Last Friday, the U.S. Food and Drug administration proposed a major new rule that could upend recent Supreme Court decisions limiting the liability of generic-drug manufacturers. The rule would eliminate current prohibitions that prevent generic-drug makers from revising safety information until the brand-name counterpart has received agency approval for similar changes. Under the proposed regime, generic-drug makers could unilaterally update product labels with newly discovered drug safety information without waiting for the brand-name counterpart to take action. The new rule could have a profound effect on SCOTUS’ decisions in Pliva Inc. v. Mensing and Wyeth v. Levine and potentially increase failure-to-warn risks for generic-drug makers.
Let’s start with a quick recap. In Mensing, the Supremes held that federal law requiring generic labels to match brand-name products prohibits unilateral revision of those labels. Mensing thus shielded generics makers from failure-to-warn suits because they cannot control the safety information they provide. In Wyeth, by contrast, SCOTUS held that federal law does not preempt a state law failure-to-warn claim that a brand name drug’s labeling did not contain an adequate warning because it was not impossible for the manufacturer to comply with both federal and state requirements. And from a regulatory perspective, under the current regime, generic-drug makers who wish to update drug labeling when new safety information becomes available must first notify the FDA and the brand-name manufacturer and wait until the brand name label change has been approved.
All this could change under the new rule, which proposes allowing generic-drug makers to independently revise drug labels by submitting a “changes being effected” (CBE) supplement, to FDA for review. (The rule also would require the generic-drug maker to provide a copy of the CBE to the brand-name drug maker.) Upon receiving a CBE from a generic-drug maker, the FDA would examine the proposed update and issue a decision applying to both the generic- and brand-name forms of the drug to ensure that both forms of the products have identical FDA-approved prescribing information. And to improve transparency, the rule would require FDA to promptly post information regarding the proposed labeling changes on FDA’s website, to which members of the public could subscribe to receive updates.
The takeaway here is that the new rule would likely eliminate preemption of failure-to-warn claims against generics makers, and thus increase liability exposure of generic-drug makers for not timely or sufficiently updating drug label warnings.. From a policy standpoint, the proposed rule would place the onus on generic drug companies to become more actively engaged in ensuring that drug safety information is accurate and up to date.
It goes without saying that the rule is likely to spark a lively debate and elicit comments from industry and consumer groups, not the least because FDA has proposed this new rule after receiving a petition from a public interest group to revise current regulations in response to Mensing. A notice of the proposed rule will be published in the Federal Register on Nov. 13, and interested parties will have 60 days to weigh in. We’ll keep you posted about developments.