May 27, 2020

May 26, 2020

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President Trump Announced Intent to Nominate Dr. Stephen Hahn as FDA Commissioner

On November 1, President Trump announced his intent to nominate Dr. Stephen Hahn to be the new FDA Commissioner. Dr. Hahn is a radiation oncologist and currently serves as the Chief Medical Officer of MD Anderson Cancer Center in Houston, Texas. At MD Anderson, Hahn manages a $5.2 billion operating budget, 20,300 employees, 7,000 trainees and more than 3,000 volunteers. He has never served in a government post.

As our readers may recall, the change in FDA leadership stems from former FDA Commissioner Scott Gottlieb’s resignation in April. Gottlieb was confirmed as FDA Commissioner in May 2017 and drove several significant initiatives from food safety modernization to youth nicotine use. In April, Dr. Ned Sharpless replaced Gottlieb as Acting Commissioner of Food and Drugs. It had been assumed that Dr. Sharpless would remain the Acting Commissioner until Dr. Hahn was confirmed. However, due to the Federal Vacancies Reform Act, Dr. Sharpless’s term with the Agency expired on November 1. The Act requires that a person may not serve in an “Acting” capacity for longer than 210 days. Dr. Hahn has since returned to his role as Director of the National Cancer Institute (NCI).

According to a press release from U.S. Secretary of Health and Human Services Alex Azar, Admiral Brett Giroir, Assistant Secretary for Health, will oversee the FDA, pending Dr. Hahn’s confirmation. In the press release, Secretary Azar stated that “Admiral Giroir has been an indispensable leader for HHS on a number of public health priorities. As Assistant Secretary for Health, whose authorities include overseeing the U.S. Public Health Service, he will be able to assume the delegable duties of the Commissioner at this time and ensure the FDA’s work continues to move forward.”

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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...