Stephen Hahn Confirmed as FDA Commissioner

The U.S. Senate confirmed Stephen Hahn, MD, as the next FDA commissioner in December by a vote of 72–18. The Senate Committee on Health, Education, Labor, and Pensions recommended Hahn's confirmation following a November hearing during which senators probed his thinking on several issues, notably how the agency would respond to the burgeoning use of electronic cigarettes (e-cigarettes), also known as vaping, and to calls for greater regulation of tobacco in general.

Stephen Hahn, MD

A radiation oncologist, Hahn, 59, most recently served as chief medical executive at The University of Texas MD Anderson Cancer Center in Houston. Before moving there in 2014, he worked at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia for 18 years and served as its chair of radiation oncology from 2005 to 2014.

President Donald Trump announced his nomination of Hahn for the post on November 1. Although Norman “Ned” Sharpless, MD, who now heads the NCI, served as interim commissioner for much of 2019, the agency has not had a permanent leader since Scott Gottlieb, MD, left the job last April.

Jennifer Grandis, MD, of the University of California, San Francisco, backed Hahn's appointment, saying that it's beneficial to have a physician-scientist in the post who understands research and patient needs. In addition, Hahn “has the political skills to navigate an already politicized environment” in Washington, she noted.

Benjamin Toll, PhD, of the Medical University of South Carolina in Charleston, agreed that Hahn is an excellent choice. “If he can do a good job at MD Anderson, I'm confident he can do a good job at FDA.”

Prior to the vote of the full Senate, Erika Sward, assistant vice president of national advocacy for the American Lung Association, said the organization does not take stances on nominees, but she wanted a commissioner who would mandate FDA reviews of e-cigarettes sooner rather than later. The next FDA head needs to “advocate within the administration for what will protect kids, not what will protect tobacco companies,” she said.

At the hearing, Hahn acknowledged that “it requires bold action to keep these [devices] out of the hands of kids.” Subsequently, the FDA released final guidance on January 2 underscoring that manufacturers of “new” tobacco products on the market since 2016 need to submit applications for review by May 12, and that the agency will prioritize enforcement of the regulations. Further, the agency has mandated the removal of all flavored tobacco products from the market, including flavored e-cigarette cartridges, except for those with menthol and tobacco flavors. Flavorings have made e-cigarettes particularly attractive to youths.

Hahn will also oversee the implementation of the FDA's Technology Modernization Action Plan, which was released in September. The plan will guide the agency as it updates and rethinks technologies such as data systems so that new discoveries can benefit the public more quickly. “We are committed to ensuring that our mechanisms for collecting, reviewing, and analyzing data are equally as sophisticated as the scientific advances that we are reviewing,” said Hahn.

Elaine Mardis, PhD, of Nationwide Children's Hospital in Columbus, OH, and president of the American Association for Cancer Research, expressed confidence in Hahn. He “understands the challenges that patients face every day,” she said, “and [he] also knows firsthand the importance of utilizing science-based evidence to evaluate the safety and efficacy of new therapies and devices.” –Mitch Leslie