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Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice things about Dr. Gottlieb before his confirmation.

Not so now.

Given what Dr. Gottlieb has said

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This guest post is from Liz Minerd, an associate at Reed Smith.  She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight Memo” on the same topic, we were only too happy to say “yes.”  So here is some in-depth analysis of the FDA’s rather unusual decision to, in effect, comment on its own meeting.  As always, our guest posters deserve all the credit, and any blame, for their efforts.

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As this blog reported here, last week—two days before the change in administrations—the FDA released a memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” available here. The Agency characterizes this 12th hour memorandum as a follow up to the two-day public meeting it held on November 9-10 regarding off-label promotion (or what the Agency refers to as “communications regarding unapproved uses of approved/cleared medical products”).  In particular, the Agency claims that it is issuing this memorandum to provide “additional background” in response to frustrations expressed by certain speakers during the November meeting regarding the Agency’s failure to adequately address the First Amendment in the public hearing notice.

However, the real purpose of the memorandum appears to be to set forth the Agency’s justification for their current restrictions on off-label promotion before a new administration and a new FDA commissioner could have a chance to revisit them. Indeed, after briefly noting the First Amendment concerns raised at the November meeting, the Agency spends the first twenty pages of the memorandum detailing its oft-repeated policy justifications for its current restrictions before addressing any of the First Amendment jurisprudence that has called those restrictions into question.  Its attitude is reflected in the memorandum’s first case citation—to the dissent in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).  [Memorandum, at p. 2. fn. 3]  The Agency’s lengthy policy discussion demonstrates that the outgoing policymakers at the FDA find very little benefit in communications from manufacturers regarding off-label uses even, though it recites that off-label uses can be the standard of care in some circumstances.  This attitude, that only the Agency can keep the public sufficiently safe, is classic governmental paternalism of the sort that the United States Supreme Court has repeatedly condemned in its First Amendment decisions over the past several decades.

For example, the Agency asserts that it seeks to “motivate” the creation of “robust scientific data” about the safety and effectiveness of drugs. [Memorandum at 4-5]  However, the current prohibitions only do so prior to approval of a product.  After approval—a time period usually much longer than the approval process itself—the current prohibitions prevent the same manufacturers from providing the same sorts of scientific data to the same audience.  Thus, the Agency’s current prohibitions actually interfere with the continued creation of robust scientific data after approval.  For example, a manufacturer can be required to post clinical trial results concerning an off-label use [Memorandum at 17-18], but is prohibited from informing doctors that they can view the results on ClinicalTrials.gov and decide whether their patients might benefit from the studied use.Continue Reading Guest Post – Midnight Madness − The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion

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Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of  the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion restrictions – although the official agenda steered away from both the terms “off-label” and “promotion”.  What follows is her summary of two days of testimony from over 60 speakers, some of whom thought that it was crazy that any damn fool can say whatever s/he wants about off-label uses, except for manufacturers, who can’t even tell the truth although knowing the most about them due to ongoing pharmacovigilance obligations, and other speakers who … do not.

As always, our guest poster deserves 100% of the credit (and any blame) for her post.  We’re only the piano-players.  Take it away Liz.

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Last Wednesday and Thursday (Nov. 9-10, 2016), the FDA conducted a public meeting on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  The FDA’s notice of the meeting (available here) stated:

FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.

What that means, stripped of regulatory jargon, is that the FDA public meeting involved potential updating of the FDA’s decades-old prohibition on truthful promotion of off-label uses by regulated manufacturers.Continue Reading Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

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We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time.  (Like here, here, and here, among many posts.)  The court battles that have garnered so much attention recently can be traced back to at least the 1990s, with the famed decision in Washington Legal Foundation v. Henney, 56 F. Supp.2d 81, 85 (D.D.C. 1999), vacated as moot by 202 F.3d 331 (D.C. Cir. 2000).  There can be lots of talk about what FDA’s policy is on what a manufacturer can and cannot say about unapproved uses for its drug or device.  Discussions about changing 21 C.F.R. § 201.128 (drugs) & 801.4 (devices) have dragged on for a while, even with the Amarin settlement and with other FDA statements suggesting that the regs do not reflect current policy.  FDA policy, of course, involves more than just a few sentences in a regulation or guidance document.  Particularly for a prohibition that has long been the crux of FDA enforcement—like warning letters and prosecutions—and has spawned or played a major role in subsidiary FCA, RICO, and product liability litigation, a decision to stop prohibiting truthful, non-misleading statements about unapproved uses for drugs and devices is not exactly the end of the story.  For one thing, criminal prosecutions that are based at least in part on manufacturer statements about unapproved uses are always on-going and U.S. cannot just hit the reset button in those cases.

We do not often post about decisions from, let alone briefs filed in, criminal cases brought pursuant to the FDCA.  That FDA enforcement sometimes results in prosecutions is something that comes up in our cases and posts, often in the context of preemption and primary jurisdiction—the FDA does not just have the authority to root out misbranded and adulterated medical products and fraud in connection with approval or post-approval reporting, but companies and individuals get prosecuted, so you should be comfortable respecting FDA’s authority, Your Honor.  It also comes up sometimes when there has been a prosecution that resulted in an indictment, plea, conviction, or sentencing memorandum that the plaintiffs want to use as evidence of something—or for issue preclusion—in a separate case.  When it comes to prosecutions based at least in part on manufacturers or their representative making statements about unapproved uses, we have an opportunity to see what FDA’s policy on off-label promotion really is these days and how it might affect behavior.  While we generally think manufacturers and their representatives try to follow applicable guidance documents, they definitely want to avoid being convicted.

Today, we take a look at two criminal prosecutions involving off-label promotion allegations, each of which has now been tried to a jury verdict.  In the first, the court denied all of the defendants’ motions in limine before the case proceeded to a defense verdict at trial. See U.S. v. Vascular Solutions, Inc., No. SA-14-CR-926-RCL, 2016 U.S. Dist. LEXIS 133717 (W.D. Tex. Jan. 27, 2016).  That opinion showed up in our searches recently, well after the acquittal of the device manufacturer and its CEO produced its own fall out, including a letter from Senator Grassley—hardly a known industry champion—to DOJ about prosecutorial misconduct.  The Vascular Solutions defendants were charged with misbranding (and conspiracy to misbrand) of its Vari-Lase device.  This device was cleared—the opinion says “approved”—for treatment of varicose veins, specifically, per the indictment’s allegations, superficial veins and not deeper perforator veins.  The U.S. contended that the company failed to seek an expanded indication and failed to provide revised labeling to account for the use of the device to treat perforator veins. Id. at *3.  Defendants filed various motions in limine based on the First Amendment and the definition of “intended use” in § 801.4.  We will discuss only two of them, particularly the government’s position.  The government announced that it would not “use promotional speech to doctors to prove the intended use of the devices for perforator vein ablation” to avoid the “possibility that the misbranding offenses criminalize promotional speech.” Id. at **6-7.  It planned, however, to use such promotional speech as an overt act in furtherance of a conspiracy.  The court agreed with the government that a lawful act, including constitutionally protected truthful commercial speech, could be used as an overt act. Id. at **7-8.Continue Reading Update on Prosecution for Truthful Off-Label Promotion

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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”

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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

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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?

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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

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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