Commercial Speech & Prescription Drug Promotion: Where Have We Been & Are We Going Anywhere?

Adam Larson

Class of 2005

April 2005

This paper is submitted in satisfaction of the course requirement for Food & Drug Law with Professor Peter Hutt and the third year written work requirement.

Abstract

Recent decisions have caused the FDA to question whether its regulations of prescription drug promotion comply with the First Amendment. This paper argues that those recent decisions do not compel the FDA to change its prescription drug promotion regulations and that they cannot be considered in isolation from the historical development of the commercial speech doctrine. When this historical development is considered, two competing interests emerge from commercial speech cases. On one hand, an interest in protecting the public welfare suggests that speech restrictions are permissible. On the other, an interest in promotion of free markets limits speech restrictions. The application of the Central Hudson test, or any other method the Court might adopt for determining prescription drug promotion cases, hinges on the balance between these interests. As a result of the uniquely significant public welfare interests at issue in the prescription drug promotion context, the FDA’s current regulations do not violate the First Amendment. In reaching this conclusion, the paper begins by summarizing the current FDA regulations of prescription drug promotion. It then reviews the historical development of the commercial speech doctrine to illustrate the emergence of the competing interests. After pausing to highlight the problems of prior restraints and compelled speech, the paper addresses the effects that recent cases involving FDA regulations have had on the commercial speech doctrine. The final section illustrates how the competing interests that emerge from the historical evolution of the commercial speech doctrine will probably be balanced when applied to the FDA’s regulations of prescription drug promotion and then comments on the use of empirical evidence and the growth of the Internet; two issues that may alter the balance between free market and public welfare interests.

I. Introduction

Judging by their sales, prescription drugs might be more American than apple pie. In 2001, 3.3 billion prescriptions were dispensed.[1] That amounts to over 10 prescriptions for every person in the United States.[2] The same year retail spending on prescription drugs reached $154.5 billion dollars.[3] In short, prescription drugs are big business. Of course, supporting such a large industry requires extensive advertising and, in 2000, promotional spending on prescription drugs totaled $15.7 billion.[4] In turn, prescription drug promotion raises concerns with the regulatory body overseeing prescription drugs, the Food and Drug Administration (FDA).

As part of its statutory mandate the FDA assures that all drugs marketed in the United States are safe and effective.[5] This sweeping regulatory power influences all stages of a drug’s life cycle. The FDA regulates pre-marketing laboratory and clinical testing, approves proposed drug labeling, sets manufacturing standards, regulates marketing practices, monitors for adverse reactions and takes enforcement actions against companies that fail to comply with its regulations.[6] Nearly ever step of this extensive regulatory structure can bring the FDA into conflict with the First Amendment’s prohibitions against restricting freedom of speech.[7]

In 2002, in Thompson v. Western States Medical Center , [8] the Supreme Court addressed an FDA speech regulation for the first time and struck down a section of the Federal Food, Drug and Cosmetic Act (FDCA) on the grounds that it unconstitutionally restricted freedom of speech by prohibiting pharmacists from advertising the availability of compounded drug products. That decision followed upon federal court rulings inWashington Legal Foundation v. Friedman [9] and Pearson v. Shalala [10] that had questioned other FDA advertising restrictions. In the wake of these rulings the FDA noted a recent trend in case law towards increased protection for commercial speech[11] and sought public comment to ensure that its regulations, guidance, policies and practices complied with First Amendment case law.[12] Many of the public comments based their analysis on the assumption that these recent cases would substantially alter the way the courts would analyze a challenge to the FDA’s regulations of prescription drug promotion.[13] Likewise, some legal commentators have suggested that these recent cases mean that FDA restrictions on prescription drug promotion are constitutionally infirm.[14]

This paper argues that such analysis does not tell the whole story. Recent cases probably do not substantially alter the application of the commercial speech doctrine to prescription drug promotion. Indeed, it is necessary to review the 30-year history of the development of the commercial speech doctrine to understand its applicability to prescription drug promotion. Such an analysis reveals that across cases the Supreme Court has struggled to balance two fundamental interests – promotion of free markets on one hand and public welfare on the other. This fundamental balancing, more than any other factors, determines the outcome of cases. Given the substantial public health and safety concerns implicated by misuse of prescription drugs, the balancing of these interests tilts the scales towards public welfare and makes FDA prescription drug promotion restrictions permissible.

Accordingly, this paper begins by summarizing the current FDA regulations of prescription drug promotion as found in the FDCA and the Food and Drug Administration Modernization Act of 1997.[15] It continues by reviewing the evolution of the First Amendment doctrine governing commercial speech with the goal of determining which factors are most relevant to prescription drug promotion.[16] This review pays particular attention to the courts’ struggles to balance the free market and public welfare interests because this balance will ultimately determine the outcome of prescription drug promotion cases. The paper then addresses prior restraints and compelled speech, two subsidiary free speech issues that can be important in the prescription drug promotion context.[17] Next, the paper addresses the effect that recent commercial speech cases involving FDA regulations have had on the doctrine.[18] Building on these ideas, the concluding section summarizes how the courts might apply the commercial speech doctrine to regulations of prescription drug promotion. This final section briefly highlights two emerging areas that may fundamentally alter the analysis. First, it discusses the growing body of empirical evidence on the effects of prescription drug promotion. It then contemplates the effects that the Internet may have on the balance between free market and public welfare interests.[19]

II. FDA Prescription Drug Promotion Regulations

Understanding the consequences of the commercial speech doctrine for prescription drugs first requires an overview of the extensive FDA regulations governing prescription drug promotion.

A. The Prescription Drug Approval Process

In brief, the FDA was established by the FDCA[20] in 1938 to regulate the importing, manufacturing, distribution and sale of drugs.[21] At the outset, the FDA must approve all new drugs entering the United States for safety and efficacy.[22] First Amendment concerns are implicated even at this early part of the process since unapproved drugs cannot be advertised.[23] Prior to approval a manufacturer must submit a New Drug Approval application (NDA) to the FDA. The NDA includes extensive, detailed safety and efficacy analysis along with any proposed labeling for the new drug.[24] The FDA will approve an NDA only if there is “substantial evidence” of the drug’s safety and effectiveness. In addition, the approval process controls aspects of the new drug’s labeling. The label on the new drug can only indicate approved uses,[25] and must include all medically relevant information about how to use the drug appropriately, such as dosage, precautions, adverse reactions and contraindications.[26] After this long and expensive process the drug can finally be marketed.[27] However, FDA maintains sweeping abilities to control the drug’s marketing and distribution.[28]

B. Prescription Drug Labeling Regulations

One area where FDA authority continues, and that implicates First Amendment concerns, is in the labeling of drugs. The FDCA definition of labeling includes “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.”[29] FDA labeling regulations are not only extensive, [30] but provide a fairly rigid labeling format for prescription drugs.[31] The most important regulations include that the required labeling must designate only those uses for which there is substantial evidence of safety and effectiveness.[32] The labeling must also provide the physician with all medically relevant information about each use of the product.[33] If a label contains false or misleading information it is deemed “misbranded”.[34] Misbranding is judged not only on what information is included in the label, but also by what information is not included.[35] Additionally, a drug can be deemed misbranded if the label does not include adequate instructions for each use of the drug.[36]

C. Prescription Drug Advertising Regulations

Unsurprisingly, the most pressing First Amendment concerns are implicated by the FDA’s prescription drug advertising regulations. This section is a brief summary of the highlights of those extensive regulations. Since 1962, the FDA has had the sole authority to regulate prescription drug advertising.[37] While the term “advertising” is not defined in the FDCA, FDA regulations state that it includes “advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.”[38] Notably, the definition only includes printed, published or broadcast materials.[39] Some preliminary efforts have been made to include oral statements in the definition.[40] However, Congress has repeatedly declined to amend the FDCA to include oral statements.[41] As such, the FDA probably lacks statutory authority to regulate oral communications about prescription drug products as advertising.

The FDA accomplishes regulation of prescription drug advertising by mandating a series of requirements for advertising. Briefly, the current version of these regulations requires that advertisements for prescription drugs include: (1) a statement of the established name of the drug and its formula and (2) a brief summary of information about the drug as related to side effects, contraindications for use and effectiveness in accordance with relevant regulations.[42] Advertisements must reveal all material facts and present a fair balance of information.[43] This means that negative or cautionary information must be presented in the same depth as claims about the effectiveness and safety of the drug.[44] Advertisements that do not comply with these requirements will be considered “misbranded”.[45] The detail of the regulations can be quite extensive. For example, currently the FDA lists over 30 specific situations where an advertisement may be considered false, lacking in fair balance or otherwise misleading and therefore misbranded.[46]

Although they are still extensive, over the past several decades the FDA has slowly moved to relax its restrictions on manufacturers’ ability to communicate with the public through direct-to-consumer (DTC) advertising.[47] In 1997, the FDA promulgated new draft guidance that clarified and loosened prescription drug advertising requirements for broadcast media.[48] After considering public comments and making slight revisions the FDA published it as final guidance in 1999.[49] The Guidance requires manufacturers to provide adequate provision for access to the product’s approved labeling “through an approach that will allow most of a potentially diverse audience to have reasonably convenient access”.[50] To comply with this requirement a DTC prescription drug advertisement on broadcast media must contain multiple sources to access the approved label. These sources should include: (1) a toll-free number viewers can call to have the label mailed or read to them, (2) a reference to a DTC print advertisement in a widely disseminated magazine or to a broad public pamphlet campaign, (3) a web page address and (4) a statement that healthcare providers are an additional source of product information to consumers.[51] Under this relaxed standard, the use of DTC prescription drug broadcast advertisements has skyrocketed.[52]

A final, important advertising regulation involves changes to FDA policy on “off-label” use of prescription drugs.[53] Off-label uses are uses that medical researchers and doctors find for drugs that are different than the uses tested and approved by the FDA.[54] The FDA’s policy on off-label uses reflects the agency’s inability to limit a physician’s practice of medicine.[55] As such, the FDA has stated, “a physician may prescribe [a drug] for uses or in treatment regimens or patient populations that are not included in the approved labeling.”[56] Of course this creates the potential for a large loophole in the approval process. If a company can get a drug approved for one limited use and simply publicize other uses to doctors through printed materials or seminars,[57] there is little reason to undergo the rigorous NDA process for additional uses.

Congress addressed this problem as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA).[58] One important piece of the FDAMA specifically allows drug manufacturers to disseminate off-label uses to physicians and other health care providers.[59] The statute allows manufacturers that meet certain requirements to distribute to health care professionals “written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling of a drug...”.[60] The requirements include: (1) submission of an NDA,[61] (2) that the disseminated information be in the form of an unabridged reprint of an article from a peer-reviewed scientific journal or a reference publication and that the information is not false or misleading or a significant risk to the public health,[62] (3) that any clinical research found in the information was not conducted by another manufacturer,[63] (4) that a copy of the information is submitted to the FDA,[64] and (5) that the information is accompanied by numerous prominently displayed disclosures.[65] In addition, if the FDA finds that the information is not objective and balanced it may require that the manufacturer disseminate additional disclosures.[66]

Having overviewed the FDA regulations that implicate freedom of speech concerns it is appropriate to consider the commercial speech doctrine that has evolved to govern those regulations. Given the relative youth of the commercial speech doctrine[67] and the fact that only two Supreme Court cases have dealt with restrictions on speech about prescription drugs[68] an exploration of the entire doctrine is important. While these cases do not deal with prescription drug promotion directly, the principle interests motivating most of the Court’s decisions, free markets and public welfare, are relevant across subject matter. Understanding commercial speech requires familiarity with broader free speech principles, so the next section begins with a basic discussion of the First Amendment.

III. Evolution of the Commercial Speech Doctrine and Implications for Prescription Drug Promotion

A. General First Amendment Background

The First Amendment prohibits Congress from establishing any law that curtails freedom of speech. [69] This is a simple command,[70] that the Court has had difficulty uniformly enforcing over the years.[71] The Court lacks clear guidance from the framers[72] and faces intense disagreement from commentators over the types of speech the First Amendment was intended to protect and the kinds of government action it was intended to prohibit.[73] As a result of this confusion, the Court has not read the First Amendment literally or adopted a unified theory to apply to all First Amendment cases.[74] Instead, it has slowly created a number of speech categories entitled to different levels of First Amendment protection.

Surprisingly, it was not until the early twentieth century that the court began to get major exposure to freedom of speech issues.[75] Historically, these first major struggles in the free speech doctrine involved subversive speech around the time of World War 1.[76] Other parts of the modern free speech doctrine were not developed until even later. As such, until relatively, recently areas like obscenity, false statements and commercial speech were assumed to completely lack First Amendment protection.[77] Today, the government retains the ability to regulate these types of speech, but subject to some restrictions.[78] Specifically, the Court has held that the lower value of commercial speech, fighting words, obscenity, and false statements justifies lesser First Amendment protection for these forms than for fully protected speech.[79] However, for expression that falls outside of these limited categories, the Court applies a “strict-scrutiny” standard and is generally hostile to government efforts to regulate the content of speech.[80] Thus, depending on the category of speech, quite different standards apply.[81]

Therefore, in normal First Amendment analysis, the threshold question is whether the words, images or other expression being regulated because of their content are of a type worthy of full First Amendment protection. If the answer is yes, then the regulation is not permissible unless it is the least restrictive means possible to serve a compelling government interest.[82] This is an exceedingly high standard that will very rarely be met.[83] If the answer is no, then the question becomes which of categories that receive lesser protection, like commercial speech, the speech fits into. In these cases the government interest in the regulation does not need to be compelling. But, the speech still receives some protection because the regulation must meet the test that Court has created for that category of speech.

For prescription drug promotion answering this question can prompt a fundamental, but critical, question – when will speech about drugs be classified as commercial speech? The issue is most salient when thinking about corporate speech. For example, Eli Lilly recently launched a public outreach campaign to defend Prozac against allegations about the safety of the drug.[84] Is this campaign considered commercial speech? Certainly one of the motives behind the campaign seems to be a commercial desire to not lose sales. But other motives, like defending the company and assuring current patients about safety, seem like core first amendment speech.

The law is unsettled on whether this kind of prescription drug speech would fall into the commercial speech category. Complicating matters, the Court has been particularly unhelpful in this already nebulous area. In Nike v. Kasky ,[85] a case about Nike’s right to respond to allegations about mistreatment of workers at foreign facilities, the Court took the unusual step of dismissing its grant of certiorari as improvidently granted. In short, the Court punted the issue; Justice Stevens, explaining the decision, cited the fact that the “case presents novel First Amendment questions because the speech at issue represents a blending of commercial speech, noncommercial speech and debate on an issue of public importance” as a reason not to address it at the time.[86] As the dissenting justices[87] and subsequent commentators[88] have noted, the Court will eventually have to reach the problem. But, at least for now, the court has not addressed this boundary issue. As a result, prescription drug promotion that straddles the line may turn out not to be commercial speech and therefore less subject to FDA speech regulations. An example might be the applicability of the off-label use promotion regulations to speech by a company defending the safety of a drug after controversy about an off-label use emerges in the press. For example, the controversy about off-label use of Prozac for children. As discussed below,[89] the fact that a clear definition of commercial speech has yet to emerge only compounds this problem.

Despite this problem, the bulk of commercial speech is not marginal – there is little controversy about categorizing expression such as prescription drug television advertisements as commercial speech. But, to understand the Court’s commercial speech test it is necessary to review the evolution of the Court’s justifications for giving commercial speech lesser First Amendment protection.

B. The Commercial Speech Doctrine

i. The Earliest Case Law – Valentine v. Chrestensen

Early Supreme Court jurisprudence held that the freedom of speech guarantee in the First Amendment did not extend to commercial speech.[90] Commercial speech was grouped with obscenity, false statements and fighting words as unprotected.[91] While later cases would afford commercial speech some First Amendment protection,[92] the earliest cases created a critical distinction between commercial and noncommercial speech in the first place.[93] The commercial / noncommercial distinction remains difficult to articulate and controversial to this day.[94]

In 1942, the landmark case of Valentine v. Chrestensen stood for the principle that the First Amendment did not protect commercial speech.[95] Chrestensen was an aspiring businessman who bought a decommissioned U.S. Navy submarine and planned to exhibit it in New York’s East River.[96] He began to distribute handbills advertising the submarine but quickly ran into trouble when he was informed that he was violating New York’s Sanitary Code, which prohibited distributing commercial handbills in public places.[97] Not easily thwarted, Chrestensen noted that the Sanitary Code permitted distribution of handbills containing “information or a public protest”. [98] Like any good businessman, Chrestensen seized on this loophole. He printed up double-sided handbills with his original advertisement on one side and a protest against the City Dock Department on the other. Police Commissioner Valentine was not amused. He stopped Chrestensen from distributing the double-sided bills and Chrestensen responded with a lawsuit, paving the way for the first Supreme Court commercial speech case.[99]

Justice Roberts, writing for a unanimous court, disposed of the issue in a paragraph. Without citing any precedent, the Court reasoned that, “[w]e are ... clear that the Constitution imposes no ... restraint on government as respects purely commercial advertising”.[100] At this early stage the Court made no mention of the effect that suppression of commercial speech might have on the functioning of free markets. Its concern was only for public safety and welfare.[101] Indeed, the Court seemed casual in its dismissal of the value of commercial speech. In less than a page the Court established two sweeping principles. First, that there was a distinction between commercial and non-commercial speech (though the Court did not articulate how to determine the difference). Second, that commercial speech was not entitled to First Amendment protection. Thus, at this point in the development of the doctrine, virtually any restriction on prescription drug promotion would have been permissible.

ii. The Short Life of Chrestensen

The Court followed Chrestensen for a brief period.[102] The doctrine reached its zenith in Capital Broadcasting Co. v. Mitchell ,[103] a 1971 D.C. district court opinion that the Supreme Court affirmed without comment. Sticking close to the Chrestensen precedent, the court upheld an FCC ban on the advertising of cigarettes over any electronic media.[104] The case raised serious questions about the limits of Chrestensen and its progeny. If Congress could ban all truthful, electronic advertising about cigarettes could it similarly restrict commercial speech about any product it found harmful or offensive to the public welfare? Was the public somehow entitled to such information and what were the effects on the market of withholding it? Writing in dissent, Justice J. Skelley Wright struggled with these questions. While he agreed with the majority that cigarettes were a reprehensible product, he concluded that the core of First Amendment protection is the preservation of the free market notion that people should be fully informed so that they have the ability to make up their own minds.[105]

Capital Broadcasting was the initial turning point for the commercial speech doctrine. Of course, doubts about excluding commercial speech from First Amendment protection had cropped up almost immediately after Chrestensen .[106] In fact, only 17 years after the decision, Justice Douglas remarked in a concurring opinion that the decision “has not survived reflection”.[107] But, the doctrine had held on, largely intact, for nearly 30 years. After Capital Broadcasting , the Court acknowledged that there were competing interests at play and began to change course. It did so in a series of three decisions.

