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Policy

FDA drug list is inaccurate, incomplete

August 21, 2006 | APPEARED IN VOLUME 84, ISSUE 34

FDA's required compilation of all prescription drugs that are manufactured, prepared, or compounded for commerce is incomplete and inaccurate, according to a study by the inspector general for the Department of Health & Human Services. The list, called the Drug Registration & Listing System, is mandated by the 1972 Drug Listing Act and included data on 123,856 drug products as of February 2005. By comparing the FDA list to a commercial database, the IG found that an estimated 9,187 prescription drug products were missing from the FDA compilation because companies had not submitted the required forms, and another 5,150 products were not listed because the company-submitted data contained errors that had not been resolved. In addition, the IG noted that FDA's list includes an estimated 34,257 products no longer on the market. Although most of the problem is caused by drug companies failing to submit appropriate documents, the IG puts much of the blame on FDA's failure to set up an efficient listing process and its lack of oversight. Among the IG's recommendations to get the list back in order, FDA must finalize new guidance documents for company submission forms, continue efforts to develop an electronic submission process, and take action against drug firms that consistently fail to list their products.

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