Norman Sharpless, NCI Director, Appointed as New FDA Commissioner Following Gottlieb's Departure

On Tuesday, the Trump administration announced that it would appoint Norman E. “Ned” Sharpless, current director of the National Cancer Institute (NCI), as the next commissioner of the U.S. Food and Drug Administration (FDA) starting next month. Health and Human Services Secretary Alex Azar confirmed this news during a hearing before the House Subcommittee on Health.

Less than a week ago, current head Gottlieb announced plans to step down in early April.

“Dr. Sharpless’s deep scientific background and expertise will make him a strong leader for the FDA,” Azar said in a statement. “The FDA has already made significant efforts in drug approval, combating the opioid crisis, modernizing food safety, and addressing the rapid rise in youth e-cigarette use. The agency will continue to focus on these priorities in the future.”

Sharpless is a medical scientist who worked at the Lineberger Comprehensive Cancer Center at the University of North Carolina before taking over the NCI in October 2017. He was an active supporter of Gottlieb’s efforts to strengthen regulations on tobacco and e-cigarettes.

Although it remains unclear whether Sharfstein can lead the FDA in the long term, he has consistently been regarded as one of the candidates to replace Gottlieb. In the staff nomination list submitted to the FDA, Gottlieb indicated that Sharfstein is already very familiar with the agency.

Sharpless is also well-versed in the biotechnology industry and the drug development process. He co-founded two early-stage biotechnology companies: G1 Therapeutics, an anticancer drug developer that raised $108.6 million in its 2017 initial public offering, and HealthSpan Diagnostics, a blood test developer.

“What appealed to me most about the White House was that, in addition to conducting research and serving as the Director of the National Cancer Institute (NCI), I also had opportunities for creative commercialization, particularly in advancing the transition from basic research laboratories to Phase II commercial development,” Sharpless said in a 2018 interview, shortly after he assumed leadership of the NCI.

During his tenure at the National Institutes of Health, Sharpless frequently discussed how his agency collaborated with the FDA. While serving at the NCI, he noted that his ability to drive regulatory changes and improve cancer care was limited.

He has expressed interest in using artificial intelligence (including IBM Watson and its oncology care tools) to improve treatment methods. He recognized that this technology is currently subject to significant limitations. “The NCI is still in the early stages in this field,” he stated last year. “The FDA also has many regulatory issues to address in this area.”

Following Dr. Sharpless’s appointment as FDA Commissioner, Dr. Douglas Lowy, Deputy Director of the NCI, will serve as Director of the National Cancer Institute.