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Ned Sharpless Named New Acting FDA Commissioner

  • As previously reported on this blog, on March 5, FDA Commissioner Scott Gottlieb announced plans to resign from his post as FDA Commissioner beginning in April. Gottlieb was confirmed as FDA Commissioner in May 2017 and drove several significant initiatives from food safety modernization to youth nicotine use.

  • On March 12, 2019, Alex M. Azar III, Secretary of Health and Human Services announced that Dr. Ned Sharpless would serve as acting FDA Commissioner when Scott Gottlieb steps down in April. The appointment is temporary as the administration searches for a permanent replacement to Gottlieb. Since October 2017, Sharpless has served as director of the National Cancer Institute. He is also the chief of the aging biology and cancer section in the National Institute on Aging’s Laboratory of Genetics and Genomics. “Dr. Sharpless’s deep scientific background and expertise will make him a strong leader for F.D.A.,” said Mr. Azar, in a statement.

  • Mr. Azar noted, “[t]here 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.” However, with Gottlieb’s departure, it remains to be seen whether the agency will continue Gottlieb’s efforts in the area of food and tobacco, including reevaluating certain standards of identity, modernizing the oversight of imported food and product recalls, and curbing youth e-cigarette use.

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 84


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...