iii. The Reversal of Chrestensen

First, in 1973, the majority seemed to follow Chrestensen in Pittsburgh Press Co. v. Pittsburgh Comm’n on Human Rights .[108] The case involved a newspaper that was charged with violating a city ordinance that prohibited publishing help-wanted advertisements under sex-designated headings except in certain limited cases where the employer or advertiser was free to make hiring decisions on the basis of sex.[109] While the Court upheld the ordinance, the decision turned on the illegal discrimination created by the sex-specific help wanted advertisements rather than the inapplicability of First Amendment protection to commercial speech.[110] By this point, the Court was struggling with the free market interest and the idea that the dissemination of commercial speech might have independent societal value. Therefore, the Court did not discount the defendant’s argument that “the exchange of information is as important in the commercial realm as in any other”. [111] It suggested that such an argument might be applicable in other contexts. The Court explained that it was not applicable here because the advertisements were not just commercial activity, but “illegal commercial activity”.[112] Thus, the focus was on the fact that the sex-based columns were “illegal,” not that they were commercial. The illegality distinction preserved the Court’s concern for the public welfare, but left room for free market arguments. Additional indication that the commercial speech doctrine was changing was the fact that Justices Blackmun, Stewart and Douglas dissented.[113] All three questioned the viability of Chrestensen .[114] The move for reversal gained steam the next year when Justices Stewart, Marshall and Powell joined a similar dissent by Justice Brennan in Lehman v. City of Shaker Heights .[115]

Then, in 1975, the Court held that a paid abortion advertisement was protected by the First Amendment in Bigelow v. Virginia. [116] Building on the illegality distinction from Pittsburgh Press , the Court suggested that since abortion, the activity at issue in Bigelow , was constitutionally protected the state could not prohibit advertising about it. The Court briefly touched on the effect on free markets of banning the ads. It noted that the suppression of such truthful information, even though commercial in nature, would affect the “marketplace of ideas”.[117] Still, the Court held fast to the public welfare concerns of Chrestensen. Instead of overturning precedent it distinguished the facts of Bigelow and presented a reinterpretation of Chrestensen . The Court held that “[Chrestensen ] obviously does not support any sweeping proposition that advertising is unprotected per se,”[118] and that “[t]he fact that it had the effect of banning a particular handbill does not mean that Chrestensen is authority for the proposition that all statutes regulating commercial advertising are immune from constitutional challenge.”[119] This was a dramatic re-understanding of a case that had declared, “the Constitution imposes no ... restraint on government as respects purely commercial advertising”.[120] As such, Bigelow might be viewed as functionally overturning Chrestensen and bringing commercial speech into the First Amendment family. But, as it implicated the constitutional right to abortion in the aftermath of Roe v. Wade ,[121] its value as precedent for ‘regular’ types of commercial speech was unclear. Still, while the Court went to great pains to distinguish and preserve Chrestensen ,[122] it seemed that the case was on the verge of being overturned. This clear reversal came the next year in Virginia State Bd. of Pharmacy .[123]

iv. Commercial Speech Gains Protection – Virginia State Bd. Of Pharmacy v. Virginia Citizen’s Consumer Council

In 1976, the Supreme Court held for the first time that commercial speech fell within the scope of the First Amendment in Virginia State Bd. of Pharmacy .[124] In the first commercial speech case involving prescription drugs, the Court held that a Virginia statute banning pharmacists from advertising prescription drug prices violated the First Amendment.[125] Justice Blackmun, writing for the majority, summarized the speech at issue as follows, “The ‘idea’ [the pharmacist] wishes to communicate is simply this: ‘I will sell you the X prescription drug at the Y price.’”[126] Thus, the Court reduced the case to be about the simplest kind of commercial speech – speech that merely named a price and proposed a transaction. Still, in rather sweeping language, the Court held that a profit motive does not remove such speech from First Amendment protection,[127] that the public has an important need for the commercial information in such speech,[128] and that the state could not completely suppress this information because the First Amendment protects the public’s free market interest in the receipt of truthful information about a lawful activity.[129] By affording first amendment protection to commercial speech the public can become better informed about its market decisions and the net public welfare can increase.

The critical element running through the case is the Court’s explicit acknowledgement that commercial speech is important to sustain a free market economy. While balancing between free market and a public welfare interests was evident in earlier dissents and on the periphery of cases like Pittsburgh Press and Bigelow , it was made explicit in Virginia State Bd. of Pharmacy . Though the Court agreed that the state had a valid interest in promoting high standards of professionalism among pharmacists, it was troubled that the chosen path to this result was a ban that created total consumer ignorance about prices.[130] First, the Court disliked the state’s paternalistic rationale that depriving consumers of information about their economic decisions would end up protecting them. In the alternative, it proposed that the state should “assume 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.”[131] This would ensure lower prices, better information and more competition, thus helping the free market to benefit the public. Second, the Court reasoned that public access to such commercial material was at the core of the First Amendment protection because it allowed for informed decision-making.[132] Thus, the value of commercial speech is in its ability to keep consumers better informed. In essence, the Court suggested that society might reach the best result by encouraging the dissemination of commercial information, instead of restricting it. The opinion is full of similar discussion that suggests that the governmental suppression of truthful commercial information interferes with a free market interest and that the First Amendment protects individual decision-making.[133] This free market rationale for the protection of commercial speech counters public welfare concerns about the deceptiveness of commercial speech and has emerged as the major justification for First Amendment protection in later commercial speech jurisprudence. [134]

Despite the dicta about laissez-faire economics and the value of commercial speech in maintaining free markets, the Court was unwilling to afford commercial speech the same protections as non-commercial speech. Balancing the public welfare interest meant that some restrictions must be permissible. The state had argued that price competition among pharmacists would create a dangerous cycle where the pressure for cheaper drugs would lead to poorer quality treatment and the destruction of the patient-pharmacist relationship.[135] While doubting the wisdom of keeping consumers completely in the dark, the Court did not dismiss the state’s concerns out of hand. Indeed, the Court agreed that the state had valid interests in regulating pharmacists and remained suspicious about the potentially negative effects of unchecked advertising on drug consumers.[136] The Court began to recognize a fundamental struggle between the positive, free market effects of truthful commercial speech and the potential harm to the public welfare that could result from deceptive commercial speech.

Mindful of this struggle, it held that, while commercial speech deserved some First Amendment protection, it could be subject to greater regulation than other forms of speech. In a critical footnote, the Court justified the differing treatment by pointing to commonsense distinctions between commercial and other types of speech. It explained that while commercial speech now had First Amendment protection, “[t]here are commonsense differences between speech that ‘does no more than propose a commercial transaction’ and other varieties.”[137] The Court singled out two particular differences that justified a lower level of First Amendment protection. First, commercial speech has more “objectivity” than other expression because commercial speakers’ familiarity with their products means that they can more easily verify the truth of their statements.[138] Second, commercial speech has more “hardiness” than other expression because the dependence of commercial speakers on advertising to increase sales means that reasonable regulations are less likely to silence them.[139] Further exploration of what these commonsense differences entail and why they justify a different level of protection has only taken place to a limited degree in later cases.[140] But, the idea has at least superficial appeal and thus allowed the Court to lay down some ground rules about the regulation of commercial speech in the rest of the opinion.

First, the opinion makes clear that states maintain the authority to put time, place and manner restrictions on commercial speech, so long as those restrictions are made without reference to the content of the speech, serve a significant government interest, and leave open alternative channels for communication of the information.[141] Second, it explains that states can prohibit false or misleading commercial speech and that the greater hardiness and objectivity of commercial speech might mean that these restrictions can be stricter than on other forms of speech.[142]

Virginia State Bd. of Pharmacy may have been the high water mark for constitutional protection of prescription drug promotion. The Court had enthusiastically embraced the value of a free market interest, which meant that fewer regulations would be constitutional. But, while the Court had made clear that public welfare interests were still important, no case law yet existed to assist in the balancing between the two interests. As such, it was unclear how much weight should be placed on public welfare interests. Given the expansive treatment of the free market interest in Virginia State Bd. of Pharmacy and the limited comment on public welfare, a challenge to FDA prescription drug promotion regulations soon after the case would have stood a high chance of success. However, such a challenge never came to pass, and later cases would reassert the importance of public welfare interests.

v. The Progeny of Virginia State Bd. of Pharmacy

The fundamental struggle between public welfare and free markets remained troubling to the Court after Virginia State Bd. of Pharmacy . Nevertheless, the cases immediately following Virginia State Bd. of Pharmacy continued to sound the bell for free markets and informed decision-making. For example, one year later, in Linmark Associates, Inc. v. Township of Willingboro ,[143] the Court struck down a township council ordinance forbidding homeowners from displaying for sale signs.[144] The goal of the ordinance was to prohibit practices that led to “panic selling by white homeowners” and harmed the attainment of racially integrated housing.[145] Despite this laudatory public welfare goal, the Court reasoned that, “[t]he Council has sought to restrict the free flow of these data because it fears that otherwise homeowners will make decisions inimical to what the Council views as the homeowners' self-interest. . . . Virginia Pharmacy Bd. denies government such sweeping powers.”[146] As in Virginia State Bd. of Pharmacy , the state could not ban truthful, commercial speech merely because it feared that the recipients would react to the information “irrationally”.[147] The Court cited Justice Brandeis, concurring in Whitney v. California ,[148] for the proposition that “the remedy to be applied is more speech, not enforced silence”.[149] Thus, the township was free to try to educate citizens about the benefits of not selling through publicity, or through inducements not to sell, and it could pass reasonable regulations to make sure that for sale signs were not false or misleading.[150] But, it could not interfere with citizens’ abilities to make informed choices by the suppression of truthful, commercial speech.

Beginning in Bates v. State Bar of Arizona ,[151] the free market interest influenced a line of cases involving the rights of lawyers to advertise their services.[152] These cases are particularly important in the Court’s free market jurisprudence because they went against not only local laws, but also the legal profession’s historically powerful tradition of prohibiting most public advertising.[153] In Bates , the Court held that a state bar association could not prohibit lawyers from advertising about the prices of routine legal services.[154] Like in Linmark , the state argued that permitting the messages would be adverse to the public welfare.[155] The state argued that such advertising would inevitably mislead clients because clients can not know the types of legal services they need in advance, legal services are so individualized that public advertising can not help clients make an informed comparison, and that advertising would highlight irrelevant factors that would interfere with the choice of attorney.[156] Echoing Virginia State Bd. of Pharmacy , the Court viewed the state’s arguments as hinging on an incorrect premise about the decision-making capabilities of its citizens. The Court questioned this premise, expressing serious doubt about any justification for suppressing truthful information “based on the benefits of public ignorance”.[157] To the contrary, the Court reasoned that clients are able to determine the general services they need from lawyers and that they realize the limits of relying on advertising.[158] Summarizing its discomfort with anti-free market arguments since Virginia State Bd. of Pharmacy , the Court wrote, “[w]e suspect that the argument[s] rest[ ] on an underestimation of the public”.[159]

Exploring the limits of Virginia Bd. of Pharmacy , the Court continued to invalidate some anti-free market restrictions on commercial speech.[160] However, in the two terms after Bates , it also upheld a pair of advertising restrictions on the professions. First, it upheld restrictions on the ability of attorneys to solicit clients in person in Ohralik v. Ohio State Bar Ass’n .[161] The court emphasized the danger to public welfare from the peculiar nature of in-person solicitation and the outrageousness of Ohralik’s actions.[162] It then upheld restrictions on the ability to practice optometry under a trade name in Friedman v. Rodgers .[163] Here the Court emphasized the public welfare interest, voicing concern for the unique ability of optometrist trade names to mislead and deceive.[164] As these decisions were largely limited to their facts and did not purport to overturn earlier commercial speech cases, they probably did not signal a major retreat from the free market interest.[165] However, they again made clear that, while the Court’s free market reasoning would triumph in many commercial speech cases, commercial speech did not have full First Amendment protection.[166]

In sum, the case law immediately after Virginia State Bd. of Pharmacy continued the free market rationale, especially in the area of legal advertising. However, Freidman and Ohralik signaled that the public welfare interest was still of critical importance where the Court perceived a potential for peculiar danger or confusion. While the line of legal advertising cases seems to offer considerable support for invalidating advertising restrictions as an infringing on free market interests, it may not apply with great force in the prescription drug promotion context. This is because the public welfare concerns at issue are quite different. Restrictions on legal advertising are often justified by arguing that people are incapable of determining which legal services they need and that advertising threatens to diminish lawyers’ professionalism.[167] The first justification is paternalistic and empirically questionable[168] and the second may be an excuse for maintaining monopoly prices by restricting competition.[169] In contrast, prescription drug promotion restrictions are justified by arguing that prescription drugs are very dangerous if misused or untested. The general public is poorly positioned to scientifically evaluate every claim, so the FDA acts as an intermediary. Through its approval and advertising restrictions the FDA assures safety and efficacy and limits misprescribing. The difference in the magnitude of the potential harm to public welfare and the believability of the justifications for regulation distinguish prescription drug promotion from lawyer advertising.

Indeed, the most important case from this period for prescription drug promotion is probably not a legal advertising case at all. Friedman , the case about optometrist advertising, is more applicable. Friedman shares a strong parallel with prescription drug promotion because it was about advertising in a medical field. If the danger of being misled by an eye doctor practicing under a trade name was persuasive, it seems likely that the danger of potentially serious harm from misuse of prescription drugs would justify many FDA promotion regulations.

Yet, in some ways, the Court had not come very far. It continued to struggle with the conflict between the ability of commercial speech to promote informed decision-making and its potential to mislead and harm the public; the same problem that had vexed it since Virginia Bd. of Pharmacy . While no clear answer had emerged, painstaking case-by-case determinations were becoming unwieldy.[170] By the early 1980s the Court was ready to articulate a general rubric to determine when commercial speech was protected.

vi. The Creation of the 4-Part Test – Central Hudson Gas & Electric Corp. v. Public Service Commission

The Court had made clear that commercial speech was deserving of some First Amendment protection in Virginia State Bd. of Pharmacy and the cases that followed. However, Justice Blackmun’s Virginia State Bd. of Pharmacy opinion had not articulated a clear standard of scrutiny for commercial speech. Additionally, decisions such as Ohralik and Friedman reaffirmed that commercial speech was not entitled to the full protection granted to other forms of speech. Given these inconsistent results, the task of balancing free market and public welfare interests was performed ad hoc. There was no easy rubric for determining which commercial speech regulations were acceptable. In 1980, in Central Hudson Gas v. Public Service Commission ,[171] the Court synthesized its earlier cases to formulate an intermediate standard of scrutiny to apply to restrictions on commercial speech.[172] Thought it has been refined and questioned, the Court continues to apply the four-pronged balancing test it set out in Central Hudson today.[173]

The controversy in Central Hudson arose during an acute fuel shortage where the New York Public Service Commission prohibited utilities from publishing any promotional advertising because it might increase demand for electricity.[174] The Service Commission argued that the ban served the interest of energy conservation because any advertisement by utilities would increase consumption and ultimately result in higher rates to consumers.[175] To assist it in reaching a decision, the Court developed a four-pronged balancing test to determine if a restriction on commercial speech could be upheld under the First Amendment. The Central Hudson test is as follows: (1) Is the commercial speech being restricted truthful, non-misleading speech concerning a lawful activity? (2) Does the government have a substantial interest in restricting the speech? (3) Does the regulation directly advance the government’s interest? (4) Is the regulation no more extensive than is necessary to serve the government’s interest?[176]

The Central Hudson test is applied by using a two-step method of analysis. In the first step, a court must determine the answer to prong one. If answer is ‘no’ and the speech is false, misleading, or concerning illegal activity then the analysis ends. False and misleading communication is not protected commercial speech.[177] Nor is promotion of illegal activities.[178] Second, if the answer to prong one is ‘yes,’ then a court must apply prongs two through four to determine whether the regulation directly advances a substantial government interest without unnecessarily restricting freedom of speech.

Applying the test to the facts of Central Hudson , the Court invalidated the Service Commission’s regulation.[179] Under prong one the Court found that there was no contention that the expression was inaccurate or related to unlawful activity.[180] Under the next two prongs, the Court accepted the Service Commission’s argument that a total advertising ban would result in lower consumption and therefore directly advance the state’s interest.[181] However, the Court found that the ban failed the fourth prong because it blocked too much information. For example, the ban suppressed advertisements about services that would not have caused an increase in total energy use.[182] The Court held that the Service Commission could achieve the same goal by a less restrictive means such as requiring that information about energy conservation be included in any advertisements.[183]

Several key points emerge from the Central Hudson analysis. First, in creating the Central Hudson test, the Court primarily relied on commonsense differences between commercial and other types of speech to justify giving commercial speech an intermediate level of protection.[184] As it only discussed the issue for a few sentences, the Court seemed confident that these distinctions, with limited reflection and analysis, permitted different treatment.[185] The commonsense differences premise remains commonly accepted and unquestioned, even in the more recent Supreme Court decisions. Still, it is important to note the role of commonsense differences in Central Hudson because the case arose relatively early in the commercial speech jurisprudence, at a time when the Court was more apt to closely scrutinize basic elements of the doctrine. Since the Central Hudson Court passed on the opportunity to question the commonsense differences idea, it seems less likely that future courts will take up the challenge. Especially, since subsequent decisions have followed Central Hudson in not inquiring into the idea. [186] The lack of inquiry into a basic premise of commercial speech suggests that the Court has fully accepted the commercial speech distinction and would be unlikely to question the basis of the distinction in a future prescription drug promotion case.

Secondly, although the Court failed to question the underlying premises that distinguished commercial speech, it did not retreat from its dislike of anti-free market speech regulations. The Court wrote that it “rejected the ‘highly paternalistic’ view that government has complete power to suppress or regulate commercial speech”.[187] It quoted with approval from Virginia State Bd. of Pharmacy for the proposition that people are able to perceive their own best interests if fully informed.[188] Finally, the Court reiterated the free market position that “[t]he First Amendment’s concern for commercial speech is based on the informational function of advertising”.[189] Thus, although the Court established a test that arguably scaled back the protections afforded to commercial speech, it emphasized that the free market interests that informed earlier cases were still part of the balancing test. Indeed, the free market influence on the test’s application can be seen in Central Hudson itself. For example, the Court expressed concern that a total ban might deny consumers information about potentially energy saving technologies and suggested that an acceptable solution might be to require advertisements to inform consumers about relative energy and efficiency concerns.[190]

A final major effect Central Hudson is that it probably killed off any lingering idea raised by dicta in Virginia Bd. of Pharmacy and its progeny that commercial speech might be entitled to full First Amendment protection. In this respect, Central Hudson can be viewed as a scaling back of First Amendment protection of commercial speech. Yet, Central Hudson cemented commercial speech’s place in the First Amendment panoply. Granted, it occupies a lower seat than other forms of expression, but there is little chance of a return to the reasoning of Chrestensen . As such, Central Hudson provides the jumping off point from which to approach modern prescription drug advertising cases.

