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December 2011

Daily Journal Quotes Kai Peters re: Off-Label Drug Marketing and First Amendment Defense

On November 4, The Daily Journal published an article titled, "Drugmakers Rely on First Amendment and First Amendment Defense."  San Francisco Partner Kai Peters was consulted about and quoted on the impact a recent U.S. Supreme Court ruling is having on pharmaceutical manufacturers and their counsel, especially in light of the recent announcement of GlaxoSmithKline PLC's significant resolution of a high-profile government investigation.

While GlaxoSmithKline PLC recently announced their $3 billion plan to resolve a series of federal civil and criminal investigations regarding their alleged off-label drug marketing practices and other alleged fraud, other pharmaceutical companies are planning to fight off-label cases with the First Amendment based on the U.S. Supreme Court ruling in Sorrell v. IMS Health

FDA regulations, which make it illegal for drug manufacturers to market a drug for a use other than for the FDA approved indication (as was alleged against GlaxoSmithKline), have been challenged by drug makers in recent years.  Pharmaceutical companies have argued that longstanding FDA restrictions violate the First Amendment, recently adding the U.S. Supreme Court ruling in Sorrell v. IMS Health to their supporting case law.  In Sorrell, the Supreme Court stated that, "if a law restricts truthful, non-misleading commercial speech on the basis of its content and the identity of the speaker, that law 'must be subjected to heightened judicial scrutiny.'"

Mr. Peters provided his assessment of the free speech argument, stating,  "[Sorrell] gives pharmaceutical and medical device companies some hope that the defense is stronger than it was before.  On the other hand, it is by no means a really strong defense or a defense that will be absolutely successful."  

Kai Peters