Hahn resigned as FDA commissioner; Woodcock appointed interim head

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

Dr. Janet Woodcock, the longtime head of the FDA’s center for drug evaluation and assessment, will serve as acting commissioner, according to an official.

Beginning in May, Dr. Woodcock assigned to Operation Warp Speed, the former administration’s program to accelerate vaccine development and treatment against the coronavirus.

She has worked at the FDA since 1986 and serves in a variety of key roles, including Chief Medical Officer and Deputy Commissioner.

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

Dr. Hahn’s resignation is expected, which is part of the routine departure of senior political appointments that take place when a new government takes office. In a farewell message to FDA staff on Wednesday, he wrote: ‘As a nation and as a public health agency, we have faced great challenges and turbulent times over the past year, especially those arising from the Covid-19 pandemic. Throughout, FDA employees were critical in helping to respond to the disease with much real scientific progress, such as approving the first OTC without a prescription. [over the counter] Covid test, the approval and approval of an antiviral drug and the first two FDA-authorized Covid-19 vaccines. ”

Dr. Hahn came under considerable criticism during the pandemic, and is accused of succumbing to political pressure from President Trump and the White House to grant emergency use permits for unproven treatments such as hydroxychloroquine that do not provide evidence that it does not work. In recent months, he has led the review of the first vaccines against the virus, the Pfizer and Moderna products.

In the past, among other presidential administrations, dr. Woodcock (72) set for the highest FDA position. She was first brought to the FDA’s medicine department by Dr David Kessler, the former FDA commissioner appointed as the chief scientific officer for the Biden administration’s vaccine efforts, which will no longer be called Operation Warp Speed .

Biden’s administration has not indicated when an FDA commissioner will be appointed.

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