US Senate Committee Holds Confirmation Hearing for Nominee for FDA Commissioner

The US Senate Committee on Health, Education, Labor & Pensions (HELP) held a confirmation hearing this week (November 20, 2019) for President Donald Trump’s nominee for the US Food and Drug Administration’s (FDA) Commissioner, Dr. Stephen Hahn. If confirmed by the Senate, Hahn would replace FDA Acting Commissioner Norman Sharpless, who served from April 5, 2019 to November 1, 2019 after former FDA Commissioner Scott Gottlieb stepped down from his post earlier this year.  

Dr. Hahn is the Chief Medical Executive at the University of Texas MD Anderson Cancer Center in Houston, Texas. He is a professor in the Department of Radiation Oncology, Division of Radiation Oncology at MD Anderson.

In his opening statement, Hahn emphasized the importance of the FDA in encouraging both innovation and competition. “…It is crucial that the FDA encourage innovation and competition so that Americans have access to a continuously improving universe of treatments,” Dr. Hahn said. “The American people depend on a strong FDA and, if confirmed, I will work with Congress, the Administration, and stakeholders to ensure fulfillment of that vision as its leader.”

When asked about drug pricing and sustainable market competition by Senator Tim Scott (R-SC), Dr. Hahn responded, “nothing is more important than getting innovative products into the market for the American people and providers. The generic pathway is an incredible way to do that and to introduce competition and there are many virtuous effects of the generic pathway… I am very supportive of continuing that work and accelerating the approval and safe approval, of generics.”

The Drug Competition Action Plan, initiated by Gottlieb as FDA Commissioner and continued under Acting Commissioner Sharpless, consists of a series of initiatives designed to bring greater efficiency and transparency to the generic-drug review process and to support generic-drug development as a way to increase drug competition.

Senator Patty Murray (D-WA), the Ranking Member of the HELP Committee, asked if Dr. Hahn would commit to making decisions based on science and not ideology, to which he responded: “…throughout my career, whether it was at the patient’s bedside or as a medical executive, I’ve made decisions based upon data and science congruent with the law… I commit to you that science, data, and the law, will guide decisions that I would make, if I’m fortunate enough to be confirmed by this Senate as Commissioner of Food and Drugs.”

Dr. Hahn also answered questions from Senate Committee members on topics ranging from biosimilars to drug shortages, opioids, and tobacco.

Closing the hearing, Chairman Senator Lamar Alexander (R-TN) said, “…this has been, from my point of view, a good exchange of views. You can see we have 23 members with very different points of view here on this committee. We don’t agree on everything, but we work pretty hard to find those things that we do agree on, and I would encourage you, if you’re confirmed, which I believe you will be, to work with both the Democratic and Republican members of the committee to look for areas of agreement.”

A markup of Dr. Hahn’s nomination is expected to be scheduled for December 3, 2019.

Source: US Senate Committee on Health, Education, Labor & Pensions

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