American Journal of Law & Medicine

Can speech by FDA-regulated firms ever be noncommercial?

I. INTRODUCTION

For over a century, the Food and Drug Administration (FDA or the Agency) and its precursors have regulated what companies say about their products. (1) The FDA itself notes that the regulatory scheme imposed by the Federal Food, Drug, and Cosmetic Act "depends on the use of words" and that its requirements can "explicitly limit speech." (2) For seventy years, the FDA had little reason to worry about First Amendment constraints. But since 1976, when the Supreme Court reversed its longstanding position that the First Amendment does not protect commercial speech, (3) the Agency has had to confront--perhaps more than any other federal agency--the free speech rights of regulated firms.

But how far do those rights extend, and what room do they leave for regulators like the FDA? The answer largely depends on another question: Is the speech commercial or noncommercial? The distinction is paramount. If speech by a regulated firm is commercial, then the FDA can ensure that it is not false or misleading; the Agency can require or compel certain speech; it can impose prior restraints; and it can even limit truthful speech, all within certain parameters. (4) But if the speech is noncommercial, the FDA may not do many--if any--of these things. The distinction thus determines the extent to which the government can regulate, if at all.

Unfortunately, after three decades of experience with commercial speech, the doctrinal distinctions between commercial and noncommercial speech remain marbled with points of confusion and contention. The prevailing test from Bolger v. Youngs Drug Products asks whether the speech is an advertisement, whether it refers to a specific product, and whether the speaker has an economic motive, (5) thus considering the form, content, and motivation for the speech. This test capably distinguishes paradigmatic examples of commercial and noncommercial speech. But it is unsatisfactory when categorizing less traditional or even mixed speech, thereby leaving lower courts, regulators, and regulated parties alike with significant uncertainty as to the permissible bounds of regulation.

A point of lingering uncertainty is under what circumstances speech by corporations might qualify for heightened protection as noncommercial. In 2003, the Supreme Court declined to hear Nike v. Kasky, passing on a chance to provide much-anticipated guidance. (6) Before then, the Court established that direct comments on public issues deserve heightened protection, regardless of who is speaking. (7) But what about other forms of corporate speech? Can speech by regulated firms ever be noncommercial? If so, when?

These are not minor questions for agencies like the FDA that confront myriad forms of speech that are not easily categorized. Marketers of food, drugs, devices, and dietary supplements often speak in ways that disrupt our conventional understanding of what constitutes advertising or promotion. Not only have these companies pioneered the creative use of press releases, web sites, social media, and other formats, but they also speak through intermediaries and third parties--particularly scientific and medical experts- using speakers bureaus, continuing medical education (CME) seminars, industry and academic conferences, and reprints of scientific studies and academic articles. (8) Are these forms of speech always commercial? What would it take to qualify for heightened protection?

To better answer these questions, this Article offers a framework that identifies the indicia of commercial speech--the relevant factors courts can use to distinguish commercial from noncommercial speech. Relying on both Supreme Court decisions and a systematic review of cases in which FDA-regulated firms claimed First Amendment protection, I propose a more reductionist, disaggregated approach than the three-part test in Bolger. Bolger considers the form, content and motivation for the speech. I argue that courts should recognize that they are really considering the Who, What, When, Where, Why, and How of the speech at issue: Who is speaking? What is the content of the speech? When is the speech communicated? Where is the speech directed? Why is the speaker speaking? And how is the speech communicated? These questions provide a more complete, detailed picture of the speech. And courts should acknowledge these factors and understand how they operate.

The Article evaluates how courts have applied these factors and offers a few observations. First, when courts apply the three factors from Bolger, the distinction often boils down to why the speaker is speaking--whether the speech is economically motivated. Despite claims that the Supreme Court is careful not to rest the distinction on commercial intent, which it considers almost "forbidden territory," (9) most of the factors indeed look for evidence of commercial intent. As emphasized below, commercial intent can become evident by carefully examining who is speaking, about what, when, where, why, and how. Why the speaker is speaking is the most salient factor, but perhaps the most difficult to reliably ascertain.

Second, courts frequently rely on who is speaking as a proxy for determining the speaker's motivations, notwithstanding the Supreme Court's repeated declarations that not all speech by corporations is necessarily commercial. My review found that out of twenty-four cases in which FDA-regulated firms claimed First Amendment protection, courts categorized the speech as commercial in all but two, neither of which involved FDA rules or enforcement. (10) The case law suggests that courts have developed more than a healthy dose of skepticism regarding speech by FDA-regulated firms, particularly pharmaceutical and medical device manufacturers. (11) I consider several types of distinction-blurring speech by these firms--including statements made via press releases and other forms of publicity, speech associated with charitable programs, and speech about off-label uses for FDA- approved products--and conclude that each of the factors would have to align perfectly for a skeptical court to categorize the speech as noncommercial. Thus, the answer to the question in the title (Can speech by FDA-regulated firms ever be noncommercial?) is yes, but only if the stars align.

