The Reagan-Udall Foundation is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDA by advancing regulatory science and research. With the ultimate goal of improving public health, the Foundation provides a unique opportunity to bring all parties to the table (FDA, Patient Groups, Academia, other Government entities, and Industry) to work together in a transparent way to create exciting new regulatory science.
In 2007, Congress created the Reagan-Udall Foundation for the FDA in response to the FDA’s own “FDA Science and Mission at Risk” report of the Subcommittee on Science and Technology, prepared for the FDA’s Science Board. The report assessed the state of science and technology at the FDA and its ability to support current and future regulatory science needs. The Subcommittee concluded, at that time, that “…science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” Specifically, the Subcommittee noted that while demands on the FDA had increased due to ongoing scientific innovation, resources had not kept up with the demands and exceeded the FDA’s regulatory scientific capacity.
As a result, Congress identified the need for an outside entity, separate from the FDA, that could tackle the problems identified in this report by fostering public-private partnerships. These partnerships would both effectively address and support the FDA’s national strategy to drive innovation in the scientific processes (then known as Critical Path Initiative) and tackle areas of emerging science related to drug safety.
Today, the Foundation drives and supports regulatory science research by fostering public-private partnerships and supporting ongoing training and scientific fellowships. The Foundation operates independently of the FDA, with its own Board of Directors, staff, research agenda, and funding. It does not participate in, nor offer advice to the FDA on regulatory matters or policy issues.
View the FDA’s Fact Sheet on the Foundation.