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.
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.
- 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.”
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.