Announcement of the decision from the US Court of Appeals for the Second Circuit in the United States v. Alfred Caronia generated a lot of discussion this past week, as well it might. The appellate court overturned the criminal conviction of pharmaceutical sales representative Alfred Caronia for off-label promotion of Xyrem, prescribed primarily to prevent narcolepsy. Caronia raised several defenses at trial, among them a First Amendment Freedom of Speech Motion to Dismiss which was denied. At the end of the trial Caronia was found guilty and sentenced to a year’s probation, 100 hours of public service, and a $25 dollar “special assessment’.

He appealed to the Second Circuit on several issues, including the freedom of speech claim, which, as it turns out, was all the three judge appellate panel needed to reverse, 2-1: “We conclude simply that the government cannot prosecute pharmaceutical manufacturer’s and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” (Slip Opp. at 51) There was also a vigorous dissent.

There’s no shortage of public/media discussion regarding what happens next. FDA could appeal to the United States Supreme Court, but at what cost to the regulatory scheme if they lose? Since this is an appellate court, the ruling directly effects only the states in the circuit, Connecticut, Vermont and New York. Does FDA stand pat? Does Pharma deploy the first amendment defense every time rather than pay some of those record-setting fines?

Just a few points to consider which could come out differently in a different court (all emphasis added):

Both the opinion and the dissent spent a good deal of time discussing whether or not the speech itself had been prosecuted or that the speech was merely evidentiary, i.e., it demonstrated Caronia’s intent to sell product for an off label use. If it’s the latter, Mr. Caronia still has to write that $25 check and clean up roadsides. The court ruled that it was the speech itself, quoting liberally from the District court transcript. The dissent thought the speech was evidentiary, and had plenty of quotes as well. So in another case, is all FDA have to do is make sure to emphasize that the speech itself is not being prosecuted?

• An important point raised several times in the opinion is that the FDCA does not expressly prohibit off-label promotion and that off-label use of drug products by doctors is completely legal while off label promotion by manufacturers/sales representatives is not. The court never mentions, or perhaps avoids mentioning, that the FDCA grants FDA authority over promotions but not the practice of medicine.
• Another important point was that some folks are legally allowed to discuss off-label use and others are not. For example, the court cites FDA’s own “Good Reprint Practices” to illustrate the disparity.
• Both the opinion and the dissent discussed at length the type of speech Mr. Caronia engaged in. This is important because for First Amendment purposes there are different types of speech which are afforded different levels of protection from government imposed limitations, which, in turn, receive different levels of scrutiny and “tests” to determine if they are permissible. For example, commercial speech, someone trying to sell you something, gets a lower level of protection than political speech. The same applies to the level of scrutiny applied to the limitation placed on the speech by the government. Somewhat surprisingly, the court found that Mr. Caronia was engaged in “content-based” speech. For this type of speech, any limitation imposed by the government must withstand a “strict scrutiny” standard, which is quite high. The dissent felt that the speech was commercial speech. Again, no telling what other judges might conclude.
• Finally, the opinion noted “Of course, off-label promotion that is false or misleading is not entitled to First Amendment protection” (Slip Op at 42). The accuracy, or lack thereof, of Mr. Caronia’s statements was not at issue in the District Court case. Readers might find the transcripts of the tape recordings the government presented at trial instructive, however (Slip Op at 15, 16).

It’s hard to say what’s next, but it likely won’t be dull.