In creating the Central Hudson test, the Court attempted to neatly reconcile the two divergent interests. On one hand, it called on commonsense differences to justify the public welfare interest in allowing stringent restrictions because of the potential harm that misleading commercial speech might have on the public. On the other, it emphasized that the free market interest suggests full protection for commercial speech because of its benefits to public decision-making. The test meets somewhere in the middle of the two. As such, it can be argued that the Central Hudson test is simply a scale for balancing the public welfare and free market interests. The first two steps weigh the public welfare interest by asking if the speech is inherently misleading and, if it is not, what the government’s reason is for regulating it. The more misleading the speech and the greater the potential harm to public health or safety the more compelling the public welfare interest. The final steps balance the public welfare interest against the free market interest in an unimpeded flow of information by asking how effective the regulation is in advancing the public welfare interest and whether there are alternatives available. Central Hudson laid out the test, but it would be up to later cases to see if it could be applied in a way that preserved the free market benefits of commercial speech while protecting the public welfare. The case provides a scale for the balancing the interests of prescription drug promotion but does not indicate how much the Court thinks each interest would weigh.

vii. A Step Back? – Posadas de Puerto Rico Assocs v. Tourism Co .

Central Hudson’s criteria were revised and challenged in the years that followed. Surprisingly, by far the greatest challenge to the test came only six years after its construction in Posadas de Puerto Rico Assocs. v. Tourism Co. [191] Though Posadas hinted at a repudiation of the test, it ultimately survived and remains largely intact today. Posadas concerned a Puerto Rican statute that forbid Puerto Rican casinos from advertising to local residents but permitted the casinos to advertise to tourists.[192] The plaintiffs attacked the statute on its face as an impermissible suppression of commercial speech in violation of the First Amendment.[193] Justice Rehnquist, the lone dissenter in Virginia State Bd. of Pharmacy [194] and Central Hudson [195] wrote for the slim five-justice plurality. The decision upheld the statute under a notably lax application of the Central Hudson test.

First, the Court clarified that this was “pure commercial speech,” so that the analysis was “guided by the general principles” that had been established in Central Hudson .[196] The speech at issue met the first prong of the test because it “concern[ed] a lawful activity and [was] not misleading or fraudulent”.[197] However, under the second prong, the Court had “no difficulty” in accepting that there was a substantial governmental interest in reducing demand for casino gambling because the legislature could reasonably believe that excessive gambling would reduce the health, safety and welfare of Puerto Rican residents.[198] Likewise, the majority agreed that the legislature’s belief that local advertising would increase the demand for casino gambling was reasonable. Therefore the restriction met the third prong of the test because it directly advanced the legislative interest.[199] Also under the third prong, the majority turned back an argument that the restriction was under inclusive because it left room for advertisements for other kinds of gambling such as cockfighting and horseracing.[200] The Court found this argument unpersuasive for two reasons. First, it did not change the fact that the restrictions directly advanced a legislative interest in reducing demand for games of chance. Second, the legislature could have found that there were unique dangers associated with casino gambling that called for greater advertising restrictions.[201]

Turning to the fourth prong, the Court concluded that the fit between the legislature’s ends and its means was no more restrictive than necessary.[202] The Court held that the legislature could have reasonably concluded that Puerto Rican residents were aware of the dangers of gambling but that advertising would cause them to gamble more anyway. Therefore, a less restrictive “counterspeech” policy to inform citizens about the dangers of gambling would have been ineffective.[203] It cited with approval lower court decisions discussing similar concerns when approving advertising restrictions on tobacco and alcohol.[204]

Even after concluding that the statute passed the Central Hudson test, the Court went on justify its holding under other theories. First, the Court reasoned that the greater power to ban all casino gambling necessarily encompassed the lesser power to forbid advertising about casino gambling.[205] This logic threatened to subsume the commercial speech doctrine entirely. Applied strictly, only advertising about products that enjoyed independent constitutional protection, such as contraceptives, would be protected from regulation.[206] Second, the Court suggested that the legislature has enhanced power to suppress commercial speech when it involves harmful products such as cigarettes, alcohol and gambling.[207] In effect, this theory would have created a separate “harmful products” prong on the Central Hudson test justifying some regulations that would not have otherwise been permissible.

Posadas is notable in several respects. First, it is a much less stringent application of Central Hudson than might be expected so soon after that case.[208] Not only was the test applied loosely, but the majority also accepted legislative justifications with limited questioning. At times it even supplied justifications itself. As Justice Brennan noted in dissent, the Puerto Rican legislature had never actually asserted that casino gambling would have serious harmful effects on Puerto Rican residents.[209] Additionally, the “greater includes the lesser” dicta in the opinion can be interpreted as suggesting that a different standard may exist for advertising about subjects that the Court views as dangerous. While the notion of a completely separate standard has been discounted in later cases,[210] the Court’s candid discussion in Posadas hints that the Court may effectively apply a less heightened level of commercial speech protection for dangerous or vice products. As prescription drugs are generally considered dangerous,[211] perhaps the Court would apply Central Hudson less stringently to FDA restrictions of prescription drug promotion. Even if the lower level of scrutiny is applied sub rosa. Thus, even when the Central Hudson test is enforced, the application of the test may not be as strict with dangerous products such as gambling or prescription drugs.

Finally, the case illustrates the ideological split among justices who are more concerned with the potential of commercial speech to harm the public welfare and those who are more concerned with its effects on free markets and the unrestricted flow of information. Posadas is one of the few recent cases where enough justices moved to the first group to command a majority. This ideological split in part explains how the majority and the dissenters all agreed that the Central Hudson test could be applied, but still came to different conclusions. It also explains why Posadas is devoid of the anti-paternalistic, free market language so common in earlier cases. Only the dissenting Justices picked up on this interest.[212] As Justice Brennan reminded the court “[w]e have ... consistently invalidated restrictions designed to deprive consumers of accurate information about products and services legally offered for sale.”.[213]

Still, Posadas turned on a single vote. With changes in the views and makeup of the Court later decisions returned to more balanced commercial speech protection.[214] As such, one might discount Posadas as something of a fluke – a close case about a unique and dangerous product. But, this would be a mistake. The case illustrates the ideological struggles in the Court that are critical to predicting the future of regulations of prescription drug promotion. Posadas suggests that the scales are more likely to tip towards Justices who favor public welfare concerns when dangerous products are at issue. Even if the Court does not make this change in the analysis explicit, it is still likely to animate decisions today. Depending on its opinion of the product at issue, today’s Court may apply a less stringent application of the Central Hudson test when strong public welfare interests, like the one that animated Posadas , are at involved. In this respect, Posadas is a critical precedent that suggests that the FDA’s prescription drug promotion regulations are constitutional. After all, prescription drugs can be characterized as even more unique and dangerous than gambling.

viii. The Current Day – Refining Central Hudson

Entering the late 1980s and 1990s, the Court retreated from Posadas ’ hints at a break from theCentral Hudson test. Instead, the Court set to work refining the test. In Board of Trustees of the State University of New York v. Fox ,[215] the Court held that a university rule prohibiting commercial enterprises from operating on campus did not violate the Central Hudson test.[216] The core of the opinion was a reformation of the fourth prong of the Central Hudson test. The Court reviewed its treatment of various restrictions under the forth prong in earlier cases.[217] It then concluded that the application of the test in those cases showed that Central Hudson did not require that restrictions on commercial speech be the “least-restrictive-means” to protect the government’s interests.[218] Instead, there only had to be a “fit that is not necessarily perfect, but reasonable” between the government’s “methods and its goal”.[219] As long as the methods were “narrowly tailored to achieve the desired objective” the government had discretion to determine what type of regulation to employ.[220]

Around the same time, the Court reaffirmed its commitment to free market interests in a second series of decisions about the professions.[221] In Peel v. Attorney Registration & Disciplinary Commission ,[222] the Court held that a state could not bar attorneys from publicizing their certification by private organizations.[223] The opinion criticized the “paternalistic assumption” that people were unable to understand that private certification was not the same thing as state approval.[224] In Ibanez v. Florida Department of Business and Professional Regulation, Board of Accountancy ,[225] the Court held that it violated the First Amendment to sanction a lawyer who advertised that she was also a CPA.[226] The Court did not understand how consumers could be misled by the lawyer’s “truthful representations” that she was a CPA.[227] Finally, in Edenfield v. Fane ,[228] the Court struck down a Florida statute that prohibited CPAs from soliciting clients in person.[229] The Court agreed that the state had valid public welfare interests in preventing fraud and protecting client privacy. But, it also noted that there were significant benefits to the “personal interchange between buyer and seller” created by solicitation.[230] Concerned that the state could deprive the public of this valuable information by merely asserting a legitimate interest, the Court strengthened the third prong of the Central Hudson test. It required that the state prove that the “harms it alleges are real” and that the restriction will actually alleviate them in a “direct and material way”.[231] The Court reasoned that this refinement was necessary to prevent the state from simply claiming that a restriction served a valid purpose when it actually served a different purpose that could not pass First Amendment review.[232]

The Court proceeded to re-strengthen the fourth prong of Central Hudson in Rubin v. Coors Brewing Co. [233] Rubin invalidated a federal law prohibiting beer labels from displaying alcohol content.[234] The Court agreed that the government had a substantial interest in protecting the health of citizens by preventing “strength wars” from breaking out among brewers who might advertise ever-higher alcohol content to attract more customers.[235] After dismissing a government argument that Posadas meant that a strict standard of review should apply to “socially harmful products” the Court moved to the third prong of the test.[236] In applying the third prong it used the “direct and material” standard it had adopted two terms earlier in Edenfield .[237] The Court held that the labeling restriction could not materially advance the government’s interest because it was inconsistent with the rest of the regulatory scheme. For example, potency could be advertised in other media such as billboards and magazines, just not on labels.[238] In any event, the regulation failed the fourth prong of the test because it was “not sufficiently tailored to [the government’s] goal.”[239] The Court reasoned that there were other, less restrictive options, including limiting alcohol content directly or prohibiting advertising campaigns that emphasized high potency.[240] Thus, Rubin retightened of the fourth prong of Central Hudson from what had been set out in Fox . That case had only required that the restriction create a “reasonable” fit with the legislature’s goals to meet the fourth prong.[241] In Rubin , something more than mere reasonableness seemed required.

Finally, the Court continued its free market resurgence in 44 Liquormart Inc. v. Rhode Island .[242] In 44 Liquormart , the Court was unanimous in striking down a state law that banned all advertisements about liquor pricing except at the point of sale.[243] Though the opinion is a tangled web of plurality opinions and partial concurrences, no justice dissented.[244] One oft-discussed element of the opinion is part six of the plurality opinion, which held that the “greater-includes- the-lesser” and “vice” products analysis from Posadas was erroneous.[245] However, the precedential value of these holdings is unclear because only four justices joined in the section.[246] As such, 44 Liquormart cannot be said to clearly overrule Posadas . In part five, relying on Edenfield , the plurality held that the government needed to show that the law advanced its goals to a material degree and would “significantly reduce” alcohol consumption to meet the third prong of Central Hudson .[247] The government failed to meet this burden because it could not provide any actual evidence that prohibiting alcohol price advertising would significantly reduce demand.[248] Likewise, the Court held that the law failed the fourth prong because the government had failed to show that the restriction was “no more extensive than necessary”.[249] Once again the Court proposed alternative regulations that would have preserved more speech and seemed to pull back on the Fox precedent that claimed a regulation need merely be “reasonable”.[250] The opinion continued the resurgence of the Court’s free market concerns.[251] As Justice Stevens chastised, “[t]he First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good”.[252]

Certainly, these more recent cases go some ways towards reestablishing the importance of free market interests after Posadas . Yet, their cumulative effect probably would not lead to the FDA’s restrictions on prescription drug promotion being overturned. The greatest effect of these cases is probably on the third and fourth prongs of the Central Hudson test. They seem to require better evidence that the government’s interest was advanced and that there were no less restrictive alternatives. First, as to advancement of a government interest, none of these cases presented public welfare interests as critical to public health and safety as prescription drug regulations. Fox was about commercial speech in college dorms, the Peel -Ibanez -Edenfield line involved restrictions on professional advertising, and Rubin and 44 Liquormart involved alcohol advertising. While Court agreed that there were public welfare concerns in all these cases, it may be less willing to give credence to these interests at the expense of the free markets when the interests seem less compelling – for example stopping advertising in dorm rooms. Likewise, in several of the cases, notably Ibanez and Rubin , the Court expressed puzzlement about the set up of the regulatory scheme. Only certain specific advertisements or advertising paths were blocked, so advertising was still permissible, but not in certain seemingly arbitrarily chosen ways. In contrast, the FDA’s restrictions on prescription drug promotion are comprehensive in addressing virtually every form of drug advertising. Somewhat counter-intuitively, the comprehensive nature of the FDA regulations may make them more justifiable under the third prong of Central Hudson . Secondly, the cumulative effect of these cases on the fourth prong may be a wash. Fox weakened the prong by only requiring “reasonableness” and Rubin and 44 Liquormart indicated that a better fit was required but did not overrule Fox . Given these inconclusive results, restrictions on prescription drug promotion will probably be given more leeway than reading Rubin or 44 Liquormart in isolation would suggest.

IV. Compelled Speech, Prior Restraints and Prescription Drug Promotion

Before moving on to analyze the recent crop of cases about the FDA’s prescription drug promotion regulations, two smaller, but nevertheless important, commercial speech issues deserve mention. These issues are unsettled in the commercial speech context because of limited treatment in the courts. However, depending on the direction of case law, either could have profound effects on prescription drug promotion. The first of these is the issue of compelled speech.

A. Compelled Speech

The First Amendment’s protection of the right to speech includes the right to refrain from speaking.[253] However, the current compelled speech theories were developed in a non-commercial speech context.[254] While the Supreme Court has touched on the issue in two commercial speech cases, it has not clearly extended the compelled speech theories to include commercial speech.[255] One point that is fairly established is that in comparison to non-commercial speech, “[p]urely commercial speech is more susceptible to compelled disclosure requirements”.[256] For example, Zauderer v. Office of Disciplinary Counsel ,[257] held that disclosure requirements, such as warning labels or disclaimers, might be acceptable for commercial speech because they “trench much more narrowly on an advertiser's interests than do flat prohibitions on speech”.[258] These disclosure requirements are permissible so long as “reasonably related to the State's interest in preventing deception of consumers. ”[259] As such, it seems that FDA prescription drug labeling requirements would not be as suspect as other forms of compelled speech. Especially given the long history of labeling regulations,[260] and the great potential of harm to consumers from misuse of prescription drugs, they probably pass First Amendment scrutiny.[261]

Recently, the Supreme Court ruled in two compelled commercial speech cases. In Glickman v. Wilemann Brothers & Elliot, Inc. ,[262] the Court upheld federal rules compelling California fruit producers to fund generic fruit advertisements under the authority of the Agricultural Adjustment Act.[263] Some producers challenged the validity of the rules, arguing that forced subsidization of generic advertising violated their right to free speech.[264] However, the Court held that the rules were a form of economic regulation and decided the case on those grounds, instead of as a free speech issue.[265] Therefore it determined that it was an error for the court of appeals to have applied the Central Hudson test.[266] The Court emphasized that the compelled advertising was part of a broad regulatory scheme and that it was for Congress to determine such economic questions.[267]

But, four terms later, the Court made clear that it does not read Glickman broadly in United States v. United Foods .[268] In United Foods the Court held that a federal law that compelled fresh mushroom handlers to pay assessments that were used to fund advertisements promoting mushroom sales violated the First Amendment.[269] As the Court noted, the assessments in Glickman had been part of a comprehensive set of marketing orders and rules that made fruit producers exempt from antitrust laws.[270] In contrast, in United Foods there were few components of the regulatory scheme other than the compelled advertising. The Court noted, “[h]ere, for all practical purposes, the advertising itself, far from being ancillary, is the principle object of the regulatory scheme”.[271] Thus, the Court concluded that the regulatory scheme violated First Amendment principles set down in cases about expression by groups that include people who object to the expression but are who are otherwise required to remain members of the group by law or necessity.[272]

United Foods and Glickman have not done much to clear the muddy waters of the compelled commercial speech area. While Zauderer indicates that FDA drug labeling requirements are permissible, it is still quite unclear how much of the rest of the compelled speech doctrine applies to commercial speech. Glickman sidestepped the issue entirely, while United Foods only made clear that compelled commercial speech is permissible in situations when two confusing criteria are met. First, the organization compelling the speech must be part of a comprehensive regulatory scheme. Second, the compelled commercial speech must be related, yet ancillary to the central purpose of the organization.[273] If the doctrine does apply to commercial speech, Glickman suggests that it may not affect FDA prescription drug promotion regulations. While decided on economic grounds, Glickman emphasized the existence of a comprehensive regulatory scheme as one area when compelled commercial speech is permissible. The FDCA is certainly an extensive regulatory scheme, and as such, may immunize prescription drug promotion regulations against compelled speech challenges.

B. Prior Restraints

The second subsidiary commercial speech issue is that of prior restraints. Historically, prior restraints have been considered a more drastic intrusion on free speech than subsequent punishments.[274] As such, the Court has a heavy presumption against prior restraints.[275] Unless a restriction fits into a “narrowly defined exemption” to the rule against prior restraints and is implemented “with procedural safeguards that reduce the dangers of suppressing constitutionally protected speech” it will be held unconstitutional.[276] While this seems like a clear-cut rule, the Supreme Court indicated in footnotes to Virginia State Bd. of Pharmacy and Central Hudson that commercial speech might be one of the narrow exemptions to the rule.[277] Unfortunately, the Court has not elaborated much beyond these footnotes in later cases. The clearest statement comes from Justice Brennan in a concurrence to Zauderer explaining, “traditional prior restraint principles do not apply to commercial speech”.[278] But, given the increased protection of commercial speech seen in recent cases such as Rubin and 44 Liquormart it is unclear if commercial speech would still be considered an exception to the prior restraint doctrine.

