US FDA food/drug split "not likely," but status quo is unacceptable, says PhRMA

29 March 2009

Media speculation about a possible splitting of the US Food and Drug Administration into separate regulatory functions, with medicines and  medical devices on one side and food on the other, have been down played  by Peter Pitts, a former FDA associate commissioner for external  relations. Mr Pitts, who is the president of a think-tank, the Center  for Medicine in the Public Interest, told the Marketletter that a break  up could be achieved with the nomination of Margaret Hamburg and the  agency's Commissioner and the hiring of Joshua Sharfstein as her Deputy  (Marketletter March 23).

However, such a split is not considered to be a priority for the  Chairman of the House of Representatives' Energy and Commerce Committee,  Rep Henry Waxman (Democrat, California), who is on his 17th term in  Congress. A party colleague, Rep Rosa DeLauro (Democrat, Connecticut),  has made several attempts to have a separate agency dedicated to food  safety, with critics of the current arrangements noting that a majority  of the FDA's budget is spent on drug issues.

"The history of the FDA is that the Commissioner focuses on medical  products and only turns to food safety when a crisis comes up," Michael  Taylor, a professor at George Washington University and former FDA  official told the Associated Press. One compromise offered by President  Barack Obama is a food safety task force, which Rep DeLauro warned could  become "merely a cosmetic bureaucratic endeavor."

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