September 2009 Clinical Laboratory News: News from the FDA

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September 2009: Volume 35, Number 9

Hamburg Promises Stronger FDA Actions

FDA Commissioner Margaret Hamburg announced in an address at the Food and Drug Law Institute on August 6th that FDA will act more quickly and aggressively about problems found during inspections that could directly harm consumers and patients. Hamburg said the agency would no longer require all warning letters to be reviewed by the agency’s chief counsel before being sent to manufacturers, a system Hamburg said caused “unreasonable delays” and ultimately put the public’s health at risk. The streamlining of this process may result in more warning letters being sent to manufacturers. Under the new policy, companies now will have no more than 15 working days to respond to FDA inspection findings before the agency takes further action. FDA also will move quickly to close cases after a company fixes problems uncovered during an inspection, and such information would be made public. Hamburg also said the agency needs to seek more enforcement authority to be granted by Congress, including the power to initiate mandatory recalls.

FDA Adds KRAS Testing Info to Vectibix, Erbitux Labels

FDA approved revisions to prescribing information for the epidermal growth factor receptor (EGFR) class of antibodies used in the treatment of metastatic colorectal cancer, including Erbitux (cetuximab) and Vectibix (panitumumab). The drugs are produced by ImClone Systems and Amgen, respectively. The labeling revisions include a statement that analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for Erbitux and Vectibix in patients who had KRAS mutations in codon 12 or 13, and that use of these drugs is not recommended for the treatment of colorectal cancer with these mutations. Both the American Society of Clinical Oncology and the National Comprehensive Cancer Network issued guidelines recommending that all metastatic colorectal cancer patients be tested for KRAS mutations prior to treatment with anti-EGFR monoclonal antibody therapy. This decision follows the FDA’s December 2008 Oncologic Drugs Advisory Committee meeting at which the use of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer being treated with anti-EGFR antibodies was discussed.

FDA Approves Anti-HCV, Anti-HBc IgM Assays

Ortho Clinical Diagnostics (OCD) announced the approval of the VITROS Anti-HCV assay for use on the VITROS 5600 Integrated and 3600 Immunodiagnostic Systems. The Anti-HCV assay is a diagnostic immunoassay for the qualitative detection of the IgG antibody to the hepatitis C virus in human serum and plasma. According to the CDC, a person can only be diagnosed with hepatitis C after a positive test result for an anti-HCV screening test has been verified. FDA also approved the VITROS Anti-HBc IgM assay for use on the VITROS 5600 Integrated and 3600 Immunodiagnostic Systems for hepatitis B testing. Additional hepatitis B and HIV assays, already available for use on the VITROS ECi/ECiQ Immunodiagnostic Systems, are under review or pending submission to FDA for approval for use on the VITROS 5600 Integrated and 3600 Immunodiagnostic Systems, according to OCD. Approval of the assays would provide labs with a complete infectious disease testing menu, including HIV, in addition to a comprehensive menu of routine assays on a single, automated platform.

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