At least one appeals courts has taken recent cases as signaling that the prior restraint doctrine does apply to commercial speech. In New York Magazine v. Metropolitan Transit Authority ,[279] the Second Circuit concluded that advertising space on the outside of public buses was a designated public forum and that the prior restraint doctrine applied to a transit authority decision to refuse to run an advertisement after a request from the mayor’s office.[280] Then, in Nutritional Health Alliance v. Shalala ,[281] the Second Circuit extended that reasoning to hold that the procedures safeguarding against prior restraints should not be relaxed in commercial speech cases.[282] The court went on to hold that the fourth prong of Central Hudson should be applied the same, whether prior restraints are involved or not.[283] On the other hand, other circuits have not followed the Second Circuit in explicitly extending the prior restraint doctrine to commercial speech. Additionally, there is a long judicial tradition of approving government pre-approval schemes, from permit requirements to anti-obscenity laws.[284] Likewise, in Nutritional Health Alliance , even after determining that the prior restraint doctrine applied, the Second Circuit ultimately held that under the Nutritional Labeling and Education Act the FDA could constitutionally require pre-approval of health claims on dietary supplement labels.[285] As such, even if the doctrine does apply to prescription drug promotion, it may have little practical effect on the outcome of cases.

V. Recent FDA Commercial Speech Cases and Prescription Drug Promotion

Building on the historical development of commercial speech law discussed above, [286] several recent cases have specifically addressed the issue of drug promotion and commercial speech. These cases are obviously of great importance in determining where the courts might steer the commercial speech doctrine as related to prescription drug promotion.

A. Washington Legal Foundation v. Henney

One recent case that attempted to apply the current state of commercial speech case law to prescription drug promotion is Washington Legal Foundation v. Henney .[287] This was a D.C. circuit case in which a legal foundation alleged that the FDA guidance documents on enduring materials and CMEs[288] violated its physician members’ right to receive information about off-label uses of drugs and medical devices.[289] Ultimately, the disposition of the case reflected the confusion in the commercial speech doctrine. While the district court overturned the guidance documents based on an application of the commercial speech doctrine,[290] the appeals court sidestepped the issue by deciding the case on statutory interpretation grounds and declining to rule on the constitutional controversy.[291]

The district court began by rejecting the FDA’s contention that the guidance documents were only regulations of conduct. It then determined that the guidance documents were regulations of commercial speech. Therefore, the court applied the Central Hudson test to determine if the regulations were permissible under the First Amendment.

The guidance documents passed the first two prongs. First, the court determined that the speech was not unlawful because off-label prescribing was a lawful activity.[292] It then determined that the speech was not inherently misleading because although it might be “potentially misleading,” previous case law was clear that the potential to mislead was not sufficient.[293] Under the second prong, the court held that the guidance documents directly advanced two substantial government interests. First, the court held that previous cases had consistently established that the government has a substantial interest in protecting the health and safety of its citizens.[294] Second, the government had a less compelling, but still substantial, interest in providing incentives to motivate manufacturers to go through the rigorous process to get off-label uses approved on-label.[295] However, the court rejected the government’s third proffered interest in withholding information for fear that physicians might be misled. Reflecting the free market, anti-paternalism strain in Supreme Court commercial speech cases,[296] the court observed that the alleging that speech needs to be restricted for the recipient’s own protection is “practically an engraved invitation to have the restriction struck.”[297]

The court then moved on to apply the third and fourth prongs. It concluded that the guidance restrictions met the third prong because they directly and materially advanced the government’s interest in encouraging drug manufacturers to submit previously approved drugs for approval of off-label uses.[298] But, the restrictions failed the fourth prong because they were more extensive than necessary.[299] The court reasoned that there were less burdensome alternatives, such as requiring “full, complete, and unambiguous disclosure” by the manufacturer.[300]

Subsequent to the district court’s decision the FDAMA became effective. Since the FDAMA codified two of the guidance documents a question arose as to the whether the district court’s decision still applied. The district court denied the FDA’s motion asserting that the ruling applied only to the guidance documents and ruled that the FDAMA unconstitutionally restricted commercial speech.[301]

The FDA appealed that ruling to the DC Court of Appeals. The appeals court dismissed the appeal and vacated the parts of the district court opinion that had declared the FDAMA and the guidance documents unconstitutional.[302] The appeals court vacated the district court’s decision due to a lack of constitutional controversy because at oral argument the FDA stated “neither the FDAMA nor the CME Guidance independently authorizes the FDA to prohibit or to sanction speech”.[303] In the eyes of the appeals court, this admission was enough to end the controversy for lack of a justifiable issue. Cryptically, the court stated that the FDA “retained the prerogative” to use the fact that promotional conduct fell outside the regulations as evidence in misbranding actions, [304] but noted that such usage might violate the First Amendment.[305] Given this language and the fact that commentators are unsure what effect the appeals court intended when it vacated the district court opinion,[306] Washington Legal Foundation provides no neat answers.

B. Pearson v. Shalala

In Pearson v. Shalala ,[307] the D.C. Circuit revisited an issue related to prescription drug promotion and commercial speech. In Pearson , the FDA had refused to authorize several dietary supplement health claims on product labels absent “significant scientific agreement” among experts that the claims were supported by current evidence.[308] The appeals court applied the Central Hudson test and concluded that the FDA fell short of meeting its standard because it was required to consider whether less restrictive measures, such as the inclusion of appropriate disclaimers, would render the suppressed health claims non-misleading.[309]

Under the first prong, the court recognized free market interests in discounting any possibility that the claims were “inherently misleading”. It adopted an almost sarcastic tone in stating that it was not as if the health claims had “such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale ... as if the consumers were asked to buy something while hypnotized.”[310] But, the court turned around and said that substantial government interests in protecting public health and safety and preventing consumer fraud were “undeniable”.[311] These public welfare interests countered the free market arguments. Reaching what amounted to a standstill under the first two prongs, the critical part of the analysis came in the second half of the test. First, the court discounted the first justification, reasoning that the government had not directly alleged that nutritional supplements threatened consumer health and safety and that such a justification would be constitutionally troubling anyway.[312] Interestingly, the court drew a heavy distinction between nutritional supplements and drugs at this point, writing that “[d]rugs, on the other hand, appear to be in an entirely different category--the potential harm presumably is much greater.”[313] The second justification, potential for consumer fraud, fared better but ran into difficulty when the court asked whether the fit between the government’s goals and its regulations was reasonable. The court concluded that there was a “general First Amendment preference for disclosure over suppression,”[314] and that the FDA had failed to meet its burden under the fourth prong because it had not considered disclaimers as an alternative to cure the potentially misleading claims.[315]

The implications of Pearson , especially for drug promotion, seem limited. First, Pearson was an unusually stringent application of the Central Hudson test. The court gave limited deference to the legislature’s policy judgments about claims on nutritional supplements.[316] Likewise, the court went to considerable trouble attempting to explain away the relaxation of the fourth prong in Fox. [317] Thus, it premised its decision on a strict application of the fourth prong that would seemingly require a claim-by-claim determination of whether disclaimers were adequate to prevent harm to the public.[318] In addition, the court explicitly allowed that the public welfare interests at issue in drug promotion cases might be greater and thus lead to a different result.[319] Coupling these elements with the fact that it is only a single circuit’s opinion and Pearson , though often discussed by commentators, is a relatively small contribution to the dialog on regulation of prescription drug promotion.

C. Thompson v. Western States Medical Center

A case with significantly more effect is Thompson v. Western States Medical Center .[320] In Western States , pharmacists brought an action challenging provisions of the FDAMA that prohibited advertising and promotion of compounded drug products.[321] These provisions exempted compounded products from the new drug approval requirements so long as pharmacists did not advertise them.[322] The pharmacists claimed that this advertising prohibition unconstitutionally abridged their right to free speech. In a five to four decision, the Court held that the FDAMA's prohibitions on soliciting prescriptions for and advertising compounded drugs amount to unconstitutional restrictions on commercial speech.[323]

Since the parties agreed that the speech at issue was commercial, the court moved directly into the Central Hudson test.[324] Likewise, the government conceded that the speech at issue was not unlawful or inherently misleading.[325] The government asserted three interests in prohibiting advertising: (1) preserving the effectiveness of the new drug approval program, (2) assuring that compounded drugs were available for patients who needed them and (3) that striking the proper balance between the first two interests was best achieved by restricting advertising because large-scale compounding would be impossible without advertising, while small scale compounding for particular individuals would be preserved.[326] The Court agreed that these were valid interests and that such a regulatory scheme might directly advance the government’s interest.[327] However, the scheme floundered on the fourth prong because the government failed to demonstrate that less extensive restrictions were impossible. Again, the Court retreated from its loosening of the fourth prong in Fox , emphasizing that “we have made clear that if the Government could achieve its interests in a manner that does not restrict speech, or that restricts less speech, the Government must do so.”[328] The Court suggested several less restrictive alternatives, including simply banning commercial scale compounding or limiting the amount of compounded drugs a pharmacy could make in a given period of time.[329]

The majority closed by attacking the dissent’s rationale for upholding the statue as “highly paternalistic”.[330] In dissent, Justice Breyer argued that there was an additional state interest that the majority had overlooked.[331] He argued that, apart from the interest in preventing large-scale manufacture of compound drugs, there was a substantial interest in stopping drug sales of “those compounded drugs sought by patients who may not clearly need them--including compounded drugs produced in small amounts.”.[332] To support this argument, the dissent cited one set of studies outlining a correlation between drug advertising and increased sales of the advertised drugs and another set of studies that suggested that doctors often respond to patient demands to prescribe advertised drugs.[333] The essence of the dissent’s position was that demand should be generated “doctor-to-patient-to-pharmacist, not pharmacist-to-advertisement-to-patient-to-doctor”.[334] While this is a paternalistic assumption, the dissenters were convinced that such paternalism was permissible, and perhaps necessary, given the countervailing public welfare interests in protecting the health and safety of citizens.[335] The dissent stressed that the exemption of compounded drugs from the normal drug testing requirements “inherently creates risk” and that offsetting this risk makes restrictions on commercial speech permissible.[336]

In sum, Western States clarifies that the Court will almost certainly treat FDA restrictions on drug promotion as commercial speech restrictions and apply the Central Hudson test. But, the implications of the decision for other types of prescription drug promotion may not be sweeping. First, the decision dealt with the unique situation of compounded drugs. Compounded drugs occupy a strange position in the FDCA as they are exempt from the rigorous new drug approval process on one hand and completely prohibited from advertising on the other. The restrictions on advertising of drugs that are subject to the approval process are admittedly stringent, but they do not approach a complete ban on promotion. As such, the Court might not approach a challenge to those regulations the way that it did in Western States . The Court traditionally disfavors total bans on speech,[337] but regulations, even when stringent, seem to be afforded more leeway. Second, the Western States majority agreed that preserving the new drug approval process was “clearly an important governmental interest”.[338] The Court contrasted that large-scale interest with what it characterized as “small-scale compounding”.[339] There is a sense that the Court approached the ban at issue as an overreaction to a small-scale issue that could be readily controlled with less speech-restrictive alternatives. Additionally, the Court seemed comfortable that the health and safety risks of compounded drugs were relatively low. For example, the majority gave the issue of advertising flavoring of drugs as the only concrete example of drug compounding when illustrating one of the reasons the ban was unconstitutional.[340] The Court might not apply such a lenient approach when facing a challenge to a restriction on the promotion of drugs that go through the approval process and that generate billions of dollars a year for their manufacturers. Finally, Western States was a bare majority decision. Four justices were willing to uphold a total ban on the advertising of compounded drugs. In a case where public welfare interests seemed greater, or were presented more artfully by the government, the outcome could easily change. As such, while prescription drug promotion unquestionably has some protection, it is unlikely that Western States indicates a willingness by the Court to overturn any of the key FDA regulations on prescription drug testing, labeling or advertising.

VI. Applying The Commercial Speech Case Law to FDA Regulations of Prescription Drug Promotion

A. FDA’s Public Welfare Interests Are Uniquely Significant

As preceding sections have demonstrated, the historical development of commercial speech case law and the closely connected issues of compelled speech and prior restraints have surprisingly limited and uncertain applicability to prescription drug promotion. The development of the commercial speech doctrine is largely the story of the Court’s struggle with competing free market and public welfare interests. While the balance between these interests has been clarified in areas such as professional advertising[341] and alcohol advertising[342] little case law exists about prescription drug promotion. Washington Legal Foundation , Pearson and Western States arguably affect the FDA’s ability to restrict prescription drug promotion, but all three decisions can be distinguished and are prone to other criticism.[343] This lack of case law is critical because of the vast differences in the public welfare interests at issue in prescription drug promotion and other commercial speech areas that the courts have explored. For example, the FDA’s regulatory goals of protecting the public health and safety can hardly be compared to the regulatory goal of protecting the professionalism of the legal profession. The FDA’s regulatory goals seem much more significant than those asserted in most commercial speech cases. Thus, although a massive body of case law has developed over the past 40 years, the application of the Central Hudson test to prescription drug promotions is relatively fresh territory.[344]

This section argues that the balance between the free market and public welfare interests in previous cases suggest that under the Central Hudson test the FDA may continue its current regime of prescription drug promotion regulations without violating drug manufacturers’ First Amendment rights. The critical nature of the FDA’s public welfare interests, as analyzed under the second prong, lead directly to this result. Thus, for prescription drug promotion the Central Hudson analysis functionally ends with the second prong. As such, in discussing the test, this section addresses two issues that may change this balance under the third and fourth prongs – the development of empirical research into the effects of prescription drug promotion and the growth of the Internet as a mechanism to distribute prescription drug information.

1. Application of the Central Hudson Test

i. Prongs One & Two – Balancing Public Welfare Interests

The first two prongs of the Central Hudson test ask whether the speech at issue involves a legal activity and is not inherently misleading and, if so, whether the government has a substantial interest in regulating the speech.[345] Together these prongs address the Court’s concern for public welfare interests. They weigh what will happen if the government is not allowed to restrict commercial speech by considering what the potential harm to the public would be. For prescription drug promotion, this is the most critical half of the Central Hudson test because of the serious nature of the potential harm to the public welfare. The government’s critical public welfare interests under the second prong will ultimately trump free market concerns, making the second half of the test somewhat superfluous.

a. Prong One – Is the Speech About Illegal or Inherently Misleading Activity?

Under the first prong, the question can be rephrased as asking whether the commercial speech is so threatening to the public welfare that it can be banned outright. There is little doubt that prescription drug promotion passes this test because it is not concerning an illegal activity or inherently misleading. The basic argument for illegality hinges on the fact that prescription drugs are considered misbranded under the FDCA if a manufacturer does not comply with the FDA’s promotion restrictions.[346] Since misbranding is a type of illegal conduct, this argument reasons that the promotion is by definition illegal. However, such an argument has more than a hint of circularity and has been consistently rejected by the courts. For example, in Rubin , the Court rejected the argument that a statute prohibiting alcohol content on beer labels inherently made such speech illegal.[347] Likewise, in Washington Legal Foundation , the court rejected the FDA’s argument that supplement advertising was illegal because it was prohibited by the FDCA.[348]

The argument that prescription drug promotion is inherently misleading is not much stronger. Prescription drug promotional claims should probably be considered in terms of their effect on the public as a whole, not just on medical professionals, since the public is the end consumer.[349] In any event, if prescription drug promotion regulations are not inherently misleading when the audience is considered to be consumers, they certainly would not be inherently misleading to more educated audiences. Several factors suggest prescription drug promotion might be inherently misleading. First, consumers lack the ability to independently verify prescription drug promotional claims.[350] Likewise, manufacturers have financial incentives to not disclose damaging information about prescription drugs. They have similar incentives to make promotions that appeal to consumer fears and insecurities.[351] On the other hand, all of these concerns are better arguments that prescription drug promotion has the potential to mislead, not that it is inherently misleading. In addition, the requirement that consumers visit a doctor to get prescription drugs limits the potential for misleading consumers and provides them with additional information. Finally, the fact that the Court has never found any type of commercial speech to be inherently misleading suggests that they would not do so in the case of prescription drugs.

b. Prong Two – Is There a Substantial Government Interest?

For prescription drug promotion, the second prong is the most critical part of the test. Under the second prong, the question is whether the government has a substantial interest in the regulation. In this prong the Court is asking what the public welfare concerns are that make regulation permissible. For prescription drug promotion there are at least four substantial interests. First, the FDA has interests in protecting the public health and safety by controlling access to dangerous prescription drugs.[352] The government also has an interest in providing incentives for manufacturers to complete the rigorous new drug approval process.[353] Finally, the government has an interest in preventing consumer fraud and confusion.[354] Ultimately, the gravity of these interests controls the analysis. As historical review indicates, the Court has upheld regulations with less significant public welfare interests at stake in cases like Posadas .[355] When it has refused to uphold restrictions is it because the public welfare interest asserted is unconvincing when compared to the free market benefits of allowing the advertising. This situation has occurred in recent cases, most notably Western States , but it is important to note the peculiar nature of that case (it was about a total ban on advertising) and the fact that the decision was still five to four.[356] Consumer difficulty in evaluating prescription drug health claims also suggests that free market benefits are less significant in the context of FDA prescription drug promotion restrictions.[357] Given the significant interests at issue, indications from previous case law, and consumer difficulty in understanding prescription drug promotion, the second prong of the test strongly indicates that current FDA prescription drug promotion regulations are constitutional.

ii. Prongs Three & Four – Addressing Free Market Concerns

Today, analysis under the second prong gives the most certain answer for prescription drug promotion restrictions. The restrictions protect very significant government interests, so it is difficult to argue that they do not comply with the third prong in advancing those interests. Under the fourth prong, the restrictions still leave room for commercial expression when they are complied with. They do not create total bans on speech of the type the Court was unwilling to permit in Western States .[358] Nor do they implicate the same sorts of concerns about overbreadth as seen in Rubin and 44 Liquormart .[359] As such, they directly advance significant government interests and are no more extensive than necessary. But, this is not to say that the remaining prongs of the test are unimportant. While the case law indicates that public welfare interests will currently trump free market interests in the prescription drug promotion area, recent developments such as empirical research into the effects of prescription drug promotion and the growth of the Internet may have an effect on this balancing.

