Woodcock to Take Helm While Biden Considers FDA Commissioner Choice

Jan. 18, 2021 – Under the Biden administration, longtime Center for Drug Evaluation and Research (CDER) director and FDA veteran Janet Woodcock, M.D., has been tapped to serve as the acting commissioner of the Food and Drug Administration (FDA) after current FDA Commissioner Stephen Hahn, M.D., stepped down on Jan. 20. Media reports suggest that while Joshua Sharfstein, M.D., is considered the leading candidate for the permanent FDA commissioner nomination, Woodcock remains in the running—unusual for a career scientist at the agency.

“Janet Woodcock is the obvious and most qualified choice to serve as acting commissioner during this transition,” said Coalition for Healthcare Communication Executive Director Jon Bigelow. “Her leadership should be reassuring to the public, coming after months of political attacks on the FDA’s processes and at a time when public confidence in the process for approving COVID-19 vaccines and drugs needs to be bolstered. She also will have immediate credibility within industry and on Capitol Hill,” according to Bigelow.

Most recently, Woodcock has been detailed to Operation Warp Speed as the coronavirus head of therapeutic development; Patrizia Cavazzoni. M.D., has been serving as acting CDER director since last May.

Sharfstein has been both principal deputy commissioner under FDA Commissioner Margaret Hamburg, M.D., and acting FDA commissioner before Hamburg was confirmed. He currently serves as public health dean at the Johns Hopkins Bloomberg School. In September 2020, Sharfstein authored an article In Nature stating that the FDA’s integrity “is central to the FDA’s credibility,” and should not be affected by politics. This stance likely would be welcome following the tenure of Hahn, who clearly was under pressure from the White House during the past year.

However, Fierce Pharma reports that Sharfstein “may not be the first choice of the pharma industry,” largely because he “has been a critic of drug marketing practices” and because he “often clashed with drug and device makers over tougher regulations.”

Former FDA Commissioner David Kessler, M.D., who was once rumored to be among the candidates for the FDA commissioner role, was just named to another position; Kessler will help lead, with Gen. Gustave F. Perna, Operation Warp Speed (which is expected to be renamed in the Biden administration). Kessler is placing Moncef Slaoui, M.D., who will remain as a consultant. According to The New York Times, Kessler is expected to help accelerate the manufacturing and distribution of COVID-19 vaccines in the United States and to focus on COVID-19 therapeutics and the development of antivirals.

Regardless of who is nominated for the top FDA job, one threat to protecting the FDA and other public health agencies from political pressure may come in the form of term limits for top federal health scientists, included in a Trump administration regulation submitted late last week and slated for future publication in the Federal Register.

According to a Jan. 14 article in Politico, the regulation “would mandate job reviews every five years for career federal scientists who serve as center directors at the [FDA], Centers for Disease Control and Prevention and other health agencies” that “could lead to renewal – or reassignment,” as well as “tempt top public health officials to maintain their jobs through political jockeying.”

“The FDA’s decisions should always be science-driven, and as much as possible should be separated from political influence,” remarked the Coalition’s Bigelow. “Given the strong performance of the FDA in improving the processes for drug approvals, regulation of promotion, and other key functions, it is not clear that there is any ‘problem’ to ‘solve’ with this regulation.”