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Proposed FDA Rule Would Overturn Mensing Decision

The United States Food and Drug Administration (FDA) has proposed a new rule in the Federal Register regarding generic drug labeling. On November 13, 2013, the proposed rule appeared in the Federal Register entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.”

The proposed rule would permit manufacturers of generic drugs to initiate changes to product labeling after the drug has already been approved, known as Changes Being Effected (“CBE”). This rule would thus overturn the preemption rulings of the 2011 United States Supreme Court case Pliva v. Mensing, where the Supreme Court held that state-law tort claims alleging failure to warn (i.e., failure to provide adequate warning labels) brought against manufacturers of generic medications are preempted by federal drug regulations.

The new rule proposed by the FDA would also require manufacturers of generic drugs to conform their product labeling to an approved CBE change within 30 days, whereas the previous FDA regulations only required manufacturers of generic drugs to do this as soon as possible. Finally, manufacturers of brand name drugs and manufacturers of generic drugs may now use the CBE process to add new warnings to the “Highlights” portion section of drug labels, which was restricted by the former FDA regulations.

The FDA sets forth the following summary in regard to the proposed rule:

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA’s review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a “changes being effected” (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA’s review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder’s CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the “Highlights of Prescribing Information” for drug products with labeling in the “Physician Labeling Rule” (PLR) format.

The FDA is allowing a 60-day comment period for the proposed rule, ending on January 13, 2014. At that time, the FDA will review all of the comments and publish a final rule.


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