Wednesday, January 13, 2010

Beware The FDA Bearing Regulations: An Allergan Update

We’ve previously written about Allergan’s First Amendment challenge to the FDA’s regulations relating to off-label promotion (here (last of four parts), here, and here), but in the grand tradition of the First Amendment, the war of words is escalating, mud is being slung, and court filings are name-dropping Trojan priests – but more on that later.

The past month has been busy, with the government filing its “Motion To Dismiss Or For Summary Judgment,” the public interest group Public Citizen filing an amicus brief supporting the government.  As we discussed earlier, a consortium of public interest groups (some rare disease associations and the Washington Legal Foundation) already made an amicus filing in support of Allergan’s motion - we guess Public Citizen's trying to even the score.


 
Anyway – the government’s motion. It is a 45-page whopper chock-full of pronouncements about the practical effect of numerous FDA regulations relating to promotion and labeling, so it is definitely worth a read for anyone interested in this area of the law. We’re only providing the highlights here.

 
The motion does exactly what you’d expect. It first tries to sidestep the grave constitutional issues raised by Allergan by claiming this whole shooting match isn’t ripe for adjudication. So how does the government do that?  It argues that Allergan's case relates to two proposed communications: (1) truthful warnings and safety information relating to the (off-label) use of Botox to treat a number of spasticities; and (2) promotional speech relating to an off-label use for which Allergan has an sBLA (that's jargon for a supplemental application for approval, involving a biologic) pending. Because Allergan hasn’t actually said anything yet on these two topics, the FDA hasn’t had the opportunity to shut that speech down. Therefore, says the government, where’s the beef? (OK, those are our words, but that’s the gist of the argument).

Now, the government has a bit of a problem here, because the ripeness requirement is relaxed in the First Amendment context. The government acknowledges this, but then goes on to argue that there is no live dispute involving “actual or threatened application” of a regulation to bar particular speech. Mot. at 13 (quoting Renne v. Geary, 501 U.S. 312, 320 (1991)). We don't think that makes a whole lot of sense (unless you're the government).  The government's actually saying that Allergan has to expose itself to actual prosecution - at least in the FDA’s eyes - in order to tee up this arcane, convoluted regulatory scheme for scrutiny by a court? Hmm. But we get the strategy. Every lawyer remembers first-year Con Law; courts don’t reach constitutional issues unless they have to do so, and the government’s clearly hoping that it can play keepaway until at least April, when the FDA expects to issue a decision on the sBLA.

 
The remainder of the government’s motion takes on Allergan’s “frontal assault” on the FDA’s regulations relating to labeling and promotion. Mot. at 16. And here’s where the hyperbole starts to ratchet up. The government complains that a successful challenge would “roll back the regulatory clock a half century,” and effectively “dismantle the established system of drug regulation.” Mot. at 16-17. (This theme is echoed in Public Citizen’s amicus brief, which essentially concludes that all pharmaceutical manufacturers would become “snake-oil” salesmen but-for the presence of the FDA’s regulatory scheme.)  And you thought Gallileo had it bad.

 
It’s in this section of the brief that the government demonstrates its deep and abiding love for classics. We get a reference to Scylla and Charybdis, the sea monsters of Greek myth who posed an intractable dilemma to all sailors who attempted to navigate between the two. That’s a tried and true metaphor in the law business, kind of like the Sword of Damocles. The eye-opener for us, though, was this beauty: “[T]his Laoco├Ân-like portrait, in which Allergan is being strangled by laws and regulations that prevent it from warning the public of serious health risks, is profoundly wrong.” Mot. at 18. It is mighty impressive to invoke the Trojan priest who uttered the famous warning, “beware Greeks bearing gifts,” only to be strangled by sea-serpents – even if we think it’s a wee bit overblown.

 
But in addition to name-dropping famous Greek characters, the government’s attempt to support the constitutionality of the FDA’s regulatory scheme on its face and as applied is worth a read. Here are just some of the arguments and statements the government makes:

 
  • There isn’t really a First Amendment issue here because the FDA treats promotional speech as “evidence that the use is intended,” Mot. at 19, and “[n]othing in the First Amendment prohibits the government from using a person’s speech as evidence to establish intended use.” Mot. at 20. (Did the government even read the Western States Medical case?)
  • 21 CFR § 201.128, the FDA’s “intended-use” regulation, does not violate the First Amendment. Although the regulation states that intended use may be shown by oral or written statements by a manufacturer regarding an unapproved use, that doesn’t mean that every statement will be construed as such – e.g., the non-promotional dissemination of some safety and warning information is OK (although the motion is pretty vague on this point, which sort of underscores what Allergan’s complaining about). Mot. at 21. Also, although Allergan complained that 201.128 treats an unapproved use as an intended use where the manufacturer knows of that use, “[i]n practice, FDA usually does not treat an unapproved use as an intended use solely because the manufacturer knows that the unapproved use is taking place.” Mot. at 22 (that’s our emphasis).  Wow.  The government just demonstrated the vagueness of both the regulation (the language dates from the early 1950s before anybody'd ever heard of First Amendment protection of commercial speech), and the FDA's enforcement policy.
  • Under the Central Hudson test for restrictions on commercial speech, the FDA’s regulation of off-label promotion passes muster. Off-label promotion is intended to promote an unlawful transaction, and commercial speech concerning unlawful activity is entitled to no protection. Mot. at 26.  We're frankly surprised to see this one.  The government's never prevailed on this tautological (it's illegal because we choose to ban it) position anywhere, and most of the time doesn't bother to argue this any more.
  • Even if the speech at issue was truthful and non-misleading, the FDA’s regulation “directly advances the compelling governmental interest in drug safety and public health, and by means ‘in proportion to the interest served.’” Mot. at 27 (citation omitted). What is the government interest at stake, you ask? “[D]rug manufacturers, when left to their own desires, frequently make untruthful claims about new uses, and[] encouraging manufacturers to evaluate and demonstrate the safety and effectiveness of their drugs before marketing them for new uses protects the public from promotional claims that are unsubstantiated at best, and false at worst.” Mot. at 27 (that’s the government’s emphasis).  (Can you spell "P-A-T-E-R-N-A-L-I-S-M-"?).
  • Off-label promotion undermines the incentives to do rigorous testing, and poses serious health risks. Mot. at 28.
  • Any perceived dilemma arising out of the misbranding provisions and the prohibition against distribution of unapproved new drugs arises only if manufacturers are impatient and begin promoting a new use before getting approval from the FDA. Mot. at 31.
  • It is appropriate under the regulations to consider promotional material that does not physically accompany the drug as labeling, rather than advertising. Mot. at 34. But regardless of whether that promotional material is considered labeling or advertising, regulation of it does not “trench upon the First Amendment.” Mot. at 34.  We're not sure it matters either, but that's because we think scientific speech remains scientific speech wherever it appears.
  • “It is not FDA’s position that any statement by a manufacturer about the safety or effectiveness of an unapproved use is automatically false or misleading merely because the use has not yet been approved by FDA.” Mot. at 34-35 (again, the government’s emphasis, not ours).  OK, but that's not what the regulation says.  This kind of "trust me" argument is the epitome of a chilling effect.
  • The regulations as applied to Allergan do not amount to an unconstitutional prior restraint. Much of what Allergan wishes to say appears to be permitted, but “[w]hether Allergan’s communications will be truthful and non-misleading, and whether Allergan will refrain from promotiong the unapproved uses at issue, depend on what Allergan actually says.” Mot. at 38 (government’s emphasis). In other words, there is no prior restraint here because “Allergan’s proposed speech is not subject to prior FDA approval.” Id.  It's not a "prior restraint" because you don't have to get the FDA's approval before saying it?  Huh? 
  • The fact that Medicare and Medicaid reimburse for “widely accepted” uses, including uses unapproved by the FDA, is of no moment, because “[a] drug reimbursement mistake costs money. A drug approval mistake can cost lives.” Mot. at 42.  When you don't have the facts or the law on your side pound the table.
  • Allergan’s challenge to the disgorgement remedy is speculative and would require the court to issue an advisory opinion, and anyway, the government is entitled to disgorgement under the applicable statutes and regulations. Mot. at 42-45.  In other words, the challenge is speculative - but we can do it.

So the government sure said a lot in those 45 pages, and it will be interesting to see how Allergan, and ultimately the Court, untangle these dense (an intentional double entendre) arguments. In particular, it will be interesting to see whether the Court buys the government’s position: “trust us, we would never apply regulations in an unconstitional manner, even if they look vague and unconstitutional at first blush.” And all Big Lebowski fans will be waiting with baited breath to see whether Allergan quotes the immortal Walter Sobchak in its response to the government: “For your information, the Supreme Court has roundly rejected prior restraint.”

 
In the meantime, the Court will also have a few amici to ponder. In addition to WLF et al., Public Citizen provides its own Greek chorus (see, we can do classics, too). Its amicus, as previously mentioned, finds boogey-men in every pharmaceutical manufacturer’s closet, and warns, Cassandra-like, that granting Allergan’s motion would be the death knell for safe products and a return to the days of snake-oil, quacks, and mountebanks. The entire brief is essentially a predictable march through the Central Hudson commercial speech test, arguing that “[t]he government’s interest is at its peak when protecting the public from dangerous prescription drugs and fraudulent health claims.” Public Citizen Br. at 5. According to Public Citizen, pre-market review ensures that patients get what they pay for and they they are not put at risk. In this way, it “is a crucial bulwark against the sorts of pseudo-scientific evidence that was a hallmark of fraudulent medicine before the era of federal drug regulation.” Public Citizen Br. at 8. Public Citizen spends most of its pages trying to drag the pharmaceutical industry through the mud, and criticizes Allergan for failing “to account for the drug industry’s long history of evading the restrictions on promoting products for unapproved uses.” Id. at 15. In the end, the brief devolves into a long-winded citation of a number of articles that are critical of the pharmaceutical industry. In other words, a lot of hot air, but not much substance.

We can dispose of Public Citizen's hyperbole in a sentence.  The predicate for Allergan's suit was that the scientific information it wishes to distribute about off-label uses is TRUTHFUL.  We have no more tolerance than anyone else for speech that's actually false.  This speech isn't.  Public Citizen directs its purple prose against strawmen having nothing to do with the facts before the court.

 
Now we've got cross-motions and cross (sometimes very cross)-amici.  Are there going to be cross-reply briefs?  We don't know, but we can't wait to find out.

No comments: