THE LOCHNERIZED FIRST AMENDMENT AND THE FDA: TOWARD A MORE DEMOCRATIC POLITICAL ECONOMY

Introduction

“[T]he majority has chosen the winners by turning the First Amendment into a sword, and using it against workaday economic and regulatory policy. Today is not the first time the Court has wielded the First Amendment in such an aggressive way. And it threatens not to be the last. Speech is everywhere—a part of every human activity (employ­ment, health care, securities trading, you name it). For that reason, almost all economic and regulatory policy affects or touches speech. So the majority’s road runs long. And at every stop are black-robed rulers overriding citizens’ choices. The First Amendment was meant for better things.”

Janus v. AFSCME, Justice Kagan, dissenting 1 1 Janus v. Am. Fed’n of State, Cty., & Mun. Emps., Council 31, 138 S. Ct. 2448, 2501–02 (2018) (Kagan, J., dissenting) (citations omitted). ... Close

 

The “Lochnerization” of the First Amendment is without a doubt one of the most important developments in constitutional law in recent years. 2 2 For academic discussions of the trend, see Robert Post & Amanda Shanor, Adam Smith’s First Amendment, 128 Harv. L. Rev. Forum 165, 167 (2015), http://harvardlawreview.
org/wp-content/uploads/2015/03/vol128_PostShanor2.pdf [https://perma.cc/7CJM-YEAQ] (observing “that the First Amendment has become a powerful engine of constitutional deregulation”); Jedediah Purdy, Neoliberal Constitutionalism: Lochnerism for a New Economy, 77 Law & Contemp. Probs., no. 4, 2014, at 195, 195 (describing First Amendment Lochnerization and its far-reaching implications). ... Close This was so before the explosive end of the 2018 Term, and it is particularly evident after it. 3 3 See generally Janus, 138 S. Ct. 2448 (reversing long-standing precedent and declar­ing, on First Amendment grounds, that public sector unions may not require benefi­ciaries to pay dues for activities related to collective bargaining); Nat’l Inst. of Family & Life Advocates v. Becerra, 138 S. Ct. 2361 (2018) (striking down, as inconsistent with the First Amendment, a California law requiring crisis pregnancy centers to inform women where to obtain comprehensive reproductive health services and requiring unlicensed facilities to reveal that status). ... Close As Justice Kagan laid bare on the same fate­ful day that Justice Kennedy announced his retirement, recent Supreme Court decisions have “weaponiz[ed]” the First Amendment, turning it into a powerful tool against a range of ordinary socioeconomic legisla­tion. 4 4 Janus, 138 S. Ct. at 2501 (Kagan, J., dissenting); see also Becerra, 138 S. Ct. at 2381–82 (Breyer, J., dissenting) (arguing that the majority’s decision will “invite courts . . . to apply an unpredictable First Amendment to ordinary social and economic regulation”); Sorrell v. IMS Health Inc., 564 U.S. 552, 602–03 (2011) (Breyer, J., dissenting) (noting that the majority’s decision “open[ed] a Pandora’s Box of First Amendment challenges to many ordinary regulatory practices”). ... Close There is little that can escape its reach, because we are crea­tures of speech, and governance and speech are inescapably intertwined.

There may be no edifice of public regulatory power more immedi­ately threatened by this trend than the Food and Drug Administration (FDA). A key accomplishment of both the Progressive Era and the New Deal, the FDA is perhaps the most muscular of all federal agencies, and a key American instance of public power over market imperatives. 5 5 See Daniel Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA 24 (2010) (noting that “within the United States, the [FDA] exer­cises more forceful and more discretionary powers than do national agen­cies regulating other sectors of the national economy”). ... Close It also has enjoyed extraordinarily high levels of influence and public trust throughout its long history. 6 6 Id. at 11 (describing this phenomenon of public trust particularly as applied to medicine, the FDA’s most intensive domain of regulation). ... Close

Like many agencies, the FDA governs a great deal that is readily understood as speech, such as disclosures on food labels, warnings for tobacco, and advertisements for medicines and cosmetics. 7 7 For a discussion of regulatory methods used by other agencies that similarly implicate speech, see Amanda Shanor, The New Lochner, 2016 Wis. L. Rev. 133, 166–71. ... Close But the core of its regulatory power runs much deeper and may seem far less obvi­ously susceptible to the acid bath of contemporary free speech law. For example, the FDA is a gatekeeper for new pharmaceuticals, forbidding any person from “introduc[ing] into interstate commerce” any unap­proved drug. 8 8 21 U.S.C. § 355(a) (2012). ... Close This sounds like it constructs governmental power over conduct and products, and it does. But it also can be construed as con­straining speech. An introduction for sale, after all, is often accom­plished through nothing more than speech, such as an offer for sale or advertise­ment. A “drug” is, by law, anything “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” 9 9 Id. § 321(g)(1). ... Close Intended use is commonly construed via speech, such as advertisements or labels that suggest a particular use. 10 10 21 C.F.R. § 201.128 (2018) (defining “intended use” as being discernible from, inter alia, “labeling claims, advertising matter, or oral or written statements”). ... Close A company may market furniture oil as a cleaning product. But if it markets it as a remedy for cancer, the same substance becomes a “drug” for purposes of the FDA. The FDA is a critical and revealing example, then, of the astonishingly broad reach of a weapon­ized First Amendment.

As commercial speech protections have expanded, they have, in fact, begun markedly to encroach upon the FDA’s powers. 11 11 See infra section I.B. ... Close Courts, speaking in the name of the First Amendment, are “freeing” us from regulatory approaches that have worked for decades to inform us about the prod­ucts we put in our bodies. How did we arrive here? And how might demo­cratic prerogatives over the webs of commodity exchange upon which our lives today depend be rebuilt, particularly if the Court continues down its current path?

Part I offers a brief overview of the FDA. It traces the arc of the Agency’s construction in order to illuminate the importance of its work and to show the threat posed by recent First Amendment cases, particu­larly to the Agency’s oversight of drug and tobacco markets.

Part II explores how the First Amendment, long understood as a protector of democracy, has come to pose a threat to democratic author­ity over markets. Using several landmark commercial speech cases, I show that commercial speech protection today is built upon certain distinctive and contestable conceptions of the nature of markets, states, and sub­jects. Markets are cast as neutral domains that must be kept free from democratic interference; the state is suspect and the locus of capture rather than democratic will-formation; and subjects have unitary “inter­ests” that allow no firm distinction between the realm of the political and the realm of the market. These ideas are not plucked from thin air. They are important components of the kind of market fundamentalist thought that gained prominence in the United States in the 1980s and thereafter, as has been elaborated in the literature on neoliberalism. The analysis here complements Professor Jed Purdy’s Beyond the Bosses’ Constitution 12 12 Jedediah Purdy, Beyond the Bosses’ Constitution: The First Amendment and Class Entrenchment, 118 Colum. L. Rev. 2161 (2018) [hereinafter Purdy, Beyond the Bosses’ Constitution]. ... Close and simi­larly contributes to the emerging “law and political economy” litera­ture. 13 13 For an introduction to the term and literature, see David Singh Grewal, Amy Kapczynski & Jedediah Purdy, Law and Political Economy: Toward a Manifesto, Law & Political Econ. (Nov. 6, 2017), https://lpeblog.org/2017/11/06/law-and-political-economy-toward-a-manifesto/ [https://perma.cc/MZP6-FBCY]. ... Close Law and political economy approaches are grounded in the premise that the economy and political life are not fully separable but mutually shape and influence one another. 14 14 See id. ... Close Law constructs markets, and the distribution of economic power (and “private” power more broadly) deeply shapes law. Political economy analysis seeks to illuminate this fact and to map the relationship between markets and political life as it is figured across a wide range of legal domains. 15 15 See id. ... Close

Scholars elaborating political economy approaches to law also tend to engage a further question, one resonant with the aims of this Symposium: What new theories and institutions do we need to sustain and create a more genuinely democratic and equal society? Part III addresses this question as it appears in the FDA context. It shows that there is room within current doctrine to revive robust regulatory author­ity for the Agency. It also maps another way to rescue democratic pre­rogatives if courts continue down their current path: a pivot away from the model of private market regulation upon which the FDA’s approach is built.

If courts thrust us into a world with more limited authority over pri­vate markets, we must envision a much more substantial role for the public—in this case, for example, by expanding public funding for health research. This approach could mitigate the harm done by recent court decisions and have far-reaching benefits for what we might call health democracy or health justice. It is also an instance of a broader point: As a commit­ment to market supremacy advances inside of constitutional doctrine, democratic control over our economy and society will demand new pub­lic infrastructure that displaces or routes around an increasingly ungov­ernable private sector. 16 16 For accounts similarly suggesting that a more sustainable and just political econ­omy requires attention to infrastructure, see K. Sabeel Rahman, The New Utilities: Private Power, Social Infrastructure, and the Revival of the Public Utility Concept, 39 Cardozo L. Rev. 1621, 1657–68 (2018) (financial sector infrastructure); id. at 1648–57, 1668–80 (com­munications infrastructure); David Singh Grewal, Before Peer Production: Infrastructure Gaps and the Architecture of Openness in Synthetic Biology, Stan. Tech. L. Rev., Winter 2017, at 143, 150 (infrastructure for science and peer production); Jedediah Purdy, The World We’ve Built, Dissent (July 3, 2018), https://www.dissentmagazine.org/online_articles/
world-we-built-sovereign-nature-infrastructure-leviathan [https://perma.cc/57TZ-22BJ] (envi­ronmental infrastructure). ... Close

Though beyond the ambition of this short contribution, an explora­tion of the political economy of current commercial speech law must eventually lead us also to reconsider its scope. Courts have long been confused about why our Constitution might protect speech acts in the marketplace. Current law reasons increasingly in a market-supremacist idiom, suggesting, outlandishly, that the First Amendment exists to pro­tect market order from democratic governance. 17 17 See infra notes 141–149 (discussing the market-supremacist logic employed in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011)). ... Close Protections for commer­cial speech must serve rather than subvert our democracy. Delineating a new political economy of the First Amendment that helps achieve this aim is an important task for those who seek a future that is more demo­cratic and equal than our present.

