[e-laser] Prescription for Harm: The Decline in FDA Enforcement Activity

Ernesto Burgio Mon, 26 Jun 2006 13:21:31 -0700

Title: Committee on Government Reform Minority Office

Committee on Government Reform, Minority Office; Rep. Henry A. Waxman, Ranking Member

Food Safety, Prescription Drugs, Public Health

Prescription for Harm: The Decline in FDA Enforcement Activity

Monday, June 26, 2006 --

The U.S. Food and Drug Administration was created 100 years ago to protect the public from dangerous food and drugs. From its inception as the Bureau of Chemistry within the Department of Agriculture, enforcement actions against purveyors of contaminated or unsafe products played a central role in the agencys effectiveness.

A new report by Rep. Henry A. Waxman examines how the Bush Administration has carried out FDAs historic enforcement responsibilities. The report is the result of a 15-month investigation that included a review of thousands of pages of internal agency enforcement records. It finds that there has been a precipitous drop in FDA enforcement actions over the last five years. In some cases, FDA headquarters rejected the enforcement recommendations of FDA field offices despite findings by agency inspectors that violations led to multiple deaths or serious injuries.

The report reaches three key conclusions:

FDA enforcement actions have declined under the Bush Administration. The number of warning letters issued by the agency for violations of federal requirements has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low. During the same period, the number of seizures of mislabeled, defective, and dangerous products has declined by 44%.
FDA headquarters officials have routinely rejected the enforcement recommendations of career field staff. Internal agency documents show that in at least 138 cases over the last five years involving drugs and biological products, FDA failed to take enforcement actions despite receiving recommendations from agency field inspectors describing violations of FDA requirements.
FDAs recordkeeping and case tracking practices are inadequate. Although the Federal Records Act and internal agency procedures require FDA to keep records that document agency enforcement decisions, FDA does not appear to comply with these requirements. FDAs response to Committee requests for relevant enforcement documents was haphazard, incomplete, and untimely. FDA officials explained that FDA could not provide prompt and complete responses because the agency lacks a system that enables it to track enforcement recommendations from field offices.