CHRISTOPHER ROBERTSON
OTHER CHAPTERS in this volume discuss the statutory basis for the Food and Drug Administration (FDA) and its regulation of off-label prescribing in particular (see especially Mello and Kesselheim’s Chapter 10). In this chapter, I would like to focus on the importance of the manufacturer’s intent as the predicate for FDA regulation and the production of knowledge as the purpose for FDA regulation. These two points are essential for understanding the controversy over off-label promotion, and they reveal a way forward.
I. THE MANUFACTURER’S SPOKEN INTENT
Before enactment of the Federal Food, Drug, and Cosmetic Act (FDCA), health care consumption occurred in a regime of cheap talk, where “the manufacturer was sole judge of the therapeutic benefits he should claim for his product. If a claim was fraudulent, and if the government could prove it, the federal government could deal with the problem. However, a false or misleading therapeutic claim was acceptable under the law in the absence of fraud. In other words, the more ignorant the manufacturer, the more sweeping his claims for drug benefit could be” (Rankin 1965:32; emphasis added).
The FDCA was designed to change that situation, putting physicians and consumers on firmer epistemic footing. Now, the FDCA requires that, before bringing a new drug to market, the drugmaker must submit an application to FDA with evidence that proves that the chemical compound is safe and effective for a particular, intended use.
There is an interesting conceptual, almost metaphysical, point at the core of this regime: the company’s intention that a chemical compound be used to treat a disease is what makes that compound a new “drug,” which then creates the burden to prove to FDA that the drug works for that intended purpose (21 USC § 321(g)(1)(B)–(C); 21 CFR § 201.128). Without such a drugmaker’s “objective intent,” the thing is just a chemical—not a drug—and the FDCA does not apply at all. In other words, “[t]o put the matter in practical terms: it is because of the ‘intended uses’ principle that hardware stores are generally free to sell bottles of turpentine, but may not label those bottles, ‘Hamlin’s Wizard Oil: There is no Sore it will Not Heal, No Pain it will not Subdue,’ ” as they did before the FDCA (United States v. Caronia 2012:171).
It bears emphasis that this “intended uses” principle is a premarket approval system, a regulatory mechanism distinct from holding manufacturers liable ex post for making false or misleading claims about their drugs. Nonetheless, the FDCA does that too (21 USC §§ 331, 343, 352; United States v. Ninety-Five Barrels, More Or Less, Alleged Apple Cider 1924:442). The Supreme Court has read the labeling requirements in the statute broadly to impose liability for false and misleading promotional efforts (United States v. Kordel 1948:351). In contrast, the intended-use principle creates per se criminal liability for introducing a drug into interstate commerce that has not been approved by the FDA for its intended uses. Once FDA approves a drug to enter the market for a particular use (an “indication”), physicians are free to prescribe drugs for other “off-label” uses. Off-label usage is often worthwhile and sometimes based on sound evidence of efficacy and safety. However, off-label prescribing is a major driver of health care costs and sometimes presents real risks to patients that are not offset by proven benefits.
The regulatory logic for off-label uses is the same as for the first medical use of a novel chemical compound. The manufacturer may not promote the drug for new uses because doing so would evince an intention that the drug be used as such, even while the drug has not been proven effective, approved, or labeled for such use. The drug would then be misbranded and the introduction of it into interstate commerce would be a federal crime (21 USC § 352(f)(1)). In particular, the label may be inadequate if “[s]tatements of all…uses for which such drug is intended” and “usual quantities [of dose] for each of the uses for which it is intended” are insufficiently specified (21 CFR § 201.5(a)–(b)).
As the Senate Report on the FDCA explains, “[t]he manufacturer of the article, through his representations in connection with its sale, can determine the use to which the article is to be put” (Committee on Commerce 1935:240). This regulatory evolution has been controversial (e.g., Conko 2011:159–61). Yet, what other than the manufacturer’s own speech could be better evidence of its intent?
