BioPharma, Policy

MD Anderson oncologist Stephen Hahn confirmed as FDA commissioner

The Senate voted 72-18 Thursday to confirm Hahn, a radiation oncologist and chief medical executive at The University of Texas MD Anderson Cancer Center.

Lawmakers voted Thursday to confirm a Texas oncologist as the newest head of the Food and Drug Administration.

The full Senate voted 72-18 to confirm Dr. Stephen Hahn, a radiation oncologist and chief medical executive at The University of Texas MD Anderson Cancer Center in Houston, as commissioner of the FDA.

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President Donald Trump nominated Hahn last month to succeed former Commissioner Scott Gottlieb, who stepped down in March. National Cancer Institute Director Dr. Ned Sharpless and Department of Health and Human Services official Dr. Brett Giroir had been heading the FDA as acting commissioners.

The Senate Committee on Health, Education, Labor & Pensions voted 18-5 last week in favor of Hahn’s confirmation. Still, Hahn attracted some criticism – and votes against his confirmation – for not taking a stronger stance on electronic cigarettes. Democratic Sen. Patty Murray of Washington was among those who voted against his confirmation after he “refused to commit to following through with the Trump Administration’s promise to ban non-tobacco flavored e-cigarettes that have not undergone FDA review.”

Indeed, former Commissioner Gottlieb has been particularly vocal on the issue of e-cigarettes since his departure, calling last month for a full ban on pod-based e-cigarettes. His advocacy comes amid a nationwide outbreak of lung injuries associated with vaping products.

Hahn had already been under consideration to lead the agency for a couple of months when Trump nominated him. It was initially reported in September that the administration was mulling his nomination, though Sharpless and Giroir were also reportedly in the running.

Several new therapies for serious diseases will come under FDA review on Hahn’s watch next year. Following the presentation of positive data at the recently concluded American Society of Hematology meeting, Bristol-Myers Squibb plans to seek approval for two CAR-T cell therapies – lisocabtagene maraleucel in diffuse large B-cell lymphoma and idecabtagene vicleucel in multiple myeloma, the latter of which it is developing with bluebird bio. Gilead Sciences said Wednesday that it had filed for approval of KTE-X19 in mantle cell lymphoma as well. And bluebird plans to initiate a rolling application for the gene therapy LentiGlobin in the blood disorder beta-thalassemia, which won European Medicines Agency approval earlier this year.

Photo: The University of Texas MD Anderson Cancer Center