NCI’s Ned Sharpless Tapped to Helm FDA as Acting Commissioner

FDA logo on large outdoor sign

National Cancer Institute (NCI) Director Norman “Ned” Sharpless will take over the role as acting commissioner of the U.S. Food and Drug Administration (FDA) while the White House seeks a permanent replacement for the outgoing Scott Gottlieb.

Sharpless, who was on a short-list of candidates to replace the popular Gottlieb at the regulatory agency, will take over at the FDA later this month. Sharpless has been head of the National Cancer Institute, a part of the National Institutes of Health, since 2017. Health and Human Services Secretary Alex Azar announced Sharpless' name as acting commissioner during a House Energy & Commerce Health Subcommittee Hearing on Tuesday. Azar appeared before the subcommittee to talk about the White House’s proposed 2020 budget, as well as lower drug prices and the opioid crisis.

In a brief statement, Azar said Sharpless’ “deep scientific background and expertise will make him a strong leader for the FDA.” Azar noted that despite the loss of Gottlieb, there will be no let-up in the FDA’s focus on multiple issues, including addressing the opioid crisis and discouraging the use of e-cigarettes among youth.

Gottlieb, who has held the FDA commissioner post since 2017, stunned the healthcare world last week when he announced his intention to step down at the end of this month. Gottlieb, who commutes weekly from his home in Connecticut, said he wanted to spend more time with his family.

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Sharpless said helping advance the FDA’s public health mission and building on the progress set forth by President Donald Trump, Azar and Gottlieb, will be an honor. Sharpless, who co-founded G1 Therapeutics, is well known for his deep understanding of oncology and big data. Sharpless previously ran the University of North Carolina’s Lineberger Comprehensive Cancer Center, where he was a physician-scientist, running a lab and treating patients.

On Twitter, Gottlieb said he was delighted about the appointment of Sharpless to the role of acting commissioner.

“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,” Gottlieb said.

Douglas R. Lowy, deputy director of the National Cancer Institute, will serve as acting director of that agency, Azar said.

The administration has not announced a timeline for when it might name a permanent replacement for Gottlieb. Sharpless would certainly be a contender for the position. Other potential candidates to permanently take over at the FDA include Amy Abernathy. In December Abernathy, the chief medical officer of Roche-owned Flatiron Health, was named the Principal Deputy Commissioner of Food and Drugs at the FDA. Another name brought up as a potential contender for the role is Brett Giroir, who is currently the assistant secretary for health at HHS. Giroir was the founder and CEO of consulting firm Health Science and Biosecurity Partners.

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