It’s been over two years since the FDA – in March, 2014 Draft Guidelines and then in its June 2014 “grant” of an industry-submitted citizen’s petition – promised to review its restrictions on so-called “off-label promotion” by regulated drug and medical device manufacturers.  We were skeptical at the time that all we would get is “still more agency bobbing and weaving.”

Then two years with zilch – save more Agency First Amendment losses in off-label promotion cases.  Then industry gets sufficiently frustrated by FDA inaction on off-label communication issues that it starts to take matters into its own hands.

So, a month later, we finally hear from the FDA again.

Finally, some action?

Don’t bet on it.

On August 31, 2016, a notice appeared in the Federal Register entitled “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments.”

Wonderful.  More talk, and the FDA kicks the can further down the road.  Once again the Agency refuses to recognizes the constitutional bind in which it finds itself.  Indeed, the term “First Amendment” doesn’t appear anywhere – not even once – in the notice.  Nor does the FDA so much as utter the phrase “off-label.”  Except for citations, the FDA uniformly uses the more pejorative term “unapproved.”

If not the First Amendment, then, what do we have?


Continue Reading More Talk – No Action – From FDA on Off-Label “Communication”

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011); Thompson v. Western States Medical Center, 535 U.S. 357 (2002); United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); and Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), to name the most notable.  The FDA has promised action on a number of occasions, but has never delivered.  This stonewalling has even caused the Pharmaceutical Research & Manufacturers of America (“PhRMA”) to force the issue by filing amicus curiae briefs in litigation, as we discussed here a couple of years ago.

The longstanding disconnect remains. What the FDA purports to prohibit, and what the First Amendment actually allows, in terms of truthful communications by regulated manufacturers about off-label uses are two very different things.  So PhRMA, joined this time by the Biotechnology Innovation Organization (“BIO”), is charging once more unto the breach, this time with its own industry-practice “principles” concerning off-label communications.  Here’s a link to the document itself, which is called “Principles on Responsible Sharing of Truthful & Non-Misleading Information about Medicines with Health Care Professionals and Payers.”  That’s a mouthful, so we’ll just call it “Industry Principles” in this post.

Essentially, these industry organizations are drawing a line in the FDA’s regulatory sand – telling the Agency, and their own members, that they will fill the gap caused by administrative dithering themselves. Notably, since PhRMA has already shown its willingness to litigate First Amendment issues against the FDA, we would not be surprised to see these guidelines form the basis of industry’s First Amendment position in future court challenges.

The Principles’ introduction first states the reason off-label communication is needed: “Scientific knowledge and new findings go far beyond . . . clinical trials, often are outside the scope of [FDA] parameters . . ., and often outdate the FDA-approved labeling.”  Industry Principles, at 1.  The introduction then explains why the industry cares so much.  “Biopharmaceutical companies are uniquely positioned to help health care professionals achieve the best outcomes for patients, because companies can provide timely, accurate, and comprehensive information about both approved and unapproved uses of [their] medications.” Id. Finally, it states what the industry is doing about it from this day forward.

These Principles are intended to form the basis for defining new and clear regulatory standards governing responsible, truthful and non-misleading communications to inform health care professionals about the safe and effective use of medicines.

Id. In other words, in default of FDA action, industry will set its own standards for off-label communications (including those that the FDA calls “promotion”), and will defend them in whatever fora are necessary, including in court.


Continue Reading Off-Label Marketing – Industry Groups Step into the Breach

Lately, we’ve seen some plaintiffs add gag order requests to their complement of in limine motions in advance of significant trials. Those of us who participated in the Bone Screw litigation remember plaintiffs attempting – and failing − to prevent the defendants from communicating with their customers (implanting physicians) about that litigation.  Unfortunately, no order resulted.  The first gag order relating to advertising involving civil litigation was entered at about the same time as our Bone Screw brouhaha in a securities-related case. Koch v. Koch Industries, Inc., 2 F. Supp.2d 1409 (D. Kan. 1998).  The court gagged both sides equally, and only after both sides agreed.  Id. at 1415 (“plaintiffs also ask the court to enter an order prohibiting the defendants from advertising” [and] “defendants apparently agree that the court should preclude both sides . . . from advertising”).

