The FDA is hoping that rapidly-advancing artificial intelligence capabilities will not pass it by.
The agency’s Center for Drug Evaluation and Research (CDER) has launched its own AI Council, according to an email from center director Patrizia Cavazzoni made publicly available. The council will be co-led by Sri Mantha, head of CDER’s Office of Strategic Programs, Tala Fakhouri, associate director of data science and AI policy, and Qi Liu, who helps lead innovation and partnerships.
The council’s goal will be to steer both CDER’s internal use of artificial intelligence technology and its AI policy as it pertains to regulatory decisions.
Cavazzoni told staff that the council will “ensure that CDER speaks with a unified and consistent voice on CDER AI communications and external publications.”
She also said that despite AI initiatives spawning across the center, “the changing external and federal environments for AI have brought new governance needs.” She specifically highlighted an Oct. 2023 executive order from President Joe Biden and a memo from the Office of Management and Budget as evidence of shifting federal requirements around artificial intelligence.
Existing work, namely the CDER AI Steering Committee, AI Policy Working Group, and CDER AI Community of Practice, are being sunset and woven into the new council, according to Cavazzoni. To align with both of the White House’s recent asks, the council will take stock of initiatives and be the centralized location where other offices looking to use artificial intelligence will seek guidance and support.
The new council comes just weeks after the FDA, including Cavazzoni, met with industry members and other stakeholders to discuss the agency’s role in regulating and monitoring the use of AI throughout drug development. The agency received an array of feedback, from crafting a grander vision for AI’s application to plucking “low-hanging fruit” around guiding principles.
Cavazzoni said then that the FDA was “very interested” in fielding suggestions from companies on how they’d use AI to monitor drug safety, for example.