1. Prong Three – Does the Regulation Directly Advance a Substantial Government Interest?

As just mentioned, the FDA’s prescription drug promotion regulations probably directly advance the government’s interest in promoting public health and safety. Given an uninformed consumer population the third prong seems relatively easy to meet. This is especially true if the courts are willing to accept the FDA’s assertion that the regulations directly advance a substantial interest at face value. As the historical overview indicates, the courts have traditionally not demanded empirical proof under the third prong.[360] Instead, they seem to conduct a general inquiry into whether the challenged regulation could logically advance the government’s interests. This amounts to asking whether the regulation could sensibly advance the government’s interests, rather than requiring empirical proof that it actually does. However, this relaxed standard may be beginning to change to require more empirical proof after Edenfield .[361] In that case the Court required more than “mere speculation or conjecture” and held that the restriction must “in fact alleviate [harms] to a material degree”[362] . Likewise, the dissenters in Western States pointed to the existence of empirical studies about the effects of compound drug advertising to make their case that the restrictions were constitutional.[363]

If these cases indicate a trend, the FDA may need to be cognizant of the growing body of empirical research into the effects of prescription drug promotion. This research is by no means conclusive; some studies suggest that prescription drug promotion helps educate consumers[364] while others claim that it leads to rampant unnecessary prescription.[365] Analysis of these studies is beyond the scope of this paper. But, it is sufficient to note that they may ultimately have dramatic effects on the application of the third prong. If the FDA must empirically back up or refute assertions under the third prong the balance between free market and public welfare interests might be considerably different. If enough studies demonstrated that prescription drug promotion regulations were actually retarding the flow of information and injuring consumers the FDA would be hard pressed to argue that the regulations directly advanced a substantial interest.

b. Prong Four – Is the Regulation No More Restrictive Than Necessary?

Under the fourth prong the Central Hudson test asks whether the regulation is more extensive than necessary to achieve the government’s purpose. This is the prong of the test that most encompasses the Court’s concern for free market interests. The premise behind the prong is that by restricting the minimum of information necessary to protect the public welfare the government will preserve other information to help in public decision-making. As earlier sections have argued, the great significance of the public welfare interests in prescription drug promotion suggest that the Court will be more willing to tolerate regulations that incidentally restrict more speech than necessary.[366] In light of this idea, the FDA regulations of prescription drug promotion outlined earlier in this paper likely meet the fourth prong.[367]

However, especially in recent cases, courts have looked to the availability of alternative regulatory options in determining if a regulation is more extensive than necessary.[368] One alternative with respect to prescription drug promotion is the use of disclaimers on labels and in advertisements. Although such disclaimers or other forced warnings might be considered compelled speech,[369] the Court has suggested that disclaimers may be permissibly required to counteract misleading information.[370] As such, this was the solution the district court suggested in Pearson when dealing with dietary supplement health claims.[371] Although the public welfare interests at issue in prescription drug promotion cases are more extensive than those in Pearson , such compelled disclaimers might be preferred because they are less speech restrictive than complete prohibitions.

A major problem with disclaimers is that they may not effectively provide information to correct misleading information. Some commentators suggest that disclaimers can actually increase consumer confusion.[372] Others suggest that FDA warnings can be misinterpreted by consumers as reassurance that their conditions can be treated rather than as specific information about product risks.[373] Requiring numerous disclaimers may dilute the strength of the warnings, or conversely, create an overreaction to the number of warnings.[374] As such, disclaimers in their present form, whether through a brief informational warning in a DTC television advertisement or an FDA mandated disclaimer on a label, may be ineffective.

Increased use of the Internet may affect this analysis in at least two ways. First, the Internet provides an easily accessible forum where consumers can quickly access comprehensive drug information. This reduces some of the concerns that disclaimers might be misinterpreted. Posting disclaimer information on the Internet may allow for fuller and fairer warnings that are easier for consumers to understand. Secondly, the FDA may soon be forced to confront the massive amount of unregulated drug information already on the Internet. Message boards, foreign websites that do not fall under FDA jurisdiction, search engines, blogs and even chat rooms can all be sources of drug information. If consumers can use the Internet to find sources of drug information that FDA jurisdiction cannot easily reach the rationale for prohibiting information in prescription drug promotions to protect the public welfare may be challenged.[375] As such, the Internet poses two challenges to current prescription drug promotion regulations. It may turn out to provide an alternative and more effective forum for disclaimers and quick distribution of information, making this a more viable option.[376] Also, widespread use of the Internet may erode the justification for prohibiting information in prescription drug promotions if the public can easily obtain the same information from unregulatable online sources.[377]

VII. Conclusion

Recent decisions have caused the FDA to question whether its regulations of prescription drug promotion comply with the First Amendment.[378] This paper has argued that those recent decisions do not compel the FDA to change its prescription drug promotion regulations and that they cannot be considered in isolation from the historical development of the commercial speech doctrine. When this historical development is considered two competing interests consistently emerge from commercial speech cases. On one hand, an interest in protecting the public welfare suggests that speech restrictions are permissible. On the other, an interest in promotion of free markets limits speech restrictions. The application of the Central Hudson test, or any other method the Court might adopt for determining commercial speech cases, hinges on the balance between these interests.

When Congress enacted the FDCA in 1938 its purpose was to protect the public’s health and safety. Therefore, it gave the FDA regulatory authority to pursue these public welfare interests. If anything, the critical nature of these interests has only increased over the ensuing 70 years. The size and financial clout of the pharmaceutical industry, the pervasive use of prescription drugs and the sophistication of advertising methods makes these interests as important as ever. As such, the FDA’s public welfare interests in restricting prescription drug promotion outweigh free market interests in making such promotional information available to the public. Under the Central Hudson analysis, the FDA has a substantial interest in protecting the public’s health and safety that is directly advanced by its prescription drug promotion regulations. These regulations are no more restrictive than necessary because they still permit multiple channels of drug promotion when they are complied with and because the Court is likely to tolerate relatively stringent restrictions when such critical public welfare interests are involved.

Of course the FDA must keep abreast of changes in the law and in technology that may alter this result. Information about the empirical effects of drug promotion and increased use of the Internet are two such potential changes. But, the history of the commercial speech doctrine suggests that the FDA need not preemptively alter its current regulations in response to recent case law. Consideration of doctrine reveals that the Court is respectful of public welfare interests. Indeed, it is only in the past 30 years that it even acknowledged that there was value to the functioning of free markets in commercial speech. Even in cases that overturn commercial speech regulations the Court is often sharply divided in valuing the public welfare interests.[379] Moreover, these cases have generally involved less important public welfare concerns than those at issue in prescription drug promotion. Given the gravity of the health and safety concerns involved, the FDA’s current regulations of prescription drug promotion do not violate the First Amendment.

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[1] NAT'L INST. FOR HEALTH CARE MGMT. RESEARCH & EDUC. FOUND., PRESCRIPTION DRUG EXPENDITURES IN 2001: ANOTHER YEAR OF ESCALATING COSTS 7 (May 6, 2002) available at http://www.nihcm.org/spending2001.pdf. [hereinafter “NIHCM EXPENDITURES ”].

[2] The U.S. population in July of 2004 was slightly under 300 million. See CIA World Factbook, United States (2005), available at http://www.cia.gov/cia/publications/factbook/geos/us.html.

[3] NIHCM EXPENDITURES supra note 1, at 5.

[4] NAT'L INST. FOR HEALTH CARE MGMT. RESEARCH & EDUC. FOUND., PRESCRIPTION DRUGS AND MASS MEDIA ADVERTISING 4 (2001), available at http://www.nihcm.org/DTCbrief2001.pdf. In 2000 the pharmaceutical industry employed 83,000 drug representatives at an estimated cost of $4 billion. Free samples worth $7.9 billion were handed out to doctors and $1.9 billion was spent on educational conferences for doctors. Id at 5. Direct-to-consumer advertising makes up a smaller, but rapidly increasing segment of these promotional costs. See infra note 52.

[5] See 21 U.S.C. § 355(d).

[6] See Jeffrey N. Gibbs, Food & Drug Administration Regulation & Products Liability: Strong Sword, Weak Shield , 22 TORT & INS. L.J . 194, 195-96 (1987).

[7] U.S. CONST . amend. I. (“Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.”).

[8] 535 U.S. 357 (2002). See discussion infra at note 321.

[9] 13 F.Supp.2d 51 (D.D.C.1998). [Hereinafter “WFL I”]. See discussion infra at note 287.

[10] 164 F.3d 650 (D.C. Cir. 1999). See discussion infra at note 307.

[11] Commercial speech has been defined (somewhat circularly) as speech that does “"no more than propose a commercial transaction." Pittsburgh Press Co. v. Pittsburgh Comm’n on Human Rights , 413 U.S. 376, 385 (1976). See discussion infra at note 108.

[12] Request for Comments on First Amendment Issues, 67 Fed. Reg. 34,942 (May 16, 2002). There are over 700 public comments in the FDA’s comment database for this issue, available at http://www.fda.gov/ohrms/dockets/dockets/02n0209/02n0209.htm.

[13] See e.g ., Comments of the Freedom to Advertise Coalition, In the Matter of Request for Comments on First Amendment Issues 16 (Sept. 13, 2002), available at http://www.fda.gov/ohrms/dockets/dailys/02/Sep02/091802/02n-0209-c000073-01-vol18.pdf. Comments of the Mercatus Center at George Mason University, In the Matter of Request for Comments on First Amendment Issues 2-3 (Sept. 13, 2002), available at http://www.fda.gov/ohrms/dockets/dailys/02/Sep02/091902/02N-0209_emc-000165-02.pdf. Comments of Abbott Labs, Inc., In the Matter of Request for Comments on First Amendment Issues 3-4 (October 28, 2002), available at http://www.fda.gov/ohrms/dockets/dockets/02n0209/02N-0209_emc-000213-01.pdf.

[14] See e.g. , Jonathan S. Kahan & Jeffrey K. Shapiro, The First Amendment and the Food and Drug Administration’s Regulation of Labeling and Advertising: Three Proposed Reforms , 58 FOOD & DRUG L.J. 353 (2003) (discussing implications of recent decisions on FDA restrictions of enduring materials, information about clinical experience prior to approval and information about postapproval clinical experience); Jeffrey N. Gibbs, et. al., Ripe for Revision: Reassessing the Constitutionality of Food and Drug Administration Restrictions on Protected Speech , 48 FOOD & DRUG L.J. 331 (2003) (discussing implications of recent decision for promotional material predissemination submission requirements for drugs undergoing accelerated approval and restrictions on materials discussing off-label uses).

[15] See infra Section II.

[16] See infra Section III.

[17] See infra Section IV.

[18] See infra Section V.

[19] See infra Section VI.

[20] Pub. L. No. 52-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-397).

[21] For complete histories of the development of the modern FDCA, see Patricia I. Carter, Federal Regulation of Pharmaceuticals in the United States and Canada , 21 LOY. L.A. INT’L & COMP. L. REV. 215, 224 (1999); Charles J. Walsh & Allison Pyrich, FDA Efforts to Control The Flow of Information at Pharmaceutical Industry-Sponsored Medical Education Programs , 24 SETON HALL L. REV. 1325, 1335-40 (1994).

[22] See 21 U.S.C. § 355(a), (d). A new drug is defined as a “drug not generally recognized ... as safe and effective under the conditions prescribed, recommended or suggested in the proposed labeling ....” 21 U.S.C. § 321(p). FDA’s authority to require all new drugs to be safe and effective by “substantial evidence” stems from the 1962 Kefauver-Harris Amendments, passed in the wake of the thalidomide tragedy. Carter, supra note 21, at 219-20 (1999).

[23] See 21 C.F.R. § 202.1(e)(4)(i)(a), (ii) & (iii); 21 C.F.R. § 202.1(e)(6)(i).

[24] See 21 U.S.C. § 355(b) (NDA contents); 21 U.S.C. § 355(b)(1)(F) (proposed labeling requirement). For a more detailed, discussion of the clinical trial process, and alternate routes to approval, see Carter, supra note 21, at 230-36.

[25] 21 U.S.C. § 355(d). (A drug must be “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.”).

[26] 21 C.F.R. § 201.56(d)(1).

[27] FDA approval time is notoriously long, though it has been improving. NDAs submitted in 1987 took an average of 33 months to be reviewed. That average dropped to 15 months by 1997. See Carter, supra note 21, at 234-35. The 1992 Prescription Drug User Fee Act requires pharmaceutical manufacturers to pay a fee for each NDA. The fee was $672,000 for an application requiring clinical data in 2003. See Establishment of Prescription Drug User Fee Rates for Fiscal Year

2005, 69 Fed. Reg. 46165 (FDA, August 2, 2004), available at http://www.fda.gov/cber/pdufa/userfees05.htm. Since its passage studies have shown that approval times dropped at least 50%. See Mary K. Olson, Pharmaceutical Policy Change and the Safety of New Drugs , 45 J.L. ECON. 615, 620 (2002).

[28] See 21 U.S.C. §§ 301-379 (regulations on the manufacturing, packaging, distribution, shipment and inspection of prescription drugs).

[29] 21 U.S.C. § 321(m). In regulations, FDA has further defined labeling to include “brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature reprints and similar pieces of printed, audio, or visual matter descriptive of a drug....” 21 C.F.R. § 202.1(1)(2).

[30] See generally 21 U.S.C. § 352. Briefly, this section regulates prominence of information on labels, specific warnings for habit forming substances, use of established names of active ingredients, directions for use, labeling of drugs that deteriorate, and regulations for prescription drug advertising. Id .

[31] For example, see 21 C.F.R. §§ 201.13(a) (mandating specific warnings for products containing phenindione); 201.305 (warnings for drugs with isoproterenol inhalation preparations); and 801.417 (IUDs); see generally 21 C.F.R. §§ 201.300-323 (outlining precise labeling requirements for certain drug products). See also Gibbs, supra note 6, at 212 n.116.

[32] 21 U.S.C. § 352(a).

[33] See 21 C.F.R. § 201.56(d)(1).

[34] 21 U.S.C. § 352(a).

[35] 21 U.S.C. § 321(n) (“there shall be taken into account...the extent to which the labeling or advertising fails to reveal facts material in the light of such representations....”).

[36] 21 U.S.C. § 352(f) .

[37] See Walsh & Pyrich, supra note 21, at 1339. Before 1962, there was considerable confusion as to whether the FDA or the Federal Trade Commission (FTC) had principle responsibility for prescription drug advertising. The FTC attempted to regulate prescription drug advertising under its definition of advertising, but the Wheeler-Lea Act of 1938 created a loophole for prescription drug advertisements distributed solely to the medical profession. See id. at 1336-37. Additionally, although the FTC had the power to ban false or misleading statements in prescription drug advertisements directed to the public, it could not force the affirmative disclosure of information. See id . at 1337. At the same time, the FDA attempted to regulate prescription drug advertising through a broad interpretation of its power over “labeling”. In the 1940s and 1950s the phrase “accompanying any such article” in the labeling definition was interpreted by the FDA to include anything that supplemented or explained a drug product. See e.g. ,Kordel v. United States , 335 U.S. 345, 350 (1948) (“One article or thing is accompanied by another when it supplements or explains it, in the manner that a Committee Report of Congress accompanies a bill. No physical attachment one to the other is necessary.”). Thus, the FDA claimed jurisdiction over most forms of promotional material not explicitly within the FTC’s definition of advertising. See Walsh & Pyrich, supra note 21, at 1339. For the most part, the confusion over prescription drug advertising ended in 1962 when Congress amended the FDCA to transfer jurisdiction over the regulation and enforcement of prescription drug advertising from the FTC to the FDA. See id . at 1339. However, the FTC still retains jurisdiction over the regulation and enforcement of over-the-counter drug advertising and other FDA regulated products. See JAMES ROBERT NIELSON , HANDBOOK OF FEDERAL DRUG LAW 9 (1992). So, for these products the agencies operate under a liaison agreement under which the FDA has primary responsibility for regulating the labeling of the products, while the FTC has primary responsibility for ensuring that the products' advertising is truthful and not misleading. See Working Agreement Between FTC and Food and Drug Administration, 4 Trade Reg. Rep. (CCH) ¶ 9,850.01 (1971).

[38] 21 C.F.R. § 202.1(l)(1).

[39] See 21 C.F.R. § 202.1.

[40] See Walsh & Pyrich, supra note 21, at 1344-45, n. 101 (detailing 1968 and 1974 Senate hearings on the problems of abuses by “pharmaceutical detail men”). See also discussion of continuing medical education symposium infra at note 57.

[41] See Walsh & Pyrich, supra note 21, at 1344-45, n. 102 (In 1974 a Senate bill was specifically proposed to add oral promotions to the definition of advertising, but was never acted upon by the Committee on Labor and Public Welfare.).

[42] 21 U.S.C. § 352(n). The rule permits information relating to side effects, contradictions and effectiveness to be included in “brief summary” as established in regulations. The regulations provide that the brief summary must include information about side effects, contraindications, warnings, precautions and effectiveness. See 21 C.F.R. § 202.1(e). If a brief summary is not included adequate provisions must be made to provide the information in the approved labeling. 21 C.F.R. § 202.1(e). Id .

[43] See 21 C.F.R. § 202.1(e)(5). The statement must give a fair balance and not be false, misleading or fail to reveal any material facts. Id .

[44] 21 C.F.R. § 202.1(e)(5)(ii).

[45] 21 U.S.C. § 352(n). The advertisement will be misbranded unless it contains a true statement of the name and ingredients and a brief summary of side effects, contraindications and effectiveness. Id .

[46] 21 C.F.R. §§ 202.1(e)(6)-(7).

[47] See Lars Noah, Advertising Prescription Drugs to Consumers : Assessing the Regulatory and Liability Issues , 32 GA. L. REV. 141, 147 (1997). In the 1970’s FDA allowed advertising of prescription drug prices to consumers, as long as there was no representation about the safety or effectiveness of the drug. In 1983 one drug company advertised a prescription drug on television, leading to a warning from the FDA. Soon after the FDA requested a voluntary moratorium on DTC advertising so that it could study the issue. The agency lifted the moratorium in 1985, concluding that current regulations were adequate to protect the public. Id .

[48] See Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements, 62 Fed. Reg. 43,171, 43,172 (FDA, August 12, 1997).

[49] See Guidance For Industry on Consumer-Directed Broadcast Advertisements, 64 Fed. Reg. 43,197 (FDA, August 9, 1999), available at http://www.fda.gov/cder/guidance/1804fnl.htm. [hereinafter “Guidance”] The Guidance “does not differ substantially” from the draft. See Consumer-Directed Broadcast Advertisement Guidance: Questions and Answers (visited April 1, 2005) <http://www.fda.gov/cder/guidance/1804q&a.htm>. For a review of the Guidance, see Tamar V. Terzian, Note, Direct-To-Consumer Prescription Advertising , 25 AM. J.L. & MED . 149 (1999).

[50] See Guidance, supra note 49.

[51] See GUIDANCE , supra note 49. The Guidance describes these 4 steps as “one approach” to the adequate provision requirement. Id .

[52] According to the General Accounting Office, between 1997 and 2001 DTC advertising increased from $1.1 billion to an estimated $2.7 billion, an increase of 145 percent. In the same period research and development spending only increased 59 percent to $30.1 billion. Gen. Accounting Office, Prescription Drugs: FDA Oversight of Direct-To-Consumer Advertising Has Limitations 3, 9 (GAO-03-17, 2002), available at http://www.gao.gov/new.items/d03177.pdf. Reliable estimates are less available for more recent years, but, according to a study by market research firm NOP World Health, DTC spending was $3.2 billion in 2003 and $4.2 billion in 2004. See DTC Ads Spending Soars, Consumers Warm to Them, Says Study , PHARMA MARKETLETTER , February 28, 2005.

