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National Cancer Institute Director Ned Sharpless Will Helm FDA

March 19, 2019

From the editors of The Gray Sheet

After a week of speculation as to who will succeed US FDA Commissioner Scott Gottlieb when he steps down next month, Health and Human Services Secretary Alex Azar announced during a congressional hearing that National Cancer Institute Director Ned Sharpless will step in as acting commissioner.

Norman “Ned” Sharpless, director of the National Cancer Institute, will lead US FDA as its acting commissioner when current agency head Scott Gottlieb steps down next month. The incoming acting commissioner is a veteran translational cancer researcher, inventor and executive with experience founding start-ups including a diagnostics company.

Sharpless, an oncologist, researcher and administrator who has served as the head of NCI for about 18 months, has been appointed Acting Commissioner of FDA, HHS Secretary ALEX Azar told the House Energy and Commerce Committee at a March 12 hearing reviewing the Presidents 2020 budget request.


“I want to highlight an announcement from HHS today. In a move to put into place a new Commissioner of Food and Drugs as soon as possible, I am pleased to announce that the current director of the National Cancer Institute, Dr. Norman ‘Ned’ Sharpless, will serve as Acting Commissioner of Food and Drugs, upon the conclusion of Commissioner Gottlieb’s incredibly successful tenure, ending in mid-April,” said Azar.

The secretary added that the deputy director of NCI, Dr. Douglas Lowy, would serve as acting director of the NCI when Sharpless takes the helm at FDA.

Last week, Gottlieb dropped a bombshell when he announced he was leaving his post as FDA commissioner to spend more time with his family.  (Also see “Scott Gottlieb Calls It Quits After An Active Tenure At US FDA” – Medtech Insight, 5 Mar, 2019.) The surprise announcement immediately sparked questions about who fill the leadership gap and initial reports pointed to Sharpless as one of the top candidates. (Also see “Device Week, March 8, 2019 – Scott Gottlieb Resigns” – Medtech Insight, 8 Mar, 2019.)

Soon after Azar made the announcement, Gottlieb emailed FDA staff announcing the NCI director would pick up the mantle calling him a “valued colleague” and someone who shares FDA’s mission.

On a lighter note the commissioner also pointed out Sharpless is no stranger to FDA staff as he plays basketball with medical product reviewers on a weekly basis.

“Under his skilled leadership, I’m confident the transition will be seamless, and the FDA will continue to secure its consumer protection role and advance policies to promote innovation and safety for families,” Gottlieb added.

Sharpless is expected to move to fill the FDA top spot quickly after Gottlieb leaves, as Acting Commissioners do not have to undergo the congressional confirmation process.

Sharpless Founded A Diagnostics Firm

Sharpless is a former director of the University of North Carolina’s Lineberger Comprehensive Care Center. He also has at least 10 patents and founded two companies including G1 Therapeutics Inc., which is developing immunotherapy cancer drugs. On the medtech side, he founded the diagnostics company Sapere Bio, formerly known as HealthSpan Diagnostics. Sapere is developing diagnostics that incorporate aging markers to help predict adverse health outcomes and guide clinical care.

He had to divest all his investments in those companies before he took the job at NCI in the summer of 2017.

According to some media reports, Gottlieb wants him to stay on in the commissioner role permanently. The White House did not respond to inquiries on whether it planned to nominate Sharpless as more than acting commissioner.

Sharpless would not be the first to move from a post as director of NCI to be appointed acting FDA commissioner and then be nominated for the permanent post. Andrew von Eschenbach made that transition in 2005 and 2006 under President George W. Bush. (Also see “Von Eschenbach Is Likely Nominee For Permanent FDA Commissioner” – Medtech Insight, 13 Mar, 2006.) Upon news of Sharpless’ appointment, former FDA Commissioner Robert Califf, who has returned to Duke University, said the former Tar Heel researcher was a “great choice.”

“He is an outstanding scientist, a positive, upbeat person and has experience with a biotech startup so he understands the regulated world,” said Califf who now also works for Google’s digital health offshoot Verily.

“I spoke with Ned in some detail before he took the NCI job and he has made the transition to government with grace and shown great leadership skills,” he added. “Together with [Principal Deputy Commissioner] Amy Abernethy and the outstanding leadership team at FDA [including CDRH Director Jeff Shuren]…the US is fortunate that he is making this move.”

Mark Leahey, CEO of the industry lobby group Medical Device Manufacturers Association, also praised the decision, stating Sharpless has a strong track record working on some of the nation’s most pressing health issues.

Similarly, the Alliance for a Stronger FDA, which advocates for increasing the agency’s budget, pointed to Sharpless’ track record on public health issues to laud his appointment.

“Dr. Sharpless brings a varied background in academia and government and is also an inventor and innovator with industry experience.  All of this makes him an exceptional choice for acting FDA Commissioner and we look forward to working with him to continue to build and strengthen the agency,” said Ladd Wiley, the alliance’s executive director. “We also applaud Secretary Azar for moving so promptly and bringing such an excellent and talented individual to the task of running FDA.”