When does this man sleep?
Monday, June 26, 2006
Food Safety, Prescription Drugs, Public Health
Prescription for Harm: The Decline in FDA Enforcement Activity
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 agency’s effectiveness.
A new report by Rep. Henry A. Waxman examines how the Bush Administration has carried out FDA’s 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.
* FDA’s 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. FDA’s 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.http://oversight.house.gov/story.asp?ID=1074&Issue=Food+SafetyAfter all this time, finally being in the majority he may in fact get some responses from the FDA?
Rep. Waxman and other members of Congress have been seeking information on the safety of the U.S. food supply, including the federal government’s handling of recent outbreaks involving E. coli 0157:H7 and Listeria and the recent case of Bovine Spongiform Encephalopathy (“mad cow disease”).
other investigations and queries:
Tuesday, February 27, 2007
Committee Raises Questions on FDA Food Safety Efforts
The Oversight Committee and the Appropriations Subcommittee on Agriculture request information from the Food and Drug Administration related to food safety funding, food safety inspections, current guidelines and standards, and current enforcement efforts.
Monday, December 04, 2006
Food Safety
Senior Democrats Urge USDA to Protect Americans from Contaminated Chicken
Reps. Waxman and DeLauro today called on the U.S. Department of Agriculture to set a federal standard for detecting campylobacter, a bacteria found in raw chicken that causes foodborne disease. Although USDA currently has a standard to protect against the salmonella bacteria in raw chicken, there is no such standard for campylobacter. A recent report found that 8 out of 10 chickens in supermarkets are contaminated with campylobacter.
http://oversight.house.gov/story.asp?ID=1139&Issue=Food+Safety
and much more at the oversight website...