GAO finds fault with FDA's recall process

09/28/2012 05:20:00 PM
Coral Beach

FDAMany are frustrated that the produce rule from the Food and Drug Administration has been stuck in the Office of Management and Budget for months, but the agency has taken other action related to requirements in the Food Safety Modernization Act.

The agency published eight new guidance documents and three rules in the Federal Register in the past year and a half.

The FSMA includes 90 so-called deliverables in the form of rules, notices, reports to Congress and other actions.

Michael TaylorTaylor“FDA eagerly embraces change in its food safety program and is hard at work laying the foundation for a modern, prevention-oriented food safety system,” said FDA’s deputy commissioner for foods Michael Taylor during a science writers symposium in September.

“While FDA lacks the resources to do everything at once, we have worked hard to prioritize our efforts and to deliver on both immediate and longer term FSMA mandates.”

However, FMSA mandates are not the only projects that need attention at FDA, according to a report from the Government Accountability Office.

The GAO did a performance audit of FDA’s food advisory and recall process from May 2011 to July 2012 and found significant problems.

The auditors cited FDA’s databases as being particularly problematic: “…it is not clear whether or to what extent the agency’s data on ordered food recalls can be relied upon to report accurate information to Congress and the public.”

In response to the audit report, officials from the Department of Health and Human Services said the FDA was working to correct a number of the specific issues cited by auditors, expecting them to be resolved by this fall. HHS officials did not immediately respond to requests for the status.

An assistant director at GAO said her office had attempted to contact FDA to “determine whether they have taken any actions on our recommendations in GAO’s recent Food Recall report, but the FDA liaisons have not responded yet.”



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