Tuesday, August 30, 2011

Public Citizen petitions FDA to amend regulations to counter effect of Supreme Court decision

In PLIVA Inc. v. Mensing (available here), the US Supreme Court held that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state tort-law claims based on drug manufacturers’ alleged failure to provide adequate warning labels for their products. The regulations essentially require generic drug manufacturer to have the exact same labeling as the brand-name drug, which means that these manufacturers can't update their labels about new known risks unless the brand name manufacturers do so first or unless they get special permission from the FDA.  Brand name manufacturers are allowed to update their warning without having to seek special permission of the FDA.

In order to counter the effect of the Supreme Court's decision, prominent consumer advocacy group Public Citizen has filed a petition urging the FDA to revise regulations that prevent generic drug makers from updating their warning labels to include information about known risks associated with their drugs. The petition is available here.

For more on this story go to PharmalotAboutLawsuits and the FDA Law Blog.

For more on the US Supreme Court decision on the subject go here.

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