said he hopes the agency will permanently adopt going forward.

Hahn defended the agency’s decision to require two months of vaccine follow-up for phase 3 trial participants despite some calling for more safety data, calling it “a very data science-driven decision” supported by data on when the overwhelming majority of serious side effects are seen.

“We [knew] that under the normal circumstances, we’d have six, 12 months of safety data on a vaccine, and we knew that, given the number of people who were dying from the pandemic, that we probably wouldn’t be able to have that level of safety data. We came up … with the two month median follow-up … which created some controversy, but we stood firm,” he said.

The former commissioner also addressed his misrepresentation of the efficacy of convalescent plasma as a COVID-19 treatment, a controversial event during his tenure (DID, Aug. 26, 2020) that he said he should have been more clear on. He defended the agency’s Emergency Use Authorization (EUA), however, admitting that while the treatment does provide a “relatively small benefit,” it is a safe therapy and will probably see its authorization expanded as more data are produced.

Hahn said that all decisions were made in-house regarding convalescent plasma, denying that the agency caved to pressure exerted not only by the White House but by HHS, the Centers for Disease Control and Prevention (CDC), NIH and the Coronavirus Task Force.

“All the data and the numbers-crunching were done by our career folks. They are the ones that ultimately made that decision, and I know that runs counter to the narrative,” he said. “At that point, I made the decision that we really were going to stand alone in these decisions. We’ll of course ask for consultation, but we’re going to do as much as we can to make sure that, although we want to be transparent and give as much information as possible, that just our career folks protected from any outside influence would be sitting there looking at things.” — James Miessler