April 15, 2009
Obama administration: no plans to bifurcate food/tobacco from drugs/devices
When it comes to the future of the FDA, sources inside the Obama administration assure me that they have no plans to bifurcate food/tobacco from drugs/devices. In other words, commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein will act as a team in addressing the direction of the FDA as a totality. We'll see.
That being said, this remains as contentious as ever, with Reps. Henry Waxman and Rosa DeLauro agreeing to disagree. Waxman believes that the “first step on the legislative path” should be shoring up food safety and finding ways to prevent further incidents. According to the Pink Sheet, “Waxman did suggest that he would entertain the concept of a bifurcated agency in the future. Once reforms are passed and implemented, he suggested Congress could consider ‘whether reorganization is necessary' for food safety enforcement.” But DeLauro has introduced the Food Safety Modernization Act, which would move some divisions out of FDA and form a Department of Health and Human Services agency for food safety.
That being said, a dangerous bifurcation that must be avoided at all costs is a differentiation in the vision for the future of the FDA between appointees and career staff. Hamburg and Sharfstein should listen and learn from the agency's senior staff—most specifically as to how the agency can be both regulator and colleague with the industries it regulates. A fine line to walk—but a journey worth the effort.
A shared vision, crafted together will succeed. Unity, yes. Bifurcation, no. Yes we can.
Peter J. Pitts is president of the Center for Medicine in the Public Interest, a former FDA associate commissioner and partner/director of global healthcare at Porter Novelli