- The Senate confirmed Stephen Hahn as the next FDA commissioner in an overwhelming 72-18 vote Thursday, setting up the agency to soon have its first permanent leader since Scott Gottlieb left the post in April.
- Hahn's swift confirmation garnered applause by former FDA commissioners, lawmakers and industry groups. President Donald Trump announced his intent to nominate the oncologist Nov. 1, and the HELP Committee passed his nomination to the Senate 18-5 on Dec. 3.
- Hahn will be tasked with leading an agency that oversees 20 cents of every dollar spent in the U.S. Since Gottlieb, it has been led on an acting basis by the National Cancer Institute's Ned Sharpless and HHS Assistant Secretary for Health Brett Giroir.
On the device front, Hahn will be taking over FDA as it grapples with a number of device issues including duodenoscope safety, long-term device material compatibility and how to regulate rapidly changing software as a medical device.
While senators on both sides of the aisle questioned how Hahn would approach tobacco and e-cigarette regulations leading up to the vote, he gained broad support among lawmakers. Former FDA Commissioners Robert Califf and Margaret Hamburg won greater bipartisan backing in their respective confirmatory votes, but Gottlieb was only confirmed by the Senate 57-42.
The leaders of the two major American medical device trade groups, Scott Whitaker, CEO of AdvaMed, and Mark Leahey, CEO of the Medical Device Manufacturers Association, both said they look forward to working with Hahn on ensuring timely patient access to new medical devices.
"During the confirmation process, Dr. Hahn demonstrated his deep understanding of the agency's mission to protect and promote the public health and the role of innovation in improving patient care," Whitaker said in a statement.
HHS Secretary Alex Azar called Hahn a "superbly qualified leader," adding that having a confirmed FDA leader will help expedite the administration's public health agenda.
The American Heart Association praised Hahn's confirmation, but called on the incoming commissioner to uphold "robust" medical device review standards once in office.
In response to written questions from HELP Committee Ranking Member Patty Murray, D-Wash., Hahn pledged to take advantage of the National Evaluation System for health Technology and other tools to monitor device safety and effectiveness once they are on the market.
"I think it is important for FDA to take a proactive, not passive approach to upholding the gold standard for all medical products before and after they enter the market," Hahn said.