COLEEN KLASMEIER AND MARTIN H. REDISH
I. INTRODUCTION
In order to protect the nation from harmful or worthless drugs and medical devices, the Food and Drug Administration (FDA) is legislatively authorized to control the commercial distribution of new drugs and medical devices to those whose efficacy and safety have been reviewed and approved by the agency (21 USC §§ 355(a), 360(k), 360e (2006)). Drugs and devices are approved for specific medical purposes. In numerous instances, however, the medical profession has discovered that treatments approved for one purpose may also serve other valuable medical purposes. Indeed, on a number of occasions such “off-label” uses have proven to be essential to the successful treatment of some very serious illnesses.
In these off-label situations, FDA is faced with a dilemma. On the one hand, off-label use of prescription drugs and devices gives rise to a series of major problems for FDA. While the drugs and devices in question have been vetted and approved by FDA for their designated purpose, at no point has FDA reviewed the supporting scientific data to determine efficacy for the off-label purpose. It is therefore at least conceivable that if such off-label uses are permitted, the drug or device may in reality be worthless or even dangerous for its alternative use, yet doctors may be freely employing it for that purpose. Moreover, widespread off-label use of prescription drugs and devices conceivably undermines FDA’s authority and deters manufacturers from seeking FDA approval for even widespread alternative uses. The fear, then, would be that FDA’s initial approval could serve as a wedge to permit the industry’s equivalent of the Wild West, where the rule of law was seen only rarely. It is true that the federal government could avoid this danger by categorically prohibiting all off-label uses, but this alternative is also not free from problems. As a result of such a ban, potentially valuable treatments—often for the most serious of diseases—could be effectively banned, as manufacturers often lack sufficient incentives to pursue costly, time-consuming, and uncertain supplementary approval. In any event, under the current regulatory framework, FDA asserts that it lacks legal authority to restrict the ability of doctors to prescribe drugs or devices for off-label uses.
FDA has sought to resolve this dilemma by effectively swimming halfway across a river, thereby pleasing no one and avoiding none of its quite legitimate concerns. It has resolved its dilemma by leaving off-label uses essentially unregulated but making a manufacturer’s “promotion” of an off-label use categorically illegal. As a result, while the benefits of off-label use are roughly preserved, whatever dangers might accompany such uses are in no way avoided since off-label uses are still generally allowed. It is true, of course, that with no promotion off-label use as a whole may decrease, but there is no basis, ex ante, on which to assume that the off-label use likely to be deterred is predominately the harmful version rather than the beneficial version. At the same time, while it is true that the ban on off-label promotion by manufacturers prevents at least some false or misleading claims, because the ban is all-inclusive it simultaneously prevents manufacturers from disseminating accurate information (to which they have unique access) about valuable off-label uses of which doctors otherwise may well be unaware. To be sure, those other than the manufacturer are still permitted to discuss the relative merits of off-label uses, and even manufacturers are authorized to speak in certain narrowly defined circumstances about an off-label use. But FDA could not have stated more clearly that manufacturers are prohibited from advocating off-label uses in any way. This is so even where FDA in no way challenges the accuracy, truthfulness, or completeness of that promotion. As a result, in many instances doctors are likely to be deprived of valuable information about important off-label uses that are totally lawful and extremely beneficial to some very sick people.
It should not be difficult to see that FDA’s ban on off-label promotion violates the First Amendment right of free expression. The ban, after all, prohibits truthful speech advocating lawful activity, the paradigm situation for finding suppression—even of purely commercial speech—to be unconstitutional. This does not mean that commercial speech must receive absolute protection or that FDA should be wholly deprived of authority to regulate drug and device promotion in the interests of public health. It means, simply, that governmental imposition of a categorical ban of truthful promotion of lawful commercial activity contravenes both established commercial speech doctrine and core notions of free speech theory.
In this chapter, we seek to accomplish two complementary goals. Initially, we seek to establish the unambiguous unconstitutionality of FDA’s current prohibition on off-label promotion as measured by controlling Supreme Court decisions concerning the First Amendment’s protection of commercial speech. Secondly, we seek to glean from this analysis far more significant insights about the core premises of the constitutional protection of free expression. We point to four basic postulates of American constitutional and political theory that, we assert, underlie the social contract between citizen and government implicit in a societal commitment to liberal democracy. These core premises, we believe, represent the normative foundations of the constitutional protection of not only commercial speech but indeed all speech. By demonstrating this important philosophical overlap, we demonstrate the inherent linkage between commercial speech protection and the broader premises of the constitutional guarantee of free expression.
II. FDA’S SUPPRESSION OF OFF-LABEL PROMOTION: DEVELOPMENT OF THE REGULATORY FRAMEWORK
A. Off-Label Use and Accepted Medical Practice
While the phrase “off-label use” may seem to imply dubious medical practice, the reality is quite the opposite. Two important points must be noted as we begin our analysis of the constitutionality of FDA’s prohibition on a manufacturer’s ability to promote off-label use: (1) the prescription and use of approved drugs and medical devices for purposes not set forth in their FDA-authorized labeling is legal (48 Fed. Reg. 26,733 (June 9, 1983); see also 21 CFR § 312.3(d)), and (2) not only are such practices legal, they are quite common and, indeed, often accepted medical practice (Chen 2009; see also DeMonaco 2006). The conclusion is therefore inescapable that both patients and prescribers would often be aided by the dissemination of information to the medical profession about these valuable off-label uses.
