Laura is the editorial director of The American Journal of Managed Care® (AJMC®) and all its brands, including The American Journal of Accountable Care®, Evidence-Based Oncology™, and The Center for Biosimilars®. She has been working on AJMC® since 2014 and has been with AJMC®'s parent company, MJH Life Sciences, since 2011. She has an MA in business and economic reporting from New York University.
More than 7 months after Scott Gottlieb, MD, resigned from his position as FDA commissioner, the Senate confirmed Stephen Hahn, MD, FASTRO, to be the next head of the agency.
The Senate confirmed Stephen Hahn, MD, FASTRO, with a vote of 72-18, to be the next FDA commissioner. A total of 49 Republicans and 23 Democrats voted for his confirmation with 17 Democrats and Independent Senator Angus King of Maine voting against.
Hahn will fill the position left by Scott Gottlieb, MD, in the spring; since Gottlieb’s resignation, the position was filled with 2 acting commissioners.
“Having a confirmed FDA commissioner of Dr Hahn’s caliber will be a major boost to the already rapid pace of the President’s aggressive public health agenda,” HHS Secretary Alex Azar said in a statement. “Dr Hahn brings an impressive set of scientific and leadership qualifications to the job, and I look forward to seeing the FDA and its people thrive under his leadership.
Hahn is a practicing oncologist and served top official at MD Anderson Cancer Center, but Patty Murray, D-Washington, the ranking member of the Senate Health, Education, Labor, and Pensions Committee, expressed her concern over his lack of experience and expertise to lead a regulatory agency. Murray was one of the Democrats to vote against his confirmation.
“Dr Hahn has almost no government experience, almost no public record on the policy issues related to the FDA, and no experience leading an organization anywhere near as complex as the FDA,” Murray had said during a hearing with Hahn in November.
However, some viewed Hahn’s medical and research experience, as well has his time as a leader in a large health system, more highly. According to Senator Lamar Alexander, R-Tennessee, Hahn was exactly the nominee needed to lead an agency like the FDA.
“Dr. Hahn can now get to work approving new lifesaving drugs and devices, regulating tobacco and e-cigarettes, addressing the opioid crisis, ensuring pain patients can receive the medications they need and protecting our nation’s food supply,” Alexander said in a statement.
What remains unclear is how Hahn will handle the public health issue of vaping. During his confirmation hearing, Hahn did not give a clear answer on whether he would push to ban flavored vaping products. Under Gottlieb, the agency had cracked down on vaping among youths.
Gottlieb had also been a vocal proponent of biosimilars and his support of them had continued under Acting Commissioners Ned Sharpless, MD, and Admiral Brett Giroir. However, there is no clear understanding of Hahn’s stance on biosimilars and whether he will continue the agency’s support of biosimilar competition, reported The American Journal of Managed Care®’s sister site The Center for Biosimilars®.