We aren’t the only folks on the web with opinions and commentary concerning the recent decision in United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), which (if you haven’t been following our prior posts) declared in essence that the truthful promotion of off-label use is protected speech under the First Amendment.  We’ve read a bunch of it − however, we must admit that after about the thirtieth law firm client alert stating “here’s what the court did; be careful; call us for real analysis, our eyes glazed over.  So here’s our collection of Caronia commentary that, for one reason or another, we found most interesting.
Other Bloggers
We’ll start with the always informative FDA Law Blog, which took a “deep dive”into Caronia yesterday.  It’s discussion has:  (1) a detailed rundown of how the FDA converts truthful speech about off-label use into a criminal offense (even if the FDA denies doing so); a schedule for future appellate steps in Caronia; a thoughtful analysis of how Caronia could influence prosecutions of different flavors of off-label promotion (including some distinctions between drugs and devices); and references a recent warning letter about the “evidence of intended use” approach that may become more prevalent after Caronia.
A lot of other bloggers who cover one or another aspect of the pharmaceutical beat have chimed in with Caronia commentary.  We found nicely detailed analysis and general commentary on the case at Policy and Medicine.
Point of Law has an interesting take on governmental coercion, or alternatively, why it took a drug representative to litigate this issue to a successful conclusion where multi-billion dollar corporations feared to tread.
The ACLU generally agrees with the First Amendment protecting truthful off-label promotion, and has a very accessible discussion of Caronia.  Their post raises a couple of interesting questions:  the First Amendment’s application to an experimental off-label use, and whether different rules should apply to advertisements (including DTC), as opposed in person discussions with doctors.  Maybe the ACLU will file an amicus brief if/when Caronia is further appealed.

Continue Reading Caronia Web Roundup

In our first-on-the-web quickie analysis of United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), we didn’t have time to do much more than unwrap the Second Circuit’s early Christmas present.  Now that we’ve had a little more opportunity to consider some (but not nearly all) of the implications of Caronia, we offer the following.
First and foremost, whatever anybody else might say, truthful off-label promotion is not all of a sudden “legal in the Second Circuit.”  Caronia was one individual’s successful appeal of a criminal conviction for conspiracy to introduce misbranded drugs in interstate commerce.  It was not a declaratory judgment action.  Neither the FDA nor the Department of Justice has been enjoined from doing anything.  The brave Mr. Caronia’s conviction has simply been vacated and remanded, rather than the action dismissed.  Theoretically, if it could prove falsity, the Agency could even (ignoring such things as the statute of limitations or double jeopardy) prosecute the poor guy again.  What Caronia actually held (as opposed to the court’s reasoning) was this:

[T]he government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.

2012 WL 5992141, at *15.  It did this by construing the FDCA (and with it, the FDA’s regulations) “narrowly” to avoid having to declare them unconstitutional.  That narrowing interpretation required that truth be a defense to a misbranding claim in the context of off-label promotion.

[E]ven if speech can be used as evidence of a drug’s intended use, we decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech.  We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.

Id. (emphasis added).  Although it’s by no means 100% sure, it looks like Caronia’s narrowing interpretation (the court invoked a legal doctrine of construing a statute narrowly to avoid constitutional challenge, id. at *10) carves out a truth exception to the statute itself.  So we’re probably incorrect to speak of a constitutionally mandated truth “defense.”  That would imply that the burden of proving truth is on the defendant.  By construing the statute as exempting “truthful off-label promotion,” it appears that falsity is now an element of off-label-related misbranding, with the burden of proof correspondingly falling on the government.

Continue Reading Caronia, Off-Label Promotion, And The First Amendment

The moment we saw the Supreme Court’s First Amendment decision in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), we knew it had implications for the FDA’s suppression of truthful commercial speech concerning off-label uses, and we said so.  Not only that, the dissent in Sorrell caught the FDA angle, too.  Id. at 2678. Only the dissenters didn’t like it – we did.
It appears that the first place that the Sorrell rubber is likely to meet the off-label promotion road is in our old friend, the Caronia case, which has been on appeal in the Second Circuit for what seems like forever.  As readers may recall, Caronia was an FDA “sting” where a doctor, wearing a wire, affirmatively sought out off-label promotion, and (through the manufacturer’s representative (Caronia)) drew another doctor (Dr. Gleason) who worked for a drug company, into a discussion of an off-label use.  Both the other doctor, and the rep, who facilitated the conversation, were prosecuted.  Nothing false was said, but the government went ahead anyway, and obtained a conviction.
Caronia had already been argued after Sorrell was decided.  The court (we think) on its own motion asked for additional briefing on Sorrell.  Those briefs were filed this past week.  The government’s brief – arguing in favor of criminal suppression of truthful promotion of off-label use – predictably takes the position that Sorrell doesn’t change anything.  Since we like to gripe, we’ll spend most of our time on that one.

Continue Reading Caronia, The Latest

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