As policymakers explore a range of proposals for regulating artificial intelligence, one idea gaining currency is building a new regulatory agency devoted to AI governance – and, potentially, to model that agency on the U.S. Food and Drug Administration (FDA). The FDA is the regulatory agency responsible for ensuring the safety, efficacy and security of the nation’s food, biological and media products through a rigorous product oversight and pre-market approval regime. 

Given the growing momentum around these proposals, this is a pressing moment to draw together lessons from regulatory governance. AI Now is convening a rapid expert deliberation with the goal of developing clear policy guidance on how discussions about regulating AI can be more robustly informed by past precedent. We will convene experts who have been thinking about these issues for decades, including by gathering scholarship on the FDA and other regulatory agencies.

This isn’t the first time the idea of an “FDA for AI” has been debated. Such a proposal has been under consideration for several years, alongside a range of approaches to pre-deployment licensing and certification. Proponents have outlined that such an approach offers the promise of greater regulatory friction, ensuring the burden is on companies to adequately vet their systems for efficacy and potential harm – before, rather than after, public release. Skeptics, on the other hand, have expressed concerns that such measures might feed into a broader push towards audit-style regimes that have worked unevenly in other sectors, and risk amounting to ‘check-box certification’ – instead advocating for a sectoral approach that strengthens existing enforcement capabilities.

These are hard problems to solve for. Setting a strong foundation and careful regulatory design will be key to robust and independent governance, especially given heightened concerns of regulatory capture in the well-resourced tech industry. And as Amy Kapczynski underscored in a recent AI Now Salon, there’s much to learn from the history of the FDA to inform these conversations.

AI Now Visiting Policy Research Fellow Anna Lenhart will be working on this project alongside an Advisory Council including Hannah Bloch-Wehba, Amy Kapczynski, Heidy Khlaaf, Christopher Morten, and Frank Pasquale. We look forward to sharing more from this work as it moves forward, and welcome insights along the way.