This pattern in the law—using intent as the predicate for regulation and then using speech as evidence of intent—is quite common and not peculiar to pharmaceutical regulation. As early as 1888, the Supreme Court affirmed a criminal conviction for someone who manufactured an “oleaginous substance” because he intended for it to be used as food (Powell v. Pennsylvania 1888:679). Likewise, an automobile is not subject to regulation by the Federal Aviation Administration (FAA) unless it is “intended to be used for flight in the air” (14 CFR § 1.1; defining “aircraft”).
This is all contrary to the suggestion of Redish and Klasmeier’s chapter in this volume. They argue that the intended-uses standard is unworkable, because manufacturers are routinely aware of off-label uses, potentially thus imposing criminal liability everywhere. Although the current specification of the “intended uses” principle in 21 CFR § 201.128 could be read to make mere knowledge of off-label uses sufficient enough to impose liability, it is not applied in that way, and the distinction between awareness and intent is too fundamental for the criminal law to gloss over as such. A turpentine manufacturer’s mere knowledge that its product may be abused for sundry purposes is not necessarily an intent that it be so abused. Similarly, when someone notifies General Motors that they are trying to fly a car off of a cliff, that awareness alone does not instantly and retroactively convert General Motors into an airplane manufacturer, subject to FAA regulation. In a world where off-label usage is ubiquitous, the law should draw a reasonable line that relies on overt evidence of the manufacturer’s intent, such as the manufacturer’s own promotional speech. Mere knowledge is not enough. For similar reasons, the FDA has created safe harbors permitting manufacturers to respond to questions about off-label uses and to distribute peer-reviewed literature about off-label uses (Kesselheim and Avorn 2012:2203). These dispensations allow for a workable regulatory balance.
II. PRESUMPTIONS OF TRUTH
It is peculiar that such regulatory mechanisms turn on the defendant’s own stated intent: its speech. Yet the Supreme Court has emphasized that “the First Amendment…does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent” (Wisconsin v. Mitchell 1993:489). Although scholars have made provocative arguments to the contrary (Redish and Downey 2013:698), it remains true and routine that a murder case may turn on recordings of the defendant’s stating an intent to join the conspiracy. Indeed, a federal rule of evidence specifically contemplates such situations (Fed. R. Evid. 801(d)(2); stating that “an opposing party’s statement” is excluded from hearsay and may be admissible).
Although “commercial speech” was once altogether unprotected by the First Amendment, it has evolved into a zone of “intermediate scrutiny.” In other chapters in this volume, Mello and Kesselheim and Klasmeier and Redish take opposite sides over the question of whether FDA’s proscription on off-label prescribing should meet that test. Other scholars have noted that the commercial speech doctrine has itself “evolved into a strict scrutiny test in all but name” (Piety 2012:4). Indeed, FDA suffered a stinging defeat in a 2002 case concerning a relatively obscure practice of pharmaceutical compounding (Thompson v. W. States Med. Ctr. 2002:357). And, a 2011 health care information case held that a state law prohibiting the sale of data for pharmaceutical marketing purposes was unconstitutional as viewpoint discrimination (Sorrell v. IMS Health Inc. 2011:2670–71). A more fundamental reconceptualization of this regulatory regime may be necessary.
Indeed, the FDCA suffered a severe blow in a December 2012 case in which the United States Court of Appeals for the Second Circuit invoked the First Amendment to reverse a pharmaceutical sales representative’s criminal conviction for conspiracy to sell a misbranded drug (United States v. Caronia 2012:164). “Caronia argue[d] that he was convicted for his speech—for promoting an FDA-approved drug for off-label use” (Caronia 2012:152). The Second Circuit agreed with that conceptualization of the case and said that it would “avoid constitutional difficulties by adopting a limiting interpretation” of the FDCA (Caronia 2012:162). The court “construe[d] the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs”—a landmark, unprecedented holding (Caronia 2012:168).
The Caronia court made no real effort to cabin its holding in any principled way. Are manufacturers now free to transport drugs in interstate commerce that are labeled for one use, or perhaps not labeled at all, while explicitly stating that the manufacturer intends other, unlabeled and unproven uses? If so, the crime of “misbranding” and the entire FDCA premarket approval regime begins to seem precarious.
