US FDA enforcement action decline claimed

The US Food and Drug Administration has failed to maintain its standards for enforcement under the present Republican Party administration of President George W Bush, according to a report compiled by Democrat Party Representative Henry Waxman (California). Titled: Prescription for Harm: the Decline in FDA Enforcement Activity, the report is published by the Committee on Government Reform Minority Office.

The study was the result of a 15-month investigation that included "a review of thousands of pages of internal agency enforcement records," according to a statement by the CGRMO. The report's main finding is that "there has been a precipitous drop in FDA enforcement actions over the past five years," which coincides with President Bush's term in office.

The number of warning letters issued by the FDA fell 45% from 1,154 in 2000 to 535 in 2005, the latter figure representing a 15-year low. The study did not, however, provide comparisons with trends before 2000 (a Democrat held the office for the eight previous years), making it impossible to verify if the drop was part of a long-term trend. The report also alleges that the FDA violates federal law by failing to keep records and track enforcement decisions.