II. WHY THE DISTINCTION MATTERS

The government enjoys much more latitude to regulate commercial than noncommercial speech. When the speech is commercial, the government can more easily prohibit false or misleading speech, compel speech, impose prior restraints on it, and even limit truthful speech--all of which are extremely problematic in noncommercial contexts. (12) For the FDA's purposes, this essentially means the difference between being able to regulate or not.

The disparity largely derives from the different tests courts apply. For laws targeting commercial speech, courts apply intermediate scrutiny under the famous four-part test in Central Hudson Gas & Electric Corp. v. Public Service Commission. (13) The test asks: (i) whether the speech is inherently false or misleading, and if not, continues on to ask; (ii) whether the government asserts a substantial interest; (iii) whether the restriction directly advances that interest; and (iv) whether there is a reasonable fit between the government's ends and the means it uses. (14)

By contrast, laws targeting noncommercial speech receive more stringent scrutiny. When the government wants to regulate noncommercial speech directly, it must demonstrate that it has a compelling interest, and that the restriction directly advances that interest using the least restrictive means available. (15) Even content neutral regulations that indirectly affect noncommercial speech must further an important governmental interest that is unrelated to suppressing free expression, and restrict no more speech than necessary. (16)

The first factor in Central Hudson is crucial, as it recognizes the government's authority to ask whether the content of commercial speech is false or misleading--a query generally forbidden in noncommercial contexts, where restrictions must be content neutral, regardless of the truth or falsity of the speech. (17) Thus, for example, regulators like the FDA can scrutinize the content of a manufacturer's labeling or advertising to determine whether, in the Agency's opinion, it is false or misleading. Noncommercial speech is largely immune from such content-based objections.

The last factor in both the commercial and noncommercial tests look the same, and both essentially ask whether the speech restriction is more burdensome than necessary. (18) But courts apply this criterion much differently depending on whether the speech is commercial or not, tolerating considerably greater burdens on commercial speech. (19) Thus, the distinction largely determines whether, and to what extent, the government can regulate.

Nevertheless, characterizing the speech as commercial does not necessarily mean that courts will uphold restrictions on it. (20) Courts have not hesitated to invalidate such restrictions under Central Hudson, and the Supreme Court has chastised the government for "seriously underestimat[ing] the value of commercial speech." (21)

Even so, as FDA-regulated firms devise more novel and creative ways to promote their products, regulators might be guided by Justice Brennan's warning that "those who seek to convey commercial messages will engage in the most imaginative of exercises to place themselves within the safe haven of noncommercial speech, while at the same time conveying their commercial message." (22) As I demonstrate in Part IV, courts seem to have adopted this skepticism towards FDA-regulated firms.

III. HOW THE DISTINCTION EVOLVED

The distinction between commercial and noncommercial speech first emerged in 1942, when the Supreme Court rejected a transparent attempt to add political objections to an advertisement and use the First Amendment to shield it from regulation. (23) In a "casual, almost offhand" ruling, (24) the Court held that the First Amendment does not cover "purely commercial advertising," (25) without elaborating what this meant. So, as the story goes, "the Supreme Court plucked the commercial speech doctrine out of thin air." (26)

Although this holding lingered for over three decades, the Court seemed to recognize much earlier that commercial speech deserved at least some protection. (27) And with it sprouted the need to define commercial speech with more granularity. When the Supreme Court finally held that the First Amendment protects commercial speech in the mid 1970s, (28) it explained in a footnote that "commonsense differences" could distinguish commercial from noncommercial varieties. (29) Initially, this meant speech that "does no more than propose a commercial transaction." (30)

But instead of sketching out boundaries for tougher cases, the Court was more comfortable speaking about paradigmatic examples, particularly things that clearly were not commercial speech. (31) For example, in Virginia State Board of Pharmacy, the Court explained that pure, noncommercial speech is concerned with the "exposition of ideas" about "truth, science, morality, and arts in general," including "liberal sentiments on the administration of Government." (32) In doing so, the Court contrasted such speech with price advertising for prescription drugs at issue in the case. Therefore, the early cases intuited distinctions between traditional advertising on one hand and romanticized notions of pure speech on the other. But these cases were not equipped to do much else.