It may help to thematize precisely what the Caronia court took for granted: the truthfulness of the manufacturer’s promotional claims. Accordingly, in Caronia, the court adopted this framing: “the First Amendment does not permit the government to prohibit and criminalize a pharmaceutical manufacturer’s truthful and non-misleading promotion of an FDA-approved drug to physicians for off-label use where such use is not itself illegal and others are permitted to engage in such speech” (Caronia 2012:160; emphasis added). The court recognized the importance of this point because “[o]f course, off-label promotion that is false or misleading is not entitled to First Amendment protection” (Caronia 2012:165 n.10; citing Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y. 1980:566). Indeed, the Supreme Court has for decades emphasized the role of truthfulness in its First Amendment analyses of commercial-speech regulations (e.g., Bolger v. Youngs Drug Prods. Corp. 1983:69).
Strikingly, the issue was not litigated: “The government [did] not contend that off-label promotion is in and of itself false or misleading” (Caronia 2012:165 n.10). Thus, the Caronia court apparently presumed that all of Mr. Caronia’s off-label promotional claims were true.
Similarly, in a prominent case concerning FDA’s regulation of promotional claims for dietary supplements, another circuit acknowledged that the predicate for Constitutional scrutiny is that “[t]ruthful advertising related to lawful activities is entitled to the protections of the First Amendment” (Pearson v. Shalala 1999:655; quoting In re R.M.J. 1982:203). While conceding that “evidence in support of [the promotional] claim is inconclusive” (and thus the court could not really know whether the Constitutional predicate was met), the court nonetheless held that the First Amendment prohibited FDA from proscribing the commercial speech (Pearson 1999:659). Here again, truth was simply presumed.
Scholars have routinely made this same sort of presumption of truthfulness to get their First Amendment arguments off the ground. In his critique of the FDA regime, Osborn asks: “[W]here the challenged off-label information is truthful, what is the public interest in forbidding it?” (2010:307). Likewise, in this volume, Klasmeier and Redish criticize the FDA’s regulation in this area, and offer “four core postulates of free speech theory that are indisputably contravened by the ban on off-label promotion,” the first of which is “Government may not attempt to manipulate lawful citizen behavior by means of the selective suppression of truthful expression advocating lawful activity” (234) Strikingly, several of the recent scholarly treatments of the constitutionality of off-label promotion highlight “truth” in their titles (Conko 2011; Noah 2011). It is notable that each of these critiques prominently turns on the concept of “truthfulness,” and each simply presumes that the regulated promotional claims are in fact truthful.
With this presumption in hand, the courts and commentators can paint FDA as a perverse paternalist, trying to keep people from the truth. Long before taking the bench, Justice Kagan wrote, “First Amendment law…has as its primary, though unstated, object the discovery of improper governmental motives. The doctrine comprises a series of tools to flush out illicit motives and to invalidate actions infected with them” (Kagan 1996:414). Accordingly, in Western States Medical Center, the Supreme Court emphasized that it has long “rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information” (Thompson v. W. States Med. Ctr. 2002:374; emphasis added).
Thus, for the regulation of off-label promotion, the courts and commentators seem to be presuming the truth about off-label promotional claims and presuming that FDA is motivated by a paternalistic desire to keep that truth out of the hands of consumers. As it happens, neither of these presumptions is warranted.
III. THE FDCA AS AN INCENTIVE FOR KNOWLEDGE PRODUCTION
If a sales representative says, “I wish you would try this drug as a treatment for epilepsy,” the literal meaning is just a report of his personal desire for a sale. That report may be true, but only in a trivial sense. Pragmatically, utterances like these implicitly make a claim that the drug would be safe and effective for that purpose. (Why else inject a substance into someone’s body?) That is the core propositional content of the claim.
Ultimately, we do not know whether such a drug promotional claim is true or false. And that information would be very costly to secure—millions of dollars and years of research by dozens of investigators and thousands of patients taking the drug and/or placebo, at real risk of side effects and often at real opportunity cost, compared to other treatments the patients could have tried instead.
