The New Interim Head of the FDA Seems Mercifully Normal


Ned Sharpless
Image: Daniel Sone (National Cancer Institute)

Scott Gottlieb’s immediate replacement as head of the Food and Drug Administration will be Norman “Ned” Sharpless, the current director of the National Cancer Institute, according to Health and Human Services Secretary Alex Azar. Sharpless will serve as the FDA’s interim chief once Gottlieb departs in less than a month.

Azar’s declaration came during a congressional hearing in front of the House Energy and Commerce Health Subcommittee on Tuesday. It was soon confirmed by the HHS and FDA on social media. The current deputy director of the NCI, Doug Lowy, will step into Sharpless’ role as the NCI director.

The 52-year-old Sharpless, like his predecessor Gottlieb, has a medical and scientific background. He’s had a distinguished career as a doctor and researcher in the oncology field for more than 20 years. Prior to accepting his position at the NCI in 2017, he was director of the University of North Carolina’s Lineberger Comprehensive Cancer Center.

Gottlieb gave Sharpless a ringing endorsement on Twitter, and Politico reports that he explicitly recommended Sharpless to take over the FDA.

Gottlieb’s sudden retirement, announced last week and effective next month, came as a surprise to seemingly everyone. He was certainly one of the most competent officials in the Trump administration, and during his brief time as FDA head, he promoted faster development and approval for new treatments, including generic drugs, and aggressively took on the tobacco and e-cigarette industry with new proposed regulations. Not so surprisingly, tobacco stocks rose and biotech stocks fell soon after the announcement that he would retire. Gottlieb said he wanted to spend more time with his family.

Where Sharpless may fall on these issues is an open question, though Azar said in a statement that 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.”

“I am grateful for the confidence the President and Secretary Azar have shown by asking me to assume the role of Acting Commissioner of the FDA,” said Sharpless in a statement provided to Gizmodo. “It will be an honor to advance the FDA’s critical public health mission and build on its progress toward the priorities laid out by President Trump, Secretary Azar, and Commissioner Gottlieb alongside the leadership and staff of the agency.”

Sharpless, like Gottlieb, does have some prior ties to the pharmaceutical industry. He’s listed as an inventor on several patents, and he is one of the co-founders of G1 Therapeutics, a boutique start-up hoping to develop drugs that may improve the outcomes of other chemotherapy drugs while reducing the severity of side effects. And in 2016, the year before he took over the NCI, he received over $5,000 in industry payments, including consulting fees, all from Pfizer.

Unlike Gottlieb, who has previously written for conservative think tanks, Sharpless doesn’t appear to be a Republican. He donated to former President Barack Obama’s election efforts during both his presidential campaigns, according to Federal Election Commission records.

This article has been updated to include the statement from Sharpless.





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