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NCI Director Ned Sharpless to become acting FDA commissioner

  • National Cancer Institute Director Ned Sharpless will become the interim leader of the Food and Drug Administration in early April once Scott Gottlieb’s resignation becomes effective, Health and Human Services Secretary Alex Azar said Tuesday.
  • “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.”
  • A search for a permanent FDA Commissioner is ongoing, HHS said. Sharpless has served as head of the National Cancer Institute since October 2017. Prior to that, he was director of the University of North Carolina Lineberger Comprehensive Cancer Center.

As acting FDA commissioner, Sharpless will lead the agency during the ongoing search for a permanent successor to Gottlieb and through any subsequent nomination proceedings, a process that could take some time. 

Sharpless was the among several names reported to be in consideration immediately following the news of Gottlieb’s resignation, as was HHS assistant secretary Brett Giroir. 

The 15th director of the NCI, Sharpless is an oncologist and an academic who has been an author on more than 150 publications listed on PubMed. 

He’s also the cofounder of two biotechnology companies, G1 Therapeutics and HealthSpan Diagnostics. The former company specializes in cancer therapeutics and has three drugs in clinical testing. 

A spokesperson for G1 said Sharpless had no active position with the company, either financial or consulting. He divested his stake in the company when he took on the NCI director role.

In the past, Sharpless has supported Gottlieb’s vocal positions on tobacco control as well the outgoing FDA chief’s focus on ushering through more approvals of generic drugs. 

“While this appointment is an honor and an exciting opportunity, leaving NCI is bittersweet,” Sharpless wrote in a memo to NCI staff on Tuesday. “My time here — my first experience in Federal service — has been the pinnacle of my career as a cancer researcher.” ?

Appointment of the NCI director as interim FDA head could also serve to soothe some concerns held in biotech, which saw shares of many companies in the sector fall in the wake of Gottlieb’s announcement. 

Several biotech indices traded higher on Tuesday afternoon after announcement of Sharpless’ planned appointment. 

“Investors are now likely to breathe a collective sigh of relief that former NCI director Norman (Ned) Sharpless will be named acting FDA commissioner,” wrote Christopher Raymond, an analyst at Raymond James, in a note to clients titled “Disaster Averted.” 

“Sharpless has the chops to succeed Scott at FDA,” tweeted John Maraganore, CEO of Alnylam Pharmaceuticals and this year’s chair of BIO.

At NCI, the institute’s current deputy director, Douglas Lowy, will serve as acting director, HHS said.