USA — Janet Woodcock, a distinguished figure at the Food and Drug Administration (FDA) and a contender for the agency’s top role under President Joe Biden, will retire in early 2024, marking the end of her remarkable 37-year career at the regulatory body.
Commissioner Robert Califf announced Woodcock’s retirement in an agency-wide message, acknowledging her legendary contributions to public health.
While Woodcock served as acting commissioner at the beginning of the Biden administration, some senators opposed her potential appointment to the full-time role due to her past role in approving opioid painkillers while heading the FDA’s drug review branch.
Woodcock’s tenure as acting FDA commissioner witnessed notable decisions, including the approval of the controversial Alzheimer’s disease drug Aduhelm.
Despite conflicting evidence and negative opinions from the agency’s statisticians and external advisers, the FDA, under Woodcock’s leadership, granted approval.
This decision echoed a similar controversy during Woodcock’s earlier leadership, involving the approval of Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys against expert advisers’ negative vote.
Joining the FDA in 1986, Woodcock held various roles at the Center for Biologics Evaluation and Research, regulating vaccines, blood products, and products derived from living tissues.
Her contributions to the drug evaluation and review division included the approval of numerous drugs that extended patients’ lives or helped control symptoms, alongside facing challenges with drugs like Vioxx and Avandia, which proved to be unsafe.
Woodcock’s extensive FDA career included positions in the commissioner’s office, serving as deputy commissioner, chief medical officer, and chief operating officer.
She briefly moved to the White House’s Operation Warp Speed during the COVID-19 pandemic, overseeing the evaluation of therapeutics for COVID-19 infections.
Since Califf assumed the commissioner’s position, Woodcock transitioned to the role of his principal deputy commissioner.
Her retirement marks the end of an era, symbolizing a legacy of impactful contributions and shaping the FDA’s regulatory landscape for over three decades.