Could ANDA Holders Be Responsible for Making Safety Label Changes to Warnings Before Innovators Are?

Could ANDA Holders Be Responsible for Making Safety Label Changes to Warnings Before Innovators Are?

Written by Bob Pollock • February 05, 2013

We all know that the Supreme Court decision in Pliva Inc v Mensing, 131 S. Ct. 2567 (2011) (“Mensing”) preempted failure-to-warn claims for generic applicants who may not, under the current regulations, revise their warnings until such time as the innovator’s label is revised.  In addition, the Court in Mensing affirmed that the generic drug label must be the “same as” that of the Brand name or innovator drug product (with limited exceptions not relevant here).  However, in a footnote contained at the bottom of page 15 in a January 2013 Amicus brief filed by the Government to the Supreme Court in Mutual Pharmaceutical Company Inc., Petitioner, v Karen L. Bartlett hints that changes to that long-held principle may be coming soon.

The footnote, reproduced below, implies that the FDA is actively looking to revise its regulatory framework as it relates to certain labeling changes that can be made by the generic applicant.


“2This Office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.  If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers. “


The implications of the Agency’s efforts will obviously hinge on what the term “appropriate circumstances” will mean in the proposed regulation.  Care must be taken to avoid situations where labeling for the same generic product may have certain differences in labeling, thus making it difficult for consumers and healthcare practitioners to rely on any one product’s label for all appropriate warnings and information for a specific drug.

Many generic products have as many as 10-15 approved applications.  One could imagine the confusion among consumers in the marketplace if all 15 products had somewhat different warnings.  One premise of the Hatch-Waxman Act is that therapeutically equivalent generic products can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.  That expectation applies also to the sameness of labeling relative to warnings, precautions, adverse events and contraindications. 

The Industry must keep a close eye on the Agency and evaluate any such Proposed Rule to change the labeling requirements under the Hatch-Waxman statute to assure that there will be predictability and consistency in labeling for specific products, and also that the liability associated with any such Proposed Rule does not change the careful balance for generics that was struck when the legislation was first passed in 1984.