Despite the indisputable value of off-label uses, FDA has categorically banned manufacturers of drugs and devices from promoting such uses. This is so despite the obvious reality that manufacturers are in a unique position to provide valuable information about off-label uses to the medical profession. Manufacturers possess a combination of incentive and resources to disseminate information to practitioners about off-label uses. To be sure, instances may arise in which particular claims about off-label uses could be deemed false or misleading. The same could be said about the advertising of any product or service. But FDA’s ban draws no such distinctions. Even totally truthful, valuable information, if provided in the form of “promotion,” is banned. It is difficult to comprehend the logic of such a distorted system.
B. FDA’s Rationale for the Suppression of Off-Label Promotion
Although the antecedents of FDA’s current stance on off-label promotion arose in the context of off-label use of methotrexate more than four decades ago, FDA has generally not invoked the methotrexate example to justify its restrictive approach to manufacturer dissemination of off-label use information. Naturally, FDA has relied on selected statutory provisions to assert that it is compelled to commence enforcement action against any manufacturer engaged in off-label promotion, but its efforts at justification have not ended there.
FDA has bolstered its legal arguments against off-label promotion by reciting a “parade of horribles” that agency officials assert have resulted or will likely result as a consequence of such promotion. FDA’s regulation of speech is not the ultimate objective of the regulatory scheme, although that is surely its immediate target. Instead, the purpose of the off-label promotion ban is to regulate indirectly, through enforcement aimed at manufacturers, what FDA has failed or refused to do directly—namely, the regulation of the physician’s decision to prescribe or use a drug or medical device for a particular off-label use. As careful examination of the First Amendment protection of commercial speech shows, FDA’s practice is clearly unconstitutional.
III. COMMERCIAL SPEECH DOCTRINE AND THE FDA’S PROHIBITION OF OFF-LABEL PROMOTION
A. The Existing Doctrinal Framework for Commercial Speech Protection
1. The Evolution of the Central Hudson Test
Long excluded completely from the First Amendment’s scope, commercial speech first received substantial constitutional protection in the Supreme Court’s 1976 decision in Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc. (1976), where the Court invalidated the state’s prohibition on advertising of prescription drug prices. However, for many years thereafter, the Court afforded commercial speech only “a limited measure of protection, commensurate with its subordinate position in the scale of First Amendment values” (Ohralik v. Ohio State Bar Ass’n 1978).
In its 1980 decision in Central Hudson Gas & Electric Corp. v. Public Service Commission (1980), the Court adopted a four-part test to determine whether commercial speech is protected. This test continues to control, though a number of Justices have argued for a more protective test, and in its modern application the test has taken a far more protective form than it did originally. Under that test, the first inquiry asks whether the speech in question promotes the sale of an unlawful product or service or is found to be false or misleading. If the answer to either question is yes, the speech is automatically unprotected. Assuming the speech in question has passed this first hurdle, the remaining three questions scrutinize the nature of and justification for the speech regulation. For the regulation to be upheld, it must satisfy all three of the test’s remaining prongs.
Under the test’s second prong, the government must demonstrate that its regulation of commercial speech serves a “substantial” governmental interest (ibid., 566). Once that test has been satisfied, the reviewing court “must determine whether the regulation directly advances the governmental interest asserted….” (ibid.). The court will invalidate the regulation if it “only indirectly advance[s] the state interest involved” (ibid., 564). Moreover, the regulation must materially advance the state’s interest. Government has the burden of establishing beyond mere speculation that its regulation does in fact do so (Edenfield v. Fane 1993). Even if this requirement is satisfied, the regulation must still be found to be “[no] more extensive than is necessary to serve [the substantial governmental] interest” (Central Hudson Gas & Electric Corp. v. Public Service Commission 1980).
Although in the early years of the test’s application one might have been able to characterize the Court’s protection of commercial speech as far below the level afforded more traditionally protected varieties, in recent years the Court has afforded commercial speech a level of protection that in many ways rivals full protection. It has consistently invalidated regulations of commercial speech for their failure to satisfy the third prong, the fourth prong, or a synthesis of the two (see, e.g., Lorillard Tobacco Co. v. Reilly 2001; Greater New Orleans Broad. Ass’n v. United States 1999; 44 Liquormart, Inc. v. Rhode Island 1996; Rubin v. Coors Brewing Co. 1995; City of Cincinnati v. Discovery Network, Inc. 1993). Indeed, on occasion it has invalidated expressive restrictions even in the case of FDA’s regulation of drug advertising (see, e.g., Thompson v. W. States Med. Ctr. 2002). The Court has made clear that the government may not justify its regulations of truthful commercial speech simply by invoking sweeping and unsupported assertions of justification.