I. The FDA—Then and Now

Whether in the United States or around the world, there are “few regulatory agencies of any sort . . . [that have] possessed or exercised the power held by the Food and Drug Administration.” 18 18 Carpenter, supra note 5, at 18. ... Close The FDA regulates food, supplements, cosmetics, drugs, medical devices, and tobacco, and its reach extends to more than one-fifth of all consumer products in the United States. 19 19 This figure is measured in terms of consumer value; FDA-regulated products account for approximately twenty cents of every dollar of annual spending by U.S. con­sumers. See Sheri Walker & Clark Nardinelli, Consumer Expenditure on FDA Regulated Products: 20 Cents of Every Dollar, U.S. FDA: FDA Voice (Nov. 1, 2016), https://blogs.
fda.gov/fdavoice/index.php/2016/11/consumer-expenditure-on-fda-regulated-products-20-cents-of-every-dollar/ [https://perma.cc/46XJ-EUVV]. ... Close Its creation in the early twentieth century was a powerful refutation of the rhetoric of laissez faire that then prevailed. 20 20 On the legal debates over laissez faire during this period, see generally Barbara Fried, The Progressive Assault on Laissez Faire 15–28 (1998). ... Close New gen­erations, usually responding to tragedy, repeatedly expanded the Agency’s power. In doing so, they made the Agency into a bête noire of leading neoliberal thinkers and the conservative legal movement, who have since the 1970s sought to radically curtail its authority. 21 21 See infra note 65 and accompanying text (discussing Chicago School critiques of the FDA). ... Close

Much like the Progressive and New Deal eras that birthed it, the Agency, though, can be seen in two guises: as embodying and enacting a priority for public over market values, and as relatively modest and market-facilitating in its aims. Its modesty, in fact, is part of what makes the Agency so vulnerable to the weaponized First Amendment: Most of its powers can be readily described as operating centrally on and through speech. With this backdrop in view, we begin to see better the shape of the First Amendment challenge that looms.

A. The Legislative Construction of Public Power

The FDA was born in the Progressive era, the result of a long-brewing public awakening to the dysfunctions that accompanied modern commodity markets in food and drugs. 22 22 For discussions of the Progressive era and the early history of the FDA, see, e.g., Philip J. Hilts, Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation 35–55 (2004); Peter Temin, Taking Your Medicine: Drug Regulation in the United States 18–37 (1980); James Harvey Young, Pure Food: Securing the Federal Food and Drugs Act of 1906, at 146–73 (1989). ... Close Toward the end of the nine­teenth century, crusading investigators and government inquiries had called attention to the widespread tainting of the food supply, from bread adulterated with plaster of Paris 23 23 Young, supra note 22, at 32. ... Close to “swill” milk that proved deadly to infants. 24 24 Id. at 36–39. ... Close A dangerous market in “patent” medicines had also exploded. 25 25 See Carpenter, supra note 5, at 77 (citing evidence of a meteoric expansion of the market over the nineteenth century, from just a few dozen advertised remedies in the early 1800s to tens of thousands a century later). ... Close These ostensible cures were different from the “formulary” medicines that preceded them in two key ways: Their ingredients were treated as proprietary and secret, 26 26 Formulary medicines were identified in compendia, which were developed by doctors over centuries and listed a small set of medicines, such as aspirin and morphine, along with their composition and tech­niques for manufacture. See Temin, supra note 22, at 24. Patent medicines, in contrast, were sold as proprietary, and were often little more than water, though some contained high (and undisclosed) levels of both alcohol and opioids. Id. at 25; see also Hilts, supra note 22, at 24 (contrasting the secrecy of patent medicines with long-standing efforts to codify and “set universal formulas for each known remedy, [which] had advanced from the seventeenth century to the nineteenth, with little difficulty”). ... Close and they were directly advertised to the public, typically accompanied by grandiose claims that belied their significant harms. 27 27 See Carpenter, supra note 5, at 77–79 (describing the claims made, as well as the dangers, of these medicines); Temin, supra note 22, at 25–26 (discussing patent medicine advertising). As Philip Hilts points out, advertising allowed patent medicines to emerge as “one of the first fully national markets.” Hilts, supra note 22, at 23. ... Close

The legislative response to these dangers began at the state level, but the scale of the problem and the role that increasingly national markets played within it soon led to demands for a federal response. 28 28 Temin, supra note 22, at 27. ... Close In 1906, fueled by the publication of Upton Sinclair’s The Jungle, Congress passed the path-break­ing Pure Food and Drugs Act. 29 29 Pure Food and Drugs Act, Pub. L. No. 59-384, 34 Stat. 768 (1906) (repealed 1938). On Sinclair’s role, see Hilts, supra note 22, at 49–52. ... Close For the first time, sellers had to disclose, as matter of national law, the presence of substances like alco­hol and narcotics in drugs. 30 30 Temin, supra note 22, at 30. ... Close Drugs, in turn, were defined in a manner that honed in on their marketing: They comprised not only formulary drugs but also any substance that was intended to be used to cure or pre­vent disease. 31 31 Id. ... Close The 1906 law also criminalized the adulteration of drugs and codified “misbranding” rules that required drug labels to be accurate. 32 32 Id. ... Close

The law stood as a rebuttal to any aggressively laissez faire vision of American government, “establishing the principle that it was now the job of government not just to champion commerce but also to intervene when it got out of hand.” 33 33 Hilts, supra note 22, at xii. ... Close But it also quickly proved inadequate. Court decisions narrowed its reach, 34 34 In United States v. Johnson, the Supreme Court held that the prohibition on false and misleading statements on labels applied only to claims about the identity of the compound and not its therapeutic qualities. 221 U.S. 488, 497 (1911). The Court sug­gested that issues of therapeutic benefit could only be matters of opinion, given the state of scientific knowledge at the time. Id. at 498. ... Close and companies could skirt its require­ments by making vague claims or separating advertising from labels. 35 35 See Temin, supra note 22, at 30–31. ... Close

Reformers sought to expand the Agency’s powers, but it took another public scandal to create the necessary legislative momentum. This time the culprit was “Elixir Sulfanilamide,” a patent medicine con­taminated with a highly toxic chemical that killed dozens of people. 36 36 Carpenter, supra note 5, at 89–91. ... Close In 1938, the Agency’s powers were dramatically expanded in one of the last major legislative achievements of the New Deal. 37 37 See Charles O. Jackson, Food and Drug Legislation in the New Deal, at vii (1970). ... Close Rather than simply mandat­ing disclosures or penalizing fraud, the new law banned danger­ous drugs from the marketplace outright. 38 38 See Temin, supra note 22, at 44. ... Close A seller of any “new drug” had to demon­strate that it was safe and allow the Agency time to assess the relevant evidence before marketing. 39 39 See id.; Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753, 1761–62 (1996) (discussing the introduction of premarket approval). ... Close At the same time, the federal gov­ernment’s authority expanded beyond labels to all drug advertising. 40 40 See Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, Food and Drug Law: Cases and Materials 11 (4th ed. 2014). Initially, this power resided in the Federal Trade Commission rather than the FDA. See id. ... Close

The Agency accrued still more extensive powers in 1962, in the wake of the thalidomide crisis. Thalidomide was a drug widely used in Europe by pregnant women to treat morning sickness that proved extraordinarily toxic to fetuses. 41 41 Carpenter, supra note 5, at 238–40. ... Close The harm that it wreaked on children, some born with­out arms or legs, was documented in searing images that still today mark the public’s consciousness of the risks of modern pharmaceuticals. 42 42 See Michael Winerip, The Death and Afterlife of Thalidomide, N.Y. Times: Booming (Sept. 23, 2013), https://www.nytimes.com/2013/09/23/booming/the-death-and-afterlife-of-thalidomide.html [https://perma.cc/8UNH-Z85A]. ... Close Tha­lidomide was never approved in the United States because of the tenacity of Frances Kelsey, an FDA reviewer who worked against the limits of the stat­ute to prevent U.S. approval. 43 43 See Carpenter, supra note 5, at 217–26, 249–51 (discussing Kelsey’s scrutiny of thalidomide’s FDA appli­cation). Under the law at the time, drugs were automatically approved after sixty days if the Agency did not mount an objection. Id. at 254. ... Close The tragedy, and Kelsey’s ensuing celeb­rity, galvanized the public. 44 44 See id. at 238–60 (describing the public and governmental responses to the tha­lidomide crisis). ... Close In 1962, Congress responded by granting the Agency substantially more extensive premarket review powers. 45 45 Merrill, supra note 39, at 1764–65. ... Close Now, marketers had to get the affirmative approval of the FDA and provide evidence not only of safety but also effectiveness. 46 46 Id.; see also 21 U.S.C. § 355(a) (2012) (prohibiting the marketing of a new drug prior to FDA approval); id. § 355(d) (requiring drug sponsors to provide “substantial evi­dence” of a drug’s safety and effectiveness with respect to the specific use in the pro­posed labeling, and defining “substantial evidence” as “evidence consisting of adequate and well-controlled investigations, including clinical investigations”). ... Close The amendments also gave the Agency a significant new role in overseeing the testing and pro­motion of medicines. 47 47 See Hutt, Merrill & Grossman, supra note 40, at 12; see also Merrill, supra note 39, at 1766–67 (describing the FDA’s expanded role in drug testing and approval). ... Close In implementing these new powers, the Agency created the scientific apparatus that ushered in the modern era of drug R&D: the phased, randomized controlled trials that are now the gold standard for clinical research worldwide. 48 48 See Carpenter, supra note 5, at 278–80, 292–95 (discussing the role of the FDA in trial standards); see also id. at 687 (noting the FDA’s global influence); Merrill, supra note 39, at 1777–82 (describing the FDA’s oversight of clinical trial design for pharmaceutical research and its development of requirements and guidelines for clinical trials). ... Close

