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March 13, 2019

Meet Scott Gottlieb’s Successor at FDA

Dr. Norman E. “Ned” Sharpless, currently the director of the National Cancer Institute, will temporarily fill the role of FDA commissioner beginning next month when Scott Gottlieb steps down. Gottlieb announced his resignation last week.

Health and Human Services secretary Alex Azar announced the appointment Tuesday.

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

There is no reason to think Sharpless will veer far from Gottlieb’s vision for FDA tobacco and vape and e-cigarette regulation. In fact, the White House has made it clear that the Trump administration will follow Gottlieb’s lead.

In addition to the appointment of Sharpless, the administration announced a proposed budget Monday that included $100 million in new user fees for the vaping industry, and Azar has said that there are no plans to change course on regulation of vaping products. Financial analysts agree that the administration, which arrived promising fewer regulations, is unlikely to shift course now.

While little is known about Sharpless’ views on vaping, he did make some general comments on a CBS podcast last fall. He said he thought years of research are still needed to know where vaping nicotine and e-liquid fits into public health.

“We’d love to get everyone off combustible tobacco,” Sharpless told CBS. “That’s very beneficial in terms of reducing risk for cancer and other diseases, but at the same time we don’t really know the impact of these new devices and their risks from a cancer point of view, or also the risks of significant nicotine addiction and other kinds of behavior. E-cigarettes: are they terrible or good or in-between? We need more research, and it’s a very big deal from a public health point of view.”

Both Gottlieb and Sharpless were practicing physicians. But while Gottlieb focused on policy and public health, he also became a venture capitalist and conservative health policy commentator. Sharpless, despite founding two medical device startups, has remained in active practice and research.

In addition to running the National Cancer Institute, Sharpless, 52, is in charge of the Aging Biology and Cancer Section in the National Institute on Aging’s Laboratory of Genetics and Genomics. NCI and NIA are parts of the National Institutes of Health.

Sharpless is a researcher on aging and cancer. Before assuming leadership at NCI, he was director of the University of North Carolina Lineberger Comprehensive Cancer Center, and before that he worked at the UNC School of Medicine and Harvard Medical School. He has authored more than 150 papers, reviews, and book chapters, according to his NCI biography.

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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