2. The Move Toward a More Categorical Standard
On a number of occasions, members of the Court have advocated or adopted an approach to commercial speech protection that, in certain instances, turns on more categorically established factors than does the interest balancing approach of even the more protective version of the Central Hudson test. In a number of opinions, Justices have argued that when the speech sought to be regulated or suppressed is truthful and advocates lawful purchase or use, governmental restriction of that speech is properly deemed categorically unconstitutional.
The first decision to openly advocate such a position was the plurality opinion of Justice Stevens in 44 Liquormart v. Rhode Island (1996). Justice Stevens reasoned that bans of truthful advertising for lawful products or services when those bans are designed to protect consumers from commercial harms “rarely protect consumers from such harms. Instead, such bans often serve only to obscure an ‘underlying governmental policy’ that could be implemented without regulating speech” (ibid., 502–3 (citation omitted)). Justice Thomas continues to adhere to a view similar to Justice Stevens’s (see ibid., 518–28 (Thomas, J., concurring); Thompson v. W. States Med. Ctr. 2002 (Thomas, J., concurring); Such bans, Justice Stevens argued, “usually rest solely on the offensive assumption that the public will respond ‘irrationally’ to the truth. The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good” (44 Liquormart v. Rhode Island 1996).
Although a majority of the Court has never formally adopted this categorical approach in place of the Central Hudson test, on more than one occasion a majority opinion has expressed a similar sentiment (Edenfield v. Fane 1993). Over the years, extension of categorical protection to truthful advertising for a lawful product has gained a substantial following. Indeed, at no point in recent years has a majority of the Court issued a holding on commercial speech protection inconsistent with the categorical approach.
B. Measuring FDA’S Prohibition of Off-Label Promotion Under Supreme Court Commercial Speech Doctrine
1. The Justifications for the Off-Label Prohibition: An Overview
There are three major constitutional justifications for FDA’s categorical prohibition on off-label advertising. First, it is argued that the regulated activity is not “expression” at all but instead amounts to nonexpressive conduct. Therefore, the First Amendment is wholly inapplicable. Second, even if it were assumed that expression is being regulated, the government has a substantial interest in protecting the public against false or unsupported claims about off-label uses that could lead to unsafe or economically unjustified use, and absent formal FDA approval of the drug or device for that specific use, there can be no assurance of the accuracy of the manufacturer’s off-label claims. Third, it is argued that the government has a substantial interest in inducing manufacturers to seek FDA approval for off-label uses, and prohibition on manufacturer promotion of off-label uses does just that.
None of the arguments justifies FDA’s prohibition of off-label promotion under existing commercial speech doctrine. Equally important, these arguments reveal a fundamentally flawed understanding of core premises underlying the constitutional protection of free expression in general and the constitutional protection of commercial speech in particular. Their acceptance would therefore result in adoption of a foundationally pathological version of free speech theory.
2. The Off-Label Prohibition as Regulation of Nonexpressive Conduct
FDA has argued that the prohibition of off-label promotion is not speech regulation at all but rather the regulation of nonexpressive conduct. Rather than myopically focus on the promotion itself, the argument proceeds, it is necessary to focus on the broader commercial transaction (Brief for the Appellants at 28, Wash. Legal Found. v. Henney 2000). Though it is perfectly legal for a prescription drug or medical device to be prescribed or used off label, it is unlawful for a manufacturer of such a product to sell its product with the intent that it be used off label. Promoting an off-label use, then, is deemed conclusive proof that the manufacturer is violating the law. Under FDA’s argument, the manufacturer’s promotion of off-label use is deemed to be nothing more than evidence of the broader illegal behavior of intending off-label use. Any negative impact on expression is therefore merely incidental to the regulation of nonexpressive behavior—a form of regulation subjected to a far less stringent form of constitutional analysis (see United States v. O’Brien 1968). If this argument were to be accepted, then all of the questions surrounding the protection of commercial speech would of course be rendered irrelevant. However, the argument must be rejected; it is manipulative and disingenuous on its face and inconsistent with controlling Supreme Court precedent.
Initially, it is worth noting the bizarre incongruity of punishing the sale for the purpose of off-label use while simultaneously treating the off-label use itself as completely lawful. But more important is the fact that contrary to its assertion, FDA does not employ the fact of off-label promotion merely as evidence of the illegal act. If FDA were truly concerned with the manufacturer’s nonexpressive act of sale with intent that the product be used off label, it would logically prohibit all sales of a drug widely used off label because any time the manufacturer sells its drug, it would do so with knowledge that it will be used for off-label purposes. The fact that a manufacturer fails to promote off-label use surely does not imply that it is unaware that its product will be used off label. Indeed, reimbursement for specified off-label uses of prescription drugs is well established (Kesselheim 2011).
It could perhaps be suggested that a distinction must be recognized between awareness and intent; the mere fact that a manufacturer is aware that its product is being used in a particular way does not necessarily mean that it intended that it be used in such a manner. But in this instance, the suggestion of such a dichotomy would be naïve. Countless amounts of money are made from off-label sales that were openly funded by insurance reimbursement. Yet the government makes no effort to reduce or restrict sales. Indeed, there is no indication that FDA has ever pursued a manufacturer for selling its drug with knowledge that it will be used for off-label purposes, absent off-label promotion, and the government in litigation has denied that mere knowledge is actionable. Where a manufacturer does not seek to promote off-label use, FDA makes no objection, though there can be no doubt that the manufacturer is aware when it sells its product that it will be used off label. A party is presumed to intend the natural consequences of its acts.
