But to our readers (some of whom are also clients): Pssst - we have elected judges here in Pennsylvania, and we could do with more good ones.
But here at Drug And Device law, we are interested - very interested - in specific aspects of First Amendment jurisprudence. Just click on the First Amendment topic tab over on the right hand side of your screen, and you’ll see what we mean.
Thus we’ve studied the lengthy opinion in Citizens United to divine whether there are any usable soundbites that we could employ in support of a First Amendment challenge to FDA’s ability to regulate off-label promotion (previously blogged about here, here, here, and here - and elsewhere).
You’ve been paying attention if you ask, “What does regulation of core political speech have to do with regulation of commercial speech, which doesn’t get as much protection?” We’ve been paying attention too – so we're glad you asked. Most important, there’s a lot of language in Citizens United that buttresses what FDA’s detractors have been saying for a while – you can’t cure unconstitutional bans on speech by enacting vague, overbroad, and slippery regulations that allow the speech to occur at the whim of FDA. For example:
“The Government may not render a ban on political speech constitutional by carving out a limited exemption through an amorphous regulatory interpretation.” Slip Op. at 7. The FDA has practically patented the amorphous regulatory interpretation. In fact, the Agency rarely even bothers with regulations these days, instead it does "Guidance."
“[T]he FEC has created a regime that allows it to select what political speech is safe for public consumption by applying ambiguous tests…. This is an unprecedented governmental intervention into the realm of speech.” Id. at 19. Actually, with apologies to the Court, the FEC's actiona weren't all that unprecedented. The FDA’s been doing the same thing that for decades. Just try to figure out what its “intended use” regulations, 21 C.F.R. §§201.128, 801.4, mean. Is “guilty knowledge” of off-label use enough to violate these regulations? Talk about a chilling effect.
For those of you who are fans of the blog – and we hope there are millions of you – you may recall the Government’s recent response to Allergan’s pending First Amendment challenge to FDA’s off-label regulations: “[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.” We quoted it here (second bullet point). Yup, it’s the good ole “trust us, we won’t infringe your free speech rights” argument. Hmm, sounds like this loosey-goosey approach to regulating around constitutional protections might run into problems after Citizens United. We’d call that “amorphous” and “ambiguous,” and we’d suspect that a fair number of courts would agree with that description.
But that’s not all: the Citizens United Court also made clear that complex and murky regulatory schemes do give rise to a de facto prior restraint on speech:
“This regulatory scheme may not be a prior restraint on speech in the strictest sense of that term…. As a practical matter, however, given the complexity of the regulations and the deference courts show to administrative determinations, a speaker who wants to avoid threats of criminal liability and the heavy costs of defending against FEC enforcement must ask a governmental agency for prior permission to speak. These onerous restrictions thus function as the equivalent of prior restraint by giving the FEC power analogous to licensing laws implemented in 16th- and 17th-century England, laws and governmental practices of the sort that the First Amendment was drawn to prohibit.”Slip Op. at 18.
This sure seems to undercut the Government’s argument in the Allergan case: that FDA regulation of off-label promotion doesn't constitute a prior restraint because FDA isn’t technically prohibiting speech before it happens… FDA’s just threatening to wallop you for saying something FDA thinks is off-label promotion – think Robert DeNiro with that baseball bat in the Untouchables (we could add a link, but we won't) and you'll get the idea.
And finally, of course, is this First Amendment chestnut:
“ Premised on mistrust of governmental power, the First Amendment stands against attempts to disfavor certain subjects or viewpoints. Prohibited, too, are restrictions distinguishing among different speakers, allowing speech by some but not by others.”Slip Op. at 24. That’s an apt description of FDA’s (and the rest of the government’s) approach to speech advocating off-label uses. For details, Bexis laid all that out in his amicus brief in the Caputo case. See Brief at 19-25.
We’ve just scratched the surface of Citizens United – it weighs in at over 150 pages of opinions, including a 90-page “vigorous” (to put it mildly) dissent, and there’s a lot of layers there – whether you think the result in Citizens United is parfait, an onion, or just an ogre.
But on our first pass, it strikes us that the case does have some relevance to what we do. If you buy the argument – as we do – that off-label promotion involves core scientific speech entitled to full First Amendment protection, the case has significant impact on attempts to regulate such speech in the ways FDA does. We expect the government will no doubt try to minimize the Citizens United case, and say that FDA’s regulatory scheme: (a) is targeted at “economic speech” and thus subject to lower scrutiny; and (b) is a permissible speech restriction “based on an interest in allowing governmental entities” – i.e., FDA – “to perform their functions.” Slip Op. at 24.
But they won’t be able to denigrate speech by “corporations” any longer, that’s for sure.
And no matter how much FDA and various other supporters of muzzling medical speech about off-label use try to spin Citizens United, it sure seems like many of the First Amendment themes that the decision explores are applicable whether the discussion concerns “core speech” or “economic speech.” It will be interesting to find out whethere Citizens United can be reconciled with FDA’s regulatory scheme, which on its face and as applied suffers from vagueness and overbreadth problems.