For the last six decades, then, a company marketing a medicine has had to prove first to the FDA that the medicine actually works. The com­pany also had to show—until recent First Amendment cases cast this system into doubt—that the drug worked for a particular purpose, and it could not promote the drug for unproven uses. 49 49 See 21 U.S.C. § 321(g)(1) (defining “drugs” with reference to their “intended use”); 21 C.F.R. § 201.128 (2018) (defining “intended use”). ... Close For example, a drug approved to treat severe pain in terminal cancer patients could not be legally promoted to treat individuals with chronic lower-back pain. 50 50 See William B. Schultz, Trump’s New FDA Commissioner Has a Huge Decision to Make, Wash. Post (May 16, 2017), https://www.washingtonpost.com/opinions/trumps-new-fda-commissioner-has-a-huge-decision-to-make/2017/05/16/4ee187f8-3667-11e7-b412-62beef8121f7_
story.html [https://perma.cc/9R57-34DW] (discussing rules against off-label promotion, and offering this example). ... Close This is because the costs and benefits of drugs vary by use and can be estab­lished only via careful studies. 51 51 See Amy Kapczynski, Free Speech and Pharmaceutical Regulation—Fishy Business, 176 JAMA Internal Med. 295, 295–96 (2016) [hereinafter Kapczynski, Fishy Business] (“[D]rug[s] whose adverse effects may be acceptable when used to treat patients with serious illness[es] may cause more harm than benefit if used to treat healthier patients. Even a drug that is safe, but ineffective, can be harmful, for example if it is used instead of an effective intervention.”). ... Close For example, an opioid might have fewer risks and more substantial benefits for terminally ill cancer patients than for individuals in mild pain. 52 52 See id. at 295 (noting that drugs “prescribed for unproven indications can cause serious harm” and discussing Gabitril, a medication which can cause seizures when used off-label); see also Schultz, supra note 50 (noting the risks of marketing OxyContin, a “powerful opioid,” for mild pain). ... Close

The FDA has thus long exerted extraordinary control over what drug companies can say and, therefore, sell. As robust as these powers are, though, they can also be understood as quintessentially market-making, because they help generate reliable information for consumers. As I have described in previous work, unregulated markets cannot be expected to produce high quality, unbiased information about how medi­cines work. 53 53 See Amy Kapczynski, Dangerous Times: The FDA’s Role in Information Production, Past and Future, 102 Minn. L. Rev. 2357, 2358 (2018) [hereinafter Kapczynski, Dangerous Times] (“By controlling marketing, the FDA targets a distortion inherent to systems that rely on the profit motive and patents to generate clinical trial data: it encour­ages the creation of high-quality evidence about medicines that is not biased toward posi­tive results.”). ... Close Nor are markets alone able adequately to validate the scien­tific claims made about drugs. 54 54 Id. at 2358–59 (“Validation of the results of drug trials requires significant exper­tise, significant resources, and access to all of the relevant clinical trial data. While markets sometimes produce viable third-party certifiers, they cannot produce adequate third-party validators, absent major interventions that effectively turn third parties into . . . regulatory agencies.”); see also id. (noting that FDA drug reviews involve “hundreds of thousands of pages of data, and may require reviewers to rerun data analyses, to query companies for more information, and to closely scrutinize individual trial records”). ... Close The 1962 amendments were in fact the precondition for the possibility of the modern pharmaceutical industry, and the industry has grown enormously under its protective eye. 55 55 See Rebecca S. Eisenberg, The Role of the FDA in Innovation Policy, 13 Mich. Telecomm. & Tech. L. Rev. 345, 370–71 (2007) (suggesting that the FDA’s testing and approval process resolves several market failures, resulting in “increased public confi­dence” and preserved value for drug companies); Ariel Katz, Pharmaceutical Lemons: Innovation and Regulation in the Drug Industry, 14 Mich. Telecomm. & Tech. L. Rev. 1, 7 (2007) (“[R]ather than decreasing the expected returns to innovation, this aspect of the regulation . . . contributes to the value of new drugs and therefore may actually encourage innovation.”); see also Kapczynski, Fishy Business, supra note 51, at 296 (noting the FDA’s role in “foster[ing] the development of accurate and reliable information, and chan­nel[ing] that information into settings where it can be rigorously evaluated”). ... Close

For most of its history, the FDA had no similar oversight role for the tobacco industry, which metastasized into an extraordinarily lethal enter­prise. 56 56 See U.S. Dep’t of Health & Human Servs., The Health Consequences of Smoking—50 Years of Progress 7 (2014), https://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf [https://perma.cc/53FG-BXN3] (reporting that smoking has resulted in the prema­ture deaths of over 20 million Americans since 1964). Smoking continues to kill nearly half a million Americans each year. Burden of Tobacco Use in the U.S., CDC, https://www.cdc.gov/tobacco/campaign/tips/resources/data/cigarette-smoking-in-united-states.html [https://perma.cc/2ETE-FG7S] (last updated Apr. 23, 2018). ... Close As the dangers of cigarettes became more publicly known, efforts to more closely regulate the industry gained strength. The FDA tried and failed to exert oversight over tobacco through its drug regulatory powers in the 1990s, 57 57 In 1996, FDA Commissioner David Kessler sought to bring tobacco under the Agency’s authority, reasoning that nicotine met the statutory definition of a “drug” and that tobacco products were acting as delivery devices. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 125 (2000); see also Carpenter, supra note 5, at 744–45 (discussing Kessler’s attempts to regulate tobacco). Though this was a plausible reading of the statutory text, the Supreme Court held that the Agency was acting inconsistently with Congressional intent. Brown & Williamson, 529 U.S. at 126. ... Close and Congress granted it expansive new authority over tobacco products in 2009. 58 58 See Family Smoking Prevention and Tobacco Control Act (TCA), Pub. L. No. 111-31, 123 Stat. 1776 (2009) (codified as amended in scattered sections of 5, 15, and 21 U.S.C.). ... Close Aspects of this authority resemble the Agency’s over­sight over medicines and similarly turn critically on speech. A key provision of the new law, for example, requires the FDA to regulate so-called “modified risk tobacco products.” 59 59 21 U.S.C. § 387k (2012). ... Close This was in response to dec­ades of misleading marketing in which tobacco companies pushed “light,” “low-tar,” and “mild” cigarettes as healthier alternatives, though the companies knew that these cigarettes in fact had no demonstrable health benefits. 60 60 For example, companies marketed “light” cigarettes to dissuade smokers from quitting despite knowing that they did not meaningfully reduce smokers’ risks. United States v. Philip Morris USA Inc., 566 F.3d 1095, 1124 (D.C. Cir. 2009). They also “withheld and suppressed their extensive knowledge and understanding of nicotine-driven smoker compensation,” by which smokers unknowingly take deeper puffs of weaker cigarettes. Id. at 1125 (internal quotation marks omitted) (quoting United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 861 (D.D.C. 2006)); Philip Morris, 449 F. Supp. 2d at 860. ... Close Citing this history, Congress required companies marketing products as having modified risk first to substantiate their claims to the FDA. 61 61 Marketers must show that the products: “(A) signifi­cantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole taking into account both users of tobacco products and per­sons who do not currently use tobacco products.” 21 U.S.C. § 387k(g)(1); see also id. § 387k(b)(2)(A) (defining a modified risk product as one labeled, for example, as lower risk, having reduced levels of certain substances, or including the descriptor “light”); id. § 387k(g)(2) (providing limited discretion for the Secretary of Health and Human Services to exempt qualifying products upon certain findings). ... Close Makers of new products like “e-cigarettes” 62 62 E-cigarettes “are a diverse set of battery-powered devices that deliver a nicotine-containing aerosol to the user by heating a solution (called e-liquid) of humectants (propyl­ene glycol and/or glycerin), nicotine, and flavorants.” Gideon St. Helen & David L. Eaton, Public Health Consequences of e-Cigarette Use, 178 JAMA Internal Med. 984, 984 (2018). ... Close there­fore must provide substantiating evidence before they can market them in a manner that suggests that they have health benefits. 63 63 See The Facts on the FDA’s New Tobacco Rule, FDA, https://www.fda.gov/
ForConsumers/ConsumerUpdates/ucm506676.htm [https://perma.cc/V4L2-NWP5] (last updated Nov. 9, 2017) (describing the FDA’s expanded regulatory authority over e-cigarettes and other tobacco products). ... Close

As this brief history reflects, the FDA is the product of a national commitment to the view that markets must serve public values. As muscu­lar as the Agency is, however, it can also be seen as fairly modest in its approach. Supporters have long described the Agency as aiming to make markets safe for consumers, for honest businessmen, and for virtuous competition. 64 64 For example, in urging approval of the 1938 Act, President Franklin D. Roosevelt described it in this way:
In such a situation as has grown up through our rising level of living and our multiplication of goods, consumers are prevented from choosing intelligently, and producers are handicapped in any attempt to maintain higher standards. Only the scientific and disinterested activity of govern­ment can protect this honor of our producers and provide the possibility of discriminating choice to our consumers.
President Franklin D. Roosevelt, Message to Congress (Mar. 22, 1935), in Ruth deForest Lamb, American Chamber of Horrors: The Truth About Food and Drugs app. B at 332–33 (1936). This unprecedented expansion of agency power, he urged, was aimed at a “small minority of evaders and chiselers,” and would “provide a bulwark of consumer confidence throughout the business world.” Id. at 334. ... Close Even where the Agency’s power is at its height, in the realm of drugs and tobacco, it aims not to displace markets—for example by rendering public the process of researching or communicating about products—but rather to minimize the risks that come with delegating sub­stantial authority to market actors. The model of the modern FDA assumes that private market actors will not only produce goods but also most of the evidence that we need to evaluate the worth of these goods. The FDA has long relied on an infrastructure of information provision and dissemination that is more private than public. In part for this reason, our system for understanding and controlling the risks of medi­cines and tobacco is extraordinarily vulnerable to the weaponized First Amendment.

