Hahn resigns as FDA Commissioner; Woodcock is appointed interim chief

Dr. Stephen M. Hahn, who became commissioner of the Food and Drug Administration just weeks before the coronavirus pandemic began, resigned on Wednesday when President Biden’s government began.

Dr. Janet Woodcock, longtime head of the FDA’s Center for Drug Evaluation and Review, will serve as an interim commissioner, according to an agency official.

Beginning in May, Dr. Woodcock was assigned to Operation Warp Speed, the former government’s program to accelerate the development of vaccines and treatment for the coronavirus.

She has worked at the FDA since 1986, performing a variety of important roles, including chief physician and deputy commissioner.

The Biden government has not yet appointed a permanent commissioner, but Dr. Woodcock is one of the candidates under consideration, according to several advisers to the new president’s transition team. Dr. Amy Abernethy, chief deputy commissioner, is also being considered, as is Dr. Joshua Sharfstein, a former agency employee who is vice president for public health practice and community involvement at Johns Hopkins University.

Dr. Hahn’s resignation was expected, part of the routine departure of senior political appointees that happens when a new government takes over. In a farewell message to the FDA team on Wednesday, he wrote: “As a nation and as a public health agency, we faced some major challenges and turbulent times in the past year, particularly those stemming from the Covid-19 pandemic. For all these reasons, FDA officials have been instrumental in helping to respond to the disease with very real scientific advances, such as the authorization of the first over-the-counter OTC [over the counter] Covid testing, authorization and approval of an antiviral agent and the first two Covid-19 vaccines authorized by the FDA. “

Dr. Hahn faced considerable criticism during the course of the pandemic, accused of yielding to political pressure from President Trump and the White House to grant emergency use authorizations for unproven treatments like hydroxychloroquine that produced no evidence that they worked. In recent months, he has chaired reviews of the first vaccines allowed against the virus, the Pfizer and Moderna products.

In the past, under other presidential administrations, Dr. Woodcock, 72, ran for the FDA’s first post. It was first brought to the FDA’s drug division by Dr. David Kessler, the former FDA commissioner who was appointed chief of science for the Biden administration’s vaccine efforts, which will no longer be called Operation Warp Speed.

The Biden administration did not indicate when an FDA commissioner would be appointed.

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