November 14, 2013

Overview and Analysis of FDA Proposal to Permit Generic Drug Manufacturers to Initiate Labeling Changes

Arnold & Porter Advisory

In a November 13, 2013 Federal Register notice, FDA has proposed to amend its CBE-0 regulations to create "parity" among brand and generic application holders with respect to certain safety-related labeling changes. This proposal is largely a reaction to recent Supreme Court decisions preempting most product liability claims against generic manufacturers because they cannot initiate CBE-0 labeling changes. ANDA holders, upon submission to FDA of a CBE-0 supplement, would be permitted to distribute revised generic drug labeling that differs in certain respects, and on a temporary basis, from the labeling of the brand drug. If finalized, this proposal would have a major impact on the product liability landscape for drug manufacturers, engender important shifts in the dynamics around drug labeling changes, and significantly increase the pharmacovigilance responsibilities of generic companies. It is highly likely that any final rule would result in a suit against FDA. Comments on the proposal are due by January 13, 2014. FDA has proposed that any final rule based on this proposal would become effective 30 days after the date of its publication in the Federal Register.

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