B. An Amendment Weaponized Against Regulatory Power

As the FDA accrued regulatory power, it became a prominent target for free-market theorists and anti-regulatory activists. Milton Friedman and other Chicago School economists published influential critiques in the 1970s that took aim at the Agency’s approach to pharmaceuticals. 65 65 For examples of these critiques, see generally Sam Peltzman, An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments, 81 J. Pol. Econ. 1049 (1973) (suggesting that the costs of the premarket approval process, measured by the forgone benefits of effective new medicines, exceed the benefits of avoiding ineffective medicines); Milton Friedman, Frustrating Drug Advancement, Newsweek, Jan. 8, 1973, at 49, reprinted in Milton Friedman, There’s No Such Thing as a Free Lunch 229–32 (1975) (discussing Peltzman’s article and suggesting that the 1962 amendments “should be repealed”). For a more recent critique, see generally Richard Epstein, Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation (2006). ... Close Right-wing advocacy groups also attacked the Agency in the courts. In the late 1990s, foreshadowing things to come, the Washington Legal Foundation (WLF) successfully used First Amendment arguments to pressure the Agency to permit drug companies to distribute reprints of journal articles about off-label uses. 66 66 See Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 74 (D.D.C. 1998), appeal dismissed, vacated in part sub nom. Wash. Legal Found. v. Henney, 202 F.3d 331 (D.C. Cir. 2000); Richard C. Ascroft, Note, Impact of the Washington Legal Foundation Cases on Pharmaceutical Manufacturer Practices in the United States, 34 Ind. L. Rev. 95, 118 (2000) (describing the case and the role of First Amendment arguments). Around the same time, WLF also challenged aspects of the FDA’s approach to off-label promotion on First Amendment grounds, but developments rendered the case moot. See Wash. Legal Found. v. Henney, 202 F.3d at 336. WLF has been the organization most centrally involved in this litigation and has received funding from pharmaceutical industry and tobacco lobbying groups. See Washington Legal Foundation, DeSmog, https://www.desmogblog.com/
washington-legal-foundation [https://perma.cc/E9N2-G66R] (last visited Aug. 27, 2018). ... Close

In 1999, companies marketing dietary supplements also successfully invoked the First Amendment to force the FDA to significantly liberalize its regulation of these sometimes risky products. 67 67 See Pearson v. Shalala (Pearson I ), 164 F.3d 650, 661 (D.C. Cir. 1999); Pearson v. Shalala (Pearson II ), 130 F. Supp. 2d 105, 120 (D.D.C. 2001). Recent evidence collected by the FDA suggests that supplements as a category are far from benign. An estimated 23,000 emergency visits and 2,154 hospitalizations each year can be attributed to supplements, a significant portion of these in young adults with cardiovascular symptoms after taking weight-loss or energy supplements. See Andrew I. Geller et al., Emergency Department Visits for Adverse Events Related to Dietary Supplements, 373 New Eng. J. Med. 1531, 1531 (2015). ... Close The FDA’s regulatory approach to supplements was structurally quite similar to its approach to pharmaceuticals: Companies wishing to market dietary supplements with health claims had first to show “significant scientific agreement” in sup­port of those claims. 68 68 Pearson I, 164 F.3d at 653. As the Pearson I court explained:
The FDA authorizes a claim only “when it determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, that the claim is sup­ported by such evidence.” The FDA’s authorization comes by an infor­mal rulemaking under the Administrative Procedure Act.
Id. at 652 (citation omitted) (quoting 21 C.F.R. § 101.14(c) (1998)). ... Close In both domains, the FDA’s institutional approach delegated substantial authority to market actors, and relied upon a back­ground assumption that was for decades uncontroversial: Free speech protections had no bearing on the ordinary activity of regulators seeking to shape markets and protect consumers.

Supplements companies argued, however, that they had a First Amendment right to market their wares in any way that the Agency could not affirmatively show to be false or misleading. 69 69 See id. at 653–56. ... Close The D.C. Circuit agreed—mandating as a matter of constitutional law in the domain of supple­ments much the same strategy that Congress had judged inade­quate for drugs in the 1930s. Disclaimers, the court felt, were adequate to protect consumers from being misled, and it remanded the case for factual determination. 70 70 See id. at 659–61. ... Close

The blow to supplements regulation was substantial, particularly because courts proved ill-prepared to evaluate the relevant scientific evi­dence. On remand, the FDA objected that the scientific evidence did not support the health claims made by the manufacturer. 71 71 Pearson II, 130 F. Supp. 2d. at 115 n.27. ... Close The district court reasoned, astonishingly, that “[t]he mere absence of significant affirmative evidence in support of a particular claim . . . does not translate into negative evidence ‘against’ it.” 72 72 Id. at 115. ... Close On this basis, it found the FDA’s refusal of the claim arbitrary and capricious. 73 73 Id. The court also pointed to one study that purported to support the supple­ment marketer’s claim, but the FDA questioned its validity. Id. at 116. ... Close Small wonder that dietary supple­ments have morphed into a multibillion-dollar industry that is “loosely regu­lated and plagued by accusations of adulteration and mislabeling.” 74 74 Anahad O’Connor, GNC to Strengthen Supplement Quality Controls, N.Y. Times : Well (Mar. 30, 2015), https://well.blogs.nytimes.com/2015/03/30/gnc-to-strengthen-supplement-quality-controls/ [https://perma.cc/X4YK-QJAQ]; see also Ziv Harel et al., The Frequency and Characteristics of Dietary Supplement Recalls in the United States, 173 JAMA Internal Med. 926, 927 (2013) (finding that dietary supplements accounted for more than half of FDA Class I drug recalls between 2004 and 2012); Donald M. Marcus & Arthur P. Grollman, Botanical Medicines: The Need for New Regulations, 347 New Eng. J. Med. 2073, 2073 (2002) (summarizing studies showing frequent adulteration and lack of standardization). ... Close

The FDA seemed perilously close to losing its authority to regulate drugs but for a dangling footnote in the D.C. Circuit’s decision. That footnote asserted that “drugs . . . appear to be in an entirely different category [because] the potential harm presumably is much greater.” 75 75 Pearson I, 164 F.3d at 656 n.6. ... Close What this had to do with the First Amendment went unexplained. But as the court anticipated, an analogous First Amendment challenge to the Agency’s drug regulatory powers soon followed. Without referring to, much less distinguishing, the supplements cases, the D.C. Circuit held in Whitaker v. Thompson that the same First Amendment logic simply did not apply to the FDA’s substantiation requirements for drugs. 76 76 See 353 F.3d 947, 953 (D.C. Cir. 2004) (concluding that the Agency’s approach to drugs used speech only as evidence of a crime and so presented no First Amendment problem). ... Close

Enabled by shifting Supreme Court law, and supported avidly by groups like WLF, First Amendment challenges to the FDA’s power over drugs and tobacco have taken on new life in the federal courts today. 77 77 See, e.g., Brief of Washington Legal Foundation as Amicus Curiae in Support of Plaintiffs-Appellants, Urging Reversal, Nicopure Labs, LLC v. FDA (Nicopure II ), No. 17-5196 (D.C. Cir. filed Feb. 20, 2018), 2018 WL 994268 (arguing that the Modified Risk Tobacco Product Rule of the Tobacco Control Act violates the First Amendment); Amicus Curiae Brief of Washington Legal Foundation in Support of Appellant Alfred Caronia and Reversal, United States v. Caronia, 703 F.3d 149 (2d. Cir. 2012) (No. 09-5006), 2010 WL 6351496 (arguing that the FDA’s ban on off-label drug promotion violates the First Amendment). See generally Michael A. Walsh, The First Amendment and the Emerging Tort of “Off-Label Promotion” (Wash. Legal Found., Critical Legal Issues Working Paper No. 183, 2013), http://www.wlf.org/upload/legalstudies/workingpaper/WalshWP2_4-13.pdf [https://
perma.cc/46NK-65AM] (demonstrating WLF’s commitment to deregulatory imperatives through First Amendment litigation). ... Close The firewall created by Whitaker crumbled in 2012, when the Second Circuit dealt the FDA’s authority to regulate medicines an extraordinary blow. In United States v. Caronia, the government charged a drug company detailer with promoting a drug approved for narcolepsy (and affixed with the FDA’s most serious “black box” safety warning) for a range of off-label uses ranging from restless leg syndrome to insomnia. 78 78 703 F.3d at 156–57, 171–72. ... Close A divided panel of the Second Circuit Court of Appeals concluded that the FDA’s long-standing practice of prosecuting individuals for promoting drugs for unapproved uses violated the First Amendment. 79 79 Id. at 160; see also id. at 182 (Livingston, J., dissenting) (noting that the major­ity’s opinion “calls into question a fundamental regime of federal regulation that has existed for more than a century”). ... Close The FDA could still, the court reasoned, preclude false and misleading statements by compa­nies. 80 80 Id. at 168 (majority opinion). ... Close But as the dissent recognized, this ignores the obvious problem: How are we to know what claims are false and misleading in the absence of evidence generated in the premarket approval process? 81 81 See id. at 177–80 (Livingston, J., dissenting) (concluding that the prohibition on off-label promotion “directly advances” the efficacy of the premarket approval process, which was introduced due to the concern that “doctors could not adequately evaluate frequently misleading claims by drug manufacturers without a body of objective, reliable information”). ... Close The majority threw decades of regulatory practice overboard nonetheless, under the influence of the 2011 Supreme Court decision of Sorrell v. IMS Health Inc. 82 82 564 U.S. 552 (2011). ... Close —a decision that dramatically swerved from the Court’s previous approach to commercial speech. 83 83 See Caronia, 703 F.3d at 163 (“In applying [First Amendment] principles, we have a benefit not available to the district court: the Supreme Court’s decision in Sorrell v. IMS Health, Inc. . . . .”). ... Close

