“From Weak Enforcement to Muscular Regulation”: Pharmaceutical Direct-to-Consumer Advertising and the Next Chapter in Commercial Speech Doctrine

Pharmaceutical companies spend billions of dollars annually on direct-to-consumer advertising (DTCA) to boost sales. Thus, they are understandably threatened by the September 9, 2025 Presidential Memorandum that directed the Health and Human Services (HHS) and the Food and Drug Administration (FDA) to ensure greater transparency and accuracy in prescription drug DTCA and enhance enforcement [1]. Simultaneously, the FDA announced a “crackdown on deceptive drug advertising,” claiming it would initiate rules to close what it terms “loopholes” and aggressively step up enforcement [2]. The FDA argues that a 1997 rule relaxing earlier requirements for DTCA to provide a summary of all a drug’s risks in any promotional material has been exploited by pharmaceutical companies [3]. The Central Hudson standard is the Supreme Court’s test for determining whether government regulation of commercial speech does not violate the First Amendment. Although restrictions on DTCA are not unconstitutional, they implicate the First Amendment’s protection of commercial speech. Hence, administrative reform must withstand constitutional scrutiny by meeting the Central Hudson standard. Further, enforcement must avoid arbitrary or discriminatory treatment under the Fourteenth Amendment.

There have been several attempts to regulate DTCA in the past. The 1962 Amendments to the Federal Food, Drug, and Cosmetic Act transferred regulation of prescription drug advertising from the Federal Trade Commission to the FDA and required DTCA to include truthful and accurate information about side effects [4]. Specifically, these amendments instituted a “brief summary” requirement, which required drug companies to provide a summary of all its risks in any promotional material, which was impractical for the limited time of a television commercial. The pharmaceutical industry has a long history of insufficiently informing consumers of risks of drugs, often by highlighting benefits and downplaying adverse effects [5]. For example, advertisements often superimpose positive imagery over the description of risks [6]. The FDA claims its crackdown on DTCA is long overdue to curb such misinformation. The 1997 FDA Modernization Act relaxed these regulations by enabling advertisers to meet this requirement through “adequate provision” by providing a “major statement” of risks and directing consumers to other sources of information [7]. The FDA argues that drug companies have been exploiting the “adequate provision” loophole for decades and that companies cherry-pick which risks to display while still meeting the provision guidelines [8]. Such behavior, it claims, not only misleads customers but also disrupts the patient-doctor relationship and increases the demand for drug prescriptions. Thus, there has been a resurgence of efforts to regulate DTCA, sparking constitutional debates over freedom of speech.

Regulating DTCA is not unconstitutional because it serves a substantial government interest in preserving public health and preventing consumer deception. Two foundational Supreme Court cases established the standards for government regulation of commercial speech. Central Hudson Gas & Electric Corp. v. Public Service Commission (“Central Hudson”) (1980) established a four-part test to determine the constitutionality of a regulation on commercial speech and required a showing of intermediate, not strict, scrutiny. In this case, the Public Service Commission of New York regulated advertising of electric utilities. The Supreme Court ruled that the regulation and ban violated the right to commercial speech [9]. The four-part test has established a standard for scrutiny of government-regulated advertising:

1. Is the speech lawful and not misleading?
2. Does the government have a substantial interest?
3. Does the regulation directly and materially advance this substantial interest?
4. Is the regulation narrowly tailored?

The second case, Zauderer v. Office of Disciplinary Counsel (“Zauderer”) (1985), involved compelled disclosure of information to prevent deception in advertising [10]. The Zauderer Test established that the government could regulate advertising to include uncontroversial and fact-based statements to prevent consumer deception. Central Hudson established a way the government could limit such speech while Zauderer established how the government could compel disclosure of information.

