In a November 13, 2013 Federal Register notice—Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg. 67,985 (proposed No. 13, 2013) (to be codified at 21 C.F.R. pts. 314 & 601)—the Food and Drug Administration (FDA) proposed to amend its “changes being effected” (CBE-0) regulations to create “parity” among brand and generic drug manufacturers with respect to certain safety-related labeling changes.
This proposal is largely a reaction to the recent Supreme Court decisions in PLIVA Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013), preempting most product liability claims against generic manufacturers because they cannot initiate CBE-0 labeling changes under current FDA regulations. Under the FDA’s proposal, upon submission to FDA of a CBE-0 supplement, generic manufacturers would be permitted to distribute revised generic labeling that differs in certain respects, and on a temporary basis, from the labeling of the brand drug. The corresponding branded company would then have the opportunity to respond to the generic’s proposal by submitting its own labeling supplement. If FDA ultimately approves the labeling change, it would be implemented in both the branded and generic labels.
If finalized, this proposal could have a major impact on the product liability landscape for both generic and branded drug manufacturers. If the Rule works as intended, it would likely do away with the broad preemption of claims against generic manufacturers. As to branded companies, it could undermine plaintiffs’ attempts to establish “innovator liability”—the theory that branded companies should be held liable for alleged labeling deficiencies in corresponding generic labels. If generic companies have their own responsibility to implement labeling changes, that further refutes any argument that branded companies should be legally responsible for the labeling of generic products. 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.