FDA Issues Proposed Regulations On Supplemental Applications For Labeling Changes

Proposed Rules would codify FDA's long-standing view underscoring the circumstances that justify unilateral changes to labeling by the holder of the approved application

On January 16, 2008, the Food and Drug Administration (FDA) published proposed amendments to its rules governing changes to approved applications for drugs, biologics and medical devices (the Proposed Rules). (See 73 Fed. Reg. 2848, et seq.) Specifically, the Proposed Rules would amend current FDA regulations regarding changes to an approved new drug application, biologics license application or medical device pre-market approval application in order to codify FDA's long-standing view underscoring the circumstances that justify unilateral changes to labeling by the holder of the approved application, all before FDA formally approves a supplemental application for the labeling change. (See Id. at 2849.) The process for drugs, biologics or medical devices undergoing such a unilateral labeling change is commonly referred to as a "changes being effected supplement" or "CBE Supplement."

To the extent that state law (e.g., state product liability laws) should require unilateral labeling changes in circumstances that do not meet CBE Supplement standards for such changes articulated by FDA in the Proposed Rules, FDA asserts that such state law requirements are preempted under the doctrine of implied conflict preemption pursuant to the Supremacy Clause of the United States Constitution. (See Id. at 2852-2853.)

The Proposed Rules are part of a greater debate respecting FDA preemption. Indeed, the question regarding whether and when FDA labeling requirements preempt state law claims is currently before the Supreme Court of the United States in three separate cases that have been accepted for review during this term. These cases include Riegel v. Medtronic (Riegal v. Medtronic, Inc. 451 F. 3d 104 (2d Cir. 2006), cert. granted, 76 USLW 3017 (June 25, 2007) (No. 06-179)) and Warner-Lambert v. Kent. (Warner-Lambert Co., LLC v. Kent, 76 USLW 3020 (September 25, 2007) (No. 06-1498). Notably, Riegal has already been argued and awaits an opinion. On January 18, 2008, the Supreme Court granted a writ of certiorari in the third case, Wyeth v. Levine. (Wyeth v. Levine, ___A.2d___, 2006 WL 3041078 (2006), cert. granted, 75 USLW 3500 (January 18, 2008) (No. 06-1249).) In all these cases, the Solicitor General, on FDA's behalf, has weighed in strongly in favor of preemption. A central issue in this...