One thing that’s always bothered us about how FDA goes about regulating drug and medical device manufacturers is the Agency’s penchant for declaring information that’s actually entirely truthful to be “misleading” by defining that term in a rather Orwellian fashion – that “misleading” is whatever FDA says it is. Combine that with regulations that allow truthful statements to make a product “misbranded” or “adulterated,” and we have all the makings of a significant constitutional dispute.
That’s because the First Amendment essentially prohibits the government from suppressing truthful speech – even if it’s commercial. This dispute has surfaced several times in recent FDA regulatory history. In the early 1990s, when FDA was hell-bent on restricting off-label use, it issued regulations mandating that even 100% truthful scientific speech – peer reviewed articles and continuing medical education – violated the law if manufacturers were involved and the information concerned off-label uses. The Washington Legal Foundation – an essentially libertarian public interest law center (read “anti-regulation gadfly”) – took FDA to court and the Agency found itself rather uncomfortably enjoined. See Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51, 56 (D.D.C. 1998); Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999), appeal dismissed, 202 F.3d 331 (D.C. Cir. 2000). The Agency managed to wriggle off the hook by more or less repudiating its own authority. FDA mooted some of the injunction by conceding that “nothing in either of the provisions challenged … provides the FDA with independent authority to regulate manufacturer speech.” Washington Legal Foundation v. Henney, 202 F.3d 331, 336 (D.C. Cir. 2000). This litigation was only the opening salvo.
In Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), FDA ran afoul of the First Amendment again – this time for fashioning a prior restraint on dietary supplement health claims – not because those claims were false (although some of the things being claimed on late night TV sure seem to skirt the line) – but because simple lack of prior FDA review made them “inherently misleading” regardless of truth. The DC Court of Appeals took a decidedly dim view of this and held that as long as there was a disclaimer of FDA review, the FDA had no business banning truthful commercial speech. Id. at 656, 658-59.
FDA couldn’t keep its hands out of the free speech cookie jar, however. It tried to ban truthful speech about pharmacy compounding – essentially any sort of advertising of this service – because it feared (probably with reason) that some large-scale compounders were nothing more than disguised, unlicensed manufacturers of pharmaceuticals. This dispute went all the way to the Supreme Court, and FDA got its head handed to it.
[F]orbidding advertising [must be] a necessary as opposed to merely convenient means of achieving [governmental] interests…. If the First Amendment means anything, it means that regulating speech must be a last – not first – resort. Yet here it seems to have been the first strategy the Government thought to try.
Thompson v. Western States Medical Center, 535 U.S. 357, 373 (2002) (emphasis added). There were lots of other things FDA could have done to regulate compounding directly, rather than suppress speech as a proxy. These included: (1) banning equipment needed for commercial-scale compounding; (2) prohibiting compounding beyond existing prescriptions; (3) limiting, by dollar value or volume, how much compounded product could be sold in a given period, and (4) limiting the percentage of sales revenue that could be earned through compounding. Id. at 372. The First Amendment meant that FDA had to try these approaches first, before attempting to ban truthful speech.
The last two of these alternatives, in particular, suggest analogous alternatives in the off-label use context.
Anyway, after losing Western States, FDA briefly had second thoughts. Within a few months of that decision, FDA sought public comments on the constitutionality of prohibiting truthful promotion of off-label use. 67 Fed. Reg. 34942 (May 16, 2002). But that was all. Over four years have passes and FDA hasn’t even bothered to respond to the comments it solicited. Nor has it changed its antediluvian restrictions on truthful promotion of off-label use.
First Amendment protection of commercial speech has been recognized until 1976, but FDA’s definition of “intended use” hasn’t changed since 1952. Thus any statement by a manufacturer – true or not – can create a new “intended use,” and thus a misbranded or adulterated product: Truth is not even a consideration. Indeed, even mere knowledge of an off-label use is theoretically enough to create an unapproved “intended use” and call down the wrath of FDA.
[I]ntent may, for example, be shown by labeling claims, advertising matter, or oral or written statements…. The intended uses of an article may change after it has been introduced…. [I]f a manufacturer knows, or has knowledge of facts that would give him notice that a device…is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling …for such other uses.
21 C.F.R. §801.4 (meaning of intended use) (medical devices) (emphasis added); see id. §201.128 (same definition for prescription drugs).
Maybe WLF, Pearson, and Western States made FDA somewhat gunshy, but for whatever reason the only case since then in which FDA’s put its off-label use arguments up against a First Amendment defense is United States v. Caputo, 288 F. Supp. 2d 912 (N.D. Ill. 2003). It won. While these criminal defendants might well have been prosecuted successfully simply for untrue statements, see generally United States v. Caputo, 456 F. Supp. 2d 970 (N.D. Ill. 2006), the government chose to gild the lily – including a number of truthful statements within its prosecutorial net. Maybe FDA believes this is the case that will end its First Amendment losing streak.
Lovers of free speech that we are, we certainly hope not. That’s why one of us just filed an amicus curiae brief in the Seventh Circuit in the pending Caputo appeal. Representing – surprise, surprise – WLF, the brief collects and applies the most recent First Amendment precedent to argue that FDA can’t constitutionally suppress truthful speech, whether or not it might be “promotion,” by manufacturers about off-label use. Here’s the link: WLF Amicus Brief
We’re posting the brief here, not just out of pride of authorship (not to say we don’t have any) but because the First Amendment can be a defense, as well, to a tort claim or to a qui tam Medicare fraud claim. Tort claims are just as subject to the First Amendment as any other governmental attempt to punish free speech. E.g., NAACP v. Claiborne Hardware, 458 U.S. 886, 920 (1982); New York Times Co. v. Sullivan, 376 U.S. 254, 265 (1964); In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994). Application of the First Amendment to a qui tam action attacking truthful commercial speech would conceptually be even easier – it’s just another statute being applied to suppress speech in the name of the government.
As long as the speech is objectively truthful, the First Amendment should provide a defense. Don’t forget to take advantage of this defense in appropriate cases.