The Federal Audit Office requires the FDA to clarify the approval authority for pharmaceutical companies

August 12, 2013 - Margaret Hamburg, director of FDA in the United States, has always stressed the hope that Congress can distinguish clearly the specific responsibilities of FDA in the management of pharmaceutical enterprises This statement has been recognized by the U.S government accounting office Gao A report issued by the Gao considers that FDA's responsibilities in managing pharmaceutical enterprises are still vague, and suggests that legislation should be made to clarify the legal scope of FDA's responsibilities Detailed English report: 　　FDA Commissioner Margaret Hamburg has insisted that Congress needs to explicitly spell out what kind of hammer the agency can wield when it comes to compounding pharmacies, like the one tied to last year's outbreak of fungal meningitis Not everyone in Congress agrees, but the commissioner recently got some support from a Government Accountability Office (GAO) report that found the FDA's authority remains fuzzy 　　The GAO report said that two federal circuit court decisions have led to the FDA actually having different authority in different parts of the country It also pointed to the fact that the FDA had to get warrants 11 times to inspect compounding pharmacies that resisted the agency taking a look at their production and sterility practices The report recommends that Congress pass legislation that clears up the agency's authority 　　On Wednesday, Senate Democrat Tom Harkin, chairman of the committee which has approved a bill supported by the FDA, pointed to the report as proof that legislation he backs is sorely needed He said there were two more deaths just this week from the meningitis outbreak tied to New England Compounding Center, bringing the total to 63 The letter says that the bill would give authority over the largest compounders, which operate like drug manufacturers, while leaving smaller, traditional compounders under state supervision 　　This year the FDA started a campaign to quickly inspect the largest compounding pharmacies, which often ship products nationwide But Hamburg has said that inspectors often meet resistance to getting into the facilities So far the FDA had done 56 inspections, and many have led to nationwide recalls of sterile products, including one this week Hamburg has also appeared before Senate and House committees to defend the agency's oversight and to ask Congress to pass legislation.