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FDA issues final rule on label changes

Pharma Compliance Alert, August 27, 2008

Pharmaceutical and medical device companies are only obligated to rush out warnings when they have clear evidence of a serious risk that the FDA hasn’t reviewed, according to new guidance from the agency.

Manufacturers can add or strengthen a contraindication, warning, precaution, or adverse reaction only with “sufficient evidence of a causal association” with the product. The FDA must review all other label changes.

According to the FDA, newly acquired information can be derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data, but needs to be of a “different type or greater severity or frequency than previously included in submissions to FDA.”

Eight members of Congress criticized the guidance in a January letter to FDA Commissioner Andrew C. von Eschenbach. They contend the new guidance will “drastically limit” a manufacturer’s ability to amend a label without FDA approval. They also said the new guidance sets a higher standard for amending labeling and would “inevitably result in fewer company-initiated warnings.”

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