Though the potential change is unconfirmed, media outlets reported Wednesday that one deputy commissioner would focus on the intersection between health and AI, while another will be dedicated to drugs.
The FDA is reportedly considering to add two new deputy commissioner roles, according to CNBC.
If the new positions are implemented, one of the new deputies would focus on the intersection between health and AI, while the second would oversee drugs, the publication said, citing anonymous sources familiar with the matter.
The move is not a sure thing, according to CNBC. As of publication, the FDA has not responded to BioSpace’s request for comment.
Although it’s not clear what the AI/health deputy commissioner role would entail, a leading pick for the position is Jared Seehafer, the sources said. Currently serving as a senior policy adviser at the FDA, Seehafer had previously been the CEO and co-founder of Enzyme, a company that specializes in using technology to facilitate the compliance and regulatory processes for life science companies, according to his LinkedIn page. Seehafer had also previously served as a venture partner at AI-native firm Orange Collective.
There are likewise no obvious clear front-runners for the deputy commissioner for drugs position, the details of which are also unclear, CNBC noted.
The two potential deputies would report to the FDA commissioner, a role currently filled on a temporary basis by Kyle Diamantas, the agency’s top food executive. President Donald Trump last week picked Heidi Overton as his nominee for that top spot. Overton, a doctor by training, is currently deputy director of the White House Domestic Policy Council. Overton still must be confirmed by the Senate, though analysts expect her to clear the process.
Currently, the heads of FDA’s two main review units, the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), are also filled in an acting capacity. The industry eagerly awaits permanent leadership after a carousel of directors under former Commissioner Marty Makary, who departed FDA in May.
There are signs that things are stabilizing under Diamantas. “[W]e believe the current FDA, largely in caretaker mode, appears to be more flexible on regulatory paths for applications where concerns were previously raised,” William Blair wrote to investors in June.
That note followed uniQure’s announcement that the FDA would accept its filing for Huntington’s disease gene therapy AMT-130 based on three-year data from its Phase 1/2 trial—something the agency refused to do late last year. Other companies have also seemed to benefit from Makary’s departure. After receiving two rejections for its advanced melanoma therapy, for example, Replimune received approval for Tudriqev earlier this month.
That approval, alongside the review extension for Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy, point to gains the FDA has made in its campaign to return to reliability, experts told BioSpace.
