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Safety

FDA delays rule on generic drug labels

by Glenn Hess, special to C&EN
May 30, 2016 | APPEARED IN VOLUME 94, ISSUE 22

FDA is putting off until 2017 a decision on whether to allow generic drug makers to independently update safety warnings on product labels. The rule was widely expected to be finalized this spring. Currently, brand-name drug makers have an obligation to update a label whenever they discover new information about a drug, and generic manufacturers are required to follow suit. In 2011, the U.S. Supreme Court ruled that generic drug makers could not be sued for failing to warn patients about the risks of their products because the companies do not control the content of the warning labels. FDA says its proposal would “create parity” between brand-name and generic drug makers because it would expose companies in both industries to lawsuits if they fail to properly warn of a drug’s risks. The Generic Pharmaceutical Association has objected, arguing the rule change would create confusion because drugs that are equivalent could have different warning labels.

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