Advertisements published or to be published by the parties in this case, whether selling products or ostensibly serving the public interest, seemingly carry messages directed at swaying public sentiment to that party’s side in this case. In short, this case will tried in the courthouse; any attempt to try this matter in the media ends now.  In reaching this decision, the court has considered less restrictive means of preventing unfair prejudice attributable to pretrial publicity.  Unfortunately, the court can devise no content-based restriction that will be fairly and equally applied to the parties.  In light of the parties’ respective requests for restraint, a total ban on advertising is not only simple and expedient, but seems most equitable.

Id. See also Pfahler v. Swimm, 2008 WL 323244, at *2 (D. Colo. Feb. 4, 2008) (rejecting plaintiffs’ request for civil gag order).  Moreover, no matter what the parties might have been trying to communicate to potential jurors in Koch (there had also been a rather questionable opinion “poll” taken by one of the parties), we’re sure that they weren’t discussions of life saving medical products – or even corporate feel-good advertising of the sort seen while watching “Meet the Press” and other similar Sunday talk shows.


Continue Reading In Limine Gag Orders – Can We Play, Too?

A lot of firms have already expended a lot of ink discussing the proposed memorandum of settlement filed on March 8, 2016 in Amarin Pharma’s First Amendment litigation against the FDA Here’s a link to Reed Smith’s. We’ll try not to be repetitive of what everybody else has been saying. Four points that we haven’t seen elsewhere:

Agreement to be “bound”

Sure, the FDA has “agreed to be bound,”− but to what? The phraseology preserves agency options:

Defendants agree to be bound by the Court’s conclusion that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa and, under United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), such speech may not form the basis of a prosecution for misbranding.

Proposed Amarin Settlement, first numbered paragraph. In the first clause, the FDA simply binds itself to a “conclusion” regarding “speech promoting the off-label use of Vascepa” (the drug in question). That’s very case specific.

The second clause, however, is capable of a different meaning. In that clause, the FDA binds itself to the conclusion that “under [Caronia], such [truthful and non-misleading] speech may not form the basis for misbranding.” By its terms, this second conclusion is not tied to the facts of the Amarin case. It looks like a general agreement to be bound, broad enough to be invoked by other companies. Maybe it is; maybe it isn’t, but anyone who might later seek to argue that the FDA is collaterally estopped by the decision in Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015) – to the extent that’s even possible under United States v. Mendoza, 464 U.S. 154, 162-63 (1984), something that would take more time to examine than we have at the moment − can find support in this clause. In any event, since courts rather than the FDA now have the last word on the First Amendment question, any limitation that the FDA might try to put on this concession will end up being litigated.


Continue Reading Examining The Amarin/FDA Off-Label Promotion Settlement

The other day, we posted about, inter alia, the Department of Justice’s proposed jury instruction, in the Vascular Solutions case in Texas conceding the legality of truthful off-label promotion.  In that post we asked, “Has anybody else seen the United States government make such a statement in a filed court document before?”  Friend

As we mentioned before Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label use/promotion.  Just about all our readers know that Bexis has been a long-time First Amendment advocate with respect to truthful off-label speech, since the beginning of this blog, and before.

We’re not going to rehash any of that.  There are, however, a couple of new First Amendment developments that we learned about at the conference that we want to pass along.  The first is that the Ninth Circuit (or at least a panel of that notably fractious court) has fallen into line behind Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011), and recognized that Sorrell strengthened First Amendment protections for commercial speech – at least where it’s truthful, which is the assumed cornerstone of our position on off-label promotion in the first place.

