Woodcock to Run CDER, Again

The Food and Drug Administration announced yesterday that deputy commissioner Janet Woodcock will return to her former post as head of the Center for Drug Evaluation and Research.

The Wall Street Journal noted this morning that she will be in charge of recruiting new staff to implement the recently enacted law beefing up the agency's post-market safety surveillance system. Let's hope her heart is in the task. She has been the primary architect within the agency of the Critical Path Initiative, whose mandate -- helping industry emerge from its innovation drought -- was institutionalized in the newly created Reagan-Udall Institute.

Will this new non-profit, chaired by former FDA commissioner Mark McClellan, get off the ground? Rep. Rosa DeLauro, D-CN, is holding up funding after raising questions about industry domination of its board and mission.

One of Woodcock's first tasks will be to reassure Congress that Reagan-Udall isn't just a think tank for implementing industry's wish list for speeding new drugs to market. She could do that by releasing her suggestions for the new non-profit's research priorities. Don't forget that the mission of Reagan-Udall is not just coming up with new tools for speeding new drugs to market, but developing better tools for evaluating the safety of new drugs once they're on the market.