In any event, FDA’s own actions have made clear that its goal is suppressing speech, not in regulating conduct. In United States v. Caronia (2012), the Second Circuit rejected FDA’s argument that its goal was merely to use off-label promotion as evidence of intent to misbrand because it “is simply not true” (ibid., 161). The court pointed to numerous statements at trial by FDA that the harm was the promotion itself, leading it to conclude that “the government clearly prosecuted Caronia for his words—for his speech” (ibid.). Why, one might reasonably ask, if FDA is so clear that it is the misbranding, not the promotion, that it is seeking to punish, in Caronia would it have completely abandoned that argument and instead directly challenged the speech for its own sake?
More importantly, in its proposed “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices,” FDA proposed to accept manufacturers’ distribution of articles, texts, and similar materials describing off-label uses, including through company sales representatives, as long as certain restrictions were followed. But if it is the intent to misbrand that is key to FDA, how could it logically accept any off-label promotion, regardless of whether or not it complies with predetermined restrictions? Even if those restrictions are satisfied, the fact remains that the promotion is for an unapproved purpose—by FDA’s own reasoning conclusively demonstrating the manufacturer’s intent to distribute in an off-label manner. The proposed guidance document, then, should once and for all end FDA’s disingenuous charade that what it is attacking is conduct rather than pure expression.
When the dust settles, then, it is clear that FDA’s categorical prohibition of promotional speech concerning off-label use amounts to a classic suppression of commercial speech. What makes this prohibition so problematic, it should be recalled, is that the actual behavior being advocated is perfectly lawful; neither FDA nor Congress has prohibited off-label uses themselves. Absent a showing that the suppressed promotion is false or misleading, it is by no means clear that under current doctrine suppression is ever constitutional. At the very least, suppression of truthful promotion of lawful use must satisfy increasingly demanding constitutional standards. It is highly doubtful that current FDA practice can meet them.
3. The Ban on Off-Label Promotion as a Form of Consumer Protection
One conceivable justification for the ban on off-label promotion is the fear that self-interested manufacturers will mislead consumers into using prescription drugs or devices for harmful or ineffective purposes. A drug’s use for the off-label purpose, after all, presumably has never been established through proper use of the scientific method. But the very fact that many off-label uses are widely accepted undermines this notion. There is no inherent reason why claims made on behalf of off-label uses are inherently false or misleading. Moreover, in many instances in which such a danger arises due to the incompleteness of the claim, required disclaimers are surely a less-invasive means of regulating speech than is suppression.
C. Applying Commercial Speech Doctrine to the Prohibition of Off-Label Promotion
1. Applying the Categorical Standard
The argument that off-label promotion might convince practitioners to prescribe drugs and devices that would be ineffective or harmful and that such promotion can therefore constitutionally be suppressed cannot survive scrutiny under 44 Liquormart’s categorical standard. There is no doubt that use of prescription drugs and devices off label is perfectly legal, and there exists no basis, ex ante, to categorically assume falsity of the claims made in the promotion of off-label use. In effect, then, the government is saying that the medical profession cannot be trusted to make accurate judgments as to the advisability of off-label use on the basis of free and open truthful communication. Indeed, the affront to the First Amendment is even more invidious in this context than it is under the categorical standard of 44 Liquormart. In that case, the government’s refusal to trust the judgment of the common person was declared antithetical to the very foundations of the First Amendment. In the case of off-label promotion, the government refuses to trust even trained professionals.
2. Applying the Central Hudson Test to the Prohibition of Off-Label Promotion
a. First prong: Is the speech false or misleading? Even if we were to proceed on the assumption that the Court would apply the four-part Central Hudson test, rather than the categorical standard, there is little doubt that FDA’s prohibition on off-label promotion would fail. It should be recalled that while in its original incarnation the test provided a level of constitutional protection far lower than that given more traditional forms of expression, recent case law should disabuse us of the notion that the Central Hudson test is undemanding.
For reasons already discussed, it would be incorrect to conclude that off-label promotion fails Central Hudson’s first prong on the grounds that it is inherently false or misleading. It is true that while prescription drugs and devices have necessarily passed rigorous FDA review of the scientific basis for the manufacturer’s claim of efficacy, no such review has ever been conducted for claims made on behalf of off-label uses. But it surely does not follow that all claims made on behalf of off-label uses are inherently false or misleading. Surely it is possible to imagine promotion that accurately describes how a drug or device has ameliorated disease even when the product has never been formally approved for such use. Indeed, FDA has itself openly acknowledged the efficacy of certain off-label uses. At the very least, then, promotion claiming the same efficacy for a drug or device that FDA has already conceded is effective for the purpose in question would have to be deemed truthful. It is therefore absurd to postulate some sort of ex ante, categorical presumption of the falsity of all off-label claims. But once one concedes that some off-label promotion is truthful, the burden naturally falls on government—as it does in the case of all regulation of false advertising—to prove the falsity of a particular advertisement before it may constitutionally suppress it.
