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FDA Proposes to Speed Safety Information Updates on Generic Drugs

Tuesday, November 12, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has proposed a controversial regulation that would permit updates to generic drug labeling to account for new safety information even before the labeling for the reference brand name drug has been updated. Comments on this proposal are due no later than Jan. 13, 2014. For more information about the proposed rule, or for assistance in preparing and submitting comments, please contact Arnie Friede or Shelly Garg.

If adopted, the proposed regulation would reconcile the inconsistent treatment of generic drugs and brand name drugs in terms of the ability to make unilateral changes in labeling to account for new safety information, which in theory would put generic drug and brand name drug manufacturers on an equal footing with respect to product liability. FDA believes this is reasonable given that generic drugs represent about 80% by volume of prescription drugs sold in the United States. 

The disparity that the FDA rule seeks to address is grounded in separate rulings by the U.S. Supreme Court. Under the Hatch-Waxman amendments to the Federal Food, Drug and Cosmetic Act, the labeling for a generic drug must generally be the same as the labeling for the reference brand name drug. In Pliva v. Mensing, the U.S. Supreme Court held that because there was no existing mechanism for the holder of an approved abbreviated new drug application for a generic drug to unilaterally change its labeling to account for new safety information before the brand name manufacturer changed its labeling it was impossible for an ANDA holder to modify its labeling to account for product liability concerns. Accordingly, the court held that product liability claims against generic manufacturers were preempted by federal law. By contrast, in Wyeth v. Levine, the Supreme Court held that, absent clear evidence that FDA would not have approved a labeling change to account for new safety information, the manufacturer of a brand name drug could be held liable in a product labeling action based on a failure to warn theory. 

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