Ned Sharpless

Daniel Sone/National Cancer Institute

NCI Director Norman Sharpless named acting FDA chief

Norman Sharpless, director of the National Cancer Institute (NCI) in Bethesda, Maryland, will become acting administrator of the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryland, after current FDA chief Scott Gottlieb steps down in early April.

The announcement came this morning from Health and Human Services Secretary Alex Azar at a U.S. House of Representatives hearing. “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.”

Gottlieb's resignation to spend more time with his young family in Connecticut rattled markets and FDA watchers when it was announced last week. That uncertainty is at least temporarily eased by the acting appointment of Sharpless, a physician-scientist and former director of the University of North Carolina’s cancer center in Chapel Hill who has drawn praise as NCI director since October 2017.

Sharpless has bolstered support for NCI-funded clinical trials and freed up funds for research grants by trimming the internal NCI budget. He introduced a new policy to support promising young investigators by adding 2 years to their initial 5-year research grants. A champion of big data, Sharpless had just begun to shape a plan to spend $50 million in 2020 in part to share data on pediatric cancer patients as part of a 10-year childhood cancer initiative proposed by President Donald Trump. Although he does not have an industry background, he has started two biotech companies.

The highly regarded Gottlieb reportedly recommended Sharpless as his replacement. He tweeted today: “I’m delighted by the announcement from @SecAzar that @NCIDirector will serve as acting commissioner of #FDA. Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.”

NCI Deputy Director Douglas Lowy, who served a stint as acting NCI director from April 2015 to October 2017, will again step in as acting NCI director.