The U.S. Senate, in a 72-18 vote, has confirmed Dr. Stephen Hahn, an oncologist from Texas, to be the next head of the U.S. Food and Drug Administration.
WHY IT MATTERS
President Donald Trump announced his intention to appoint the cancer doctor back in November. Yesterday’s Senate confirmation paves the way for Hahn to lead an agency grappling with a series of serious health issues ranging from the opioid crisis to flavored tobacco products and e-cigarettes.
FDA also plays a major role in regulating digital health startups, clinical decision support, medical devices and artificial intelligence applications.
Hahn previously served as the chief medical executive at MD Anderson Cancer Center in Houston, a post he has held since 2018, and had served as head of the radiation oncology division since 2015.
THE LARGER TREND
The most recent Senate-confirmed FDA commissioner, Dr. Scott Gottlieb, who served from May 2017 to April 2019, was widely respected across the healthcare industry for his forward-thinking approach to artificial intelligence. (“He was like the best part of the entire administration,” health technology pioneer Eric Topol told Healthcare IT News.)
Given AI’s “enormous promise for the future of medicine,” as Gottlieb explained in 2018, he helped lead the development of “a new regulatory framework to promote innovation in this space and support the use of AI-based technologies” and help ensure safe use of “one of the greatest benefits of machine learning – that it can continue to learn and improve as it is used.”
Since Gottlieb stepped down, FDA has been making other strides towards more advanced use of artificial intelligence, including using AI, blockchain and IoT technologies to create a more digital, traceable and safer regulatory system for food.
In August, the FDA announced it would embark on a multi-year research partnership with precision medicine company Synapse to see how secure patient data can be better put to work in the development of oncology treatments. Syapse will work with the FDA’s Oncology Center of Excellence and other stakeholders across the agency on regulatory issues around testing and treatment patterns, dosing and safety and oncology outcomes.
ON THE RECORD
While the new FDA commissioner will surely take an active role in AI and medical device innovation, he also will have his hands full with other pressing public health challenges – especially e-cigarettes.
Lisa Lacasse, the president of the American Cancer Society’s Cancer Action Network voiced her support for his confirmation in a written statement, calling Hahn “well-positioned” to lead the FDA forward.
“Currently, there is no bigger issue facing the agency than the youth tobacco epidemic,” Lacasse’s statement noted. “It’s imperative Commissioner Hahn immediately work to advance and implement effective policies to stem the tide on this worsening epidemic.
“Dr. Hahn can now get to work approving new life-saving 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,” Sen. Lamar Alexander, R-Tennessee, chair of the Senate HELP Committee, tweeted following the confirmation.