FDA's Visionary Missionaries
This article was originally published in RPM Report
The Reagan-Udall Foundation is a private non-profit organization that will help FDA develop new scientific tools to enhance its regulatory mission. Here are the board members of the public-private partnership.
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The Reagan-Udall Foundation is an early priority for FDA in implementing the landmark legislation enacted by Congress in 2007. It is also a lightning road for criticism from Congress about the agency's relationship with regulated industry. We asked foundation chairman Mark McClellan for a status report.
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.
Why is FDA so excited about the Reagan-Udall Foundation? Why is a key legislator so concerned? If both had to answer with a single word, it would be Avandia. The safety questions surrounding GSK's former blockbuster anti-diabetic go a long way towards explaining both the potential for and the political backlash against the foundation.