The Food and Drug Administration logo prior to a press conference at Health and Human Services Headquarters in Washington, April 22, 2025.
Nathan Posner | Anadolu | Getty Images
The Department of Health and Human Services will create two new deputy commissioner positions at the Food and Drug Administration, one of which will focus on the intersection of technology, health and artificial intelligence, CNBC reports.
Another new position will be deputy commissioner for narcotics, two people familiar with the project said. The agency already has several deputy commissioners, including an acting deputy commissioner for food, but it is unclear who will fill the role permanently.
The appointment of a new leader comes as part of the Trump administration believes it is an attempt to expand its influence over the agency, according to HHS officials, who asked not to be identified because they are not authorized to speak publicly.
Officials said no final decision or formal announcement regarding the new role has yet been made.
Jared Seehafer, a senior FDA adviser and medical device industry veteran, is the top candidate for the technology position, according to three people familiar with the matter. Mr. Seehafer is the co-founder and former CEO of Enzyme, a life sciences compliance software company, and most recently worked at a venture capital firm in San Francisco before assuming the FDA advisory role last August.
Kyle Diamantas, who most recently served as deputy commissioner for food, became acting FDA commissioner in May following the resignation of Marty McCulley over the approval of fruit-flavored e-cigarettes. It’s unclear whether Diamantas will return to the role.
CNBC was unable to learn of specific candidates for the position of deputy commissioner for narcotics.
The two new positions will report directly to Heidi Overton, President Donald Trump’s pick for FDA director, who still needs Senate confirmation, according to two people familiar with the plans.
HHS did not respond to multiple requests for comment.
The new leadership structure comes after a turbulent period for the FDA.
The agency has come under intense scrutiny over its response to Cyclospora outbreaks in multiple states linked to iceberg lettuce, adding to widespread concerns that federal budget and staffing cuts are hampering the agency’s ability to curb foodborne outbreaks.
The FDA has also been in the spotlight for a series of decisions regarding certain new drug products.
For example, the FDA granted early approval earlier this month for: Replimune After a high-profile regulatory battle with the company and two previous rejections of the drug, the company has decided to acquire Tudrigev, a melanoma treatment.
In March, the FDA also required additional clinical trials of UniQure Inc.’s experimental Huntington’s disease drug, including a fake or “fake” brain surgery placebo, which also prompted a fierce backlash from the biotech industry. The regulator then reversed its stance and gave the green light for UniQure to apply for accelerated approval based on interim data.
And on Monday, the FDA granted a three-month extension of review of Capricor Therapeutics’ experimental Duchenne muscular dystrophy drug to consider additional data. This came after an FDA advisory committee voted 9-3 against recommending the product for approval.
Meanwhile, the FDA is increasingly using artificial intelligence to assist its employees with internal operations, including the Elsa-generated AI tool that the agency uses for tasks such as summarizing and drafting documents. At the same time, FDA regulators are responsible for evaluating the safety and effectiveness of medical products that incorporate AI.
Last week, the FDA released a discussion paper outlining potential approaches to regulating generative AI-enabled medical devices. Instead of issuing formal guidance, the agency is seeking input from patients, clinicians, developers, and other stakeholders.
The new deputy director for technology will oversee both the agency’s own internal use of AI and the review of AI-enabled products, the people said.
