Auditors: FDA Needs To Step Up Foreign Inspections

Concerns about the inspection program highlighted after the agency learned that contaminated doses of heparin probably came from a Chinese plant that was never inspected.

WASHINGTON (AP) -- The Food and Drug Administration is making progress in conducting more inspections of foreign drug manufacturers, but still inspects relatively few facilities.
The agency conducted 30 such inspections in the last fiscal year and plans to conduct at least 50 this year, according to government auditors.
The FDA is responsible for overseeing the safety and effectiveness of drugs marketed in the United States regardless of where they are manufactured. Concerns about the inspection program were recently highlighted, auditors said, when the agency learned that contaminated doses of the blood thinner heparin had probably come through a Chinese plant that the agency had never inspected.
About $10 million was dedicated for foreign inspections in the latest fiscal year. Auditors estimate the FDA would need far more resources to inspect, every two years, each of the 3,249 foreign drug establishments listed by the agency.
''However, FDA's plans currently call for incremental increases that will have little impact in the near future to reduce the interval between inspections,'' auditors said.
The Government Accountability Office's report will be part of a hearing Tuesday by a House oversight and investigations subcommittee.
The auditors said it's just too early to determine the effectiveness of the FDA's plans for improved oversight of foreign facilities. For example, the agency has said it's exploring the creation of a cadre of investigators who would conduct foreign inspections, but it has not provided any additional details or time frames.
Also, the agency plans to establish foreign offices in three Chinese locations -- Beijing, Shanghai and Guangzhou. Later, it will consider setting up locations in India, the Middle East, Latin America and Europe.
Health and Human Services Secretary Mike Leavitt, who returned Saturday from a visit to Asia, said he's been insistent with trading partners that if they want access to U.S. markets, they have to meet U.S. standards for quality and safety. At the same time, too much reliance on inspections could deter trade.
''If we begin to constrain consumers' ability to get products, that creates other pressures,'' Leavitt said. ''We have to find the right balance between regulation and market demands.''
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