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Hahn offers advice to incoming Biden administration

Posted 11 January 2021 | By Michael Mezher 

Hahn offers advice to incoming Biden administration

With the transition to a new administration less than two weeks away, US Food and Drug Administration (FDA) Commissioner Stephen Hahn on Friday told reporters at an Alliance for Health Policy briefing that he has offered his help to the incoming administration but does not expect to stay on as commissioner.
“I have had the opportunity to talk to transition team and I have certainly offered my willingness to help after the transition in any way that they see fit,” Hahn said.
Hahn took the reins at FDA in December 2019 — following the abrupt departure of his predecessor Scott Gottlieb — around the same time as the first cases of what would become known as COVID-19 were identified in Wuhan, China. Thrust into one of the most prominent roles in the US response to the pandemic, Hahn oversaw the review and authorization of hundreds of products under emergency use authorizations (EUAs) and endured intense political pressure from outgoing President Donald Trump.
Asked about his advice to the incoming administration, Hahn said that FDA needs to continue its science-based approach to the vaccines. “We need our evaluation from a regulatory and clinical development point of view to have these rooted in science. We can’t move from that and make any mistakes with respect to allocating vaccines,” he said, referring to ongoing debates about single- or half-dose approaches.
Hahn also urged opening vaccine eligibility to a broader population to boost their uptake. “I would strongly encourage that we move forward with giving states the opportunity to be more expansive in who they can give the vaccine to, particularly as more supplies become available,” he said. “It is an urgent issue to get as many people vaccinated as soon as possible.”
After a tumultuous year involving unprecedented levels of political pressure on the agency to authorize treatments and vaccines for COVID-19, Hahn said the transition provides a good opportunity for the nation to look at how to keep FDA an independent, science-based regulatory authority.
“We need to think very carefully of what are the measures we can take to continue to ensure that moving forward. I very much, after my tenure, look forward to participating in that conversation. We’ve faced unprecedented challenges this year and we have worked really hard … to maintain the regulatory independence and science-based approach to our decisions,” he said, adding that all avenues of discussion regarding shoring up the agency’s independence “should be on the table.”
“We shouldn’t run away from having that conversation in the future,” Hahn added.
While President-elect Joe Biden has not yet named his pick for FDA commissioner, Hahn is expected to resign from his position when the new administration takes power. As for his future plans, Hahn said he is, “Going to take a little time off, spend time with my wife and our kids when it’s appropriate.”
“Then I’m going to rethink what I do with my career, I haven’t made any decisions at this point about what I’m going to do,” he said.
Alliance for Health Policy

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