[53] See generally Edmund Polubinski III, Note, Closing the Channels of Communication: A First Amendment Analysis of the FDA's Policy on Manufacturer Promotion of “Off-Label” Use , 83 VA. L. REV. 991 (1997) (describing drug industry dissemination of off-label uses by circulating enduring materials and through continuing medical education symposium and arguing that FDA regulation of such activities may be unconstitutional).

[54] Off-label uses are “common and well accepted in the medical community”. Polubinski, supra note 53, at 998. In 1994, the American Medical Association Vice President for Science and Education estimated that 40 to 60 percent of all drug prescriptions are for off-label uses. Fran Kritz, FDA Seeks to Add Drugs' New Uses to Labels , WASH. POST, HEALTH SECTION , Mar. 29, 1994, at 11.

[55] The FDA probably lacks authority to regulate the practice of medicine. See 21 U.S.C. § 396 (“Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health-care-practitioner-patient relationship.”). See also Polubinski, supra note 53, at 999.

[56] Citizen Petition Regarding the Food and Drug Administration's Policy on Promotion of Unapproved Uses of Approved Drugs and Devices; Request for Comments, 59 Fed. Reg. 59820, 59821 (1994).

[57] The FDA has release 3 guidance documents on these topics. First, it released two guidance documents regulating manufacturer distribution of “enduring materials” (these are copies of peer-reviewed journal articles and medical reference texts). See Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data, 61 Fed. Reg. 52,800, 52,801 (1996) (guidance on reprints of journal articles) and Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed. Reg. 52,800, 52,801 (1996) (guidance on distributing reference texts). Second, it released guidance on manufacturer involvement with continuing medical education seminars (CMEs). See Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074 (1997) (regulating involvement in CMEs); The guidance on CMEs is still in effect and lists 12 factors the FDA will consider in determining if a CME is independent of the influence of a financially supporting drug company. Id . However, only the guidances on enduring materials were codified as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA). All three guidance documents were at issuing in Washington Legal Foundation v. Henney , 202 F.3d 331 (D.C. Cir. 2000), discussed infra at note 288.

[58] See Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115 (codified in scattered sections of the FDCA at 21 U.S.C. §§ 343-3 to 397 (1997)). Among other topics, the Act addresses pediatric drug studies, fast track drug approval, streamlined clinical research, small-scale manufacturing and pharmacy compounding of drugs. Id.

[59] See Polubinski, supra note 53, at 995-1005.

[60] 21 U.S.C. § 360aaa(a). Information about unapproved uses may be distributed to (1) health care practitioners, (2) pharmacy benefit managers, (3) health insurance issuers, (4) group health plans, and (5) Federal or State governmental agencies. Id .

[61] 21 U.S.C. § 360aaa(b)(1)(A). An abbreviated new drug application (ANDA) is acceptable if the drug qualifies. See 21 U.S.C. § 360aaa(b)(5). If certain qualifications are met an ANDA may not even be necessary. See § 21 U.S.C. 360aaa-3(c)-(d).

[62] 21 U.S.C. § 360aaa(b)(2) (referring to rules at 21 U.S.C. § 360aaa-1).

[63] 21 U.S.C. § 360aaa(b)(3). A manufacturer may use another manufacturer's clinical research if that manufacturer gives permission. Id.

[64] 21 U.S.C. § 360aaa(b)(4).

[65] 21 U.S.C. § 360aaa(b)(6)(A). Disclosures must include: (1) that the use does not have FDA approval, (2) whether the information is being distributed at the manufacturer’s expense (3) any financial relationship between the authors and the manufacturer, (4) the approved labeling, (5) information about whether there are approved treatments available, (6) the name of the group funding the study (7) a bibliography of related scientific research. Id .

[66] 21 U.S.C. § 360aaa(c). The FDA may require the manufacturer to disseminate: (1) additional objective and scientifically sound information about safety and efficacy, (2) a statement by the FDA, based on data available to it, that relates to the safety or effectiveness of the new use. Id .

[67] The modern commercial speech doctrine is usually traced back about 30 years to Virginia State Bd. Of Pharmacy v. Virginia Citizen’s Consumer Council , 425 U.S. 748 (1976).

[68] The two cases about prescription drugs are one of the oldest, Virginia State Bd. of Pharmacy , 425 U.S. at 770 (1976) (drug price advertising) and one of the newest, Western States , 535 U.S. at 357 (2002) (compound drug advertising).

[69] See supra note 7.

[70] The First Amendment is simple in comparison to other provisions in the Bill of Rights in that it provides a more categorical restriction on governmental power. Most other provisions are qualified. For example, the Fourth Amendment protects against “unreasonable searches and seizures”. The Fifth Amendment requires “due process” to deprive someone of life, liberty or property. The Eighth Amendment prohibits “excessive” bail or fines and forbids “cruel and unusual” punishment. See William Van Alstyne, A Graphic Review of the Free Speech Clause , 70 CAL L. REV. 107 (1982) (“the First Amendment is exceptionally crisp and unambiguous”).

[71] The lack of uniformity in application of the First Amendment might be attributed to lack of consensus about the framer’s intent, the existence of different categories of speech, and the potential effects of government restrictions. Jo-Jo Baldwin, Note, Constitutional Law- Freedom of Speech. No Longer That Crazy Aunt in the Basement, Commercial Speech Joins the Family . 44 Liquormart, Inc. v. Rhode Island, 116 S. Ct. 1495 (1996), 20 U. ARK. LITTLE ROCK L.J. 163, 167-68 (1997); see also Van Alstyne, supra note 70 (graphically illustrating competing constructions of the free speech clause).

[72] See Constitution of the United States: Analysis & Interpretation, 92d Cong., 2d Sess., Senate Document 92-82, at 936 (1973) (“Debate in the House is unenlightening with regard to the meaning the Members ascribed to the speech and press clause and there is no record of debate in the Senate.”). The lack of debate over the free speech clause may not have been accidental. During ratification, James Madison warned about the dangers of intensely debating “abstract principles, of which the judgment may not be convinced” and advised “that if we confine ourselves to an enumeration of simple, acknowledged principles, the ratification will meet with but little difficulty”. 1 Annals of Congress, 738 (August 15, 1789).

[73] Historians disagree about the framers’ intent. One position, famously advanced by Professor Zechariah Chafee, Jr., argues that the First Amendment abolished the doctrine of seditious libel and established a broad libertarian view of freedom of speech. See ZECHARIAH CHAFEE, JR., FREE SPEECH IN THE UNITED STATES 19-21 (1941). The opposite position maintains that careful historical study of the Framer’s period shows that they did not have a libertarian understanding of freedom of expression and that authors who argue that they did “succumb[ ] to an impulse to recreate [the past] so that its image may be seen in a manner consistent with our rhetorical tradition of freedom”. LEONARD W. LEVY, EMERGENCE OF A FREE PRESS , xiv (1985). In sum, the historical analysis is indeterminate. See DANIEL A. FARBER, ET. AL., CONSTITUTIONAL LAW 616 (3d ed. 2003) (“Not surprisingly, the conclusions to be drawn from this ambiguous history seem to depend mostly on the presuppositions of the historian.”).

[74] See generally David Cole, Agon at Agora: Creative Misreadings in the First Amendment Tradition , 95 YALE L.J. 857 (1986) (discussing the rhetorical mechanisms Justices use to “manipulate and rehash precedent in order to make their own mark”). One major exception to the departure from literalism is Justice Hugo Black. Although his First Amendment views never reached a majority of the Court, Justice Black apparently believed in an absolutist approach to the First Amendment and was opposed to balancing First Amendment rights with governmental interests. See TINSLEY E. YARBROUGH, MR. JUSTICE BLACK AND HIS CRITICS 131-32 (1988). Black wrote, “[t]he First Amendment does not speak equivocally. It prohibits any law ‘abridging the freedom of speech ....’ It must be taken as a command of the broadest scope that explicit language ... will allow.” Bridges v. California , 314 U.S. 252, 263 (1941).

[75] See Alex Kozinski & Stuart Banner, The Anti-History and Pre-History of Commercial Speech , 71 TEX. L. REV. 747, 759 (1993). (“First Amendment cases are a staple of the Supreme Court's docket now, but until World War I ... the First Amendment was hardly ever before the Supreme Court or the lower federal courts.”).

[76] See e.g. ,Schneck v. United States , 249 U.S. 47 (1919) (affirming conviction for conspiracy to violate the Espionage Act of 1917); Gitlow v. New York , 268 U.S. 652 (1925) (affirming conviction under New York’s “criminal anarchy statute”); Whitney v. California , 274 U.S. 357 (1927) (affirming conviction for violating the California Criminal Syndication Act). For an overview of the World War I period, see generally David M. Rabban, The Emergence of Modern First Amendment Doctrine , 50 U. CHI. L. REV. 1205 (1983). For the development of the First Amendment before World War I, see generally Howard O. Hunter, Problems in Search of Principles: The First Amendment in the Supreme Court from 1791-1930 , 35 EMORY L.J. 59 (1986); Alexis J. Anderson, The Formative Period of First Amendment Theory: 1870-1915 , 24 AM. J. LEGAL HIST. 56, (1980); LEVY , supra note 73.

[77] See Charles Gardner Geyh, The Regulation of Speech Incident to the Sale or Promotion of Goods and Services: A Multifactor Approach , 52 U PITT. L. REV . 1, 1-13 (1990) (“Prior to the 1976 decision of Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council ... [l]ike obscenity or fighting words, commercial speech (or at least commercial advertising) was deemed to fall outside the scope of the First Amendment.”).

[78] See R.A.V. v. City of St. Paul , 505 U.S. 377, 383-84 (1992) (“[T]hese areas of speech [defamation, obscenity, and fighting words] can, consistent with the First Amendment, be regulated because of their constitutionally proscribable content (obscenity, defamation, etc.)--not that they are categories of speech entirely invisible to the Constitution, so that they may be made the vehicles for content discrimination unrelated to their distinctly proscribable content.”).

[79] See Virginia State Bd. Of Pharmacy , 425 U.S. at 770 (holding that commercial speech is of lower value); R.A.V. , 505 U.S. at 383 (holding that fighting words have relatively low value); Young v. American Mini Theatres, Inc. , 427 U.S. 50, 63 n. 18 (1976) (allowing restrictions on pornography); FCC v. Pacifica Found ., 438 U.S. 726, 744 (1978) (holding that there is no absolute protection for profane speech); Gertz v. Robert Welch, Inc. , 418 U.S. 323, 340 (1974) (holding that there is no constitutional value in false statements).

[80] The Court has endorsed a “content-neutral” First Amendment principle. Content neutrality forbids the government from abridging speech based on the content, message or viewpoint communicated. See R.A.V. , 505 U.S. at 382 (“Content-based regulations are presumptively invalid.”); Simon & Schuster, Inc. v. Members of N.Y. State Crime Victims Bd. , 505 U.S. 105, 114 (1991). (A statute is presumptively unconstitutional if it imposes a financial burden because of the content of speech.). See also Daniel A. Farber, Commercial Speech and First Amendment Theory , 74 NW U. L. REV. 372, 374 (1979). Therefore the Court usually applies a difficult to meet strict-scrutiny standard to content-based speech regulation. The Court will strike down the regulation unless it is the least restrictive means available to serve a compelling government interest. See Sable Communications of Cal., Inc. v. FCC, 492 U.S. 115, 126 (1989) (“[t]he Government may ... regulate the content of constitutionally protected speech in order to promote a compelling interest if it chooses the least restrictive means to further the articulated interest”). Regulations rarely survive strict-scrutiny review. See Geyh, supra note 77, at 7 (“This standard is so rarely met that it is tantamount to restating, for the benefit of lawyers uncomfortable with plain English, that the regulation will rarely, if ever, be allowed to stand.”). However, when a restriction suppresses speech for reasons unrelated to the content of speech (noise regulations, for example) the Court often uses a lower standard of review, which usually results in the Court upholding the restriction. See Geoffrey R. Stone, Content-Neutral Restrictions, 54 U. Chi. L. Rev. 47, 47-48 (1987). This results even though a content-neutral restriction can suppress the content of speech as easily as a content-based restriction. See id . at 54. Additionally, it is important to remember that strict-scrutiny does not apply to speech the Court considers “lower value” – like commercial speech, obscenity and fighting words. See supra note 79.

[81] This is not to say that the categories of lesser-protected speech might not change in the future. As Professor Thomas Emerson observed, “[T]he theory of freedom of expression is a sophisticated and even complex one ... It must be restated and reiterated not only for each generation, but for each new situation.” Thomas Emerson. Toward a General Theory of the First Amendment , 72 YALE L.J. 877, 894 (1963).

[82] See supra discussion in note 80.

[83] See Geyh, supra note 77, at 7.

[84] Eli Lilly and Company, Lilly Launches Public Outreach Initiative to Correct Allegations About Company and Prozac (January 13, 2005), available at http://www.prnewswire.com/cgi-bin/micro_stories.pl?ACCT=916306&TICK=LLY&STORY=/www/story/01-13-2005/0002825053&EDATE=Jan+13,+2005.

[85] 539 U.S. 654 (2003) (writ of certiorari dismissed as improvidently granted).

[86] Nike , 539 U.S. at 663.

[87] Nike , 539 U.S. at 683-84 (Kennedy J., dissenting, joined by Breyer & O’Connor, JJ.)

[88] See e.g. , Erwin Chemerinksy & Catherine Fisk, What Is Commercial Speech? The Issue Not Decided in Nike v. Kasky , 54 CASE W. RES. L. REV. 1143, 1147 (2004).

[89] See discussion of the commercial / noncommercial distinction, infra at Note 94.

[90] See Valentine v. Chrestensen , 316 U.S. 52 (1942).

[91] See Geyh supra note 77, at 1-14.

[92] See Virginia State Bd. of Pharmacy , 425 U.S. at 770; Central Hudson Gas & Electric Corp. v. Public Service Commission , 447 U.S. 557, 566 (1980).

[93] See Alex Kozinski & Stuart Banner, Who’s Afraid of Commercial Speech? , 76 VA. L. REV. 627, 628 (1990) ( examining the origins and questioning the reasoning behind the commercial / non-commercial speech distinction).

[94] For discussion of the commercial / noncommercial distinction see Geyh, supra note 77, at 1-13 (examining the origins of the commercial / noncommercial speech distinction); Steven Shiffrin, The First Amendment and Economic Regulation: Away From a General Theory of the First Amendment , 78 NW. U. L. REV . 1212, 1216-1220 (1983) (arguing that “the Court’s doctrinal treatment of commercial speech has been inadequate”); Nat Stern, In Defense of the Imprecise Definition of Commercial Speech , 58 MD. L. REV . 55, 87-107 (1999) (contending “that judicial reluctance to embrace a set of all-encompassing criteria for commercial speech represents a healthy pragmatism, not jurisprudential failure”).

[95] Chrestensen , 316 U.S. at 54.

[96] Chrestensen , 316, U.S. at 52-53.

[97] Chrestensen , 316 U.S. at 53.

[98] Chrestensen , 316 U.S. at 53.

[99] Chrestensen , 316 U.S. at 54.

[100] Chrestensen , 316 U.S. at 54.

[101] See Chrestensen , 316 U.S. at 54-55 (The court remarked on the legislative prerogative to disallow “undesirable invasion of, or interference with, the full and free use of the highways by the people....”).

[102] See e.g. , Breard v. Alexandria , 341 U.S. 622, 641 (1951) (holding that the First Amendment was protection “[o]nly [for] the press or oral advocates of ideas” and not “solicitors of gadgets or brushes”); Murdock v. Pennsylvania , 319 U.S. 105, 110-11 (1943) (quoting Chrestensen for the proposition that states may prohibit distribution of “purely commercial leaflets”).

[103] 333 F. Supp. 582 (D.D.C. 1971), aff’d without opinion sub nom . Capital Broadcasting Co. v. Acting Attorney General Kleindienstat , 405 U.S. 1000 (1972).

[104] See Capital Broadcasting Co. , 333 F.Supp. at 584 (“Congress has the power to prohibit the advertising of cigarettes in any media.”).

[105] See Capital Broadcasting Co. , 333 F. Supp. at 593 (Skelley Wright, J., dissenting) (“At the very core of the First Amendment is the notion that people are capable of making up their own minds about what is good for them and that they can think their own thoughts so long as they do not in some manner interfere with the rights of others.”).

[106] See Breard , 341 U.S. at 642 (noting that “the fact that periodicals are sold does not put them beyond the protection of the First Amendment”); for an overview of the evolution of the commercial speech doctrine since Chrestensen , see generally Kozinski & Banner, supra note 75.

[107] Cammarano v. United States , 358 U.S. 498, 514 (1959). (Douglas, J., concurring).

[108] 413 U.S. at 387-388.

[109] Pittsburgh Press Co. , 413 U.S. at 377-378.

[110] Pittsburgh Press Co. , 413 U.S. at 389.

[111] Pittsburgh Press Co. , 413 U.S. at 388.

[112] Pittsburgh Press Co., 413 U.S. at 388 (analogizing the sex-designated ads to ads captioned “narcotics for sale” or “prostitutes wanted” and arguing that all could be restricted because of the illegality of the activity).

[113] Pittsburgh Press Co. , 413 U.S. at 398 (Douglas J., dissenting); Id. at 401 & n.6 (Stewart J., dissenting); Id. at 404 (Blackmun J., dissenting).

[114] Id.

[115] 418 U.S. 298, 314-15 (1974). (Brennan, J., dissenting, joined by Stewart, Marshall & Powell, JJ.).

[116] 421 U.S. 809, 821-22 (1975).

[117] Bigelow , 421 U.S. at 826.

[118] Bigelow , 421 U.S. at 820.

[119] Bigelow¸ 421 U.S. at 819-20.

[120] Chrestensen , 316 U.S. at 54.

[121] 410 U.S. 113 (1973).

[122] Bigelow , 421 U.S. at 822-824 (distinguishing Chrestensen ).

[123] 425 U.S. 748 at 760. (The court observed that “[s]ome fragment of hope for the continuing validity of a “commercial speech” exception arguably might have persisted because of the subject matter of the advertisement in Bigelow .”).

[124] 425 U.S. at 770.

[125] Virginia St. Bd. of Pharmacy , 425 U.S. at 770.

[126] Virginia St. Bd. of Pharmacy , 425 U.S. at 761.

[127] Virginia St. Bd. of Pharmacy , 425 U.S. at 762 (“Our question is whether speech which ‘does no more than propose a commercial transaction,’ is so removed from the ‘exposition of ideas,’ ... that it lacks all protection. Our answer is that it is not.”).

