There’s a problem with attorney advertising in the prescription medical product space – but it’s not the one you normally hear us defense-side litigators kvetching about. Quite apart from its litigation-generating effects, attorney advertising can have adverse public health consequences when all the anti-pharma hyperbole causes patients to cease taking targeted products in violation of
More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective description of what the cases DO say with enormous chunks of pie-in-the-sky suggestions of what…
Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the chorus of defense hacks who bemoan the Ninth Circuit’s supposedly liberal, pro-plaintiff bias. You see, we…
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…
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.
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.
We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part:
We have also added a document to the docket for the public hearing titled “Memorandum: Public Health Interests and First Amendment Considerations Related
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.
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.
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.
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?
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.