Since truth or falsity is not knowable a priori, it instead depends on investments by those who have incentives to make those investments, in legal and institutional contexts that define those incentives. No individual patient or individual physician could find it rational to undertake a large-scale research study to prove safety and efficacy of some company’s patented drug (Elhauge 1996:1526). That costly task must fall to the one entity that has the economic interest in reaping the aggregate benefits of its drug: the drugmaker.
Courts and commentators have long understood that intellectual property has a similar epistemic purpose: to incentivize the production and disclosure of knowledge (e.g., Sinclair & Carroll Co. v. Interchemical Corp. 1945:330–31; Turner 1969:451). In particular, the patent laws are aimed at producing “useful” knowledge (35 USC § 101). In the pharmaceutical sector, that means the manufacturer identifying “a specific disease against which the claimed compounds are alleged to be effective” (In re Brana 1995:1565). Although the patent system does not require the rigorous proof of the FDCA, it does include a disclosure requirement, designed to contribute to the larger body of scientific knowledge.
By promoting new unproven uses for their drugs, manufacturers attempt to expropriate additional value from their legally enforced monopolies and their sunk costs of research and development. They replace research with marketing. Similarly, the Federal Trade Commission Act is designed to combat “unfair methods of competition,” which includes a proscription on making unsubstantiated health claims (Fed. Trade Comm’n v. Direct Mktg. Concepts, Inc. 2010:302). The problem is that such unproven off-label uses can become substitutes, whose real quality is unobservable in any particular case, thereby reducing the demand for drugmakers to invest in producing and proving the efficacy of new drugs or new uses of old drugs.
The FDCA can thus be understood as creating the incentive for drugmakers to produce knowledge to support new uses of the products that enjoy (or enjoyed) government-enforced monopolies. This epistemic and economic motive, tying investments to market rewards, is much different than the paternalist one caricatured by the courts and commentators.
IV. WHY COURTS CAN ACKNOWLEDGE THEIR IGNORANCE
In this light, should the courts continue to presume that off-label promotional claims are true and grant them immunity under the First Amendment, even while the drugmaker has rationally declined to make investments in discerning that truth? Arguably, no.
It is striking to compare the FDCA to the courts’ own routine use of the rules of evidence to regulate the speech of attorneys and witnesses. The courts emphatically do not presume truth of self-interested conclusory assertions about scientific questions; they deride them as mere “ipse dixit” and altogether ban them from being uttered in court (Gen. Elec. Co. v. Joiner 1997:146).
Imagine a litigant who proposed to put a drug salesman on the stand to testify that a drug was in fact safe and effective—given the salesman’s lack of expertise and lack of supporting evidence, the judge would exercise her “gatekeeping” role to exclude such unreliable testimony (Daubert v. Merrell Dow Pharm., Inc. 1993:597; Fed. R. Evid. 702). Under this regime, the proponent of a claim bears the burden of proving that the proposition is reliable and thus admissible. The courts’ orders in limine thus become prior restraints, carefully delineating what may and may not be said, ultimately under threat of jail for contempt of court.
There is some irony in the courts telling other regulators that the First Amendment bars their efforts to regulate speech while the courts blithely use speech regulations to achieve the courts’ own aims in their own domain. Other scholars have noted, and passed over, this difficulty, saying that “no one would challenge seriously under the First Amendment” such judicial regulations of speech (Sullivan 1998:569). Indeed, research has failed to reveal a single case in which the rules of evidence have been challenged on First Amendment grounds.
Courts admittedly do presume truth in other contexts. In the particular setting of a criminal trial, the burden is generally upon the government to prove the elements of any crime, which is to say that there is a presumption of innocence. For example, the Ninth Circuit recently affirmed pharmaceutical company executive Scott Harkonen’s conviction for wire fraud (United States v. Harkonen 2013:636). The jury found that Harkonen issued a press release making materially false statements claiming the efficacy of a drug. The Court overruled his First Amendment claims, holding that the wire fraud statute’s elements required proof that the speech was false or fraudulent, a burden met by the government, thereby putting the speech outside the First Amendment.
Falsity is not an element, however, in off-label promotion cases under the misbranding statute. In Caronia, for example, the truth or falsity of Mr. Caronia’s promotional claims was irrelevant to the charged crime, since the utterances need only show his intention to sell the drug for an unapproved purpose. Thus, the elements of the crime do not themselves impose a burden on the government to prove falsehood. There is no presumption of truthfulness. Whether the First Amendment should independently impose such a burden on the prosecutor is the remaining question.
It is also important to distinguish these cases from ones where the drugmaker’s claim is concededly truthful but arguably misleading. If the government concedes truth of the claim itself, but asserts that it may engender misunderstandings by hearers, the government bears the burden of proving those effects (e.g., Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio 1985:646). Once truth has been conceded, that approach is sensible, given the epistemic value of truth and our aversion to paternalism as a motivation for speech regulation. Here, however, the present question is distinct: Who should have the burden when the government makes no such concession about the safety and efficacy of a drug and the truthfulness is unknown? That question is open.
Typically, “the standard First Amendment rule [is] that the burden of proof as to constitutionally relevant facts must lie on the party who would stifle the speech, not the speaker herself” (Netanel 2013:1113). Similarly, in this volume, Redish and Klasmeier say that the burden “naturally” falls as such. Closer inspection of the doctrine, however, suggests that in these circumstances the burden could instead fall on the defendant-speaker.
One point of reference is defamation and libel. Under the common law, still existing in many states, “when a plaintiff proves publication of words that are defamatory per se [such as an allegation of sexual deviance], the elements of falsity and malice (or fault) are presumed, but may be rebutted by the defendant” (Costello v. Hardy 2004:140–41). In the 1986 case of Philadelphia Newspapers, Inc. v. Hepps, the Supreme Court held “at least where a newspaper publishes speech of public concern, a private-figure plaintiff cannot recover damages without also showing that the statements at issue are false” (1986:768–69). How this doctrine would apply to cases not involving newspapers, and involving commercial speech instead, remains unclear. In 2013, the Iowa Supreme Court concluded that unless the speech is a matter of public concern by media defendants (such as newspapers), then the First Amendment permits courts to place the burden of proving truth on the defendant-speaker (Bierman v. Weier 2013:448). In this light, it would similarly be permissible to put the burden on the drugmakers to prove the truth of their promotional claims as a predicate for any First Amendment claims they assert.
Beyond the domain of truth and falsity, there are several related questions of who bears the burdens in First Amendment litigation. For intellectual property cases under the Lanham Act, the defendant bears the burden to prove that the use of a valid mark is protected speech (e.g., Parks v. LaFace Records 2003:444). Similarly, the Supreme Court has said that to the extent that there is a First Amendment right to use copyrighted works, it is satisfied by the fair use exception, which functions as an affirmative defense (Campbell v. Acuff-Rose Music, Inc. 1994:590). On the other hand, in the child pornography case of Ashcroft v. Free Speech Coalition, the Supreme Court rejected the notion that an affirmative defense satisfied the First Amendment problem. Here, the burden of the affirmative defense was not truthfulness of the representation but rather a showing that the depicted persons were of legal age. The Supreme Court held that such a burden was simply infeasible, given that “the defendant is not the producer of the work, he may have no way of establishing the identity, or even the existence, of the actors” (2002:255). Arguably, in contrast, a drugmaker is in a much better position to prove the truth of its own representations about the efficacy of its own drugs.
The foregoing suffices to suggest that there is room within current constitutional doctrine to allow for a more realistic approach to truth and falsity in the regulation of off-label promotion. The fundamental insight is this: it would be rather strange if the Constitution required the courts to adopt a presumption about the safety and efficacy of any given chemical compound for treating any given disease, a leap of faith that Congress, FDA, physicians, and scientists would prudently refuse to take, and which the rules of evidence prohibit the courts themselves from taking, when that very question is put into issue. Instead, the Constitution allows courts candidly and prudently to concede their ignorance about safety and efficacy, until given a warranted basis for belief. Whether it should defer to the FDCA as the test for the truth depends on whether the courts understand its larger epistemic purpose.
V. THE FDCA AS THE TEST OF TRUTH
While not purporting to be a comprehensive treatment of the First Amendment issues implicated by the regulation of drug promotions, this chapter has developed a few themes. First, it has shown how the FDCA’s regulatory regime, like so many other areas of the law, turns on the defendant’s own speech revealing its intent, but this chapter has also shown how that regime is precarious under an expanding First Amendment doctrine. While most clear in the domain of off-label promotion, the precariousness seems to cut even deeper, to undermine the FDCA’s New Drug Application requirement itself. This threat motivates the project to explore whether FDA regulation of promotion could be reconstructed in a constitutionally sufficient way.
Second, this chapter has shown that the notion of truthfulness is at the core of much scholarly and judicial analyses in this domain but that the notion is deployed presumptuously. In fact, the truth or falsity of the drugmaker’s promotional claims is unknown, largely because the drugmaker has declined to invest in making such a proof. The FDCA is designed to incentivize the drugmakers to make that investment, a function that is undermined if courts presume the truth as a predicate for providing immunity under the First Amendment.
The argument here is focused on the particular circumstances of off-label promotion: a nonmedia defendant, engaging in self-interested commercial speech, about a product that it has declined the option of proving to FDA the efficacy and safety for the indication suggested, where talk is cheap since efficacy and safety cannot be known through accumulation of anecdotes alone, in a domain where the costs of falsehood can be life-or-death for patients that forgo other treatments and suffer side effects, and where the actual crime alleged regulates behavior (the introduction of a drug in interstate commerce), not speech in the first place. In other contexts, the First Amendment analysis may be quite different. But here, the First Amendment should protect truthful speech only where we can say with some warrant that the label applies.
Once shown in this light, it becomes clear that the current FDCA premarket approval regime already provides a constitutional framework for truthful promotion of drugs. The advantage of using this procedure, which Congress enacted, is that FDA has the institutional capacity to provide a robust and scientifically rigorous assessment of the drugmaker’s promotional claims. Because the FDA approval regime provides an avenue for truthful speech, prosecution for off-label promotion would thus raise no constitutional problem.
If the courts nonetheless refuse to defer to the epistemic test established by the coequal branches, the courts still need not adopt judicial naiveté. If a drugmaker refuses or fails to prove a promotional claim to FDA, the courts should, at the very least, impose on drugmakers the burden of proving their claims true as an affirmative defense at a jury trial. Conceiving FDA as something of a safe harbor, this alternative framework gives drugmakers two chances to prove truth, without going so far as to presume whatever they say is true (Washington Legal Foundation v. Henney 2000:335–36). In some cases, the epistemic basis for the claim will be quite strong; there are instances in which Medicare and payers have done their own systematic reviews and found enough evidence to merit billions of dollars of reimbursements. Still, when the evidence is weak, the manufacturer will contemplate the difficulty of actually proving the truth of its off-label promotional claims in a court of law, controlled by the limits on the admissibility of expert testimony and scientific evidence. Thus, the opportunity to prove the affirmative defense of truthfulness may actually provide little succor to defendants who lack rigorous scientific support for their claims.
Without some sort of reconstruction of FDA regulation of off-label promotion—of the sort suggested here, or by Mello and Kesselheim in the prior chapter—the Supreme Court’s expansive First Amendment doctrine threatens to return us to a pre-FDCA world where drugs are presumed to cure any disease that the drugmakers say they cure, at least until somebody proves them false. Especially in contexts where information is expensive, the speaker is in the best position to purchase that information, and the stakes are high, the First Amendment should not proceed on bald presumptions about the truth.
NOTE
The ideas in this chapter are developed in significantly more detail in the 2014 article “When Truth Cannot Be Presumed,” Boston University Law Review 94:545. Disclosure: The author has represented litigants asserting First Amendment defenses (outside the context of food and drug regulation) and represented amicus curiae the New England Journal of Medicine et al. in the Sorrell case discussed herein.
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