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Safety

Industry Asks FDA To Ditch Changes To Drug-Label Rules

by Glenn Hess
May 4, 2015 | APPEARED IN VOLUME 93, ISSUE 18

Trade groups representing the branded and generic pharmaceutical industries are urging the Food & Drug Administration to scrap its proposal to change the way generic drug labels are updated to reflect safety risks. FDA has proposed to allow generic drug manufacturers to independently modify labels if they become aware of new safety issues that might pose a risk for consumers. Currently, generic drug makers must wait until either FDA requires an update to the drug’s labeling or the original manufacturer decides to change its label. At that point, the generic drug must bear the same label as the reference drug. But the proposed rule creates a scenario “where potentially conflicting information from multiple manufacturers for single medicines could be widespread,” causing confusion and putting patient safety at risk, says the Generic Pharmaceutical Association (GPhA). Instead, GPhA and the branded drug lobby, the Pharmaceutical Research & Manufacturers of America, say FDA should determine whether new warnings on drug labels are needed and, if so, require all manufacturers to make the changes.

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