Of course, like any form of advertising protected by the commercial speech doctrine (or any fully protected advocacy, for that matter), off-label promotion is just that—promotion. For that reason, it is not likely to explore fully both sides of the issue. But the strategic selectivity of expression designed to promote the interests of the speaker in no other context automatically renders the expression false or misleading. To the extent that the failure of commercial speech to include negative information has the potential to mislead the listener, under established doctrine government may require the speaker to communicate that information (see Zauderer v. Office of Disciplinary Counsel 1985). In the case of off-label promotion, for example, at the very least it would make sense for government to require that the manufacturer indicate that FDA has never approved the particular use described in its promotion. But that does not mean that government may suppress the communication completely when the danger can be avoided by the provision of more information rather than less.
b. Second prong: What is the government’s “substantial interest”? Assuming the regulated speech is found not to be false or misleading, a reviewing court will proceed to an examination of the three remaining elements in the Central Hudson test. The first of those remaining inquiries—whether the regulation furthers a substantial governmental interest—is usually not very difficult to satisfy. That is equally true in the context of the suppression of the promotion of off-label use, at least to the extent that interest is defined in the broadest manner. No one could deny that government has a substantial interest in preserving the populace’s health and safety, and to the extent the complete suppression of the promotion of off-label use furthers that interest in a material way and goes no further than necessary, then the Central Hudson test would be satisfied. But neither of those final two requirements is met by FDA’s prohibition.
c. Third prong: Does the regulation materially advance the government’s substantial interest? If one assumes that FDA’s “substantial interest” under the second prong is to promote the safety and welfare of the populace by reducing the dangers of off-label use, it is purely speculative whether a ban on off-label promotion will achieve that goal. The federal government has conceded that not only are many off-label uses not only not harmful, they may in fact be quite beneficial. It is presumably for this reason that the federal government provides for reimbursement of off-label uses in at least some cases. The question then becomes, should we want practitioners to be made fully aware of valuable off-label uses? The answer most assuredly must be yes; it would be unacceptable for ill patients to be deprived of valuable and lawful treatments for the simple reason that their doctors were unaware of their existence. Yet FDA’s categorical ban on manufacturer promotion will likely have this impact. Indeed, regional variations in practice patterns and between community-based practitioners and those based in academic settings, and corresponding variations in patient outcomes, strongly suggest that this is the case. It is therefore impossible to assert that public health and safety will be advanced by the categorical prohibition of off-label promotion.
d. Fourth prong: Does the regulation go further than necessary? The fourth prong of Central Hudson requires that the regulation of commercial speech go no further than necessary to serve the government’s substantial interest. While the Court noted early on that government does not necessarily have to employ the very least restrictive alternative in order to satisfy Central Hudson’s fourth prong (see Board of Trs. v. Fox 1989), in recent years it has significantly increased the burden that this requirement imposes on government, on more than one occasion invalidating the suppression of commercial speech because of its failure to satisfy its demands. The Court has invalidated commercial speech regulations under this prong either because alternative nonspeech means of achieving the government’s goal were available or because the regulation swept too far, impinging upon protected speech that failed to give rise to the harm sought to be prevented (see, e.g., 44 Liquormart, Inc. v. Rhode Island 1996). The off-label promotion prohibition violates both aspects of the fourth prong.
Initially, there can be no doubt that to the extent the government’s goal is to prevent false or misleading promotion, the categorical prohibition contravenes the fourth prong. There is no way FDA can establish, ex ante, that promotion is either false or misleading merely because it promotes an off-label use. FDA’s categorical ban subsumes truthful promotion of these uses, as well as any conceivably improper uses. Secondly, we have already demonstrated that viable means of controlling nonexpressive behavior are available to the government to prevent dangers to the public health arising from unjustified or dangerous off-label uses—simply prohibit some or all off-label uses. There can be absolutely no doubt of Congress’s constitutional power to enact such a ban because it would be controlling the use of products that have traveled in interstate commerce. Indeed, the fact that the federal government refuses to employ its authority to prohibit off-label use renders rather hollow its argument that promotion of such uses threatens the public health.
Our argument underscores the inconsistency of the off-label promotion ban with both versions of Central Hudson’s fourth prong. On the one hand, the goals of the ban could be achieved by nonexpressive regulations. On the other hand, the ban sweeps much too far, including both expression that does give rise to the asserted danger and expression that does not do so.
IV. OFF-LABEL PROMOTION, COMMERCIAL SPEECH, AND THE FOUNDATIONS OF FREE EXPRESSION
A. Recognizing the Overlap Between Commercial Speech and the Traditional Categories of Protected Expression
By exploring the serious constitutional pathologies underlying the off-label promotion ban, we are able to grasp how suppression of commercial speech simultaneously undermines foundational precepts of American political and constitutional theory that underlie the First Amendment protection of all speech. In so doing, we are able to underscore the important theoretical overlap between the protection of commercial speech on the one hand and the protection of other more traditional categories of expression on the other.
If we are correct in this suggested overlap, we will be able to draw important implications for the First Amendment’s currently accepted theoretical framework. A number of respected scholars have either categorically rejected extension of First Amendment protection to commercial speech (Baker 1976) or proposed significant restrictions on its protection (Post 2000), reasoning that the profit motivation of the speaker distinguishes it from more traditionally protected categories of expression. While in recent years the Supreme Court has extended a significant level of First Amendment protection to commercial speech, it has long pointed to what it considers the “common sense differences” between that type of speech and the more traditionally protected forms of expression (see Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc. 1976). These conclusions have already been subjected to serious challenge. The constitutional flaws that inhere in FDA’s suppression of off-label promotion, we believe, underscore the fallacies in the argument that commercial speech is less deserving of First Amendment protection.
B. The Underlying Postulates of the Theory of Free Expression
There are many different, and often conflicting, theories of free expression. There are, however, certain core postulates of political theory without which any system of free expression would be incoherent. At some level, dispute may well exist as to the exact number and content of these postulates. But there are at least four such postulates that are clearly contravened by the governmental suppression of off-label promotion. This is so even though most, or all, of the expression suppressed by FDA’s prohibition is described as commercial speech.
The four core postulates of free speech theory that are indisputably contravened by the ban on off-label promotion are the following:
1. Government may not attempt to manipulate lawful citizen behavior by means of the selective suppression of truthful expression advocating lawful activity.
2. The self-motivated nature of expression does not automatically render it false or misleading, thereby removing it from the scope of constitutional protection.
3. Government has greater power to regulate conduct than it has to regulate expression.
4. Government may not hold fully protected expression hostage as a means of extortion.
When viewed in the context of noncommercial speech, presumably no educated observer could dispute the accuracy of these postulates or their centrality to any coherent system of free expression. Violation of any of these four postulates would correctly be deemed to undermine core notions of free speech theory. The social contract implicit in the relationship of citizen to government in a liberal democratic society would be undermined if government could disrespect the intellectual dignity of its citizens. Yet, as the prohibition on off-label promotion illustrates, the exact same pathologies may occur when government violates these core postulates in the context of commercial speech, just as much as when other types of expression are suppressed; the same lines between government and citizen have been improperly crossed in both contexts.
1. Postulate One: Government May Not Attempt to Manipulate Lawful Citizen Behavior by Means of the Selective Suppression of Truthful Expression Advocating Lawful Activity
In a democratic society, basic choices of policy are, ultimately, made by the populace—if only indirectly, through their elected representatives. To be sure, in certain instances the Constitution imposes limitations on majority choices, but even in those cases a supermajority of the populace may alter constitutional commands where it deems them to be no longer acceptable. Government may, of course, prohibit certain behavior, but the inherent logic of democracy prevents it from prohibiting the populace from debating the merits of those prohibitions. Where government has left behavioral choices to the individual, the premises of liberal democracy prevent the government from attempting to influence those choices through selective suppression of one side of a debate.
The point can be made clearer by viewing it through the lens of traditional political debate. If the First Amendment means anything, it prohibits government from suppressing one side of a political debate because it fears that the public might be convinced to make “the wrong” choice. For example, had the government sought to suppress opposition to the Iraq war because it feared that the public might be convinced to end that war, the suppression would undoubtedly have been found to infringe the First Amendment. In a democratic society, government may seek to influence the choices of the populace not by means of selective suppression but rather by making its own contributions to that debate. Indeed, it is impossible to point to a single respected First Amendment scholar who would deem such a selective ban to be constitutional. The reason is that vesting such power in government would necessarily prove too much, for it would undermine the fundamental premise underlying the commitment to self-government in the first place—namely, the citizen’s ability to make lawful choices on the basis of free and open debate.
Given that no one could seriously challenge the constitutional pathology of paternalistically driven selective suppression in political debate, it is puzzling that so many have no difficulty authorizing such paternalism when the subject of the speech is commercial rather than political. There is no way one may legitimately compartmentalize respect for citizens’ ability to make lawful choices on the basis of free and open debate. Either a democratic society trusts citizens to make such choices or it does not—in which event it automatically transforms from a democratic society to an authoritarian one. The fact that a dictatorship is benevolent does not make it a democracy. Yet, if citizens are deemed incapable of making lawful choices on the basis of free debate in the commercial realm, why all of a sudden do we deem them capable of making such choices in the political realm? When viewed through the lens of the relationship between government and citizen, the fact that in the commercial realm the speaker is seeking to make a profit is wholly irrelevant; the pathology in terms of democratic theory is not so much the suppression of the speaker’s right as it is the lack of respect for the citizen’s ability to make lawful choices—a lack of respect that inheres in the government’s selective suppression, regardless of the speaker’s purposes.
Recognition of this fundamental element of the liberal democratic social contract between government and individual, then, leads to a rejection of the core distinction drawn between commercial and political speech. FDA’s prohibition of off-label promotion, despite its concession that many off-label uses are extremely valuable and the fact that the promotion is not inherently false or misleading, serves effectively to underscore the point.
