Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases

Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal

Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application).

Federal preemption stems from FDA regulations that do not permit the holder of an approved ANDA to change labeling to add new safety information the generic company becomes aware of until and unless the brand name company that holds the NDA for the reference listed drug (RLD) modifies the labeling. This interpretation was affirmed by the U.S. Supreme Court in 2011 in the Pliva, Inc. v. Mensing case. The Court, however, left the door open when it added “Congress and the FDA retain the authority to change the law and regulations if they so desire.”

In November 2013, the US Food and Drug Administration (FDA) began the process to do just that when it published a proposed rule that will require generic drug companies to update the labeling of their drugs in light of new safety risks even though the RLD labeling for those products has different information on warnings, precautions, contraindications, adverse reactions and the like.

Under the proposed regulation, when the ANDA holder has “newly acquired information” that presents “sufficient evidence of a causal association” between the unlabeled warning and the approved generic drug, the generic manufacturer must submit a Changes Being Effected (CBE-0) supplement to its ANDA and immediately change its label. Also, the ANDA holder will be required to send the NDA holder both the labeling change and a copy of the information supporting the change. Any changes ultimately approved by FDA would affect both the generic label and the RLD holder’s labeling.

The FDA has noted that “if this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.”

Interested parties wishing to provide input on the proposed rule must submit comments by January 13, 2014. The full text of the proposed rule is available at this link.

The Pliva v. Mensing, 131 S.Ct. 2567 (2011) decision is available at this link: http://www.supremecourt.gov/opinions/10pdf/09-993.pdf.

About the Author: Alina Denis Jarjour is a business attorney, corporate governance / compliance professional and mediator. In addition to being a private practitioner, Alina has served in executive level legal, operational and governance/compliance roles within life sciences, telecommunications and technology companies. Her firm, Jarjour | Legal, works closely with clients engaged in the life sciences, tech / telecom, media, healthcare, consumer products and non-profit activities in and outside of the United States. Alina is an alumna of the University of Pennsylvania Law School, is bilingual (English/Spanish) and speaks frequently on business development, regulatory, compliance, conflict resolution and legal topics.

This article was originally published in the Florida Bar December 2013 Health Law Monthly Updates.

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