FDA chief Martin Makary sets June deadline for genAI rollout

Original from: Medical Device Network

The US Food and Drug Administration (FDA) has set an “aggressive” timeline to implement generative artificial intelligence (genAI) across the agency by 30 June 2025.

According to the agency, the technology has amply demonstrated its value in enabling FDA personnel to spend less time on “tedious, repetitive tasks that often slow down the review process”.

The news follows a pilot of genAI’s application in scientific review tasks.

FDA commissioner Dr Martin Makary said he was “blown away” by the agency’s first genAI-assisted scientific pilot review.

He commented: “We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process.

“The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”

Dr Makary has directed all FDA centres to begin deployment immediately, with the goal of ‘full integration’ by the end of June to accelerate genAI adoption.

While not all details of the genAI transformation plans were immediately clear, it is understood that work will continue to “expand use cases, improve functionality and adapt to the evolving needs of each centre” after June 30, but by this date, all centres are required to be operating on a “genAI system” integrated with the FDA’s internal data platforms.

The genAI rollout efforts are being coordinated by Jeremy Walsh, the FDA’s newly appointed chief AI officer.

Dr Makary continued: “There have been years of talk about AI capabilities in frameworks, conferences and panels, but we cannot afford to keep talking. It is time to take action.”

Under the leadership of Health and Human Services (HHS) Secretary Robert F Kennedy, Jr (RFK Jr), the combined workforce of US health agencies such as the FDA and the Centers for Disease Control and Prevention (CDC) has been reduced from 82,000 full-time employees to 62,000.

During a webinar hosted by NAMSA last month, Dr Jeff Shuren, who served as director of the FDA’s Center for Devices and Radiological Health (CDRH) from 2009 until July 2024, said it would “not be surprising” if the cuts resulted in longer device review times at the FDA, at least in the near term.

“One of the challenges moving forward will be to assure that the FDA’s premarket review programme has the expertise that it needs, and that time and attention is put into recruitment and retention,” said Shuren.

While the introduction of genAI at the FDA offers potential benefits, it remains uncertain whether the technology can fully compensate for the reduction in staff under RFK Jr’s leadership.

Source: FDA chief Martin Makary sets June deadline for genAI rollout