Congressional obstacle for Reagan-Udall Foundation

Executive Summary

Rep. Rosa DeLauro (D-Conn.) is asking FDA to stop all activities related to the creation of the Reagan-Udall Foundation until policies are established that safeguard against industry influence. The foundation was established by the FDA Amendments Act to advance the agency's Critical Path initiative and identify unmet scientific needs, but is currently unfunded. In a letter to FDA Nov. 1, DeLauro expresses concern that Critical Path activities, including those by the Reagan-Udall Foundation, could lead to the "approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials." The congresswoman further suggests that funds for the foundation be withheld until other FDA initiatives are fully funded...