FDA gets an "F"

WASHINGTON, D.C. – A 2007 report by the Office of Inspector General of the U.S. Department of Health and Human Services (HHS) states, "weaknesses in the FDA's information systems and management processes hinder the agency's ability to oversee clinical trial inspections." The report said the FDA inspected just one per cent of clinical trial sites from 2000 to 2005. Of the estimated 350,000 trial sites, the FDA is believed to have inspected just 2,855. The report also revealed a lack of follow up on sites which had been issued a warning letter after being classified as “Official Action Indicated” (OAI) for regulatory violations. The FDA must re-inspect sites that have been sent a warning letter to ensure there are no repeat violations, but according to FDA data, which was noted to be inadequate in the report, the agency only conducted three follow-ups for every 100 inspections that were classified as OAI. That’s three percent, an “F” in anybody’s grade book.