[128] Virginia St. Bd. of Pharmacy , 425 U.S. at 765 (“[T]he particular consumer's interest in the free flow of commercial information, ... may be as keen, if not keener by far, than his interest in the day's most urgent political debate.”).

[129] Virginia St. Bd. of Pharmacy , 425 U.S. at 773.

[130] Virginia St. Bd. of Pharmacy , 425 U.S. at 769 (“for on close inspection it is seen that the State's protectiveness of its citizens rests in large measure on the advantages of their being kept in ignorance.”).

[131] Virginia St. Bd. of Pharmacy , 425 U.S. at 770.

[132] Stern, supra note 94, at 60 (“[t]he Court tied the accessibility of commercial information to the issue of public decisionmaking, often thought to lie at the heart of the First Amendment, by arguing that the free flow of commercial information helps citizens to make informed decisions”).

[133] Virginia St. Bd. of Pharmacy , 425 U.S. at 765 (“So long as we preserve a predominately free enterprise economy, the allocation of our resources ... will be made through numerous private economic decisions. It is a matter of public interest that those decisions ... be intelligent and well-informed.”).

[134] Martin H. Redish, Tobacco Advertising and the First Amendment , 81 IOWA L. REV . 589, 613 (1996) (explaining that “[s]ubsequent decisions have adhered to the anti-paternalism model originally adopted in Virginia Board ...).

[135] Virginia State Bd. of Pharmacy , 425 U.S. at 768.

[136] Virginia State Bd. of Pharmacy , 425 U.S. at 766, 771-72.

[137] Virginia State Bd. Of Pharmacy , 425 U.S. at 771 n.24 (“a different degree of protection is necessary to insure that the flow of true and legitimate commercial information is unimpaired”).

[138] Virginia State Bd. Of Pharmacy , 425 U.S. at 771 n.24 (“[O]rdinarily the advertiser seeks to disseminate information about a specific product or service that he himself provides and presumably knows more about than anyone else.”).

[139] Virginia State Bd. Of Pharmacy , 425 U.S. at 771 n.24 (“Since advertising is the sine qua non of commercial profits, there is little likelihood of its being chilled by proper regulation....”).

[140] Some commentators have argued that the “commonsense differences” distinction is meritless. See e.g. , Kozinski & Banner, supra note 93, at 634-38; Farber, supra note 80, at 385-86; Martin H. Redish, The Value of Free Speech , 130 U. PA. L. REV. 591, 633 (1982).

[141] Virginia St. Bd. of Pharmacy , 425 U.S. at 771.

[142] Virginia St. Bd. of Pharmacy , 425 U.S. at 771-72 (“Untruthful speech, commercial or otherwise, has never been protected for its own sake ... [T]he greater objectivity and hardiness of commercial speech, may make it less necessary to tolerate inaccurate statements for fear of silencing the speaker.”).

[143] 431 U.S. 85 (1977).

[144] Linmark Associates, Inc ., 431 U.S. at 86-87, 96.

[145] Linmark Associates, Inc ., 431 U.S. at 86, 95.

[146] Linmark Associates, Inc. , 431 U.S. at 96.

[147] Linmark Associates, Inc. , 431 U.S. at 96-97.

[148] Whitney v. California , 274 U.S. 357, 377 (1927) (Brandeis, J., concurring).

[149] Whitney , 274 U.S. at 377, cited in 431 U.S. at 97.

[150] Linmark Associates, Inc. , 431 U.S. at 97-98.

[151] 433 U.S. 350 (1977).

[152] See also In re R.M.J. , 455 U.S. 191 (1982) (invalidating various restrictions on lawyer advertising); Shapero v. Kentucky Bar Association , 486 U.S. 466 (1988) (invalidating restrictions on targeted, direct-mail advertising); But see , Florida Bar v. Went for It, Inc. , 515 U.S. 618 (1995) (upholding ban on targeted, direct-mail advertising within 30 days of an accident).

[153] See generally Fred S. McChesney, Commercial Speech in the Professions: The Supreme Court’s Unanswered Questions and Questionable Answers , 134 U. PA. L. REV . 45 (1985).

[154] Bates , 433 U.S. at 384.

[155] Bates , 422 U.S. at 368-377 (suggesting that attorney advertising would threaten lawyers’ professionalism and focus on client service, be inherently misleading to the public, and harm the administration of justice).

[156] Bates , 422 U.S. at 372-373.

[157] Bates , 422 U.S. at 375.

[158] Bates , 422 U.S. at 374-75.

[159] Bates , 422 U.S. at 375.

[160] See e.g. , Carey v. Population Services International (1977) (striking down a ban on the advertising and display of contraceptives).

[161] 436 U.S. 447 (1978).

[162] Ohralik , 436 U.S. at 467. The Court noted that Ohralik solicited one young accident victim while she was “in a hospital room in traction” and used information he had gained from her to induce the other victim to agree to representation. Id .

[163] 440 U.S. 1 (1979).

[164] Friedman , 440 U.S. 1 at 12-14 (“A trade name frees an optometrist from dependence on his personal reputation ... [it] even allows him to assume a new trade name if negligence or misconduct casts a shadow over the old one.”).

[165] But see , Jonathan Weinberg, Note, Constitutional Protection of Commercial Speech , 82 COLUM. L. REV. 720, 727-28 (1982) (Arguing that the cases “signaled a retreat from [the Court’s] protection of commercial speech”).

[166] See Ohralik , 436 U.S at 456, (the Court is comfortable “allowing modes of regulation of commercial speech that might be impermissible in the realm of noncommercial expression”); Friedman , 440 U.S. at 10 n. 9 (quoting the same language from Ohralik with approval).

[167] See Bates, 422 U.S. at 372-73.

[168] See e.g. , Benjamin Hoorn Barton, Why Do We Regulate Lawyers?: An Economic Analysis of the Justifications for Entry and Conduct Regulation , 33 ARIZ. ST. L.J. 429, 483 (2001).

[169] See Deborah L. Rhode, Solicitation , 36 J. LEGAL EDUC. 317 , 326 (1986) (discussing the ways anti-solicitation rules protect lawyers’ own self-interest).

[170] Certainly the length of commercial speech cases tended to increase over the years. For a quick comparison, Valentine v. Chrestensen (1942) was 2 pages, Bigelow v. Virginia (1975) was 19 pages, Virginia State Bd. of Pharmacy (1976) was 23 pages and Bates v. State Bar of Arizona (1977) was 25 pages.

[171] 447 U.S. at 557.

[172] Central Hudson , 447 U.S. at 563-64.

[173] See e.g. , Western States, 535 U.S. at 367-68 (“Although several members of the Court have expressed doubts about the Central Hudson analysis ... there is ‘no need to break new ground. Central Hudson , as applied in our more recent commercial speech cases, provides an adequate basis for decision.’”) (quoting Greater New Orleans Broadcasting Assn., Inc. v. United States, 527 U.S. 173, 184 (1999)); Lorillard Tobacco Co. v. Reilly , 533 U.S. 525, 554-555 (2001) (Discussing the same issue and quoting the same language from Greater New Orleans ).

[174] Central Hudson , 447 U.S. at 560.

[175] Central Hudson , 447 U.S. at 568-69.

[176] Central Hudson , 447 U.S. at 566.

[177] See Friedman , 440 U.S. at 13, 15-16; Ohralik , 436 U.S. at 464-65.

[178] See Pittsburgh Press Co. , 413 U.S. at 388.

[179] Central Hudson , 447 U.S. at 571.

[180] Central Hudson , 447 U.S. at 566-67 (The Court also discounted the argument that the monopoly status of the appellant altered the analysis.); accord , Consolidated Edison Co. of New York, Inc. v. Public Service Commission , 447 U.S. 530, 533 (1980).

[181] Central Hudson , 447 U.S. at 569 (the Court did not require empirical proof of the asserted link between advertising and increased consumption).

[182] Central Hudson , 447 U.S. at 569-70.

[183] Central Hudson , 447 U.S. at 570.

[184] Central Hudson , 447 at 562. When appealing to “commonsense distinctions” the Court appears to mean the greater verifiability and durability of commercial speech as first discussed in Virginia St. Bd. of Pharmacy , 425 U.S. at 771 n. 24. However, this is somewhat ambiguous because the Central Hudson court cites to Ohralik and Bates for discussion of “commonsense distinctions” instead of citing directly to Virginia St. Bd. of Pharmacy . Central Hudson , 447 U.S. at 562; see supra text accompanying note 137 for discussion of the greater verifiability and durability of commercial speech.

[185] The reasoning behind the commonsense differences is not explored in the Court’s more recent opinions, which usually take Central Hudson as a starting point. See e.g. ,Western States , 535 U.S. at 367-68. The only limited exploration of the reasoning has been in dissents. See e.g. ,Posadas de Puerto Rico Assocs .v. Tourism Co. of Puerto Rico , 478 U.S. 328, 350 (1986) (Brennan, J., dissenting).

[186] See Kozinski & Banner, supra note 93, at 634 (“These two differences pop up in most of the commercial speech cases in the few years after Virginia State Board of Pharmacy . They drop out of the more recent cases, which no longer need to resort to theory because they can draw upon the case law instead.”).

[187] Central Hudson , 447 U.S. at 562.

[188] Central Hudson , 447 U.S. at 562 (“‘[P]eople will perceive their own best interests if only they are well enough informed, and . . . the best means to that end is to open the channels of communication rather than to close them. . . .’”) (quoting Virginia State Bd. of Pharmacy , 425 U.S. at 761-62).

[189] Central Hudson , 447 U.S. at 564.

[190] Central Hudson , 447 U.S. at 570-71.

[191] Posadas de Puerto Rico Assocs. , 478 U.S. at 328.

[192] Posadas de Puerto Rico Assocs ., 478 U.S. at 334.

[193] Posadas de Puerto Rico Assocs ., 478 U.S. at 331.

[194] Virginia State Bd. of Pharmacy , 478 U.S. at 781-90 (Rehnquist, J., dissenting).

[195] Central Hudson , 447 U.S. at 584-606 (Rehnquist, J., dissenting).

[196] Posadas de Puerto Rico Assocs ., 478 U.S. at 340.

[197] Posadas de Puerto Rico Assocs ., 478 U.S. at 340-41.

[198] Posadas de Puerto Rico Assocs ., 478 U.S. at 341.

[199] Posadas de Puerto Rico Assocs ., 478 U.S. at 341-42.

[200] Posadas de Puerto Rico Assocs ., 478 U.S. at 342.

[201] Posadas de Puerto Rico Assocs ., 478 U.S. at 342.

[202] Posadas de Puerto Rico Assocs ., 478 U.S. at 343-44.

[203] Posadas de Puerto Rico Assocs ., 478 U.S. at 344.

[204] Posadas de Puerto Rico Assocs ., 478 U.S. at 344. The Court cited Capital Broadcasting , 333 F.Supp at 585 (discussing congressional evidence that the cigarette Labeling Act of 1965 was ineffective) and Dunagin v. City of Oxford, Miss. , 718 F.2d 738, 751 (CA5 1983) (discussing the concern that advertising would promote additional alcohol consumption even though people were well aware of the dangers of alcohol). Id .

[205] Posadas de Puerto Rico Assocs ., 478 U.S. at 346-47. A few years later the Court specifically rejected the “greater includes the less” argument in the commercial speech context in Rubin v. Coors Brewing Company , 514 U.S. 476, 482 n.2 (1995).

[206] Posadas de Puerto Rico Assocs ., 478 U.S. at 345 (citing Carey , 431 U.S. at 700-02 (contraceptives as commercial speech); Bigelow , 421 U.S. at 818-20 (abortion as commercial speech).).

[207] Posadas de Puerto Rico Assocs ., 478 U.S. at 346.

[208] See Posadas de Puerto Rico Assocs ., 478 U.S. at 344 (describing the last two steps of the test as “involving[ing] a consideration of the ‘fit’ between the legislature’s ends and the means choosen to accomplish those ends”).

[209] Posadas de Puerto Rico Assocs ., 478 U.S. at 354 (Brennan, J., dissenting, joined by Marshall & Blackmun, JJ.).

[210] See infra discussion at note 246.

[211] For example, the Restatement (Second) of Torts calls drugs “unavoidably unsafe products”. As the comments explain “There are some products which ... are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs ... Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous ... for this very reason [many drugs] cannot legally be sold except to physicians, or under the prescription of a physician.” Restatement (Second) of Torts § 402A cmt. k (1965); In addition, it is estimated that 125,000 Americans die each year from ingesting prescription medicines. Bryan Christopher Moody, Prescription Medication and Consumer Protection: A Time for Reform , 5 J. PHARMACY & L. 19, 19 (1995).

[212] Posadas de Puerto Rico Assocs ., 478 U.S. at 350-53 (Brennan, J., dissenting, joined by Marshall & Blackmun, JJ.).

[213] Posadas de Puerto Rico Assocs ., 478 U.S. at 350 (Brennan, J., dissenting, joined by Marshall & Blackmun, JJ.).

[214] The Justices joining the majority in Posadas were Rehnquist, Burger, White, Powell and O’Connor. The dissenters were Brennan, Stevens, Marshall and Blackmun. Only Rehnquist, O’Connor and Stevens remain on the Court today.

[215] 492 U.S. 469 (1989).

[216] In Fox, students at the State University of New York held a dorm-room “Tupperware party” in violation of a university ordinance forbidding commercial enterprises on campus. Fox , 492 U.S. at 471-72. The university asserted a substantial interest in promoting an educational rather than commercial atmosphere on campus. Id. at 475. The students claimed the ordinance violated their right to free speech and that the “Tupperware party” involved both commercial speech and “pure speech” about fiscal responsibility. Id. at 474. The Court determined that the case only involved commercial speech and proceeded under Central Hudson . Id. at 474-75.

[217] Fox , 492 U.S. at 479 (the Court noted that most of the restrictions it had invalidated using the test were “substantially excessive”).

[218] Fox , 492, U.S. at 479-80.

[219] Fox , 492 U.S. at 480.

[220] Fox , 492 U.S. at 480.

[221] In addition to the cases discussed in this paragraph, see Shapero , 486 U.S. at 466 and In re R.M.J ., 455 U.S. at 191. Also compare Went For It , 515 U.S. at 618, a 1995 case that was an exception to the line of free market professional advertising cases. All three are discussed infra in Note 152.

[222] 496 U.S. 91 (1990).

[223] Peel , 496 U.S. at 110.

[224] Peel , 496 U.S. at 105.

[225] 512 U.S. 136 (1994).

[226] Ibanez , 512 U.S. at 138-39.

[227] Ibanez , 512 U.S. at 137.

[228] 507 U.S. 761 (1993).

[229] Edenfield , 507 U.S. at 763.

[230] Edenfield , 507 U.S. at 766.

[231] Edenfield , 507 U.S. at 770-71 (“[The third prong of Central Hudson ] is not satisfied by mere speculation or conjecture ... [the government must demonstrate] that the harms it recites are real and that its restriction will in fact alleviate them to a material degree.”).

[232] Edenfield , 507 U.S. at 767-771.

[233] 514 U.S. 476 (1995).

[234] Rubin , 514 U.S. at 491.

[235] Rubin , 514 U.S. at 478-79.

[236] Rubin , 514 U.S. at 482, n.2.

[237] Rubin , 514 U.S. at 487-88.

[238] Rubin , 514 U.S. at 487-88 (noting the “overall irrationality of the Government's regulatory scheme”).

[239] Rubin , 514 U.S. at 490.

[240] Rubin , 514 U.S. at 490-91.

[241] For a discussion of the Fox approach to the fourth prong, see supra notes 216-221 and accompanying text.

[242] 517 U.S. 484 (1996). For another recent case continuing in the same vein, see Lorillard Tobacco Co , 533 U.S. at 525 (invalidating restrictions on truthful tobacco advertising).

[243] 44 Liquormart , 517 U.S. at 489.

[244] Justice Stevens wrote a eight-part principle, plurality opinion. 44 Liquormart , 517 U.S. at 488-517. Justices Ginsberg, Kennedy, Scalia, Souter and Thomas joined in parts one, two, and seven. The same justices, with the exception of Thomas, joined in part eight. Justices Ginsberg, Kennedy and Souter joined in parts three and five while Justices Ginsberg, Kennedy and Thomas joined in part six. Only Justices Ginsberg and Kennedy joined in part four. Additionally, there were multiple concurrences. Justice Scalia wrote an opinion concurring in part and concurring in the judgment. See id. at 517-18 (Scalia, J., concurring). Justice Thomas wrote an opinion concurring in part and concurring in the judgment. See id. at 518-528 (Thomas, J., concurring). Justice O’Connor, joined by Chief Justice Rehnquist, Justice Souter and Justice Breyer, wrote an opinion concurring in the judgment.See id. at 528-34 (O’Connor, J., concurring).

[245] 44 Liquormart , 517 U.S. at 508-14 (This discussion was in part six of the plurality opinion, a part only joined by four justices – Stevens, Kennedy, Thomas and Ginsberg.); see also Arlen W. Langvardt & Eric L. Richards, The Death of Posadas and the Birth of Change in Commercial Speech Doctrine: Implications of 44 Liquormart , 34 AM. BUS. L.J. 483, 553 (1997) (arguing that this part of 44 Liquormart represents a blurring of the commercial / noncommercial distinction that may result in the doctrines merging in the future).

[246] 44 Liquormart , 517 U.S. at 508-14.

[247] 44 Liquormart , 517 U.S. at 505. (Part five of the plurality opinion was joined by five justices.).

[248] 44 Liquormart , 517 U.S. at 505-506 (“[T]he State has presented no evidence to suggest that its speech prohibition will significantly reduce marketwide consumption.”).

[249] 44 Liquormart , 517 U.S. at 507. (In part five of the plurality opinion, joined by five justices).

[250] 44 Liquormart , 517 U.S. at 507 –08 (The Court proposed higher liquor prices or educational campaigns as less speech restrictive alternatives.).

[251] This is especially noticeable in parts three, four and five of the plurality opinion. Though none of those parts commanded a majority. See 44 Liquormart , 517 U.S at 495-508. See also Justice Thomas’s concurring opinion, 44 Liquormart , 517 U.S at 520 (J., Thomas, concurring). (“In case after case following Virginia Bd. of Pharmacy , the Court, and individual Members of the Court, have continued to stress the importance of free dissemination of information about commercial choices in a market economy; the antipaternalistic premises of the First Amendment; the impropriety of manipulating consumer choices or public opinion through the suppression of accurate ‘commercial’ information.”).

[252] 44 Liquormart , 517 U.S. at 503.

