Some Drug Industry Advocates Want FDA Split Into Two Agencies

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health
Article Date: 24 Mar 2009 - 5:00 PDT

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Some pharmaceutical industry officials and congressional lawmakers are pushing for splitting FDA into two agencies that would focus separately on food and medical products, the AP/Houston Chronicle 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.

The Pharmaceutical Research and Manufacturers of America has not taken a position on a split FDA.

Steve Brozak -- president of the investment broker WBB Securities, which focuses on pharmaceutical drug and biotechnology companies -- said, "Every CEO that I know in health care is in favor of this, but none that value their share prices will go on the record for fear of retribution from the FDA."

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."

In the Senate, Richard Durbin (D-Ill.) has introduced a bill (S 510) that would expand FDA's regulatory abilities and increase its budget by $775 million for food safety.

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 (Perrone, AP/Houston Chronicle, 3/22).

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