OpenAI is reportedly in discussions with the U.S. Food and Drug Administration (FDA) about using AI to help evaluate pharmaceuticals, according to a new report from Wired.
At the center of the talks is a project called "cderGPT," likely named after the FDA's Center for Drug Evaluation and Research (CDER). A small team from OpenAI, along with representatives connected to Elon Musk's "Department of Government Efficiency," have held several meetings with FDA officials. No formal agreement has been reached so far.
The meetings were reportedly led by Jeremy Walsh, the FDA's first AI officer. Walsh also met with Peter Bowman-Davis, a Yale student currently on leave who now serves as acting Chief AI Officer at the U.S. Department of Health and Human Services. Bowman-Davis is part of the "American Dynamism" team at Andreessen Horowitz. OpenAI declined to comment on the discussions.
FDA has been testing AI for years
Former FDA Commissioner Robert Califf told Wired that the agency has been experimenting with AI for several years, though it's still unclear which parts of the process actually rely on AI. In December 2023, the FDA issued a research grant focused on developing large language models for internal applications, such as precision medicine and regulatory science.
Industry leaders and experts such as Rafael Rosengarten of Genialis generally support the use of AI to automate certain regulatory review steps, but they also call for clear rules about training data and performance standards. Of course, there are also concerns about the potential unreliability of large language models, especially when they produce convincing hallucinations.
In January, OpenAI introduced a special government version of ChatGPT, "ChatGPT Gov", designed to meet U.S. regulatory requirements. The company is also seeking FedRAMP certification to handle sensitive government data. The FDA already uses fast-track programs such as "Fast Track" and "Breakthrough Therapy" to accelerate drug reviews.
