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House committee report shows decline in FDA warning letters

Pharma Compliance Alert, June 28, 2006

The number of warning letters from the FDA has dropped more than 50% over the last five years, pointing to a decline in FDA enforcement, according to a report issued this week by the Committee on Government Reform's Democratic staff. Specifically, the number of warning letters for drugs dropped 39% from FY 2000 to 2005, and 14% for biologics.

However, the decrease in warning letters does not appear to be the result of increased compliance from manufacturers, says the report, which was prepared for Rep. Henry Waxman (D-CA). According to the 15-month investigation, internal documents show that in at least 138 cases over the last five years involving drugs and biological products, the FDA didn't take enforcement actions despite receiving recommendations from agency field inspectors.

Click here to read the full report.

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