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Thursday, November 01, 2007

Information Gaps Hinder FDA's Ability to Monitor Imported Drugs

Today, the House Energy and Commerce Committee held an oversight hearing on FDA's Foreign Drug Inspection Program. While unsafe imported pharmaceuticals have not garnered the same level of attention as unsafe imported foods and toys, the future does not look bright: FDA's drug inspection program is plagued by a lack of basic information.

The Government Accountability Office (GAO) released a new report in conjunction with the hearing. Among other things, GAO found:

FDA inspects relatively few foreign establishments. Data from FDA suggest that the agency may inspect about 7 percent of foreign establishments in a given year. At this rate, it would take FDA more than 13 years to inspect each foreign establishment once, assuming that no additional establishments require inspection. However, FDA cannot provide an exact number of foreign establishments that have never been inspected.

The hearing comes one day after The New York Times published the results of its investigation into Chinese chemical companies that produce pharmaceutical ingredients with little oversight or safety measures. As it relates to the FDA's role in monitoring the Chinese exporters, the investigation found, "China has an estimated 80,000 chemical companies, and the United States Food and Drug Administration does not know how many sell ingredients used in drugs consumed by Americans."