Undermining the Foundation: High Stakes in Fight Over Reagan-Udall

The Reagan-Udall Foundation is the one piece of the FDA drug safety law enacted in 2007 that both FDA and industry are excited about. Congressional appropriators, however, have serious concerns. The stakes are higher than they seem: in the short run, the Critical Path and active surveillance systems may depend on the foundation. In the long run, the question is whether industry has any say in the evolution of regulation.