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S&P Global Market Intelligence – Health panel clears way for Senate consideration of US FDA candidate Hahn

S&P Global Market Intelligence – Health panel clears way for Senate consideration of US FDA candidate Hahn

The Senate Health, Education, Labor and Pensions Committee voted 18 to 5 to advance the nomination of cancer doctor and radiation oncologist Stephen Hahn to lead the U.S. Food and Drug Administration.


Hahn is the chief medical executive at the University of Texas MD Anderson Cancer Center in Houston.


He has no regulatory or industry background. His only government experience was serving in the U.S. Public Health Service at the U.S. National Cancer Institute from 1989 to 1995.


As head of the FDA, Hahn would be responsible for overseeing an 18,000-employee agency that regulates 77% of the nation’s food supply, over 20,000 approved prescription medicines, 6,500 medical devices, 1,600 animal drugs and 85,000 tobacco products, not including e-liquids.


FDA-regulated products account for about one-fifth of the U.S. economy.


The FDA was left without a permanent leader after the unexpected departure in April of Scott Gottlieb, who exited the commissioner’s job after less than two years.


Ned Sharpless, director of the U.S. National Cancer Institute, filled in temporarily until Nov. 1 when President Donald Trump nominated Hahn to take the helm.


Brett Giroir, the assistant secretary for health at the U.S. Department of Health and Human Services, is serving as acting commissioner pending Hahn’s confirmation.


The Senate health committee heard testimony from Hahn at a Nov. 20 hearing. Since then, he has answered an additional 205 questions, “325 if you include subquestions for the record from senators,” Alexander said at the Dec. 3 session.

The Tennessee lawmaker said the committee has received 13 letters of support for Hahn, representing nearly 80 organizations.


“A confirmed commissioner is critical to ensure FDA is best positioned to continue to carry out the agency’s important mission for millions of Americans,” more than 20 groups, including Friends of Cancer Research, said in one letter.

The past five FDA commissioners — Republican and Democratic appointees — also urged a quick confirmation in their letter to Senate leaders.

Political pressure concerns

Alexander insisted Hahn was “exactly the type of nominee we want to lead an agency as important as the FDA.”


But Sen. Patty Murray, D-Wash., ranking member on the Senate health committee, questioned whether Hahn held the qualifications necessary to lead the agency and whether he was committed to basing his decisions on science, data and the law, as the cancer doctor swore to do during his Nov. 20 confirmation hearing.


“Ultimately after considering his experience and answers to this committee, I’m just not convinced Dr. Hahn is the right person for the job,” Murray said at the Dec. 3 hearing.


The Washington Democrat said she was particularly concerned that when pressed several times by members of the committee on both sides of the aisle, Hahn declined to commit to implementing a strong policy to clear the U.S. market of non-tobacco flavored e-cigarettes that have not undergone FDA review, “like the Trump administration promised to do before it heard from the tobacco industry and reversed course.”


“That is a big red flag for me and why I will be voting against his nomination,” she said ahead of the vote.


“I will be watching every day to be sure he lives up to his commitment to be guided by science and data,” Murray added.


Sen. Mitt Romney, R-Utah, who was one of the committee members who had pressed Hahn on whether he would resist pressure from the White House and lobbyists on e-cigarettes and vaping, said he was voting in favor of the Trump candidate but “with some degree of concern.”


“I had hoped in his hearing that he would express very clearly that he would follow the science with regard to stop vaping and would place the interest of public health above all other interests, including political interest,” Romney said. “And

that if for some reason he was directed to take action that was contrary to his view as a professional, as a scientist and as a doctor that he would clearly state that he was being directed to do so, at the minimum, and even consider resignation.”


Romney said he was concerned about the “massive public health emergency with 5 million kids in high school who are vaping and becoming addicted to nicotine, and that because this has political implications for various people, that we may not do what’s right for the American people.”


While Romney said he backed Trump’s nominee to lead the FDA because “he’s a solid professional with the right instincts and the right record,” the Utah Republican said he would insist Hahn communicate with lawmakers and the public about how his decisions on e-cigarettes and vaping are made and carried out.


Romney added that he hoped Congress would also take immediate legislative action on e-cigarettes and vaping and set a national standard “to protect young people.”…