Health Law

FDA Takes Step One: Admits It Has A Problem

By Marler Clark

In a bit of news that is less surprising than it should be, the AP today reports that the FDA has for the last several years failed to perform a large percentage of required audits for inspections being conducted (under contract) by the States.  According to today's report (based on documents recently released to Congress:

The Food and Drug Administration conducted only about half the state food safety audits it promised in the two years before the recent peanut salmonella outbreak, according to new documents the agency sent to Congress.

The documents show the agency did not do any of the required audits of state-run food inspections in five states during those states' budget years spanning 2007 and 2008. And the FDA was unable to say whether audits were conducted at all in 11 additional states during that time, including Georgia and Texas, where salmonella was found in two peanut plants during a wide-ranging peanut recall earlier this year.

Only 14 states saw 100 percent of the audits completed.

As you will recall, the failure of state-performed inspections was a key contribution the recent nationwide Salmonella outbreak linked to contaminated peanuts processed by the Peanut Corporation of America.  Ditto the Conagra pot pie Salmonella outbreak, and the Peter Pan peanut butter Salmonella outbreak.  Double ditto the Veggie Booty Salmonella outrbeak. 

But at least the FDA seems to starting its long overdue recovery process, taking the first step by admitting it has a problem.  As the AP story reports:

Stephen R. Mason, acting assistant commissioner for legislation at the agency, said the recent salmonella outbreak "has highlighted limitations in our current approach and has prompted internal discussions on potential enhancements to the audit program." 

An agency spokesperson, trying hard to put the best spin on things, goes on to offer the following lame rationalization:

FDA spokeswoman Susan Cruzan says the agency is "evaluating approaches" for improving the audits.

"Although FDA has not been able to fulfill the goal of conducting 100 percent of the audits expected under FDA's internal auditing policy, FDA has audited each state at least once, has good knowledge of the state programs and state inspection personnel, and works to improve the programs as needed," she said.

Having admitted the problem, one can now only hope that the FDA will move on to the crucial next step: Stop Being in Denial.

Full post as published by Food Poison Blog on May 18, 2009 (boomark / email).