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Regulatory Focus – NCI’s Sharpless to Serve as Acting FDA Commissioner

Regulatory Focus – NCI’s Sharpless to Serve as Acting FDA Commissioner

The US Department of Health and Human Services (HHS) announced Tuesday that Dr. Ned Sharpless, current director of the National Cancer Institute (NCI) at the National Institutes of Health, will serve as acting US Food and Drug Administration (FDA) commissioner when Scott Gottlieb steps down next month.


Sharpless, who has served as NCI director since October 2017, previously served as director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center, a position he held since January 2014. He earned his medical degree from the UNC School of Medicine, completed his internal medicine residency at the Massachusetts General Hospital and a hematology/oncology fellowship at Dana-Farber/Partners Cancer Care.


His knowledge of the biopharma industry is also extensive as he cofounded two clinical-stage biotech companies: G1 Therapeutics and HealthSpan Diagnostics.


During his time at NCI, Sharpless also spearheaded collaborations with FDA, including via a joint oncology fellowship program and in work to accelerate childhood cancer drug development.


Gottlieb, while noting Sharpless plays on a weekly basketball team with some FDA review staff, said in a statement: “Dr. Sharpless is a valued colleague to the FDA and is deeply committed to public health. Over my time at the FDA, I got to know him very well. Dr. Sharpless shares our mission and I know he will be embraced warmly by the Agency’s professional staff.”


Friends of Cancer Research Founder & Chair Ellen Sigal said in a statement: “As we look ahead to the future, we have no doubt that Dr. Sharpless will continue to navigate and direct the FDA in a manner that best benefits patients, and we look forward to executing critical work with him in his new role.”


Industry group PhRMA said in a statement: “America’s innovative biopharmaceutical research companies are committed to working with Norman Sharpless as he assumes the role of Acting FDA Commissioner. We believe that it’s important a permanent FDA commissioner is nominated and confirmed in the near future to best meet the needs of the agency’s regulatory commitments and to fulfill its mission of protecting public health.”


At FDA, Sharpless will have big shoes to fill as Gottlieb’s work to speed the review of generic drugs, crackdown on e-cigarettes and modernize the Office of New Drugs and the Office of the Commissioner has made him a tough act to follow.…