The new case is Retail Digital Network, LLC v. Appelsmith, ___ F.3d ___, 2016 U.S. App. Lexis 140, slip op. (9th Cir. Jan. 7, 2016).  It’s not about drugs, devices, or the FDCA, but rather about alcoholic beverage advertising.  At issue was another absolute ban on commercial speech that failed to take truth or falsity into consideration.  The state of California, in order to prevent kickbacks and other preferential treatment (taking the state’s professed interest at face value), flatly prohibits manufacturers of alcoholic beverages from any paid advertising at retail establishments.  Id. at *2-3 (citing Cal. Bus. & Prof. C. §25503(f)-(h)).  Almost 30 years ago the Ninth Circuit held this provision constitutional under the pre-Sorrell commercial speech test established in Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557 (1980).  See Actmedia, Inc. v. Stroh, 830 F.2d 957 (9th Cir. 1986).  Retail Digital, however, held that Sorrell toughened First Amendment protections.  The Actmedia decision was “clearly irreconcilable” with Sorrell, because “Sorrell requires heightened judicial scrutiny of content-based restrictions on non-misleading commercial speech regarding lawful products, rather than the intermediate scrutiny” of Central HudsonRetail Digital, 2016 U.S. App. Lexis 140, at *3.


Continue Reading Latest First Amendment Off-Label Notes – Has DoJ Finally Come Around?

The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  A couple of anonymous, obviously plaintiff-side, comments to our “breaking newsAmarin post suggested that the Amarin First Amendment victory for truthful off-label promotion might have a downside.  Both comments raised the same issue:  what happens to “impossibility” preemption in the drug warning context once First Amendment protection is extended to truthful pharmaceutical promotion?

One response would be that, if such speech is fully protected, as the Supreme Court indicated in Sorrell v. IMS Health, Inc. – “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment” − 131 S. Ct. 2653, 2660 (2011), then it’s game over.  The same First Amendment protection equally precludes private suits under New York Times Co. v. Sullivan, 376 U.S. 254 (1964).  “What a State may not constitutionally bring about by means of a criminal statute is likewise beyond the reach of its civil law.”  Id. at 277.  See also In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994) (First Amendment precluded product liability action).  Sullivan also roundly rejected the “commercial” overtones of otherwise fully protected speech as a basis for suppressing it through tort litigation:

The publication here was not a ‘commercial’ advertisement. . . .  That the [defendant] was paid for publishing the advertisement is as immaterial in this connection as is the fact that newspapers and books are sold. . . .  To avoid placing such a handicap upon the freedoms of expression, we hold that if the allegedly [tortious] statements would otherwise be constitutionally protected from the present judgment, they do not forfeit that protection because they were published in the form of a paid advertisement.

376 U.S. at 266 (citations and quotation marks omitted).


Continue Reading When They Don’t Have Anything, They’ll Try Anything

Today is Veteran’s Day.  This is a holiday that escapes the attention of too many people – until they stare at their empty mailboxes in puzzlement.  It is a federal holiday, but most of us go about our usual business. Too bad. The holiday was originally designed for parades and gratitude.   Veteran’s Day was Monday-ized between 1968-75, but right-minded people with a sense of history insisted that it be restored to traditional, date-specific status.  Veteran’s Day is celebrated on November 11 because that is the anniversary of the World War I armistice.  In 1918, the guns went silent on the eleventh hour of the eleventh day of the eleventh month.  The meaning of that date is more important than creating yet another three day weekend to encourage folks to travel and spend.  Odds are that you know of someone in your own family history who served this country in time of war.  Maybe there is a legend about a great-great grandfather who huddled in Flanders’ fields in the Great War.  Or a Marine who hit the beach at Iwo Jima.  Or a soldier who flew helicopters in Da Nang but never wanted to talk about it.  Or a college roommate who is grateful his time over in the sandbox was relatively short.  Or a friend in the reserves who just last month was called to Afghanistan to help move some hardware home.  Maybe you had a big lump in the throat when you shook hands good-bye.

