Norman Sharpless, MD, Named Acting FDA Commissioner

Norman Sharpless, MD

Secretary of Health & Human Services (HHS) Alex Azar has named National Cancer Institute (NCI) Director Norman “Ned” Sharpless, MD, as acting US Food and Drug Administration (FDA) commissioner.

The appointment—which comes a week after the FDA announced the sudden resignation of 23rd Commissioner Scott Gottlieb, MD—will temporarily place Sharpless at the helm of the FDA beginning in early April.

Sharpless was first appointed as NCI director by President Donald Trump in June 2017, as has served in office since October of that year. He previously served as director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center, and as an appointed member of the Association of American Cancer Institutes’ board of directors, as well as the National Institute of Aging’s National Advisory Council on Aging.

Gottlieb had held the position since May 2017, having been appointed by Trump and confirmed by the Senate in a 57-42 vote. A permanent FDA commissioner must be nominated by Trump and approved by Senate vote. Azar confirmed a search for a successor to Gottlieb is currently underway.

In a statement provided while speaking on a hearing with the US House of Representatives Tuesday morning, Azar called Sharpless’ “deep scientific background” and expertise in the medical field an indicator of his capability in leading the FDA.

“There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes,” Azar said.

In a tweet responding to the announcement, Gottlieb expressed delight in Sharpless temporarily filling his role as commissioner.

I’m delighted by the announcement from @SecAzar that @NCIDirector will serve as acting commissioner of #FDA. Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.

— Scott Gottlieb, M.D. (@SGottliebFDA) March 12, 2019

“Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role,” Gottlieb wrote. “FDA will benefit greatly from his leadership.”

Sharpless thanked Trump, Azar, and Gottlieb for their involvement and support as he begins to assume the role.

(1/3) Change is good, but bittersweet. It is difficult for me to say goodbye to @theNCI family as I head to @FDA to serve as acting commissioner. Rest assured that our shared goals for patients and the public’s health will translate into my new duties.

— Dr. Ned Sharpless (@NCIDirector) March 12, 2019

“Change is good, but bittersweet. It is difficult for me to say goodbye to @theNCI family as I head to @FDA to serve as acting commissioner,” he wrote in a tweet. “Rest assured that our shared goals for patients and the public’s health will translate into my new duties.”

As a result of the acting appointment, NCI Deputy Director Douglas Lowy, MD, will assume acting director duties for NCI in Sharpless’ absence, according to the HHS.