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Akron Univ. School of Law

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Monday, March 30, 2009

Splitting the FDA

Kaisernetwork.org provides information on the recent talk about splitting the FDA into two separate agencies with one focusing on food and another focusing on medical products.  The site reports,

Some drug industry executives think a split FDA might result in faster product approvals because the agency would not "be distracted by high-profile food-safety breakdowns," according to the AP/Chronicle. FDA this year will spend 73 cents on food safety for each dollar that it will spend on medical product regulation, according to the Institute of Medicine. . . .

Rep. Rosa DeLauro (D-Conn.) has introduced legislation (HR 875) to move FDA's food safety responsibilities to a separate entity that would have additional responsibilities to order product recalls and increase food inspections. DeLauro said that she supports a newly created federal food safety task force, but added that the task force must not be "merely a cosmetic bureaucratic endeavor" and should "produce definitive recommendations that result in the modernization of our food safety regulatory structure." . .

Peter Pitts, a former FDA associate commissioner for external affairs and co-founder of the Center for Medicine in the Public Interest, said that President Obama's recent nomination of two public health specialists for the top FDA slots indicates that the president favors splitting up the agency. Pitts said, "[Commissioner-nominee Margaret] Hamburg is a safety and security expert, and it seems pretty clear she would become administrator of the food agency," while "[Deputy Commissioner-nominee] Josh Sharfstein would then slide over" to lead the drug agency. . .

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