fbpx Skip to main content

Public Policy Newsletter Article

Senate Confirms Hahn as FDA Commissioner

  • 2019-12-18T04:21:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

On December 11, the Senate voted 72 to 18 to confirm Dr. Stephen Hahn as commissioner of the Food and Drug Administration. Dr. Hahn, radiation oncologist and chief medical executive at the University of Texas M.D. Anderson Cancer Center, was nominated by President Trump 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.

At MD Anderson, Hahn manages a $5.2 billion operating budget, 20,300 employees, 7,000 trainees, and more than 3,000 volunteers. MD Anderson is also involved with the largest number of clinical trials in the United States.

Hahn will be tackling FDA’s response to e-cigarettes, its continued response to the opioid crisis and the use of real-world data in the approval process of new medicines. Hahn will also likely be looked at to continue the FDA’s recent stream of generics approvals as a means to lower the cost of prescription medicines.

During Hahn’s confirmation hearing in November, Hahn answered questions on everything from drug prices and biosimilars to drug shortages and opioids. On pricing, Hahn expressed that it is an urgent issue and is very interested in the ways the FDA can stimulate competition and lower drug pricing. He stated that ultimately, this an access issue. In regards to importation, he said he would look into specifics on whether that individual policy could work. Hahn discussed the FDA’s role in assessing the safety and security of the nation’s drug supply and is committed to working with Congress on drug shortages and over-the-counter drug monograph reform.

Throughout the hearing, Hahn reiterated that he makes decisions based on data, science and the law and is very committed to FDA’s gold standard. He expressed the need to accelerate innovation with greater accuracy and certainty to keep pace with science. He also emphasized the importance of speeding competition and eliminating anti-competitive practices for biosimilars. He also discussed implementing all the provisions of the 21st Century Cures Act.

The agency didn’t provide a timeline for when Hahn will take over his duties as commissioner.