If you’ve been reading us for a while, you know how worked up we get about how the FDA’s overbearing and paternalistic regulatory scheme infringes on the free speech rights of manufacturers. And if you haven’t been reading us for a while (or just want a refresher), click on the “First Amendment” link to the right (or at the end of this post) and you’ll see our collection of Greatest Hits on the topic – some short and some long (hey, we warned you, we can get worked up about free speech).

One of those posts was about United States v. Caronia, a case where the government chose to prosecute a sales rep for promoting Xyrem off-label. Way back in 2008, we railed against the District Court’s decision to reject the defendant’s First Amendment arguments and deny a motion to dismiss, allowing this criminal case to go forward. Turns out we were right to be miffed; ultimately, the case went to a jury, which convicted the sales rep on the charge of conspiracy to misbrand Xyrem.

After a tortuous post-trial and sentencing process – one year probation, 100 hours community service, and a $25 fine in case you’re wondering – Mr. Caronia was finally able to appeal his conviction to the Second Circuit. The appellant’s opening brief and the Washington Legal Foundation’s (“WLF”) amicus brief were filed a couple of weeks ago, and we’ve had a chance to take a gander – and we’ve also seen this informative Legal Pulse piece from our friends at WLF, laying out WLF’s read on the case.

First things first. As we were perusing the briefs, a few facts struck us as either interesting or significant:

1) Mr. Caronia was convicted of promoting Xyrem to combat “excessive daytime sleepiness,” an off-label use at the time (Xyrem was approved at the time for the treatment of cataplexy in narcolepsy patients). But here’s the crazy part – FDA approved Xyrem for “excessive daytime sleepiness” very shortly after the off-label discussions took place. In fact, the government did not claim that the statements were false or misleading, and withdrew its original charge that Mr. Caronia engaged in fraud. So the speech at issue here was truthful and non-misleading – and it was speech about a lawful use of Xyrem. That didn’t matter to the government, though – in FDA’s eyes, a drug is “misbranded” solely because the promotion is for an off-label use, regardless of whether the information imparted is true or not. Talk about overbroad and not narrowly tailored to further a substantial interest…but we’re getting ahead of ourselves a bit.

2) The particulars of the government’s “sting” and the speech at issue are also significant. Mr. Caronia was encouraged to use his co-defendant, Dr. Gleason, as a promotional speaker on Xyrem. Back in 2005, Mr. Caronia received calls from Dr. Charno, a confidential government informant who asked for information about Xyrem. In response, Mr. Caronia brought Dr. Gleason to Dr. Charno’s office, where Dr. Gleason talked about an off-label use of Xyrem while Mr. Caronia sat quietly and listed. (According to appellant’s brief at p. 9, the informant repeatedly asked off-label questions pursuant to training he received from the feds). So now you have doctor A telling doctor B about a lawful off-label use largely because he was being pumped by doctor B, the information being provided is truthful and non-misleading, and the speech relates to a use for which the drug was approved shortly after. And yet the government still pressed this prosecution. Weird. And paternalistic. But we’re getting ahead of ourselves again.

3) Even weirder is that the government insisted on continuing to pursue Mr. Caronia even after the manufacturer of Xyrem took a plea bargain. In fact, the Vice President of Jazz Pharmaceuticals, the maker of Xyrem, testified at trial that she knew a conspiracy to misbrand Xyrem existed within the company, but had no knowledge of Mr. Caronia’s specific participation.

It will be interesting to see the government’s spin on these facts, because from where we’re sitting, this case is a real head scratcher. Why waste FDA resources, court time, and taxpayer dollars pursuing this case? And, coincidentally, put at risk the (unconstitutional) regulatory scheme that the government usually jealously guards – remember, after all, that these are the same guys who routinely try to moot constitutional challenges by approving a drug for the off-label use at issue (after the lawsuit’s been filed, of course. The WLF and Allergan challenges are two of the better-known examples of this tactic.). Or did the government think it could sneak away with a ruling against some poor guy in an obscure criminal prosecution? If so, that strategy has failed.

On the law, both the appellant’s brief and the amicus get it right – this is an unconstitutional speech ban unsupported by a sufficient government interest. First of all, there was nothing misleading about the truthful communication here. In fact, as WLF points out, Dr. Gleason was permitted to use Xyrem to combat “excessive daytime sleepiness.” He was also permitted to talk to patients about that use. And he was permitted to suggest that use to other doctors – at least until he was paid by the manufacturer. And even after he became a paid speaker, Dr. Gleason was still permitted to talk to other doctors about the off-label use in response to an unsolicited request for information. See WLF Brief at 5-6. This kind of speaker-based discrimination runs afoul of the First Amendment, particularly where that speech is about core scientific information affecting public health (nice turnabout, WLF – the public health mantra is usually the government’s justification for restricting this speech). Indeed, this is bizarro paternalism, allowing a doctor to say “use this stuff” to (mostly) medically uneducated patients, but not allowing a doctor (or the manufacturer, for that matter) to make the same suggestion to a sophisticated health care professional. See WLF Brief at 7.

Turning to the speech restriction at issue, both briefs hammer home the point that Central Hudson’s commercial speech test wasn’t satisfied here, because under that test, the government may regulate speech only if it proves that the government has a substantial interest, that the speech restriction directly advances that interest, and that the restriction is no more extensive than necessary. App. Brief at 38, WLF Brief at 9. Remember – the government’s position in the court below was not that the speech was factually inaccurate or misleading – rather, the government urged and got a conviction for truthful, non-misleading speech. See, e.g., WLF Brief at 22. So the speech ban had to be narrowly tailored to directly advance the government’s purported interest – a test that FDA’s regulatory scheme flunks:

1) With respect to FDA’s purported interest in ensuring that physicians receive “complete” or “accurate” information about a particular drug, it is absurd to suggest that a speech restriction about an off-label use pending FDA approval furthers that goal. In fact, it is paternalistic and antithetical to that goal, because it deprives doctors of valuable information. See WLF Brief at 24-25, App. Brief at 40-41.

2) With respect to FDA’s purported interest in encouraging manufacturers to seek approval for off-label uses, prohibiting speech is a curious and blunderbuss way to accomplish that goal. Both briefs catalog a number of alternatives short of a total speech prohibition that would incent manufacturers to seek approval. And manufacturers have plenty of encouragement to seek approval for widespread off-label uses. And, of course, this purported interest makes no sense where, as here, the manufacturer has already sought approval and is within days of getting that approval. But now we’re just piling on, so we’ll stop.

We’ll have to wait to see the government’s response to all of this, but based on what FDA’s been saying in Allergan, we have a pretty good hunch that we’ll be hearing more about the horrors of off-label use gone awry, and perhaps more “trust us, we would never use our vague regulatory scheme to infringe your rights.” Although it’s pretty hard to make that second argument on these facts. Here’s to the hope that the Second Circuit rejects those arguments and sees the First Amendment light (although we should note that the Second Circuit could dodge the issue if they accept the appellant’s alternative argument that the verdict sheet was erroneous). As always, stay tuned and we’ll let you know what happens.