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FDA Direction Emerges as Commissioner Makes Exit

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LAKEVILLE, Minn. Just more than two weeks ago, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb informed U.S. Health and Human Services (HHS) Secretary Alex Azar, the White House and FDA employees that he would leave the agency within the month in order to spend more time with his family in Connecticut. Gottlieb’s family has remained in Connecticut while he has commuted between there and Washington during his time at the FDA. Within a week of Gottlieb’s announcement, President Trump appointed National Cancer Institute (NCI) Director Ned Sharpless as acting chief of the agency.

The FDA falls under the purview of the HHS. Upon the announcements, Azar told the media, “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 indicated that under the acting commissioner the “FDA will continue to secure its consumer-protection role and advance policies to promote innovation and safety for families.” As it relates to tobacco and nicotine regulation, Director of the Center for Tobacco Products Mitch Zeller will continue in his role in determining the direction of the agency as it relates to tobacco- and nicotine-product regulation.   

While Gottlieb announced many important initiatives related to tobacco and nicotine in his two years at the FDA, few new regulations and applications have yet made it through the lengthy regulatory process. Who fills Gottlieb’s shoes permanently will have a considerable impact in the regulatory direction of the agency in the final 21 months of Trump’s term. Gottlieb raised many issues and publicly indicated desired actions, but usually has not chosen to propose specific rules that can only take affect after navigating the administrative rulemaking process. He initiated dialogue on reduced-nicotine cigarettes, limiting where certain types of products may and may not be sold, and restricting flavors in tobacco products, including vapor. The agency has also weighed in on changing the age of purchase for tobacco products, but that change would require Congressional action with the necessary approval of the president.

Sharpless, the acting FDA chief, ran the Lineberger Comprehensive Cancer Center at the University of North Carolina before being appointed to head of the NCI about 17 months ago. Not to be confused with the American Cancer Society, NCI is the federal government’s principal agency for cancer research and training. Sharpless is both a physician and a scientist and has written more than 150 scientific papers and holds 10 patents.

It is not yet known whether Sharpless will be an interim commissioner or whether he will eventually assume leadership of the FDA on a permanent basis. The permanent FDA commissioner is appointed by the president with the advice and consent of the Senate. That means whomever is nominated will appear before the Senate Health, Education, Labor & Pensions Committee, chaired by Sen. Lamar Alexander (R-Tenn.).

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