A New Commissioner for the FDA: What It Means for the Next Year

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Stephen Hahn, now under consideration to be the commissioner of the Food and Drug Administration (FDA) is an energetic, evidence-oriented scientist who will face some of the toughest challenges needing attention by the government. 

Hahn will need to provide direction on issues such as how to regulate vaping products to assure they can be used safely; how to reduce the mis-prescribing and misuse of opioid products; how to help reduce the cost of drugs; and how to prepare for the next golden age of medicine, when gene therapy will enable people with genetic diseases and who now face certain disabling or early death can live healthy lives, with a single treatment. 

Knowing Hahn, he is up to the challenge.  He has navigated MD Anderson, arguably the most prominent cancer hospital in the world, through difficult times. He has shown leadership wherever he has worked, whether at the University of Pennsylvania where he was chair of radiation oncology or MD Anderson, where he has been medical director. In both institutions he quickly was promoted to positions of increased responsibility. 

Hahn combines a strong background in medicine and scientific research with a confident management style and with an informal manner that fosters open communication. Hahn commands any meeting that he attends because of this combination of talents. He is a clear leader.

What, then, can we expect from Hahn as he prepares to take over the country’s leading regulatory agency, an agency that oversees the safety and, when applicable, effectiveness of products that account for one quarter of consumer spending in the US, and whose judgments influence the decisions of every comparable regulatory agency in the world.

First and foremost, Hahn made clear at his November 14 confirmation hearing that he will make decisions based on science. He has advanced his career by making sound, evidence-based judgments about medical matters and sound management decisions that have been right for his institutions. 

Second, he will make decisions that best serve patients. As an oncologist, Hahn is known for creating close and committed relationships with patients. Even when serving in administrative capacities, he has continued to practice medicine as well. He is committed to the patient’s interests and his decisions at FDA will reflect that commitment.

Third, he is known for seeing the big picture. FDA is the gatekeeper in the midst of one of the most revolutionary times in human medical history and at a time when international boundaries in terms of drug development and the manufacture of all products are tumbling. Hahn knows that the FDA of the future must have staff that can understand and oversee not just medical and other advances; that can focus needed attention on food safety; that can assure the continued development of innovative devices; that can address ongoing health issues such as vaping and tobacco use; and that can use and in some cases introduce the latest technologies such as advancing artificial intelligence into the regulatory oversight process. The world can take advantage of innovations in food production and medical treatments, and can have continued confidence in the safety products such as cosmetics, only if the FDA has the capacity to provide needed guidance and leadership. 

Hahn’s confirmation by the Senate seems on track to occur sometime before the end of the year so he can take office quickly. FDA has had an acting commissioner since April but, like most organizations, benefits from permanent leadership.

This is an exciting time for FDA as it recognizes the need to move ahead with regulatory oversight in a rapidly-evolving world. FDA must be in a position to provide direction and guidance and appropriate protection for the consumer, but at the same time not be an obstacle to progress.

Under Hahn, the FDA will be in good hands.

Wayne Pines is President of Healthcare at APCO Worldwide in Washington, D.C. and a former Associate Commissioner at FDA. 

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