Janet Woodcock, MD, Appointed as Acting FDA Commissioner

January 20, 2021
Kevin Kunzmann

The longtime FDA expert assumes the role following the resignation of Stephen Hahn, MD.

Coinciding with the new presidential administration, the US medical community welcomed a change to leadership Wednesday.

Janet Woodcock, MD, has been appointed as acting commissioner of the US Food and Drug Administration (FDA), following the resignation of Stephen Hahn, MD, at the very end of the Trump administration.

Woodcock, a 35-year veteran in the FDA, currently serves as the agency’s Center for Drug Evaluation and Research (CDER) director. She also is a member of the coronavirus 2019 (COVID-19) vaccine response team Operation Warp Speed.

In a note to the FDA staff Wednesday afternoon, Woodcock expressed her personal pride in her role within the agency during the ongoing pandemic, thanking her team for enduring “hardships while carrying out our public health mission, balancing work and family, and trying to stay safe.”

“Every outside forum I interact in, people thank me profusely for the FDA and the work it is doing on their behalf,” Woodcock wrote. “I believe that life will improve in 2021, but I don’t know how quickly that will happen. The hope keeps me going.”

Woodcock also stressed that her recusal from FDA decision-making on products pertinent to Operation Warp Speed—excluding investigational vaccines or diagnostics seeking emergency authorization—will continue in her role as commissioner.

Woodcock replaces Hahn, the previous Chief Medical Officer of the MD Anderson Cancer Center, who had served in the position for approximately 13 months after the resignation of former Trump-appointed commissioner Scott Gottlieb, MD.

In his own message to the FDA staff today, Hahn highlighted the agency’s work in response to the pandemic under his leadership.

“Through it all, FDA employees have been critical in helping to respond to the disease with very real scientific advances like the authorization of the first nonprescription OTC [over the counter] Covid test, the authorization and approval of an anti-viral agent and the first two F.D.A. authorized Covid-19 vaccines,” Hahn wrote, according to The New York Times.

Presumably, Hahn’s most memorable achievements while commissioner will be the FDA’s Emergency Use Authorization (EUA) granted to Pfizer’s BNT162b2, and Moderna’s mRNA-1273, the first vaccines indicated for the prevention of COVID-19.

Presently, the Biden administration has not indicated its timeline for appointing a new FDA commissioner. Gottlieb was appointed to the role in May 2017, following Trump’s inauguration that January.


x