Sources inside the Obama administration assure me that they have no plans to bifurcate food/tobacco from drugs/devices. In other words, Commissioner-designate Hamburg and proposed Principal Deputy Commissioner Sharfstein will act as a team in addressing the direction of the FDA as a totality.
That being said, the issue of whether or not food safety and security remains inside the FDA or becomes its own agency within HHS remains as contentious as ever, with Representative Waxman and Representative DeLauro agreeing to disagree.
Mr. Waxman (D-CA) 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 a reorganization is necessary" for food safety enforcement.”
But Representative Rosa DeLauro, (D-CT), the chair of the House Agricultural Appropriations Subcommittee which oversees FDA's budget, 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. The bill, H.R. 875, has 40 co-sponsors.
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. Drs. 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.
Exhibit A: The Reagan/Udall Foundation and the Critical Path Initiative.
After all, the FDA must work to both protect and advance the public health.
A shared vision, crafted together will succeed.
Unity, yes. Bifurcation, no.
Yes we can.
That being said, the issue of whether or not food safety and security remains inside the FDA or becomes its own agency within HHS remains as contentious as ever, with Representative Waxman and Representative DeLauro agreeing to disagree.
Mr. Waxman (D-CA) 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 a reorganization is necessary" for food safety enforcement.”
But Representative Rosa DeLauro, (D-CT), the chair of the House Agricultural Appropriations Subcommittee which oversees FDA's budget, 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. The bill, H.R. 875, has 40 co-sponsors.
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. Drs. 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.
Exhibit A: The Reagan/Udall Foundation and the Critical Path Initiative.
After all, the FDA must work to both protect and advance the public health.
A shared vision, crafted together will succeed.
Unity, yes. Bifurcation, no.
Yes we can.