[253] See e.g. ,Riley v. National Federation of the Blind of North Carolina , 487 U.S. 781, 796-97 (1988) (“[T]he First Amendment guarantees ‘freedom of speech,’ a term necessarily comprising the decision of both what to say and what not to say.”).

[254] See e.g. ,West Virginia State Board of Education v. Barnette , 319 U.S. 624 (1943) (requiring children to say the Pledge of Allegiance in school is an unconstitutional interference with freedom of thought and belief); Talley v. California , 362 U.S. 60 (1960) (requiring a pamphleteer to publish his name and address violates the First Amendment by discouraging the pamphleteer from his underlying right to publish his work). There are two distinct theories for protecting compelled, non-commercial speech. The first holds that compelled speech is unconstitutional because it interferes with a person’s “freedom of belief”. The second holds that compelled speech is unconstitutional because it deters the speaker from undertaking other protected activities. Kathryn Murphy, Note, Can the Budweiser Frogs Be Forced to Sing a New Tune?: Compelled Commercial Counter-Speech and the First Amendment , 84 VA. L. REV. 1195, 1204-05 (1998).

[255] See Edward J. Schoen, et. al., United Foods and Wileman Bros.: Protection Against Compelled Commercial Speech – Now You See It, Now You Don’t , 39 AM. BUS. L.J . 467, 519 (2002) (characterizing the Court’s approach to compelled commercial speech as “problematic” and limited to “difficult-to-understand” circumstances).

[256] Riley , 487 U.S. at 796 n.9 (1988).

[257] 471 U.S. 626 (1985).

[258] Zauderer , 471 U.S. at 651.

[259] Zauderer , 471 U.S. at 651.

[260] See generally , Jean Lyons & Martha Rumore, Food Labeling--Then and Now , 2 J. PHARMACY & L . 171 (1994) (tracing the extensive history of federal compelled food-labeling statutes).

[261] But see International Dairy Foods Ass'n v. Amestoy , 92 F.3d 67 (2d. Cir. 1996), where the Second Circuit ruled that a state statute that required milk producers to disclose the use of bovine growth hormone on their milk labels violated the Central Hudson test. Id. at 69.

[262] 521 U.S. 457 (1997).

[263] Glickman , 521 U.S. at 460, 477.

[264] Glickman , 521 U.S. at 460.

[265] Glickman , 521 U.S. at 470 (“The fact that an economic regulation may indirectly lead to a reduction in a handler's individual advertising budget does not itself amount to a restriction on speech.”).

[266] Glickman , 521 U.S. at 474.

[267] Glickman , 521 U.S. at 476-77.

[268] 533 U.S. 405 (2001).

[269] United Foods , 533 U.S. at 408-415.

[270] United Foods , 533 U.S. at 412 (“The opinion ... proceeded upon the premise that the producers were bound together and required by the statute to market their products according to cooperative rules.”).

[271] United Foods , 533 U.S. at 411-13.

[272] See e.g., Keller v. State Bar of Cal ., 496 U.S. 1 (1990) (objecting members of state-mandated bar association were not required to give speech subsidies for matters not related to the larger regulatory purpose which justified the required association).

[273] United Foods , 533 U.S. at 411-13.

[274] See generally Thomas I. Emerson, The Doctrine of Prior Restraint , 20 LAW. & CONTEMP. PROBS. 648 (1955), for a classic history of the prior restraint doctrine.

[275] See e.g. ,Organization for a Better Austin v. Keefe, 402 U.S. 415, 419 (1971) (“[a]ny prior restraint on expression comes to . . . [the] Court with a ‘heavy presumption’ against its constitutional validity.”).

[276] Southeastern Promotions Ltd. v. Conrad , 420 U.S. 546, 559 (citing Bantam Books v. Sullivan , 372 U.S. 58, 71 (1963)).

[277] Central Hudson , 447 U.S. at 571 n. 13 (“We have observed that commercial speech is such a sturdy brand of expression that traditional prior restraint doctrine may not apply to it.”); see also Virginia State Bd. of Pharmacy , 425 U.S. at 771-72, n. 24.

[278] Zauderer , 417 U.S. at 668 n.13 (Brennan J., joined by Marshall J., concurring in part, concurring in the judgment in part, and dissenting in part).

[279] 136 F.3d 123 (2nd Cir. 1998).

[280] 136 F.3d at 131-32.

[281] 144 F.3d 220 (2nd Cir. 1998) (holding that prior restraint analysis applies to commercial speech but that a general health claim regulation was sufficiently well-defined to survive prior restraint analysis).

[282] Nutritional Health Alliance , 144 F.3d at 227-228.

[283] Nutritional Health Alliance , 144 F.3d. at 227-228.

[284] See e.g. ,Cox v. New Hampshire , 312 U.S. 569 (1941) (upholding a parade permit law); Times Film Corp. v. Chicago , 365 U.S. 43 (1961) (upholding a film prescreening law); Fehlhabner v. North Carolina , 675 F.2d 1365 (4th Cir. 1982) (upholding an obscenity nuisance statute).

[285] Nutritional Health Alliance , 144 F.3d at 228 (“[A] restraint of up to 540 days, in the context of evaluating, pursuant to defined standards, whether commercial health claims are truthful and non-misleading, is constitutionally valid.”).

[286] See infra Part II.

[287] 202 F.3d 331 (D.C. Circ. 2000). [Hereinafter “WFL III”]

[288] The guidance documents restricted manufacturer distribution of peer-reviewed journal articles and reference textbooks (“enduring materials”) and manufacturer sponsorship of CMEs. Subsequently the guidance document on enduring materials was codified as part of the FDAMA. See discussion of the guidance documents supra at note 57.

[289] WFL III , 202 F.3d 331 at 333-34.

[290] See WFL I , 13 F.Supp.2d at 51.

[291] WFL III , 202 F.3d 331 at 336-37.

[292] WFL I , 13 F. Supp.2d at 66 (dismissing the FDA’s argument that the activity was illegal because it made the drug “misbranded” under the FDCA as “tautological”).

[293] WFL I , 13 F. Supp.2d at 66-67. The court quoted Ibanez , 512 U.S. at 146, for the proposition that claiming that speech was “potentially misleading” did not meet the government’s burden. It noted that the in the Final Guidance on CME activities the FDA had remarked that the activities at issue were “clearly potentially misleading” but had never claimed they were “inherently misleading”. Id.

[294] WFL I , 13 F. Supp.2d at 69-70. (noting that “The Supreme Court has consistently held that the government has a substantial interest in protecting the health and safety of its citizens”).

[295] WFL I , 13 F. Supp.2d at 70-71 (finding that, in light of the fact that Congress has “declared that all uses for a drug must be proven safe and effective by the FDA” there was a substantial interest in providing incentives for getting drugs approved).

[296] WFL I , 13 F. Supp.2d at 70. The court quoted from 44 Liquormart , Virginia State Bd. of Pharmacy and Posadas . It summarized that “[i]n light of the fact that the Supreme Court has repeatedly rejected governmental attempts to equate less information with better decision-making ... concerns about a physician's ability to critically evaluate materials presented to him is not a 'substantial interest.’” Id .

[297] WFL I , 13 F. Supp.2d at 70.

[298] WFL I , 13 F. Supp.2d at 72.

[299] WFL I , 13 F. Supp.2d at 72-73. The court said that the restriction need not be the least restrictive means, but that it must still reasonably fit the ends sought. It then reasoned that full disclosure would address the concern that physicians might be misled and that manufacturers that failed to provide full disclosure would be subject to all FDA enforcement options because the materials would be inherently misleading. Id .

[300] WFL I , 13 F. Supp.2d at 73.

[301] Washington Legal Foundation v. Henney , 56 F. Supp. 2d 81, 88-89 (D.D.C. 1999) (“In conclusion, the Court finds that the FDAMA unconstitutionally restricts protected commercial speech.”). [Hereinafter “WFL II”]

[302] WFL III , 202 F.3d at 337.

[303] WFL III , 202 F.3d at 336.

[304] WFL III , 202 F.3d at 336.

[305] WFL III , 202 F.3d at 336 n. 6 (“A manufacturer, of course, may still argue that the FDA's use of a manufacturer's promotion of off-label uses as evidence in a particular enforcement action violates the First Amendment.”).

[306] See e.g. , Richard M. Cooper, The WLF Case Thus Far: Not with a Bang, But a Whimper , 55 FOOD & DRUG L.J . 477, 487 (2000) (declaring in discussion of the intended effect of vacating the lower court’s decision that “[i]n sum, the court of appeals has created a mess...”); James O’Reilly & Amy Dalal, Off-Label or Out of Bounds? Prescriber and Marketer Liability for Unapproved Uses of FDA-Approved Drugs , 12 ANNALS HEALTH L . 295, 311-315 (2003).

[307] 164 F.3d at 650.

[308] Pearson , 165 F.3d at 651. A “health claim’ is a “claim made on the label or in labeling of ... a dietary supplement that ... characterizes the relationship of any substance to a disease or health-related condition.” See 21 C.F.R. § 101.14(a)(1). Dietary supplements are separately defined in the FDCA. See 21 U.S.C. § 321(ff)(1). Although dietary supplements are not subject to the same regulations as drugs, health claims may only be made if the FDA approves the claims prior to marketing. See 21 U.S.C. § 343(r)(5)(D). In Pearson , the appellants wanted to make four such claims: (1) antioxidant vitamins may reduce the risk of certain cancers (2) fiber may reduce the risk of colorectal cancer (3) omega-3 fatty acids may reduce the risk of heart disease and (4) folic acid may reduce neural tube defects. See Pearson , 165 F.3d at 652. The FDA rejected the health claims because they did not fit into the health claims safe-harbor for dietary supplements it had established under the authority of 21 U.S.C. § 343(r)(5)(D). Id. at 653. That safe harbor provides, in part, that “FDA will promulgate regulations authorizing a health claim only when it determines, based on the totality of publicly available scientific evidence ... 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.” See 21 C.F.R. § 101.14(c) .

[309] Pearson , 165 F.3d at 657-58.

[310] Pearson , 165 F.3d at 655.

[311] Pearson , 165 F.3d at 656.

[312] Pearson , 165 F.3d at 656.

[313] Pearson , 165 F.3d at 656 n.6.

[314] Pearson , 165 F.3d at 658.

[315] Pearson , 165 F.3d at 657-69.

[316] Compare Posadas , 478 U.S. at 341-44 (illustrating considerable deference to legislative judgment); See also discussion of Posadas supra at note 192.

[317] Pearson , 165 F.3d at 658.

[318] Compare Fox, 492 U.S. at 479. The Court noted that only when a regulation is “substantially excessive, disregarding far less restrictive and more precise means, will it be set aside.” Id.

[319] Pearson , 165 F.3d at 656 n.6.

[320] 535 U.S. at 357.

[321] Western States , 535 U.S. at 360. Drug compounding is a process where a pharmacist combines ingredients to create a medication tailored to the needs of a particular patient. It is typically used to prepare medications that are not commercially available. Id. The challenged provisions exempted “compounded drugs” from the FDA’s standard drug approval requirements if providers of the compounded drugs abided by several restrictions, including that the prescription be “unsolicited,” 21 U.S.C. § 353a(a), and that the providers “not advertise or promote the compounding of any particular drug, class of drug, or type of drug,” 21 U.S.C. § 353a(c). See Western States , 535 U.S. at 364-65.

[322] Western States , 535 U.S. at 364-65.

[323] Western States , 535 U.S. at 364-377.

[324] Western States , 535 U.S. at 368.

[325] Western States , 535 U.S. at 368.

[326] Western States , 535 U.S. at 368.

[327] Western States , 535 U.S. at 371 (“Assuming it is true that drugs cannot be marketed on a large scale without advertising, the FDAMA's prohibition on advertising compounded drugs might indeed ‘directly advanc[e]’ the Government's interests.”).

[328] Western States , 535 U.S. at 371. The Court discussed Rubin and 44 Liquormart as examples of decisions were a restriction was found “more extensive than necessary”. Id .

[329] Western States , 535 U.S. at 372.

[330] Western States , 535 U.S. at 375 (quoting Virginia State Bd. of Pharmacy , 425 U.S. at 769).

[331] Western States , 535 U.S. at 378 (Breyer, J. dissenting, joined by Rehnquist, Stevens, & Ginsberg, JJ.).

[332] Western States , 535 U.S. at 379 (Breyer, J. dissenting).

[333] Western States , 535 U.S. at 383-84 (Breyer, J. dissenting) (“There is considerable evidence that consumer oriented advertising will create strong consumer-driven demand for a particular drug ... [a]nd there is strong evidence that doctors will often respond affirmatively to a patient's request for a specific drug that the patient has seen advertised.”).

[334] Western States , 535 U.S. at 382.

[335] Western States , 535 U.S. at 380. The dissent argued, “compounded drugs carry with them special risks” because they are not subject to the drug approval process. Id .

[336] Western States , 535 U.S. at 380.

[337] See e.g. , 44 Liquormart , 517 U.S. at 501 (“[C]omplete speech bans, unlike content-neutral restrictions on the time, place, or manner of expression ... are particularly dangerous because they all but foreclose alternative means of disseminating certain information.”).

[338] Western States , 535 U.S. at 369.

[339] Western States , 535 U.S. at 370.

[340] Western States , 535 U.S. at 377.

[341] See discussion of cases about the professions supra at notes 151-166, 221-232.

[342] See discussion of the alcohol advertisement cases, Rubin and 44 Liquormart supra at notes 232-252.

[343] See discussion of these cases supra in Section V.

[344] There is a slight possibility that the Central Hudson test would not apply to certain types of prescription drug promotion, but Western States , 535 U.S. at 368, strongly indicates that this would not be the case since the Court applied the Central Hudson test in that case and the FDA did not even bother to object to the application.

[345] See supra at note 171, discussing the Central Hudson test.

[346] See 21 U.S.C. § 352.

[347] See Rubin , 514 U.S. at 482-83; discussionsupra at note 233.

[348] See WLF I , 13 F.Supp.2d. at 66.

[349] See WFL I , 13 F.Supp.2d at 66-67.

[350] See Polubinski, supra note 53, at 1026.

[351] See e.g. Teresa Moran Schwartz, Esq., Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule , 46 FOOD DRUG COSM. L.J. 829, 836 (1991) (explaining how the manufacturers of Rogaine marketed to fears of male-pattern-baldness).

[352] See e.g. Pearson , 164 F.3d at 655-56; WLF I , 13 F.Supp.2d at 69; Western States , 535 U.S. at 368.

[353] See Western States , 535 U.S. at 358-59.

[354] See Pearson , 164 F.3d at 655-56.

[355] See discussion of Posadas supra at note 191.

[356] See discussion of Western States supra at note 320.

[357] See e.g. David C. Vladeck, Truth and Consequences: The Perils of Half-Truths and Unsubstantiated Health Claims for Dietary Supplements , J. PUB. POL’Y & MKT ., June 30, 2000 at 132 (“Indeed, no one realistically expects consumers to wade through volumes of preliminary and often conflicting and inconclusive scientific literature involving clinical trials, laboratory animal experiments, and epidemiological studies to assess whether a particular health claim is well founded. That task often confounds experts. Even the most well-informed, health-conscious consumer could easily fall prey to preliminary scientific findings disseminated as part of a sales pitch.”).

[358] See discussion of Western States supra at note 320.

[359] See discussion of Rubin and 44 Liquormart supra at notes 233-252.

[360] See e.g. Lorillard Tobacco Co. , 533 U.S. at 555 (“We do not ... require that ‘empirical data come ... accompanied by a surfeit of background information .... [W]e have permitted litigants to justify speech restrictions by reference to studies and anecdotes pertaining to different locales altogether, or even, in a case applying strict scrutiny, to justify restrictions based solely on history, consensus, and simple common sense.’”) (quoting Went For It , 515 U.S. at 628).

[361] See discussion of Edenfield supra at note 229.

[362] Edenfield , 507 U.S. at 770-71

[363] Western States , 535 U.S. at 383-84 (Breyer, J. dissenting).

[364] See e.g. Joel S. Weissman, et. al., Consumers’ Reports On The Health Effects of Direct-To-Consumer Drug Advertising , HEALTHAFFAIR , February 26, 2004 at 82-95;

John E. Calfee, Public Policy Issues in Direct-to-Consumer Advertising of Prescription Drugs , 21 J. PUB. POL’Y & MKT. 174, 174-93 (2002).

[365] See e.g. Michael S. Wilkes et. al., Direct-to-Consumer Prescription Drug Advertising: Trends, Impact, and Implications , HEALTHAFFAIR, Mar.-Apr. 2000 at 110–128; Phillip R. Alper, Direct-to-Consumer Advertising: Education or Anathema? , J. AM. MED. ASS’N, 282, no. 13, (1999) at 1226–1228; Sidney M. Wolfe, Direct-to-Consumer Advertising—Education or Emotion Promotion? , NEW ENG. J. MED. 346, no. 7 (2002) at 524–526; Mark F. Hollon, Direct-to-Consumer Marketing of Prescription Drugs: Creating Consumer Demand , J. AM. MED. ASS’N 281, no. 4 (1999) at 382–384.

[366] See discussion supra at notes 345-357.

[367] See discussion of current FDA prescription drug promotion regulations supra at Section II.

[368] See e.g. 44 Liquormart , 517 U.S. at 507 (“[A]lternative forms of regulation that would not involve any restriction on speech would be more likely to achieve the State’s goal....”). Western States , 535 U.S. at 372 (“Several non-speech-related means of drawing a line between compounding and large-scale manufacturing might be possible....”).

[369] See discussion of compelled speech, supra at notes 253-272.

[370] See, e.g., In re R.M.J ., 455 U.S. at 201 (“[A] warning or disclaimer might be appropriately required ... to dissipate the possibility of consumer confusion or deception.”).

[371] See discussion of Pearson , supra at notes 307-319.

[372] See Vladeck, supra note 357.

[373] See Jon D. Hanson & Douglas A. Kysar, Taking Behavioralism Seriously: Some Evidence of Market Manipulation , 112 HARV. L. REV . 1420, 1455 (1999).

[374] See Lars Noah, The Imperative To Warn: Disentangling the “Right to Know” From the “Need To Know” About Consumer Product Hazards , 11 YALE J. ON REG . 293, 381-390 (1994).

[375] See Emilé L. Loza, FDA Regulation of Internet Pharmaceutical Communications: Strategies for Improvement , 55 Food & Drug L.J. 269, 270-73 (2000).

[376] See Shane M. Ward, WLF And The Two-Click Rule: The First Amendment Inequity of the Food & Drug Administration’s Regulation of Off-Label Drug Use Information on the Internet , 56 FOOD & DRUG L.J. 41, 52-55 (2001).

[377] See Loza, supra note 375, at 273.

[378] See supra note 12.

[379] See e.g. Western States , 535 U.S. at 372-380.