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OIG: FDA’s Rx database flawed, pharmas largely at fault

Pharma Compliance Alert, August 23, 2006

The FDA's prescription drug database is inaccurate, largely due to insufficient reporting by pharmas, according to an HHS Inspector General audit of the listing. The audit found that more than 9,000 prescription drug products are missing from the database and more than 34,000 in the directory are no longer on the market or are listed in error.

Although pharmas are required to list their drugs with the FDA, the OIG found that for 16% of the missing listings, drug firms confirmed that they hadn't submitted the required FDA forms. In almost all of the remaining cases in which pharmas said they submitted the forms, the OIG was unable to confirm it. However, in 9% of cases the FDA failed to process the forms correctly. The OIG is calling on the FDA to finalize guidance for submitting forms, move toward electronic submissions, and take action against pharmas for not complying. Read the entire report on the OIG's Web site.

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