WASHINGTON — The Trump administration on Tuesday announced it would name Ned Sharpless, the director of the National Cancer Institute, the acting commissioner of the Food and Drug Administration next month.

The announcement came just a week after the current commissioner, Scott Gottlieb, announced he plans to resign in early April.

Health secretary Alex Azar confirmed the announcement at 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 the NCI in October 2017.

“Dr. Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,” Azar said in a statement. “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.”

Sharpless was an enthusiastic supporter of Gottlieb’s aggressive push to increase tobacco and e-cigarette regulations.

While it remains unclear whether Sharpless will lead the FDA in a long-term capacity, he was seen as a likely pick to replace Gottlieb. Sharpless is already well acquainted with the agency, Gottlieb said in a staff memo the FDA provided to STAT.

“In fact, he plays on a weekly basketball team with some of our medical review staff,” Gottlieb wrote.

Sharpless is also familiar with the biotechnology industry and the drug-development process. He has co-founded two early-stage biotech companies: G1 Therapeutics, a developer of cancer drugs that raised $108.6 million in a 2017 initial public offering, and HealthSpan Diagnostics, a developer of blood tests.

“One of the things that made me appealing to the White House was that in addition to working in research and as a cancer center director, I’d had some work in the commercialization of ideas, from a basic science lab into a Phase 2 trial asset,” Sharpless told STAT in a 2018 interview, shortly after taking over NCI.

Even from his post within the National Institutes of Health, Sharpless spoke often about 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 expressed a longtime interest in using artificial intelligence, including IBM Watson and its cancer care tool, to improve treatments — recognizing that the technology is limited. “It’s early days for the National Cancer Institute in this area,” he said last year, “and most of the regulatory issues are really for the FDA to tackle.”

Douglas Lowy, NCI’s deputy director, will serve as acting director of the cancer research institute while Sharpless serves as acting director of the FDA.

Sharon Begley contributed reporting. 

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  • So, he plans on focusing mostly on costly cancer drugs which are not a guaranteed treatment, but chronic pain patients who could easily function in society for many years get no mention! Is there any plan to reinstate the primary practitioner to order pain meds for their patients truly in need? Yeah, we know which one takes precedent. No money in it for pain patients since the drugs are already on the market and are a minute cost of chemotherapy agents!! I guess they just want all of us to commit suicide or use the illegal drugs being imported which is the real opioid crisis!! Why are cancer patients more important than people with severe degenerative spinal disorders, arthritis, neuropathy from diabetes or previous nerve injuries, etc? I am sick of being considered part of the opioid crisis when all I need is Tramadol!!

  • I hope Sharpless pays equal attention to medical and dental device safety as to drug development and cancer care. The fastest way to cures is to prevent harm, and thereby reduce the incidence and burden of cancers, autoimmunity and toxicity reactions, infections, inflammation, and chronic diseases.

    FDA badly needs to set a new standard for pre-screening all non-emergency medical and dental patients for biocompatibility with device materials before they are installed, in addition to stronger upfront screening of each device for safety, and periodic review as new information comes to light.

    It is time to add precision devices and precision dentistry to precision medicine. Why? Patients have wide diversity in genetics, prior and synergistic exposures, methylation pathways, allergies, autoimmunity, toxicity, and more. It pays to get it right the first time.

    P.S. With a name like his, it doesn’t look good for the needlestick industry (joke)…

  • Another industry insider. He must own stock in IBM, if he is peddling the Wilson failure, as AI. “Commercialization” is how our healthcare sytem bcame so broken. At least the Cancer Industry is profitable.

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