Of course, between these two easily identifiable poles resides a great swath of speech that is neither purely commercial nor noncommercial. And eventually litigants would ask the Supreme Court to categorize speech that did not rest comfortably on either end. Indeed, the Court foreshadowed this problem in Virginia State Board of Pharmacy, noting that commercial speech is not "wholly undifferentiable from other forms." (33) But the Court's 1980 opinion in Central Hudson simply explained that commercial speech is any "expression related solely to the economic interests of the speaker and its audience." (34) This definition also seemed too tautological.

The Court recognized that it would need to formulate a test for the tougher cases. Three years later, in Bolger v. Youngs Drug Products, the Court broadened its analysis into an implied totality of the circumstances test, asking whether the speech is an advertisement, whether it refers to a specific product, and whether the speaker has an economic motive. (35) Though none of these factors alone could render the speech "commercial," together they could. (36) The Court thus gradually shifted from "commonsense" distinctions that could differentiate only classic cases of paradigmatically commercial or noncommercial speech to a series of factors that could handle more difficult ones.

Yet even the more modern test in Bolger is marbled with points of confusion and contention. Summarizing the criticisms, one scholar found that "the Bolger test has attracted scant endorsement among commentators" who call it "perplexing," "unworkable," and other unflattering things. (37) To some, even the basic distinction between commercial and noncommercial speech "makes no sense." (38) Justice Thomas would virtually obliterate it. (39) Others argue that it is impossible to categorically distinguish commercial from noncommercial speech in any satisfactory way, (40) as many cases simply do not reflect "a clean distinction between the market for ideas and the market for goods and services." (41) Still others maintain that commercial speech should not be protected by the First Amendment at all because it does not further any of the First Amendment's underlying goals or rationales. (42) Finally, in the middle, dozens of scholars have argued for altering or refining the distinction in various ways, (43) as I do here.

Unfortunately, the Supreme Court recently declined an opportunity to clarify the distinction in Nike v. Kasky. (44) In the late 1990s, Nike defended its overseas labor practices against charges that it was underpaying and mistreating foreign workers by using a public relations campaign that included letters to newspaper editors and university administrators, press releases, and other non-advertising documents. (45) After a consumer sued Nike under California's unfair competition laws (46) for making false and misleading statements, the California Supreme Court held that Nike's speech was commercial "[b]ecause the messages in question were directed by a commercial speaker to a commercial audience, and because they made representations of fact about the speaker's own business operations for the purpose of promoting sales of its products." (47)

On appeal, the U.S. Supreme Court denied certiorari after originally granting it, (48) passing up the opportunity to clarify whether Nike's speech was commercial or not. Justice Breyer's dissent argued that although a commercial speaker was addressing its business practices to a commercial audience, the form, content, and regulatory context were all noncommercial, pointing towards heightened protection. (49) The dismissal surprised those who predicted that the Court would declare Nike's speech to be noncommercial. (50) Given the Roberts Court's current composition and its aggressive stance towards First Amendment rights, one could certainly envision a different outcome today.

IV. A SURVEY OF THE DISTINCTION IN FDA-RELATED CASES

How have courts made the distinction between commercial and noncommercial speech in FDA-related cases? My research found twenty-four cases since the 1976 Virginia State Board of Pharmacy opinion in which an FDA-regulated firm argued that its speech was protected by the First Amendment. (51) Of these, seven involved FDA-regulated firms but did not involve FDA rules or enforcement--three alleging unfair competition under the Lanham Act, (52) three challenging state prescription confidentiality laws, (53) and one involving product liability claims. (54) I include these cases because they generally involve FDA-regulated firms invoking First Amendment defenses of their speech. The Table below identifies the speech at issue in each case, and whether the court deemed it to be commercial or not. I analyze these cases below.

Of these twenty-four cases, only two held that the speech was noncommercial, both of which were Lanham Act cases. (56) Of the seventeen FDA-related cases, no court found the speech to be noncommercial, supporting the observation that "every major lawsuit challenging FDA speech restrictions has proceeded under the assumption that the speech in question is commercial in character." (57) However, of these seventeen cases, three courts did not categorize the speech. (58)

Of the remaining fourteen FDA-related cases in which the court affirmatively found the speech to be commercial, nine did so without really applying (and sometimes without even citing) the Bolger test, for example by jumping straight into Central Hudson. (59) Granted, five of these nine involved statements in the label or labeling of FDA-regulated products, which most parties concede are properly categorized as commercial. (60) And some clearly involved commercial advertising or marketing, in which case the parties often did not even contend that the speech was noncommercial. (61)

Only a handful are what could be considered difficult cases, supporting Nat Stern's observation that most commercial expression is clear-cut. (62) Perhaps the most well-considered opinion was penned by Judge Lamberth in WLF v. …

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