2. Postulate Two: The Self-Interested Nature of Expression Does Not Automatically Reduce the Level of Constitutional Protection
FDA, it should be recalled, prohibits manufacturer promotion of off-label use; it does not, however, prohibit others from discussing such use. FDA, then, has necessarily made the decision that the harm it seeks to prevent derives exclusively from manufacturer promotion. The assumption implicit in that dichotomy is that the self-interested nature of the promotion somehow renders the expression both less worthy and more dangerous. As previously noted, the logic of such a dichotomy, to the extent it were to justify categorical suppression, is inherently inconsistent with the Supreme Court’s commitment to the protection of commercial speech in the first place; under the Court’s definition, all commercial speech is manufacturer speech; yet under the Court’s doctrine it is extended a significant level of constitutional protection. Thus, the categorical suppression of speech for no reason other than the fact that it is made by an economically self-interested party is inconsistent with accepted Supreme Court jurisprudence.
Beyond its doctrinal difficulties, it is interesting to explore the consistency of FDA’s expressive discrimination against manufacturers from the broader perspectives of constitutional and political theory. In a democracy, it is generally understood that individuals will often act out of their own self-interest and will employ expression as a means of convincing others to take actions to advance that self-interest. The long history and current power of political interest groups are conclusive proof of that political reality. In the world of noncommerical speech, no one would seriously suggest that the self-interested nature of expression somehow reduces the level of First Amendment protection it receives. When the unemployed urge others to support the extension of unemployment benefits, no one would ever contemplate the possibility that their expression receive reduced protection merely because they possess a self-interested economic motivation for their expression.
One could easily come up with hundreds of similar examples. Yet in the case of off-label promotion, FDA appears to have made the wholly unsupported, ex ante assumption that manufacturer speech will be inherently distorted, and therefore suppressed, for no reason other than the self-interested economic nature of the speaker’s expression. Once again, when viewed through the lens of accepted political practice and modern democratic theory, the categorical discrimination against sellers for no reason other than the fact of the self-interested nature of their expression is rendered wholly incoherent. Few examples underscore this theoretically flawed dichotomy better than does FDA’s ban on off-label promotion but not on off-label discussion.
3. Postulate Three: The Government Has Greater Power to Regulate Conduct Than It Has to Regulate Speech
In the traditional world of free expression, no one would ever question that expression has considerably greater constitutional protection than most forms of conduct. For example, under certain circumstances, at least, one has the right to advocate unlawful conduct (see, e.g., Brandenburg v. Ohio 1969); yet one surely has no constitutional right to engage in that unlawful conduct. While some scholars have challenged the conclusion that speech is truly “special” (Schauer 1984), it is not all that difficult to grasp the key differences. Expression deals more directly with the unique ability to think and reason on multidimensional levels—qualities that are essential in a democratic society (see Redish 1982). Moreover, while of course expression can cause harm, as an ex ante matter it is reasonable to presume that the harm caused by expression will generally be less immediate and concrete than harm caused by physical conduct. For purposes of a constitutional protection in which broad judgments must be made, it is therefore reasonable to draw a categorical distinction between expression and conduct. By providing special protection to expression, this is exactly what the First Amendment does.
In the area of commercial speech, the distinction has not always been so clearly understood. For a time, the Court proceeded on the wholly misguided assumption that government’s greater power to regulate conduct subsumed the “lesser” power to regulate expression advocating that conduct, even where the conduct is not prohibited (see Posadas de P.R. Assocs. v. Tourism Co. of P.R. 1986). This “logic,” of course, completely ignores the fact that because the First Amendment extends greater protection to expression than to conduct, it is, in reality, the regulation of the expression that is the “greater” power. Indeed, acceptance of this logic outside of the commercial speech context (and there is no logical basis for confining it in such a manner) would overturn over eighty years of Supreme Court jurisprudence in the constitutional protection of unlawful advocacy (see Redish 1984). In his opinion announcing the judgment of the Court in the 1996 decision in 44 Liquormart v. Rhode Island (1996), Justice Stevens categorically and vigorously rejected the specious logic of prior Supreme Court jurisprudence (ibid., 509). The Court’s vigorous protection of commercial speech since that decision confirms that the Court as a whole has concurred in Justice Stevens’s rejection of the “greater includes the lesser” logic.
FDA’s ban on off-label promotion runs directly counter to this core First Amendment premise and in doing so highlights its importance. Whether the federal government in general or FDA in particular wishes to control or even prohibit off-label uses is an issue on which the First Amendment is wholly agnostic. This is so because such actions would regulate conduct, not expression. Yet while categorically prohibiting promotion of off-label use, the government has for the most part not restricted off-label use. Indeed, as we pointed out earlier, FDA has gone so far as to permit the use of drugs that have not been approved for any purpose at all. Instead of allowing the advocacy and restricting the conduct, FDA has prohibited the advocacy but permitted the conduct, leaving doctors to fend for themselves in finding out about potentially life-saving off-label uses. In following this policy, FDA has turned the First Amendment on its head, creating an Alice-in-Wonderland world in which speech receives less protection than the conduct it advocates. Such an inversion of constitutional values would surely not be permitted when traditionally protected noncommercial speech is involved; there is no basis in logic or experience to justify it in the context of commercial speech.
