FDA’s Janet Woodcock will step down early next year

Janet Woodcock will bring a career at the FDA spanning almost four decades to a close next year, retiring from her current role as principal deputy commissioner of the regulator.

Woodcock (75), who led the FDA as acting commissioner during the COVID-19 pandemic and was replaced on a permanent basis by Robert Califf in February 2022, is planning to step down at the end of January and has said she will not be looking for any roles outside the FDA.

She has worked at the agency since 1986, and served as director of the Center for Drug Evaluation and Research (CDER) for more than a decade on two occasions, initially between 1994 and 2004 and then from 2007 to 2020, when she was asked to be the therapeutics lead for Operation Warp Speed, the federal response to COVID-19.

Her time at the agency has not been without controversy. For example, she faced criticism for the controversial approval of Sarepta’s Exondys 51 therapy for Duchenne muscular dystrophy in 2016 against the advice of the FDA’s independent expert advisors and has been accused of a lack of oversight during the opioid crisis and impeding access to emergency contraception.

On the other hand, she is credited with introducing sweeping reforms at the FDA, streamlining processes, and stripping away bureaucracy, which has made the review process for drugs more efficient, consistent, and transparent.

In a post on X (formerly Twitter), Califf described Woodcock as “a legend in every sense of the word,” adding that she has made “an indelible mark on so many of us, and on public health.”

Former FDA Commissioner Scott Gottlieb, who held the post during the Trump administration between 2017 and 2019, also said on the same social media platform that Woodcock “presided over a historic period of medical advance and has played a pivotal role in safely guiding some of the most impactful changes in medicine to patients.”

He added: “She made enduring improvements in [the] FDA’s operations that set a global standard, creating our modern regulatory system, and was a steady hand amid numerous changes in leadership, providing a sounding board and sage advice to many who have led the agency.”

The FDA said it will provide an update on Woodcock’s successor as principal deputy commissioner “in due course.”