Thanksgiving is three weeks away, but today is also a day for thanks.

President George H.W. Bush is a veteran.  He was a navy aviator in World War II.  On September 2, 1944 Bush piloted a Grumman TBM Avenger plane that attacked Japanese installations on Chichijima.  Bush’s aircraft was hit by flak and his engine caught on fire. Nevertheless, Bush finished the mission and released bombs over his target, scoring several damaging hits. With his engine ablaze, Bush flew several miles away from the island, where he and one other crew member bailed out.  The other man’s parachute did not open. Bush waited for four hours in a raft,  until he was rescued by the lifeguard submarine USS Finback.  According to Bush, while he floated in the Pacific, not knowing for sure whether he would make it, he thought about many things, including the Bill of Rights.  Some ridiculed that story, but are we really so cynical as to discount the possibility that someone contemplating  what they were fighting for might think it right and even a little noble to be on the side that favors freedom of speech?  Thanks to that Greatest Generation, and thanks to all the great generations that followed who served to preserve our freedoms, including the freedoms of defense hack lawyers like us to scribble our silly blogs.

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Today’s case actually has something to do with freedom of speech.  It is an off-label/first amendment speech with a twist – the plaintiff doctor sued a writer for criticizing his off-label use of a drug.  The action was brought under both the Lanham Act and Florida common law.  The issue was whether the speech in question was the type of commercial speech that might be susceptible to such claims (with all the requisite balancing) or whether it was noncommercial speech that was immune from attack.  In Tobinick v. Novella, 2015 U.S. Dist. LEXIS 150083 (S.D. Florida Sept. 30, 2015), the court decided that the speech at issue was not actionable under the Lanham Act because it is not commercial speech, and that the Florida unfair competition claims failed as well because they rely on a similar theory of liability.


Continue Reading Happy Veteran’s Day/In Praise of Free Speech and a SD Fla. Decision

Today we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use.

First, we’ve mentioned Pacira Pharmaceuticals v. FDA before as the latest First Amendment follow-up action to Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  What we have for you now are the two industry-side amicus briefs filed in support of Pacira’s First Amendment motion against the FDA.  This one was filed by PhRMA, and this one was filed by something called the Medical Information Working Group, which is a consortium consisting of Amgen, Bayer, Boehringer, Lilly, Genentech, GSK, J&J, Novartis, Novo Nordisk, Pfizer, and Sanofi.  Impressive lineup.  And to think we can remember when nobody was willing to take on the FDA about truthful off-label promotion for fear of retaliation….  What a difference a few wins make.

We’ve read through the two amicus briefs and we heartily recommend them to anyone interested in bringing the FDA’s reign of (t)error in this area to long-overdue end.  Briefly, the MIWG brief makes the following points:  (1) the FDA’s ban is an “ambiguous tangle of regulations, nonbinding guidance documents, and severe enforcement practices”; (2) pharmaceutical promotion is First Amendment protected speech under Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011); (3) truthful off-label promotion provides valuable information to physicians and patients alike; (4) what FDA claims is “misbranding” is the same information it has pledged in other contexts to “work hard to address”; (5) Pacira’s speech is really on-label promotion that the FDA has attempted to suppress through an improperly crabbed reading of the drug’s intended use; (6) off-label use is legal, common-place, medically valuable, and sometimes the medical standard of care; (7) more truthful speech about off-label use is better than less; (8) the FDA’s ban unconstitutionally discriminates on the basis of both speaker and content; (9) the basis for the FDA’s ban is unconstitutionally vague and ambiguous; (10) FDA’s “safe harbors” are arbitrary and constitutionally inadequate; (11) the FDA has taken inconsistent positions on what off-label promotion is allowed; (12) the FDA has never even defined “promotion”; (13) the FDA’s vagueness and contradictory policies chills protected speech − truthful pharmaceutical promotion; and (14) because of this chilling effect there is both standing and justiciability.


Continue Reading First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell