FDA Law blog; FDA Proposes a Rule that Would Undercut Generic Drug Preemption

By Jennifer M. Thomas –

The generic drug industry has waited with bated breath since, as we reported hereand here, FDA signaled that it was “considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.”  See Amicus Brief of the United States at 15, n. 2, Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) (No. 12-142).  On Friday, November 8, 2013, the wait was over.

FDA’s Proposed Rule would allow generic manufacturers to independently updateproduct labeling through the “changes being effected” (“CBE-0”) supplement process that is currently only available to branded drug manufacturers with respect to product safety labeling.  Under the Proposed Rule, generic manufacturers could unilaterally change their safety-related product labeling, and those changes could take effect simultaneous with the companies’ notification of FDA and of the branded drug manufacturer – no prior approval required.

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