Ned Sharpless to be Acting Commissioner of the FDA



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WASHINGTON – The Trump administration announced Tuesday that it would appoint Ned Sharpless, director of the National Cancer Institute, interim commissioner of the Food and Drug Administration next month.

The announcement was made just a week after current commissioner, Scott Gottlieb, announced his intention to resign in early April.

Health Secretary Alex Azar confirmed the announcement during a hearing before the House Energy and Commerce Health Subcommittee. The news was first reported by Fox Business Network.

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Sharpless, a physician scientist, ran the Lineberger Comprehensive Cancer Center at the University of North Carolina before taking over from the NCI in October 2017.

"Dr. Sharply's deep scientific knowledge and expertise will make him a strong leader for the FDA, "Azar said in a statement. "Ongoing efforts in drug approval and the fight against the opioid crisis, including the modernization of food safety and the fight against the rapid increase in the consumption of electronic cigarettes by consumers. youth"

Sharpless was an enthusiastic supporter of Gottlieb's aggressive pressure to increase regulations on tobacco and electronic cigarettes.

Although it is not clear whether Sharpless will lead the FDA in the long run, he was perceived as a likely choice to replace Gottlieb. Sharpless already knows the agency well, Gottlieb said in a memo provided by the FDA at STAT.

"In fact, he plays in a weekly basketball team with some members of our medical review team," wrote Gottlieb.

Sharpless is also familiar with the biotechnology sector and the drug development process. He co-founded two start-up biotechnology companies: G1 Therapeutics, an anti-cancer drug developer who raised $ 108.6 million during its IPO in 2017, and HealthSpan Diagnostics, a blood test developer.

"One of the things that made me attractive in the White House was that in addition to working in research and as a director of cancer center, I had worked at marketing the drug." ideas, from a basic science lab to a phase 2 trial. ", Sharpless told STAT in an interview in 2018, shortly after taking control of NCI.

Even at the National Institutes of Health, Sharpless often explained how his agency could work with the FDA – and how, at NCI, his powers to better regulate and improve cancer care were limited.

He has long expressed interest in using artificial intelligence, including IBM Watson and its cancer treatment tool, to improve treatments, while recognizing that technology is limited. "This is the beginning for the National Cancer Institute in this area," he said last year, "and most of the regulatory issues are really at the expense of the FDA."

Douglas Lowey, NCI Deputy Director, will assume the position of Acting Director of the Cancer Research Institute, while Sharpless will serve as Acting Director of the FDA.

Sharon Begley contributed to the reports.

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