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Pink Sheet – Hahn's Nomination Heads To Full Senate Following Bipartisan Endorsement From HELP Committee

Pink Sheet – Hahn's Nomination Heads To Full Senate Following Bipartisan Endorsement From HELP Committee

Executive Summary

The Senate HELP Committee votes 18-5 to send Stephen Hahn’s nomination to head the US FDA to the full chamber, although a few senators raised concerns over Hahn’s responses to questions about e-cigarettes during his confirmation hearing.

Stephen Hahn’s nomination to serve as commissioner of the US Food and Drug Administration advanced to the full Senate following a relatively painless 18-5 vote from the Health, Education, Labor and Pensions Committee on 3 December.

However, a few senators raised concerns with Hahn’s non-committal answers to questions about whether he would support a policy banning non-tobacco e-cigarette flavors raised during his confirmation hearing. (See sidebar.)


Sen. Patty Murray, D-WA, the ranking member of the HELP Committee, cited the issue when explaining why she would vote against the nomination.


“I was particularly concerned that when pressed several times by members on both sides of the aisle, Dr. Hahn refused to commit to implementing a strong policy to clear non-tobacco flavored e-cigarettes that have not undergone FDA review for the market, like the Trump administration promised to do before it heard from the tobacco industry and reversed course,” Murray said. “That is a big red flag for me, and why I will be voting against his nomination.”


Murray also cited concerns about Hahn’s lack of government experience and his public record on FDA policy issues.


Sen. Mitt Romney, R-UT, voted in favor of Hahn’s nomination, but noted he did so “with some degree of concern” over Hahn’s answers to vaping-related questions.


“I had hoped in his hearing that he would express very clearly that he would follow science with regard to vaping,” Romney said. “Specifically that he would place the interest of public health above any other interest, including political interest, and that if for some reason he was directed to take action that was contrary to his view as a professional and as a scientist and as a doctor, that he would clearly state that he was directed to do so, at the minimum, and perhaps even consider resignation.”


“I will vote for Mr. Hahn because I believe he is a solid professional with the right instincts and the right record,” Romney added. “But I do intend to insist that he communicate to us and this committee and to the nation how his decisions are being carried out and being made with regard to this national epidemic.”


Senators Elizabeth Warren, D-MA, Bernie Sanders I-VT, Maggie Hassan D-NH, and Tina Smith, D-MN, joined Murray in opposing Hahn’s nomination.


Committee chairman Sen. Lamar Alexander, R-TN, said the full Senate will plan to vote on the nomination “before the end of the year.”


Hahn has received broad support from external stakeholders for the top job at the FDA. Alexander noted during the vote that the committee received 13 letters representing nearly 80 organizations supporting Hahn’s nomination.


A letter signed by more than 40 organizations, including the American Society of Clinical Oncology, the EveryLife Foundation for Rare Diseases, and Friends of Cancer Research, stated that Hahn “is the right person to ensure the FDA keeps pace with science and innovation without sacrificing the safety and efficacy gold standard established by the agency.”


“As chief medical executive at The University of Texas MD Anderson Cancer Center, he not only has the knowledge and experience gained by managing the cutting-edge research and medical practices of one of the world’s most innovative teaching hospitals, but also firsthand expertise of patient needs and a deep understanding of the breadth of work that needs to be achieved on their behalf,” the letter states.


Hahn also won the endorsement of former FDA commissioners Scott Gottlieb, Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan in a letter to Senate leadership.


“We believe Dr. Hahn has the experience and commitment to public health and public service needed to provide this leadership,” the former commissioners said.…