On March 27, the U.S. Food and Drug Administration held a public meeting regarding its proposed generic-drug labeling rule. The rule proposed by the FDA in November 2013, titled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” would allow a generic manufacturer to use the CBE-0 process to implement a safety-related labeling change for its drug unilaterally, prior to the FDA approving the label change. This is an unprecedented position by the FDA but an increasingly important decision because if the proposed rule goes into effect it would advance consumer safety by providing more incentives for generic-drug companies to propose labeling updates, including increased civil liability for generic-drug companies.
At present and since the passage of the 1984 Hatch-Waxman Act, generic-drug makers are prohibited from updating the warnings provided with their medications because they are required to match the label of the brand-name version of the medication. In 2011, the U.S. Supreme Court decision in Pliva v. Mensing, 131 S. Ct. 2567 (2011), held that it is impossible for generic-drug makers to comply with federal regulations and state warning requirements, and therefore shielded generic drugmakers from liability for failing to warn consumers and doctors about potential risks associated with the medications they sell under the doctrine of federal pre-emption. Since Mensing, various state and federal courts have found that generic-drug manufacturers can be held liable for failing to update their label to match the label of the brand-name medication in a timely fashion. However, the new proposed rule would largely negate the pre-emption argument by generic drugmakers, by allowing them to update labels when they learn of risks associated with their medications and, in turn, be held accountable for failure to warn of known safety risks associated with the generic medication.
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