AI could speed up FDA drug evaluation process

The FDA is exploring a partnership with OpenAI to accelerate the drug approval process through artificial intelligence, potentially transforming how new medications reach patients. This initiative represents a significant shift in regulatory technology application, as the FDA commissioner recently revealed the agency has already completed its first AI-assisted scientific review and is actively pursuing further AI integration to address the decade-long timeline typically required for new drugs to reach the market.

The big picture: FDA commissioner Marty Makary has publicly questioned the lengthy drug approval process and signaled the agency’s commitment to modernization through artificial intelligence.

• Makary wrote on social media: “Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things? We’ve just completed our first AI-assisted scientific review for a product and that’s just the beginning.”
• The commissioner discussed AI’s potential to accelerate approvals for diabetes treatments and certain cancer therapies during an American Hospital Association meeting.

Behind the scenes: OpenAI representatives have held multiple meetings with FDA officials and associates from Elon Musk‘s Department of Government Efficiency.

• The discussions center around a project tentatively called cderGPT, likely referencing the FDA’s Center for Drug Evaluation and Research.
• Jeremy Walsh, recently appointed as the FDA’s first AI officer, is leading these discussions with OpenAI.

Where things stand: Despite ongoing meetings between OpenAI and the FDA, no formal contract has been signed yet.

• OpenAI has declined to comment on the potential partnership or the nature of the discussions.
• The initiative appears to be in early exploratory stages, with multiple stakeholders involved in shaping the potential collaboration.

Why this matters: Implementing AI in the drug approval process could significantly reduce the time required to bring life-saving medications to market, potentially benefiting millions of patients waiting for new treatments.