A criminal case against a low-level pharmaceutical employee, charged with improperly promoting an FDA-approved drug for an off-label use, is rapidly developing into a major test case of whether FDA’s efforts to ban truthful speech conflict truthful speech.  This week, the U.S. asked that one of its top appellate advocates be permitted to participate in oral arguments.  

Alfred Caronia is appealing to the Second Circuit in New York from his conviction for promoting the sale of a “misbranded” drug.  The drug in question, Xyrem, is FDA-approved; but FDA contends that any drug should be deemed misbranded if it is being promoted for an off-label use, i.e., a use not approved by FDA.  FDA does not contend, however, that anything said by Caronia was untruthful, and the off-label Xyrem uses of which he spoke have now been approved by FDA (and thus are now part of Xyrem’s amended labeling).

When briefing was completed last month, the Second Circuit initially stated that it would decide the case without oral argument – a strong signal that it was likely to affirm the conviction.  But after reviewing a First Amendment brief submitted by the Washington Legal Foundation in support of Caronia, the court changed its mind and set the case for oral arguments.  Then WLF asked (with the consent of all parties) to be permitted to participate in oral arguments, for the purpose of arguing that FDA violated the First Amendment by seeking to impose criminal sanctions on Caronia for speaking truthfully.

This past week, the United States asked the court that it be permitted to bring in its own reinforcements for oral arguments.  An Assistant U.S. Attorney from Brooklyn was initially scheduled to argue for the prosecution.  But the U.S. has now asked that it be allowed to add Douglas Letter to its roster.  Letter, a veteran attorney in the Department of Justice’s Civil Division in Washington, is considered one of the federal government’s top appellate advocates and a First Amendment expert. 

FDA apparently is beginning to recognize that First Amendment challenges to its authority are being taken seriously by the federal courts.