Congressman Henry Waxman has published a new report on the FDA - the result of a 15-month investigation. It finds that there has been a "precipitous drop in FDA enforcement actions over the last five years." The main findings:
* 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.
Harvard's Dr. Jerry Avorn, in a letter accompanying the report, writes, "one is left with the image of an organization unable or unwilling to do its job effectively."
Posted by schwitz at June 27, 2006 07:00 AM | TrackBack