- The Washington Times - Monday, March 23, 2009

As momentum builds to rework the nation’s food-safety system after a salmonella outbreak linked to peanuts, the drug industry is hoping for a happy side effect: faster approvals for new medicines.

Drug-industry advocates are quietly allying with some of their longtime critics in pushing to split the Food and Drug Administration into two agencies, one for food safety and one for medical products.

President Obama bolstered hopes for a breakup on Saturday when he named two public-health specialists to the agency’s top positions and appointed an advisory group to reassess the nation’s decades-old food-safety laws.

Drug executives see a chance to speed up drug approvals that have lagged amid a drought of new products, provided their regulator is no longer distracted by high-profile food-safety breakdowns.

“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,” said Steve Brozak, president of WBB Securities, an investment brokerage focused on drug and biotech companies.

While FDA’s food and drug staffs are separate, Mr. Brozak and others think the public lashings over food outbreaks have made senior officials even more risk-averse on drug approvals. Even before the recent food-safety problems, the FDA was under pressure from Congress for failing to catch problems with drugs such as Merck’s Vioxx, which was pulled from the market in 2004.

“The history of FDA is that the commissioner focuses on medical products and only turns to food safety when a crisis comes up,” said professor Michael Taylor, a former FDA and U.S. Department of Agriculture official now at George Washington University.

This year, the agency will spend just 73 cents on food safety for every dollar spent on drugs, according to the Institute of Medicine.

Recent outbreaks connected with spinach, lettuce, peppers and tainted milk from China have created a drumbeat for change.

Margaret Hamburg, a former New York City health commissioner, has been tapped to address these issues as Mr. Obama’s pick for FDA commissioner. Her deputy will be Joshua Sharfstein, a pediatrician and critic of the safety of children’s cold medicines.

One former FDA official said Mr. Obama’s appointment of two safety experts suggests he favors splitting the agency.

“Peggy Hamburg is a safety and security expert, and it seems pretty clear she would become administrator of the food agency,” said Peter Pitts of the Center for Medicine in the Public Interest, an industry-funded advocacy group. “Josh Sharfstein would then slide over” to head the drug agency.

The FDA’s associate commissioner for food, Dr. David Acheson, would only say, “The agency welcomes all discussions about ways to make our food supply even safer.”

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