FDA Proposes Stricter Rules On Drug Label Changes

By Christine Caulfield (January 16, 2008, 12:00 AM EST) -- The U.S. Food and Drug Administration has published proposed regulation changes to drug and medical device labeling that would restrict the rights of pharmaceutical manufacturers to change product labels without agency approval.

The proposed revision comes as the U.S. Supreme Court considers whether to hear argument by drugmaker Wyeth Pharmaceuticals Inc. that federal laws governing labeling take precedence over state product liability legislation.

The new rules, if adopted, would limit the ability of drug companies to unilaterally alter labels under a "changes being effected" product supplement before FDA review.

The law as it stands allows manufacturers considerable leeway to revise labels,...

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