4. Postulate Four: Government May Not Hold Fully Protected Expression Hostage as a Means of Extortion
Recall that one of the conceivable justifications turns not at all on the constitutional unworthiness of the off-label promotion itself. It turns, rather, on the asserted need for FDA to be able to coerce drug manufacturers into making off-label uses on label. Doing so requires the manufacturers to conduct expensive and detailed scientific studies supporting the efficacy and safety of the off-label use, something they understandably may often not be inclined to do. By prohibiting their ability to promote off-label use, FDA is able to pressure them into undertaking the necessary steps to make the uses on label. In effect, the government is asserting that it is constitutionally authorized to suppress speech that it readily concedes, if only for purposes of argument, is on its four corners fully deserving of protection, in order to extort certain actions out of private entities that have absolutely no legal obligation to undertake such action.
It is hard to imagine government even attempting such outrageous actions when the speech in question is noncommercial, but if it did so there can be little doubt that its actions would be held unconstitutional. By much the same reasoning, government could presumably prohibit individuals from attending religious services unless individuals engaged in specified behavior, despite the existence of the First Amendment’s Free Exercise Clause. One shudders to think what might result if government sought to achieve the same result by suspending citizens’ Eighth Amendment right against cruel and unusual punishment.
Where citizen behavior on its face falls within the scope of a constitutional protection, it would be absurd to permit government to suppress that behavior in order to induce citizens to engage in behavior in which they have no legal obligation to engage. Yet that is exactly what FDA is doing when it seeks to justify the suppression of off-label promotion on the grounds that it is seeking to induce manufacturers to make the uses on label. The surreal aspect of such extortive behavior is underscored by the fact that the federal government has full constitutional authority to directly require the manufacturers to transform the off-label uses into on-label form, simply by directly prohibiting the prescription of approved drugs for off-label use (U.S. Const. art. i, § 8, cl. 3 (Commerce Clause); U.S. Const. art. i, § 8, cl. 18 (Necessary and Proper Clause). While the court in United States v. Caronia (2008) reasoned that the federal government lacked such constitutional authority, such a conclusion preposterously ignores the last sixty years of Commerce Clause jurisprudence (see, e.g., Gonzales v. Raich (2005) (upholding federal power to criminalize sale of drugs traveling in interstate commerce); Katzenbach v. McClung (1964) (upholding Title II of 1964 Civil Rights Act, which prohibited discrimination in restaurants that sell food that traveled in interstate commerce)). Whether FDA itself, under the current regulatory framework, possesses such authority is wholly irrelevant to the constitutional analysis. If the federal government, as an entity, wishes to require that a prescribed drug be on label, there is no doubt of its constitutional authority to do so. The government therefore cannot be permitted to suppress expression as an indirect means of achieving its goal, when it has available a perfectly legitimate direct means of achieving the same end. Whether it would be simpler—or simply more expedient—for the government to achieve its goal indirectly by suppressing protected speech is irrelevant to the constitutional inquiry. The suppression of fully protected, potentially valuable expression is far too high a price to pay for governmental convenience.
V. CONCLUSION
In light of the Supreme Court’s vigorous protection of commercial speech rights in recent years, FDA’s continued suppression of off-label promotion is quite puzzling. There is no basis to support the assumption that all off-label uses are harmful. To the contrary, off-label uses are often extremely valuable, a fact that government officials have readily conceded. There is absolutely no basis to support the assumption that all manufacturer promotion of off-label uses is inherently false or misleading, and FDA makes no such assumption. Indeed, it is quite conceivable that manufacturer promotion could inform doctors of life-saving or improving off-label uses of which they would not otherwise have been aware. Thus, we are dealing with a situation in which the suppressed speech truthfully advocates lawful action that might well maximize the welfare of all involved. Yet an agency of the federal government has categorically prohibited such expression.
Under current Supreme Court commercial speech doctrine, truthful commercial advertising for a lawful product or activity is extended substantial First Amendment protection. Government must show beyond the level of mere speculation that the suppression of such speech materially advances a substantial interest and goes no further than necessary to achieve that end. The Court has regularly invalidated regulations of commercial speech because of their failure to satisfy those requirements. Moreover, there is a strong indication in modern Supreme Court doctrine that any suppression of truthful advertising for a lawful activity designed to protect the listener from making a lawful choice is categorically unconstitutional.
When viewed on the more foundational levels of American political and constitutional theory, the ban on manufacturer promotion of off-label use becomes even more bizarre. The suppression of truthful commercial advertising promoting lawful activity does far more than contravene the First Amendment rights of the seller. Far more invidious to the foundations of the liberal democratic social contract is the government’s lack of respect the ban demonstrates for the citizenry’s ability to make well-informed, lawful choices on the basis of truthful advocacy.
For all of these reasons, the ban on the promotion of off-label use must—and, at some point in the near future, almost certainly will—be held to violate the First Amendment. It is unfortunate that those vested with governmental power have not themselves recognized this fact. But rest assured that the judiciary will soon educate them.
NOTE
This chapter is a modified version of the article “Off-Label Prescription Advertising, the FDA, and the First Amendment: A Study in the Values of Commercial Speech Protection,” 37 American Journal of Law & Medicine 315 (2011), copyright ©2011 by American Society of Law, Medicine & Ethics, Boston University School of Law; reprinted with permission.
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