Prior to Sorrell, long-settled doctrine required commercial speech to be analyzed under the Central Hudson test—a form of intermediate scru­tiny that permitted far more regulation of commercial than of political speech. 84 84 See Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 563, 566 (1980) (holding that commercial speech may be regulated if it is false or mislead­ing or relates to unlawful conduct, or if it advances a substantial government interest in direct fashion, and is not more extensive than necessary). ... Close Sorrell suggested instead that more scrutiny of laws regulating commercial speech might be warranted, at least when the laws in ques­tion were “content- and speaker-based.” 85 85 See Sorrell, 564 U.S. at 563, 571 (noting that the law in question “imposes a speaker- and content-based burden on protected expression, and that circumstance is sufficient to justify application of heightened scrutiny”). ... Close Reasoning from cases about political speech that had long been kept carefully distinct from those involving commercial speech, the Court suggested that any law that imposed content- and speaker-based distinctions on speech was immedi­ately suspect. 86 86 See id. at 571 (noting that “[i]n the ordinary case it is all but dispositive to con­clude that a law is content-based and, in practice, viewpoint-discriminatory” (citing R.A.V. v. City of St. Paul, 505 U.S. 377, 382, 391–92 (1992))). ... Close As the dissent warned, this framing asked courts to begin to review and strike down vast amounts of regulatory conduct since it is common for regulation to target particular content and particular speak­ers. 87 87 See id. at 587–92 (Breyer, J., dissenting) (suggesting that the court “has embarked upon an unprecedented task—a task that threatens significant judicial interfer­ence with widely accepted regulatory activity”). ... Close Caronia proved the dissenters all too prescient.

Shortly after Caronia, a district court dealt the Agency an even more significant defeat. In Amarin Pharma, Inc. v. FDA, citing the First Amendment, a Southern District of New York judge granted a company the right to market a drug approved for one narrow use to a vastly broader population, over the FDA’s strenuous objection. 88 88 See 119 F. Supp. 3d 196, 198, 237 (S.D.N.Y. 2015) (granting the company prelimi­nary relief and declaring certain marketing statements to be truthful and nonmisleading, over FDA objection). ... Close The Agency appealed neither case 89 89 See Katie Thomas, F.D.A. Deal Allows Amarin to Promote Drug for Off-Label Use, N.Y. Times (Mar. 8, 2016), https://www.nytimes.com/2016/03/09/business/fda-deal-allows-amarin-to-promote-drug-for-off-label-use.html (on file with the Columbia Law Review). ... Close and recently sought public comments on whether it should fundamentally revise its approach to off-label promo­tion. 90 90 Notice of Public Hearing and Request for Comments, Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, 81 Fed. Reg. 60299 (Sept. 1, 2016). ... Close Reports suggest that the FDA may be poised to voluntarily grant much more latitude to marketers, citing changing First Amendment law as the impetus. 91 91 See, e.g., David Pittman, Pharma Considerations Loom in Spending Bill, Politico: Prescription Pulse (Mar. 19, 2018), https://www.politico.com/newsletters/prescription-pulse/
2018/03/19/pharma-considerations-loom-in-spending-bill-142047 [https://perma.cc/Y9A9-TZCG] (reporting on a First Amendment Working Group eval­uating the issue at the FDA and concluding that “Commissioner Scott Gottlieb is likely to move toward the drug industry’s position—more freedom to communicate off-label information”). ... Close

The FDA’s authority over tobacco products is now similarly in doubt. As soon as the FDA made clear that it considered e-cigarettes within its regulatory scope in 2016, no fewer than nine First Amendment lawsuits were filed spanning five federal circuits. 92 92 See FDA Deeming Rule, Pub. Health & Tobacco Pol’y Ctr., http://tobaccopolicycenter.
org/tobacco-control/recent-cases/fda-deeming-rule/ [https://perma.cc/CM5T-6FA3] (last visited Aug. 27, 2018) (compiling cases filed in the U.S. District Court for the District of Columbia; U.S. District Courts in Florida and Alabama; U.S. District Court for the Southern District of West Virginia; U.S. District Court for the District of Minnesota; and U.S. District Court for the Central District of California). ... Close A key circuit court decision on the matter is poised to come in Nicopure Labs, LLC v. FDA, currently pending in the D.C. Circuit. 93 93 See Notice of Appeal, Nicopure II, No. 17-5196 (D.C. Cir. filed Aug. 31, 2017). The district court rejected plaintiffs’ First Amendment claim on the grounds that distribution of e-cigarettes and vaping devices was conduct rather than First Amendment protected speech. See Nicopure Labs, LLC v. FDA, 266 F. Supp. 3d 360, 415 (D.D.C. 2017). The lower court further held that even if this distribution were to be speech, its regulation passes muster under the First Amendment by advancing a substantial governmental inter­est of limiting youth exposure to tobacco. See id. at 415–16. ... Close Appellant-Manufacturers—again supported by groups like WLF  94 94 See Litigation, Wash. Legal Found., https://www.wlf.org/litigation/ [https://perma.
cc/5HWW-VPPP] (last visited Aug. 27, 2018) (listing cases supported or litigated by WLF). ... Close —argue that Congress’s and the FDA’s evidentiary requirements for modified-risk tobacco products violate the First Amendment. 95 95 For example, they contend that this is so because the requirements apply when manufacturers make certain claims (e.g., “no tar”) and apply only to manufacturers. See Opening Brief of Appellants at 23–24, Nicopure II, No. 17-5196 (filed Feb. 12, 2018). ... Close The FDA, in response, argues that its premarket review power for modified-risk tobacco products is similar to its pre­market review power for drugs and so should survive under the D.C. Circuit’s Whitaker decision. 96 96 See Brief for Appellees at 27–29, Nicopure II, No. 17-5196 (filed May 2, 2018). ... Close Further, the FDA contends that the power should survive Central Hudson because “it is narrowly tailored to serve the govern­ment’s substantial interest in ensuring that statements about such products are complete, accurate, and relate to the product’s overall risk.” 97 97 Id. at 3. ... Close

These cases pose significant risks to public health, whether from more extensive (and less well-understood) off-label uses of drugs or more extensive (and less well-understood) uses of electronic and conventional cigarettes. 98 98 Evidence suggests that medicines used off-label come with substantially greater risks. See Tewodros Eguale et al., Association of Off-Label Drug Use and Adverse Drug Events in an Adult Population, 176 JAMA Internal Med. 55, 61 (2016). E-cigarettes seem to incorporate fewer toxic substances than conventional cigarettes, but their long-term health effects for individuals are not yet known, and their public health effects are uncer­tain. An excellent source on the topic is the recent consensus study report by a committee of the National Academy of Science, Engineering, and Medicine. See Nat’l Acad. of Sci., Eng’g & Med., Public Health Consequences of E-Cigarettes (Kathleen Stratton et al. eds., 2018). The report concluded that while e-cigarettes contain “fewer numbers and lower levels of most toxicants than does smoke from combustible tobacco cigarettes,” exposure to nicotine levels vary widely, and “the absolute risks of the products cannot be unambigu­ously determined at this time,” particularly over the long-term. Id. at 1. The review also concluded that “[t]he net public health effect, harm or benefit, of e-cigarettes depends on three factors: their effect on youth initiation of combustible tobacco products, their effect on adult cessation of combustible tobacco products, and their intrinsic toxicity.” Id. The population-level implications depend substantially on issues about which there is currently very little evidence—such as whether they will help adult smokers quit in the long-term better than other available approaches. Id. Crucially, if e-cigarettes do not help lead adult smokers to quit—a matter about which there is little evidence—“e-cigarette use could cause considerable harm to public health in the short and long-term due both to the inherent harms of exposure to e-cigarette toxicants and to the harms related to subsequent combustible tobacco use by those who begin using e-cigarettes in their youth.” Id.; see also id. at 10 (finding that there is “insufficient evidence from randomized controlled trials about the effectiveness of e-cigarettes as cessation aids compared with no treatment or to Food and Drug Administration-approved smoking cessation treatments”). ... Close And consider this: If it is unconstitutional for the FDA to require approval before allowing marketing of new uses of drugs, can it possibly be constitutional for the FDA to require premarket approval of any new drug? Why can’t companies market any new elixir as a cure for cancer, until the FDA comes to court and shows their claims to be false or misleading? We are on the road to a dangerous new world.

How did this come to pass? To understand it, we must reckon with the contemporary political economy of the First Amendment: with the right relation between markets and democratic governance put into play in recent decisions, and the vision of markets, subjects, and state that ani­mate their reasoning and that follow in their wake. Reckoning with it requires first seeing how these ideas have worked their way into doctrine, and then moving outside of doctrine to consider the contours of a new political economy of drug and tobacco research, one with more robustly public infrastructure at its core.

