Cortez considers -
whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.
I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various factors and indicia of commercial speech that they actually use. I find that courts often use the speaker's commercial identity as a proxy for commercial intent, which otherwise is the most salient factor. The Article then considers various forms of speech by FDA-regulated companies that blur the distinction between commercial and noncommercial speech, including publicity, statements via new media, speech through experts and intermediaries, and scientific speech, including speech about off-label uses for their products.
The Article concludes that each of the various factors courts use to distinguish commercial from noncommercial speech would have to align perfectly for courts to give it heightened First Amendment protection.He notes that
For over a century, the Food and Drug Administration (FDA or the Agency) and its precursors have regulated what companies say about their products. 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.” 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, 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.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, 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. Before then, the Court established that direct comments on public issues deserve heightened protection, regardless of who is speaking. 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. 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,” 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.
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. 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.