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FDA Calls for More Foreign-Drug Inspectors

The Food and Drug Administration needs more inspectors and a comprehensive computer database to better track products entering the U.S. from foreign sources, a top drug-safety official told lawmakers.

The FDA focuses its inspections on domestic companies, with about 1,200 inspections conducted annually in the U.S. Meanwhile, only about 300 foreign facilities are inspected each year. The latter number amounts to only about 10% of the firms shipping prescription drugs or their ingredients into the U.S., said Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research.

The small number of foreign inspections seemed particularly relevant during the hearing amid concerns about the blood thinner heparin and its imported ingredients. Two weeks ago, the drug was linked to four deaths and adverse reactions in about 350 patients. Millions of patients take the drug every year to avoid potentially life-threatening blood clots.

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