II. The Political Economy of Commercial Speech

We are all accustomed to reading cases for their holdings and rationale, but decisions also embody deeper worldviews. 99 99 See, e.g., Purdy, Beyond the Bosses’ Constitution, supra note 12, at 2174–75 (sug­gesting that the Supreme Court’s characterizations of capitalist democracy embody “a worldview, . . . a way of organizing institutions and events into certain patterns of salience, highlighting certain priorities and dangers and discounting others”). ... Close The concep­tions of markets, states, and subjects on display in key Supreme Court commercial speech cases reflect logics that are profoundly marked by the era in which they emerged. Most critically, they are shaped by the imagi­nary of neoliberalism—a powerful set of interlinked arguments that have had substantial influence in the United States, and transnationally, over the last several decades. 100 100 On acceptance of the term, including by some of its proponents, see Quinn Slobodian, Globalists: The End of Empire and the Birth of Neoliberalism 2–3 (2018). For a piece explaining the term in a manner especially attuned to law and legal scholarship, see generally David Grewal & Jedediah Purdy, Introduction: Law and Neoliberalism, 77 Law & Contemp. Probs., no. 4, 2014, at 1, 1. ... Close

The history of neoliberalism is commonly traced back to the 1947 founding of F.A. Hayek’s Mont Pèlerin Society. 101 101 See, e.g., Angus Burgin, The Great Persuasion 104 –05 (2012). ... Close But it was in the 1970s and 1980s, under the influence of thinkers like Milton Friedman 102 102 Id. at 154. ... Close and James Buchanan, 103 103 See Nancy MacLean, Democracy in Chains 135–37 (2017). ... Close that neoliberal thought came to prominence. One mark of this prominence is the world-changing shifts in governance made in its image, including the Reagan and Thatcher revolutions, structural adjustment and the “Washington Consensus” at the IMF and World Bank, and the “shock-therapy” transitions in post-Communist countries. 104 104 See, e.g., Adam Tooze, Neoliberalism’s World Order, Dissent (Summer 2018), https://www.dissentmagazine.org/article/neoliberalism-world-order-review-quinn-slobodian-globalists [https://perma.cc/BEJ7-E37C]; see also Naomi Klein, The Shock Doctrine: The Rise of Disaster Capitalism 7–13 (2007) (discussing neoliberalism’s role in affecting large-scale post-disaster reforms). ... Close

In Professor David Harvey’s influential description, neoliberalism is the view that “human well-being can best be advanced by liberating individual entrepreneurial freedoms and skills within an institutional framework characterized by strong private property rights, free markets, and free trade.” 105 105 David Harvey, A Brief History of Neoliberalism 2 (2007); see also Grewal & Purdy, supra note 100, at 1 (referring to neoliberalism as “the revival of the doctrines of classical economic liberalism, also called laissez-faire, in politics, ideas, and law”). ... Close Sutured together here are visions of the proper role and rela­tionship of markets, of the state, and of the human subject. Mar­kets are spaces of neutrality and of justice that must be “free” from politi­cal inter­ference and given maximum scope to order human affairs. 106 106 See Wendy Brown, Undoing the Demos: Neoliberalism’s Stealth Revolution 17 (2015) (arguing that neoliberalism insists on the “‘economization’ of political life and of other heretofore noneconomic spheres and activities”); Harvey, supra note 105, at 3 (“[S]ocial good will be maximized by maximizing the reach and frequency of market transactions . . . .”). ... Close The social is dissolved in favor of preference-maximizing individuals whose prefer­ences are best satisfied via voluntary transactions in mar­kets. 107 107 As Margaret Thatcher famously said, “There is no such thing as society.” Interview by Douglas Keay with Margaret Thatcher, Prime Minister, U.K. (Sept. 23, 1987), https://
www.margaretthatcher.org/document/106689 [https://perma.cc/U9AN-VWQC]; see also Brown, supra note 106, at 39 (“[H]omo oeconomicus approaches everything as a market and knows only market conduct; it cannot think public purposes or common prob­lems in a distinctly political way.”). ... Close The state, in turn, is modeled as just one among many market actors. 108 108 For key works in this genre, see generally James M. Buchanan & Gordon Tullock, The Calculus of Consent (1962); Mancur Olson, The Logic Of Collective Action (1965). ... Close Politics is simply the process of interest-group competition, rather than a domain where we develop public aims or express public will. 109 109 See, e.g., Friedrich A. von Hayek, Whither Democracy?, in The Essence of Hayek 352, 357 (Chiaki Nishiyama & Kurt R. Leube eds., 1984) (describing unfettered democracy as “not based on agreement of opinions, but . . . [on] aggregations of special interests mutually assisting each other”). ... Close Indeed, the state is an object of suspicion, because its status as sovereign gives it the quali­ties of a monopolist, protected from market discipline and the virtue-enhancing rigors of competition. 110 110 See, e.g., William A. Niskanen, Bureaucracy and Representative Government 31 (1971) (characterizing government agencies as monopolists and monopsonists). ... Close Freedom, in this analysis, is found in the marketplace when properly protected from public interference. 111 111 See Friedrich A. von Hayek, Principles of a Liberal Social Order, in The Essence of Hayek, supra note 109, at 363, 366 (describing “the order of the market” as a central means of reconciling divergent human purposes for mutual benefit, and thus as central to free society). ... Close As political theorist Wendy Brown puts it, “The guarantee of equality through the rule of law and participation in popular sover­eignty is replaced with a market for­mulation of winners and losers. Liberty itself is narrowed to market con­duct, divested of associations with mastering the conditions of life, existential freedom, or securing the rule of the demos.” 112 112 Brown, supra note 106, at 41. ... Close

As legal realists and critical legal scholars showed long ago, of course, there is no such thing as a self-regulating market, nor is there any economic domain that is separable and cordoned off from politics. 113 113 For discussions of the interrelationship between law, power, and distributive con­sequences, see generally Robert Hale, Freedom Through Law: Public Control of Private Governing Power (1952); Duncan Kennedy, The Stakes of Law, or Hale and Foucault!, 15 Legal Stud. F. 327 (1991). ... Close This is in part because government is a condition of modern market ordering. Government creates and enforces rights to property and con­tract and establishes and underwrites the financial system and social infrastructures that make modern market society possible. 114 114 See, e.g., Hale, supra note 113, at 10–12 (discussing the government’s construc­tion and enforcement of contract and property rights). This is, in part, what political economist Karl Polanyi meant when he said “laissez faire was planned.” See Karl Polanyi, The Great Transformation 141 (Octagon Books 1980) (1944). ... Close But, equally as important, it is because the ideal of market supremacy is also in deep tension with the project of democracy. 115 115 See Grewal & Purdy, supra note 100, at 3 (“[The] contest . . . between capitalist imperatives and democratic demands . . . is persistent because of pressures that capitalist markets make on the legal and political order—pressures not just for familiar protections of property and contract, but also for a favorable return on investment and managerial authority . . . .”). ... Close If markets are to be given free rein, they also must be protected from the political power of the majority. The neoliberal project must be a project of governance because it must hem in democratic powers to shape markets and to make choices about distribution. 116 116 See Slobodian, supra note 100, at 2 (“[T]he neoliberal project focused on design­ing institutions—not to liberate markets but to encase them, to inoculate capitalism against the threat of democracy . . . .”); see also MacLean, supra note 103, at 1–12, 61–73 (describing Buchanan’s thought, and public choice theory, as aiming to discredit govern­ment and hem in the power of majorities, and linking it to historical thought and political developments in the United States that protect racial hierarchy and states’ rights). ... Close

The best understanding of neoliberalism, then, identifies it not as a utopian economic theory but as a fundamentally political project, one that redefines the tools and contours of economic and social manage­ment—putting some on the side of free markets and others in the domain of impermissible regulation—in order to achieve practical ends, chief among them the opportunity to accumulate by those empow­ered to wield capital. 117 117 See Slobodian, supra note 100, at 19 (suggesting that neoliberalism’s aim in “re-embedding” the market was “to prevent state projects of egalitarian redistribution and [to] secure competition”). ... Close Newer histories of neoliberal thought thus emphasize its demand for a world “kept safe from mass demands for social justice and redistrib­utive equality by the guardians of the economic constitution.” 118 118 Id. at 16. ... Close Neolib­eralism does not, in fact, demand minimal state interference. 119 119 It is notable, too, that neoliberalism has taken hold contemporaneously with the elaboration of a vast carceral and surveillance state, especially in the United States. For theories of the relation between the two, see generally, for example, Bernard E. Harcourt, The Illusion of Free Markets: Punishment and the Myth of Natural Order (2012); Loïc J. D. Wacquant, Punishing the Poor: The Neoliberal Government of Social Insecurity (2009). ... Close Rather, it offers a distinctive picture of the legitimate ends to which the state can be put. It demands a state that can protect profit-making from majoritar­ian wishes and that can insinuate forms of market order into domains of human life previously characterized by nonmarket logics.

That neoliberal thought should find a comfortable home inside of constitutional jurisprudence is, in this sense, not a surprise. If markets are to be protected from majorities, some sovereign entity must step in to limit majority power, to insist on a “market freedom” that is also an instance of governmental control. Sheltered from the more immediate democratic will-formation facilitated by legislatures, courts may even be privileged institutions for neoliberal reforms.

Commercial speech law, in fact, takes shape in constitutional law during the period of the ascendance of neoliberal thought and politics. It is the 1976 case of Virginia Pharmacy that first brings commercial speech under the protection of the First Amendment. 120 120 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748 (1976). ... Close Plaintiffs had challenged a Virginia law that forbade pharmacists to advertise the prices of prescrip­tion drugs, arguing that this impinged upon the pharmacist’s right to speak. 121 121 Id. at 749–50. ... Close But the Court had never before held that speech that “does ‘no more than propose a commercial transaction’” was entitled to Constitutional protection. 122 122 Id. at 762 (quoting Pittsburgh Press Co. v. Human Relations Comm’n, 413 U.S. 376, 385 (1973)). ... Close

How did the Court justify the extension of the First Amendment, long understood as committed to the protection of political speech or speech on matters of public concern, to purely commercial speech? By way of an analogy that dissolves any distinctive status of the political: The “consumer’s interest in the free flow of commercial information,” the Court declares, “may be as keen, if not keener by far, than his interest in the day’s most urgent political debate.” 123 123 Id. at 763. ... Close The founding conceit of the doctrine, then, is one that dissolves politics into homogenous “interests,” with no distinction between our interests as citizens and our interests as consumers.

