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Compounders' recalls come as Hamburg faces tough questions

Fight over FDA authority goes another round
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FDA Commissioner Margaret Hamburg headed into yet another U.S. House committee meeting today with ammunition to defend her agency's record on dealing with compounding pharmacies. Even as she prepared to face tough questioning, the FDA was issuing more recalls of sterile products from a number of the 30-high risk compounders the agency has been inspecting during a crash campaign this year. The FDA last week issued a report showing that despite all of the publicity and calls for reform in the industry, some compounders made it difficult for inspectors to check their facilities. The FDA has been arguing it needs a new law to give it explicit authority to oversee large compounders while some members in Congress argue it has what it needs but just has been derelict in its duties. Howard Sklamberg, director of the office of compliance for the drug division of FDA, told The New York Times that the sterility problems uncovered at compounding pharmacies in 18 states were higher than what would be expected at conventional drug manufacturers. The FDA had to get a warrant from federal court to inspect one of the 30 compounding pharmacies and four others initially resisted the inspection. StoryMore