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Drug industry hopes for FDA split

If the agency is divided into two, one to oversee food and the other medicine, speedier drug approvals could be one side effect.

March 22, 2009|Associated Press

WASHINGTON — 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 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 healthcare 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.

Although the FDA's food and drug staffs are separate, Brozak and others believe the public anger over food outbreaks -- involving such items as spinach, lettuce, peppers, and tainted milk from China -- have made senior officials even more risk-averse on drug approvals.

Even before the recent problems, the FDA was under pressure from Congress for failing to catch problems with drugs like Merck's Vioxx, which was pulled in 2004.

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

Experts say there's no reason for the agency that regulates complex, $3,000-a-month biotech drugs to also oversee $3 jars of peanut butter.

The Government Accountability Office endorsed a single food agency in 1999.

Lawmakers have been trying to realize it ever since.

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