We must incorporate commercial speech into our constitutional order, the Court further suggested, as an inexorable extension of our commit­ment to free markets:

So long as we preserve a predominantly free enterprise econ­omy, the allocation of our resources in large measure will be made through numerous private economic decisions. It is a matter of public interest that those decisions, in the aggregate, be intelligent and well informed. To this end, the free flow of commercial information is indispensable. And if it is indispensa­ble to the proper allocation of resources in a free enterprise system, it is also indispensable to the formation of intelligent opin­ions as to how that system ought to be regulated or altered. Therefore, even if the First Amendment were thought to be pri­marily an instrument to enlighten public decisionmaking in a democracy, we could not say that the free flow of information does not serve that goal. 124 124 Id. at 765 (footnote omitted) (citations omitted). ... Close

The Court invokes here a background “free enterprise economy” that has become so natural, so American, that it takes on a quasi-constitu­tional status. We have markets, and therefore information must flow to inform private decisions in order that the “public interest”—here again, reduced to efficiency—be served. The influence of Chicago School think­ing is palpable.

In concluding that the advertisement of prices warranted constitu­tional protection, the Court also selected a distinctive image of the sub­ject of its concern. The state had defended its law as a means to help maintain professionalism among pharmacists. The Court rejected this justification—the idea, we might say, that the state has an interest in call­ing forth certain kinds of nonmarket subjects—and insisted instead on the primacy of market-rational, self-interest-maximizing man: We should assume, the Court insisted, “that . . . information is not in itself harmful, that people will perceive their own best interests if only they are well enough informed, and that the best means to that end is to open the channels of communication rather than to close them.” 125 125 Id. at 770. ... Close

There is also a distinctive, if submerged, picture of the state here. If the free flow of commercial information is of such importance to the public and to the functioning of our “free enterprise economy,” we might ask, why would majorities restrict it? It makes sense that majorities might outlaw unpopular political speech. But why would majorities deny themselves the information needed to make good economic decisions? What do the people have against a good bargain? Legislatures must, it seems, not be enacting the will of a majority. Rather, they must be follow­ing the will of “interest groups,” in Chicago and Virginia School parlance.

Relying in this way on key aspects of the neoliberal imaginary, the Court cast the First Amendment, for the first time, as having an interest in “the free flow of commercial information” about “who is producing and selling what product, for what reason, and at what price.” 126 126 Id. at 765. ... Close Note, also, the ambiguity in the key passage cited above: Does the First Amendment protect commercial speech because it elevates the aim of “proper alloca­tion of resources in a free enterprise system” to a constitu­tional value? 127 127 See id. ... Close Or does it protect commercial speech because—and when—such speech is indispensable to the formation of public opinions about the govern­ance of markets? 128 128 See id. ... Close The latter is surely the better read­ing of the hold­ing—if not the full gestalt—of the excerpt above, and is consistent with far more regulation of commercial speech than is the for­mer view.

Choosing the latter view in cases that followed, the Court con­structed a hierarchy: It permitted far more regulation of commercial than political speech based on an understanding of core differences between the two. 129 129 Bd. of Trs. of the State Univ. of N.Y. v. Fox, 492 U.S. 469, 477 (1989) (“‘[C]ommercial speech [enjoys] a limited measure of protection, commensurate with its subordinate posi­tion in the scale of First Amendment values,’ and is subject to ‘modes of regulation that might be impermissible in the realm of noncommercial expression.’” (second alteration in original) (quot­ing Ohralik v. Ohio State Bar Ass’n, 436 U.S. 447, 456 (1978))). ... Close Commercial speech was “a hardy breed of expres­sion,” 130 130 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 564 n.6 (1980). ... Close one that did not merit the protection of overbreadth doctrine or the doctrine of prior restraints. 131 131 See id. at 565 n.8, 571 n.13. ... Close Commercial speech could be regulated by content (indeed, was defined via its content) and received protec­tion only if it was not false or misleading. 132 132 See id. at 563–64, 564 n.6. ... Close Even true and nonmisleading commercial speech could be regulated under the Central Hudson test, if the state had a substantial interest and the law directly advanced that interest. 133 133 Id. at 564. ... Close

Then came Sorrell v. IMS Health Inc. 134 134 564 U.S. 552 (2011). ... Close As described above, Sorrell cre­ated a powerful new weapon against ordinary commercial regulations when it transposed the Court’s hostility to laws that single out particular political content or political speakers onto laws that single out particular commercial content or commercial speakers. 135 135 See supra notes 84–87 and accompanying text. ... Close The move was unprecedented, 136 136 Sorrell, 564 U.S. at 588 (Breyer, J., dissenting) (“[N]either of these categories—‘content-based’ nor ‘speaker-based’—has ever before justified greater scrutiny when regulatory activity affects commercial speech.”). ... Close and extraordinarily disruptive. Regulators often do and must regulate according to content and viewpoint, as the dissenters pointed out with many examples. Cosmetic companies might be required to substantiate the claim that a “product contains ‘cleansing grains that scrub away dirt and excess oil’” while “opponents of cosmetics use need not substantiate their claims.” 137 137 Id. at 589–90. ... Close Salesmen might be allowed to access credit databases to run credit checks but not to search for new custom­ers. 138 138 Id. at 587. ... Close Or, the FDA might forbid drug companies to promote drugs for unapproved uses, though academic researchers may recommend for or against the same uses. 139 139 Id. at 590. ... Close

The dissent warned of precisely the invasion of regulatory preroga­tive that is now upon us. 140 140 Id. at 589–91. ... Close How can the decision be justified? Cen­trally, the majority in Sorrell reasons via the logic of nondiscrimination—with the victim of alleged discrimination market actors themselves. 141 141 See id. at 564–65 (majority opinion). ... Close

The state law under challenge in Sorrell barred pharmacies from sell­ing prescribing data to data vendors without affirmative consent from doctors. 142 142 Id. at 557. ... Close The legislature’s aim was to protect doctors from “harass­ment” by pharmaceutical company detailers, who made frequent visits to urge them to purchase more or different medicines. 143 143 See id. at 572, 575. ... Close Companies also disproportionately promote expensive medicines; 144 144 Id. at 560–61, 580. ... Close by diminishing detail­ing, the state hoped to “improv[e] public health and reduc[e] healthcare costs.” 145 145 Id. at 572. ... Close Academic researchers and nonprofit groups that engaged in “counter-detailing” were exempted from the law because they did not pose these same problems. 146 146 Id. at 559–60. ... Close

The majority, however, saw this disparity not as a response to a mar­ketplace structured by forces that give profit-seeking actors particular incentives and advantages. Rather, they described the state as interfering in a marketplace that was by definition a space of neutrality, and doing so with a discriminatory purpose: the “disfavor[ing] of specific speakers, namely pharmaceutical marketers.” 147 147 Id. at 564. ... Close The state here appears not as the representative of public will but as a coercive monopolist, seeking to “burden the speech of others in order to tilt public debate in a preferred direction.” 148 148 Id. at 578–79. ... Close

The embrace of a market-supremacist logic that chooses markets over majorities is now complete. It is a market here—in the exchange of data—that is being protected; no one is speaking to the public. Gone is the logic in Virginia Pharmacy that tethered commercial speech protec­tion to the value of democratic politics by linking the exchange of infor­mation in the marketplace to the “formation of intelligent opinions.” 149 149 Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 765 (1976). ... Close The First Amendment’s role here is to protect markets from the public. Protecting markets, in turn, requires that we integrate institutions gov­erned at least in part on a different logic—here, the doctor’s office—ever more fully to logic of the marketplace.

Sorrell was a triumph for the brand of neoliberal thought that seeks to shield market actors and structures from democratic power. And, as the dissenters predicted, cases like Caronia and Nicopure have inevitably followed. What can be done in response?

III. Toward a More Equal and Democratic Political Economy of Commercial Speech

A. Modern Commercial Speech Law Permits Information-Forcing and Prior Restraints

A better approach to cases like Caronia and Nicopure is possible, even inside of the four corners of First Amendment doctrine as we know it today. Sorrell invited, but did not demand, heightened constitutional pro­tection for content- or speaker-based commercial speech. Its holding turned on an application of Central Hudson, 150 150 See Sorrell, 564 U.S. at 571–72. ... Close and a decisive return to the Central Hudson approach would lead courts to uphold the regulatory structures at stake in both Caronia and Nicopure. As Central Hudson makes clear, commercial speech is protected because it serves an “informational function” for listeners. 151 151 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 563 (1980); see also Robert Post, The Constitutional Status of Commercial Speech, 48 UCLA L. Rev. 1, 11–15 (2000) (discussing the informational role of commercial speech protec­tion and noting its “audience oriented” nature). ... Close The FDA’s substantiation requirements for both pharmaceuticals and tobacco are designed to protect the public by informing it: Companies are permitted to market if they produce evidence. There is nothing discriminatory, moreover, about applying the schemes to companies but not to doctors or other third parties. It is logical, and well within the government’s prerogative, to determine that companies are better situated to produce the knowledge in question. 152 152 See Kapczynski, Fishy Business, supra note 51, at 295–96 (making these points and showing their relevance to Central Hudson). ... Close The FDA’s regulatory approaches to medicines and tobacco, as described earlier, can be understood as informing consumers, and so are in no real tension with modern commercial speech law.

