The Department of Health and Human Services is planning to create two new deputy commissioner roles at the Food and Drug Administration, one of which would focus on technology and the intersection of health and artificial intelligence, CNBC has learned.
The other new position is for a deputy commissioner for drugs, according to two sources familiar with the plan. The agency already has several deputy commissioners, including an acting deputy commissioner for food, though it is unclear who will step into that role permanently.
HHS officials would appoint the new leaders in what some in the Trump administration view as a bid to exert greater influence over the agency, according to the sources, who asked to remain anonymous because they were not authorized to speak publicly.
No final decisions or formal announcements about the new roles have been made, the sources said.
Jared Seehafer, a senior advisor to the FDA and medical devices industry veteran, is the leading candidate for the technology role, according to three people familiar with the matter. Seehafer is a 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 stepping into his FDA advisory role in August of last year.
Kyle Diamantas was most recently the deputy commissioner for food before stepping in as the acting FDA commissioner in May after Marty Makary's resignation over the agency's authorization of fruit-flavored vapes. It's unclear if Diamantas would return to that role.
CNBC could not learn of any specific candidates for the deputy commissioner for drugs role.
The two new positions would report to President Donald Trump's pick for FDA commissioner, Heidi Overton, who still needs to be confirmed by the Senate, according to two people familiar with the plan.
HHS did not respond to multiple requests for comment.
The new leadership structure would come after a tumultuous stretch for the FDA.
The agency has faced intense scrutiny over its handling of a multistate cyclospora outbreak linked to iceberg lettuce, which exacerbated broader concerns about federal budget and staff cuts hindering the agency's ability to rein in foodborne outbreaks.
The FDA has also been under the spotlight for a series of decisions around certain new drug products.
For example, the FDA earlier this month granted accelerated approval to Replimune for its melanoma drug, Tudriqev, following a high-profile regulatory battle with the company and two prior rejections of the treatment.
In March, the FDA also drew sharp backlash from the biotech industry after demanding an extra clinical trial – including a fake or "sham" brain surgery placebo – for an experimental Huntington's disease treatment from UniQure. The agency later reversed its stance and greenlit UniQure to file for accelerated approval based on mid-stage data.
And on Monday, the FDA granted a three-month review extension for Capricor Therapeutics' experimental Duchenne muscular dystrophy drug to consider additional data, which came after an advisory committee to the agency voted 9-3 against recommending approval of that product.
Meanwhile, the FDA has increasingly turned to artificial intelligence to help employees with internal operations, including via its Elsa generative AI tool, which the agency has used for tasks such as document summarization and drafting. 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 for regulating generative AI-enabled medical devices. Instead of issuing formal guidance, the agency seeks input from patients, clinicians, developers and other stakeholders.
The new deputy commissioner for technology would oversee both the agency's own internal use of AI and its review of AI-enabled products, according to the people familiar with the matter.
