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Case Detail


In re: Proposed Labeling Changes for Approved Drugs
On May 18, 2016, FDA announced that it has postponed (until at least April 2017) its controversial proposed rule that would permit generic drug companies to unilaterally change their product labeling. FDAs decision to postpone final action on the rule until after the presidential election marks a victory for WLF, which has repeatedly urged FDA to abandon the rule. There was an obvious but unstated reason for FDAs proposal: to increase potential tort liability. FDA apparently hopes that granting generic manufacturers authority to make unilateral label changes will undermine the rationale underlying court decisions barring tort suits against generics. WLF argued that the change would spawn confusion by presenting doctors with multiple and potentially conflicting sets of health warnings for a single drug. WLF also argued that the rule would violate federal law, which prohibits generic drug makers from using labeling that differs from the labeling for the underlying brand-name drug.
Case Status:
FDA has postponed rulemaking until at least April 2017.
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