Thursday, December 13, 2012

Caronia Web Roundup


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 LawBlog, 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 referfences 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.

Modern Health Care discusses Caronia’s potential impact on the government’s civil litigation through which it has monetized its now-unconstitutional ban on truthful off-label promotion.  The piece is also helpful in identifying other pending appeals that raise similar First Amendment issues, which could produce either additional headaches for censorious regulators – or else circuit splits for appeals to the Supreme Court.

Other bloggers focus on that might be considered “false” – or in the alternative “true”–  in the context of off-label promotion, see Pharmalot (a piece written by Arnie Fried, who’s usually a friend of the blog), and PharmaExec, raising the prospect of utilizing the FTC test for this task.

The folks at Health Reform Watch have an interesting piece on speech as evidence of intent and query whether there was some way for the government could improve its woeful record in Caronia on appeal.

Forbes has a post particularly interesting for criminal practitioners, about Caronia’s impact on misdemeanor misbranding prosecutions.

Law Firms

We’re not going to bother with “alerts” that just describe the holding and say “call us for advice.”   We’ve already done the former, and the latter is obvious.  But some firms put out alerts with information or viewpoints that we found interesting.  Fulbright & Jaworski , for example, delves into whether Caronia’s reach could be limited to criminal prosecutions.

Kaye Scholer offers more meat in its “analysis” than most law firm commentary:  on issues like falsity, likely government responses, and other pending cases.

Morrison & Foerster takes a look at Caronia from the white collar criminal defense point of view, but they left us freeloaders wanting more.  The same could be said for Sidley’s Original Source blog, which touches on the Caronia’s False Claims Act implications.  It raises the interesting point whether the truthfulness of off-label promotion could be affected by whether the use is a “medically accepted indication” for Medicare purposes (another way of phrasing the ACLU question), but stops there.  Beggars can't be choosers, we guess.

Fagre’s Beyond Healthcare Reform blog raises the interesting issue of whether Caronia could be avoided “by focusing on the distribution of a drug without adequate directions for the intended off-label use,” but again we would have liked to read more about this.  Another interesting Faegre product is a video discussion of Caronia (more entertaining than the usual written memo), including friend of the Blog Prof. Ralph Hall.

Covington’s Inside Medical Devices blog mentions something near and dear to our hearts, the applicability of Caronia to medical devices, but leaves analysis of this important question to paying customers (the 47% will have to make do with the discussion of that issue in our most recent post).

Gibson Dunn’s offering includes a useful checklist of the larger “areas” implicated by Caronia.

Law Schools

Not much out of academe yet (it takes time to check all those footnotes), but the Cantabs (that’s Harvard to those of you not used to Ivy League nicknames) are on it.  One piece from them advocates dissemination of more rather than less information about off-label uses, but comes close to advocating the kind of counter-detailing disapproved in Sorrell.  Another of their offerings agrees that the burden of proof has been shifted, but doesn’t seem to like it very much.

The HealthLawProf Blog points out something we’d missed – that Judge Livingston, who dissented in Caronia, had also dissented in Sorrell, with little if any impact on the Supreme Court’s result.  They also caution against a “Pyrrhic victory” by the pharmaceutical industry – something we were already considering years ago.  See E. Blackwell & J. Beck, “Drug Manufacturers’ First Amendment Right To Advertise and Promote Their Products for Off-Label Use:  Avoiding a Pyrrhic Victory,” 58(3) Food & Drug L.J. 439 (2003) (Pubmed link here).

Our Side

In the wake of Caronia the American Enterprise Institute released a white paper about the public health consequences of the government’s prosecution of truthful off-label information, and its monetization of First Amendment violations; but we have to think that Caronia was only the excuse – that the rest of the piece had been completed in advance and AEI was just waiting to plug in a couple of paragraphs about the decision.

We specifically looked for commentary at the Washington Legal Foundation, which distinguished itself by filing an amicus brief in Caronia, but didn’t find anything substantive.

The Other Side

ATLA doesn’t like Caronia.  No surprise there.  Public Citizen probably doesn’t either, although they’re being  remarkably tight-lipped about it.

In a classic example of how the press will distort things and report only what it wants to, here’s a critical article from the LA Times that amazingly doesn’t even mention that the dispute in Caronia was over “truthful” promotion.  A blog called SkepticalRaptor made the same mistake.  Caronia would be a very perplexing decision indeed if it allowed false off-label promotion – but it simply doesn't.

As our own commentary about the burden of proof issue suggested, the FDA is apparently “horrified” that it might actually have to prove that off-label promotion is false, according to this article in PharmaExec.

Miscellaneous

The New England Journal of Medicine put out a “Perspective” on Caronia, which we include for completeness.  While it explains to doctors what’s going on, it doesn’t do much for us lawyers.

1 comment:

Anonymous said...

I am still wondering how "truthful" promotion means in practice.

1. If there is one published study suggesting good safety/efficacy balance and 4 studies (unpublished) of which company is aware that show the contrary, is promotion of that indication "truthful"?

2. Does it matter if FDA has the unpublished data?

3. Do all five studies need to be mentioned to be "truthful"?

4. Must one prove conscious intent to deceive--as opposed to, well, speculative reflection--in order for promotion to be "truthful"?

5. If speculative reflection is presented as something more substantive than speculative reflection--like: "Yeah, we're working on that; very promising possibilities"--is it "truthful"?