GAO To Slam FDA Over Foreign Inspections

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china.jpgAlthough the FDA increased inspections of foreign drug plants last year, the agency still checked only 11 percent of the sites that supply pharmaceutical ingredients to the US market. That’s what GAO health care director Marcia Crosse will tell the House Energy and Commerce Committee this morning at a hearing to discuss the FDA’s oversight of foreign manufacturing, according to Reuters.

Concern about FDA oversight has risen since the finding of a contaminant in some batches of Heparin that were made with raw ingredients from China, where officials are now are voicing doubts that a contaminant identified in Heparin was the root cause of 81 deaths and severe allergic reactions in hundreds of Americans.

“FDA’s plans represent a step forward in filling the large gaps in FDA’s foreign drug inspection program, but do little to accomplish short-term change,” Crosse will tell the committtee. A copy of Crosse’s testimony was provided to Reuters. Also testifying will be FDA commish Andy von Eschenbach. Here’s the witness list.

More than 80 percent of active ingredients in US drugs come from abroad, with more than half from India and China. The latest FDA review found the agency checked 11 percent of more than 3,200 foreign ingredient makers registered with the FDA in fiscal 2007, which ended in September. Nineteen of more than 700 sites in China were among those inspections. “FDA has made progress in conducting more foreign inspections, but it still inspects relatively few establishments,” Crosse will testify.

The GAO estimated it would cost between $67 million and $71 million to inspect all 3,200 foreign sites every two years. The FDA has proposed spending about $11 million on foreign inspections in fiscal 2008, the GAO said. “FDA will need to devote considerable resources to this area if it is to increase the rate of inspections. However, FDA’s plans currently call for incremental increases that will have little impact in the near future,” according to her testimony.

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