Particularly when dangerous products are concerned, there also should be—and always has been—room for prior restraints against com­mercial speech. 153 153 See, e.g., Brief of Amici Curiae First Amendment Scholars in Support of Appellee at 4–8, Nicopure II, No. 17-5196 (D.C. Cir. filed May 9, 2018) (providing support for the argument that prior restraints have always been acceptable where commercial speech is concerned). ... Close There is also room, and precedent, for judicial humil­ity about courts’ scientific capacities. 154 154 See, e.g., Nat. Res. Def. Council v. EPA, 824 F.2d 1211, 1216 (D.C. Cir. 1987) (not­ing that it is generally “not for the judicial branch to undertake comparative evaluations of conflicting scientific evidence”). ... Close Such humility should lead judges away from interpretations of constitutional doctrine that require them to play the role of expert regulator. 155 155 See Kapczynski, Fishy Business, supra note 51, at 295 (describing how courts must stand in for FDA regulators under the approach taken in Amarin). ... Close Finally, because the FDA’s approaches to pharmaceutical and tobacco regulation aim centrally at the regulation of material commodities, they can be construed as not implicating com­mercial speech at all but merely using speech to establish the requisite intent, that of violating federal law by selling an unapproved substance. 156 156 See Whitaker v. Thompson, 353 F.3d 947, 953 (D.C. Cir. 2004) (relying on this argument to uphold FDA’s authority over unapproved medicines); see also Kapczynski, Fishy Business, supra note 51, at 295 (explaining how the logic of Whitaker applies in the off-label context). ... Close

A more democratic First Amendment, and one still recognizable in current doctrine, would also admit that history and experience can help us distinguish between settings in which governments are likely to abuse their powers and settings in which governments are likely to be necessary to give effect to collective judgments about how we wish to live and order our values. Historical experience and empirical evidence can and should inform courts’ understandings of the markets and regulators in question. Where evidence shows—as in the examples of drug detailing and evidence production about medicines and tobacco—that markets exhibit patterned forms of power and disempowerment, First Amendment analy­sis can and should take this into account. The question, as Professor Purdy puts it, is “what kind of interaction a democratic republic should build between economic and political power, and for what reasons.” 157 157 Purdy, Beyond the Bosses’ Constitution, supra note 12, at 2163. ... Close The answers are necessarily particular and derived from experience, rather than abstract and rooted in ungrounded assertions of market neutrality.

B. Rebuilding Public Infrastructure

What, however, if the courts continue down their current path? The question brings us beyond doctrine to what we, at the Symposium, began to call questions of “infrastructure.” 158 158 Infrastructure, conventionally understood, constitutes the basic facilities that are needed for democratic life and to meet public needs. Speech, like travel, requires infrastructure—inputs to many different outputs, developed with a view of what we all require to collectively govern our democracy and lives. For a similar definition of infra­structure, see Brett M. Frischmann, Infrastructure: The Social Value of Shared Resources 61 (2012). ... Close In a democracy, our shared infra­structure must respond to public needs and priority setting. The odd thing about applying this insight in this context is that, because the First Amendment has wandered so far, the infrastructure we must consider—infrastructure for health research—has little obvious connection to the First Amendment. But if courts take from the public the regulatory sticks needed to incentivize information production by private market actors, we will have little choice but to reassess our infrastructure for health research and insist on a much more substantial role for public funding and public priority setting.

The model of information production that the FDA currently facili­tates allocates enormous responsibility to the private sector. Private com­panies are expected to conduct the studies that inform us whether their products work. This system was never ideal: It generates serious conflicts of interest and works against transparent access to information. 159 159 See Kapczynski, Dangerous Times, supra note 53, at 2363–65, 2371–72 (discuss­ing companies’ “high powered incentives” to avoid negative information and the “awkward fit” between transparency and the profit-motivated system for evidence development). ... Close Relying on private sector research also has broader implications for the price and nature of the products that are developed. 160 160 High-quality scientific research is expensive, particularly for products like phar­maceuticals, and patent law and other exclusive rights have been expanded over the decades to permit industry actors to recoup these costs. See Amy Kapczynski & Talha Syed, The Continuum of Excludability and the Limits of Patents, 122 Yale L.J. 1900, 1904 (2013). But that has generated market power that has led to astronomical price increases. As I’ve shown in previous work with Professor Talha Syed, relying on exclusive rights to incentivize research also distorts research, because not all kinds of innovations are similarly suscepti­ble to exclusion. See id. at 1916–21. Even under the most expansive possible patent law, for example, patents on tangible goods like medicines will be far easier to exclude than patents on talking cures, exercise regimes, or natural substances. See id. at 1935–37. And the profit motive will not incentivize the production of information that makes a product look bad—meaning that markets under conditions of exclusive rights are likely to produce systematically biased information. See id. at 1925–26. Regulation can correct for this, but likely not perfectly. Finally, market driven R&D systems prioritize according to not just willingness but ability to pay and so will tend to benefit those with more resources. See Amy Kapczynski, The Cost of Price: Why and How to Get Beyond Intellectual Property Internalism, 59 UCLA L. Rev. 970, 999–1000 (2012). Profit-driven R&D systems, for exam­ple, will neglect medicines needed predominantly by the poor (such as treatments for tropical diseases). Assuming risk aversion and discounting, profit-maximizers will also neglect interventions for high-risk but low-probability events like influenza pandemics. See Amy Kapczynski, Order Without Intellectual Property Law: Open Science in Influenza, 102 Cornell L. Rev. 1539, 1559–60 (2017) [hereinafter Kapczynski, Order Without Intellectual Property Law]. ... Close Investing more in public funding for research could redress these problems and also serve to make health research more egalitarian. 161 161 There are many ways to do this, from direct and mediated government funding for research to prizes or other financial rewards that work in a more decentralized fashion. For discussions of alternatives to the patent system, see generally Dean Baker, Ctr. for Econ. & Policy Research, Financing Drug Research: What Are the Issues? (2004), http://www.cepr.net/documents/publications/intellectual_property_2004_09.pdf [https://perma.cc/8KCY-9DUR]; James Love & Tim Hubbard, Prizes for Innovation of New Medicines and Vaccines, 18 Annals Health L. 155 (2009). There are many kinds of research—epidemio­logical work, basic science R&D, and drug development for neglected diseases, for example—that have never been well-rewarded in markets and that have long been conducted, if at all, via government funding. See generally Kapczynski, Order Without Intellectual Property Law, supra note 160, at 1558–61 (summarizing the literature showing that markets will neglect such research, and offering examples of government conducting it instead, in the field of influenza). ... Close

Publicly funding research could also mitigate the damage done if courts undermine the regulatory “stick” that the FDA has used to date to encourage balanced evidence production by marketers. 162 162 See generally Ian Ayres & Amy Kapczynski, Innovation Sticks: The Limited Case for Penalizing Failures to Innovate, 82 U. Chi. L. Rev. 1781 (2015) (introducing the idea of innovation “sticks” and discussing the role of penalties in inducing innovation and the production of new information). ... Close If, for exam­ple, the FDA cannot require companies to provide evidence before mar­keting drugs off-label, then the public can fund research to deter­mine whether off-label uses are warranted—and pay for this research via the cost-savings that will result from more appropriate prescribing.

This is an example, in the end, of a broader point. As the First Amendment emerges as a tool to insulate free market actors from regul­ation, it will increase the stakes of a turn to the public. Just as the judicial attack on the ACA has fueled calls for Medicare for all, 163 163 See Paul Waldman, The Next Big Thing for Democrats: Medicare For All, Wash. Post (Apr. 19, 2018), https://www.washingtonpost.com/blogs/plum-line/wp/2018/04/19/
the-next-big-thing-for-democrats-medicare-for-all/ [https://perma.cc/LX9M-XGXV]. A direct expansion of public insurance would, of course, sidestep both the Spending Clause and Commerce Clause challenges raised in National Federation of Independent Business v. Sebelius, because Congress would not be regulating private actors or conditioning spending. See generally 567 U.S. 519 (2012). ... Close attacks on the state’s power to regulate the market may, and should, fuel demands for a more robust public role and less reliance on increasingly ungovernable private actors.

C. Reconsidering Commercial Speech Protection

Finally, considering the political economy of commercial free speech law should also lead us to revisit the proper justification for constitutional protection for commercial speech, and so the proper scope of that pro­tection. Courts have come startlingly close, in recent cases, to declaring the purpose of commercial speech protection to be the enforcement of ideals christened in Mont Pèlerin and further developed in Chicago and Virginia—most prominently, the notion that markets are free by defini­tion, and that the freedom that the First Amendment commits us to is the freedom of markets to be protected from popular political will. The First Amendment has long been understood as centrally aimed at pro­tecting “free political discussion to the end that government may be responsive to the will of the people.” 164 164 Stromberg v. California, 283 U.S. 359, 369 (1931). ... Close The view that it commits us to free market supremacy has no serious constitutional argument in its favor and subverts a keystone of genuine democracy: the power of majorities to determine when and how to embed markets in public values.

Conclusion

Fundamentally, we govern markets; we are governed by democratic politics. 165 165 A similar point is made by Professors Amanda Shanor and Robert Post:
When we engage in public discourse, the First Amendment accords us the privileges of “rulers” who exercise the prerogatives of self-determina­tion. We are given the freedom and autonomy to speak as we will. But when we engage in commercial speech, we are not participating in dem­ocratic self-determination; we are instead transacting business in the marketplace. We are accordingly communicating as “subjects” who are “ruled.”
Post & Shanor, supra note 2, at 171–72. ... Close This is a distinction that must have constitutional salience, or we will lose our democracy to the antidemocratic imperatives of laissez faire. Any protections for commercial speech must serve rather than sub­vert our democracy. For this view to prevail in the Courts, progressives must, of course, accumulate the political power to shape appointments, and the intellectual and political power to build a discursive alternative to market-supremacist thought. The way will not be easy. But it is the only path to returning the First Amendment, that “guardian of our democ­racy,” 166 166 Brown v. Hartlage, 456 U.S. 45, 60 (1982). ... Close to the better things for which it, and we, were meant.