HHS Plans New FDA Deputy Commissioner Roles for Technology and Drugs

HHS plans new FDA deputy commissioner roles for technology and drugs, sources say

* The Department of Health and Human Services is planning to appoint deputy commissioners for technology and drugs at the FDA, creating new roles at the agency, CNBC has learned. * Like existing deputy commissioner roles, the two new positions would report into Trump's pick for FDA commissioner, Heidi Overton, who still needs to be confirmed by the Senate. * No final decisions or formal announcements have been made, CNBC sources said. The logo for the Food and Drug Administration is seen ahead of a news conference at the Health and Human Services Headquarters in Washington, April 22, 2025. Nathan Posner | Anadolu | Getty Images 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. Choose CNBC as your preferred source on Google and never miss a moment from the most trusted name in business news.

HHS plans two new FDA deputy commissioner roles, including AI

One role would cover technology and artificial intelligence; the other would oversee drugs. No final decisions have been made HHS is moving to establish a pair of new deputy commissioner positions at the FDA -- one covering technology and artificial intelligence, the other overseeing drugs -- CNBC reported, citing two unnamed sources familiar with the plan. No final decisions or formal announcements have been made. HHS officials view the new positions as a way to exert greater influence over the agency. The two roles would report to Heidi Overton, President Donald Trump's nominee for FDA commissioner, who has not yet been confirmed by the Senate. CNBC, citing three people familiar with the matter, reported that Jared Seehafer, a senior advisor to the FDA and medical devices industry veteran, is the front-runner for the technology position. Before joining the FDA, Seehafer had co-founded and led Enzyme, a compliance software firm serving the life sciences sector, and had most recently been at a San Francisco venture capital firm. He moved into his FDA advisory role in August of last year. No candidates have been identified for the deputy commissioner for drugs role. The new deputy commissioner for technology would oversee both the FDA's internal use of AI and its review of AI-enabled medical products. Internally, the FDA has been leaning more heavily on AI to support staff workflows, with its generative AI tool Elsa deployed for things like summarizing documents and helping with drafting. A discussion paper the FDA published last week laid out possible frameworks for overseeing generative AI-enabled medical devices, inviting feedback from patients, clinicians, developers, and other stakeholders ahead of any formal guidance. The FDA already has several deputy commissioners. Kyle Diamantas previously served as deputy commissioner for food and moved into the acting commissioner role in May after Marty Makary stepped down. It is unclear whether Diamantas would return to that position. The planned restructuring comes amid a turbulent period for the agency. Among the pressures facing the agency are questions about its response to a multistate cyclospora outbreak tied to iceberg lettuce and a string of high-profile drug approval decisions that have attracted outside attention. Earlier this month, the agency granted accelerated approval to Replimune for its melanoma drug Tudriqev following two prior rejections of the treatment. In March, the FDA sparked significant industry pushback when it required UniQure to conduct another trial before advancing its experimental Huntington's disease therapy, only to later change its position and permit the company to seek accelerated approval on the strength of mid-stage results.