The Food and Drug Administration logo is seen before a news conference at Health and Human Services Headquarters in Washington, April 22, 2025.Nathan Posner | Anadolu | Getty Images The Department of Health and Human Services plans to create two new deputy commissioner positions 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 that of a deputy drug commissioner, according to two sources familiar with the plan. The agency already has several deputy commissioners, including an acting deputy commissioner for food, although it is unclear who will take on that role permanently. HHS officials would name the new leaders in what some in the Trump administration see as an attempt 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 have been made about the new roles, the sources said. Jared Seehafer, a senior adviser to the FDA and a medical device industry veteran, is the leading candidate for the tech job, according to three people familiar with the matter. Seehafer is 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 his FDA advisory role in August of last year. Kyle Diamantas was most recently deputy food commissioner before taking over as acting FDA commissioner in May after Marty Makary resigned over the agency’s authorization of fruit-flavored vapes. It’s unclear if Diamantas would return to that role. CNBC was unable to learn of any specific candidate for the position of deputy drug commissioner. The two new positions would report to President Donald Trump’s nominee 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 period for the FDA. The agency has faced intense scrutiny for its handling of a multi-state cyclospora outbreak linked to iceberg lettuce, exacerbating broader concerns about the federal budget and staffing cuts that hamper the agency’s ability to control foodborne outbreaks. The FDA has also been in the spotlight for a series of decisions regarding certain new pharmaceutical products. For example, earlier this month the FDA granted Replimune accelerated approval for its melanoma drug, Tudriqev, following a high-profile regulatory battle with the company and two previous rejections of the treatment. In March, the FDA also sparked a strong backlash from the biotech industry after requiring an additional clinical trial – including a sham or “sham” brain surgery placebo – for an experimental Huntington’s disease treatment from UniQure. The agency later reversed its stance and gave UniQure the green light to apply 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 agency advisory committee 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 through its generative AI tool Elsa, which the agency has used 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 possible approaches to regulating AI-enabled generative medical devices. Instead of issuing formal guidelines, the agency seeks input from patients, doctors, developers and other stakeholders. The new deputy technology commissioner would oversee both the agency’s internal use of AI and its review of AI-enabled products, according to people familiar with the matter. Choose CNBC as your preferred source on Google and never miss a moment from the most trusted name in business news.
