FDA Chief: Agency Kept Independence With Science as Its 'North Star'

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Some Trump administration appointees have resigned in protest of the riot at the US Capitol building, but US Food and Drug Administration (FDA) Commissioner Steve Hahn, MD, says he will stay on the job through the swearing-in of President-elect Joe Biden on January 20 to ensure that the agency operates smoothly in the face of the ongoing coronavirus pandemic.

Dr Steve Hahn Flickr

During a call with reporters on January 8, Hahn enumerated what he saw as the agency's many achievements over the past year. He said he was most proud of how the FDA had stood firm in the face of what he called "a number of externalities" thrown in the agency's direction.

"We have ensured that our north star has been and remains that our decisions are firmly guided by science," Hahn said in a briefing sponsored by a Washington, DC–based education organization, the Alliance for Health Policy.

"It is so important for the FDA that we remain an independent regulatory body, that our decisions are rooted only in data and science and medicine," said Hahn. He said careful thought should be given as to what measures to take "to continue to ensure that moving forward."

The agency has 18,000-plus "incredible career scientists," he said, adding, "They understand on a personal and also professional level what this pandemic has meant."

Hahn also affirmed that he wants there to be a scientific process to answer questions of whether one dose of the two-dose vaccine is effective. "Remember that 98% of subjects in clinical trials received both doses. We do not have robust data to suggest that protection would be at the same level or duration with one dose. If Americans want 95% protection for the Pfizer vaccine, for example, they need to follow the regimen used in clinical trials" and receive both doses, he said.

Nonetheless, he said that it's reasonable to scientifically address that question as well as another question that recently arose: Could doses be stretched by using a half dose of the Moderna COVID-19 vaccine? "We also want to see data on that and are working closely with the company and [the National Institutes of Health}. When that data is available, we look forward to evaluating it."

"Moral Imperative"

The FDA could have done and should do some things differently moving forward, said Hahn. He noted that the agency will soon release the Pandemic Recovery and Preparedness Plan, which has been in the works for months and will address how the FDA can modernize and improve.

Given continuing concerns about lack of representation in clinical trials and vaccine hesitancy and uptake among people in the Black community, Hahn was asked how the Biden administration could reassure these individuals that their concerns are being addressed.

Everyone must "acknowledge the fact that there are real issues behind the mistrust," Hahn said. "This is real, and it's legitimate, and we have to acknowledge it, and we have to hit it head on," he said.

"It's a moral imperative. Our decisions have to be rooted in all of America, not just one group," said Hahn, adding, "It's something I'd like to dedicate myself to going forward."

The commissioner said that after he leaves office, he will spend time with his wife and children and will "rethink what I do with my career."

He has made no decisions but said he is certain what he does will involve "increasing equity, helping those who have been most affected by this pandemic, and trying to help us address the underlying issues associated with that."

Christine Lehmann, MA, contributed to this article.

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Cite this: FDA Chief: Agency Kept Independence With Science as Its 'North Star' - Medscape - Jan 11, 2021.