Top FDA official Woodcock to retire early next year

Janet Woodcock, a top Food and Drug Administration official who had been on the short list to head the agency under President Joe Biden, will retire in early 2024 after 37 years at the regulator.

Her retirement, first reported by Endpoints, was announced in an agency-wide message from Commissioner Robert Califf.

“A legend in every sense of the word, Janet has made an indelible mark on so many of us, and on public health,” the announcement read. “There isn’t enough space or time here to properly capture her accomplishments, sing her praises, and most of all, thank her.”

Woodcock had served as acting commissioner at the beginning of the Biden administration until Califf assumed office in February 2022. At one time she was seen as a leading candidate to assume the full-time commissioner’s role, but some senators opposed her over her role in approving opioid painkillers while heading the FDA’s drug review branch.

During her tenure as acting FDA commissioner, the agency also signed off on the Alzheimer’s disease drug Aduhelm, despite the conflicting evidence presented by its developer, Biogen, in support of approval, as well as negative opinions from the agency’s own statisticians and outside advisers.

The decision was reminiscent of another approval that was made while Woodcock was head of the FDA’s Center for Drug Evaluation and Research: the controversial call to approve Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys over a negative vote from expert advisers convened to review that drug.

Woodcock joined the FDA in 1986, first having several roles at the agency’s Center for Biologics Evaluation and Research, which regulates vaccines, blood products and products derived from living tissues like cell and gene therapies. In 1994, she joined the drug evaluation and review division as director. During her time there, dozens of drugs gained approval that have extended patients’ lives or helped them control symptoms, while others, like the pain reliever Vioxx and the diabetes pill Avandia, proved to be unsafe.

In 2004, she joined the commissioner’s office, serving as deputy commissioner, chief medical officer and chief operating officer. She returned to drug evaluation in 2007, where she served until the COVID-19 pandemic. She moved to the White House’s Operation Warp Speed, where she was in charge of evaluating therapeutics to treat COVID-19 infections.

Since Califf assumed the commissioner’s position, Woodcock has served as his principal deputy commissioner.

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