September 23, 2011
This article is an interpretation of current law and is offered for informational purposes only. This material is not legal advice and should not be construed or used as a substitute for the advice of an attorney.
On August 29, 2011, the non-profit consumer group, Public Citizen, filed a citizen petition with the FDA seeking changes to federal regulations that would overturn the United States Supreme Court's ruling in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). In Mensing, the Supreme Court held that state failure-to-warn claims against generic drug manufacturers were preempted by federal law mandating identical labeling by generic drug manufacturers and the brand equivalent. If the petition is granted, not only will the preemption defense provided by Mensing disappear, but, generic drug manufacturers will be burdened with new requirements, potentially expanding the types of claims they are subject to in state litigation.
Prior to Mensing, the issue of whether a generic drug manufacturer could be liable for inadequate or inaccurate labeling was in flux. While plaintiffs filed state law claims based upon a label's failure to provide adequate warnings of prescription drug risks, generic drug manufacturers argued that their hands were tied, since federal law required that their labeling be "the same as" the brand equivalent. However, the methodologies for making labeling changes that were available to brand drug manufacturers were not available to generic drug manufacturers. In Mensing, the Supreme Court agreed with the generic drug manufacturers' argument, holding that these manufacturers could not utilize the processes set forth in federal regulations that serve to notify the FDA of unilateral labeling changes, since the labeling for a generic drug must mirror that of the brand.
Public Citizen's petition requests that the FDA, through notice and comment rulemaking, amend the Code of Federal Regulations to give generic drug manufacturers the ability to change their labels through either the "Changes Being Effected" or "Prior Approval Supplement" processes, processes currently only available to brand manufacturers. The petition also requests that current regulations, which allow the FDA to withdrawal approval for a generic drug when the labeling does not match its brand name equivalent, be amended to specify that this penalty does not apply to generic drug manufacturers who change their labeling using the processes above. The FDA must provide a response to the Petition within 180 days.
The FDA's response has the potential to greatly impact insurers of generic drug manufacturers. Currently, the question of how the courts will apply the Mensing decision and its grant of federal preemption to state failure-to-warn claims is being addressed in drug litigation across the country. Granting the citizen petition, however, will allow state litigation to proceed unfettered against generic drug manufacturers. Furthermore, the types of state claims levied against generic drug manufacturers could expand if the FDA amends federal regulations to require these manufacturers to amend their labeling.
