The US Food and Drug Administration has failed to maintain its standards for enforcement under the present administration, according to a report compiled by Democrat Party Representative Henry Waxman.
The report, resulting from a 15-month investigation into internal agency enforcement records, concludes “there has been a precipitous drop in FDA enforcement actions over the past five years,” which coincides with President George W 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, a 15-year low. At the same time, seizures of unsafe products also declined, to 20 in 2005, from 36 five years ago, but the number of reports written by FDA inspectors describing violations stayed roughly constant.
The study did not provide comparisons with trends before 2000, when a Democratic administration was at the helm, making it impossible to gauge whether 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, and Waxman claims that FDA staff “routinely rejected the enforcement recommendations of career field staff.”
In at least 138 cases since 2000 that were documented in the report, the FDA did not take enforcement action against violations of the agency’s regulations involving drugs and biological products, in cases that were recommended for action by the FDA’s own field inspectors.
Responding to these claims, the FDA stated that it had imposed criminal fines and restitutions worth over $2.5 billion. David Elder, the FDA’s Office of Enforcement director, said: “FDA enforcement cannot be properly judged by the number of actions taken by the agency.” The agency also said that it increasingly focuses its efforts on “combating the greatest health risks.”
The report, entitled: Prescription for Harm: the Decline in FDA Enforcement Activity, has been published by the Committee on Government Reform Minority Office, is available from the CGRMO website.