Critics in the pharmaceutical industry contend that the recent administration’s posture targeting DTCA could violate the constitutional protections afforded commercial speech because Central Hudson and Zauderer extended the umbrella of First Amendment and Fourteenth Amendment protections to commercial speech. Indeed, as one commentator has put it: “DTC drug ads cannot be banned … the speech of pharmaceutical marketing itself” is protected [11]. Regulatory observers also caution that “the First Amendment presents extreme hurdles to such efforts,” especially those that seek to eliminate the “adequate provision” rule [12]. Further, Thompson v. Western States Medical Center (2002) invalidated certain advertising prohibitions, striking down the FDA’s attempt to limit speech for not directly advancing governmental interest and being more extensive than necessary to serve that interest [13]. Additionally, Sorrell v. IMS Health (“Sorrell”) (2011) held that certain content and speaker-based restrictions did not withstand intermediate scrutiny and thus unconstitutionally burdened commercial speech of pharmaceutical companies without adequate justification [14].

In response, the government could argue that there are numerous examples of ongoing DTCA disseminating false or deceptive claims, which meet the Central Hudson and Zauderer standards for permitting governmental regulation. The government could satisfy the “substantial interest” prong of Central Hudson by pointing to evidence that FDA regulation can reduce overprescriptions and reduce healthcare costs, while also ensuring more accurate advertisements. Specifically, increased DTCA has led to more prescriptions in both Medicare and non-Medicare populations [15]. and the introduction of DTCA led to increased unit drug prices in Medicaid populations [16]. As the single largest payor of health costs in the nation, the Government could thus satisfy its showing of intermediate scrutiny.

Courts are likely to be skeptical about new FDA regulations that eliminate the “adequate provision” safe harbor by requiring companies to list all drug risks within the advertisement itself. Such moves are likely to be struck down as unduly burdensome compelled disclosures that amount to an indirect ban on free commercial speech. More nuanced regulations such as requiring clearer or conspicuous disclosures, particularly those supported by scientific evidence, are likely to be upheld under the existing standards. It remains to be seen how the efforts of this more muscular executive branch in the DTCA arena will be received by the judiciary.

The pharmaceutical industry might yet find solace in the conservative majority of the Supreme Court, which could chafe at the concept that commercial speech should receive less protection than other kinds of speech. In recent decades, the Supreme Court has expanded free-speech protections for commercial speech; for example, in 44 Liquormart, Inc. v Rhode Island, Inc. v. Rhode Island (1996), Sorrell v. IMS Health Inc. (2011), and Expression Hair Design v. Schneiderman, 581 U.S. 37 (2017). Given the composition of the current Court, the 1980 Central Hudson test could be further chipped away. In a concurring opinion in 44 Liquormart, Justice Thomas wrote that “[the Central Hudson] test makes no sense to me” and that he “would return to the reasoning and holding of Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc. (1976)” [17], a case in which the Court ruled that “the free flow of commercial information is indispensable” and declared invalid the 1942 decision of Valentine v. Chrestensen (1942), which had held that “the Constitution imposes no such restraint on government as it respects purely commercial advertising” [18]. The late Justice Scalia, whose views still cast a long shadow over the current Supreme Court, concurred with Justice Thomas in 44 Liquormart, stating that “the Central Hudson test … seems … to have nothing more than policy intuition to support it” [19]. Justice Alito, an ardent proponent of free speech and critic of government regulation, wrote in Matal v. Tam (2017) that the “idea [that the government has a purported interest in preventing speech expressing ideas that offend] strikes at the heart of the First Amendment [20].

This conflict between pharmaceutical companies and the FDA will lead to interesting legal tussles over bedrock principles of the Constitution. This legal fight will provide the Court a valuable opportunity to further refine and clarify the standards for pharmaceutical advertising in particular and commercial speech in general. Drug companies demand the freedom to advertise their products, seeking to increase market share and profits, and courts will likely challenge such regulations. However, the FDA claims many advertisements mislead consumers and disincentivize lifestyle changes. FDA Director Marty Makary called the crackdown “overdue,” as the FDA’s “weak enforcement” of DTCA in the last three decades has led to a “public health crisis” [21]. The conflict between consumer protection and freedom of speech, manifested in the FDA’s desire to curtail DTCA is a core constitutional debate that will likely endure long after a final ruling.

Footnotes

[1] The White House, “Memorandum for the Secretary of Health and Human Services the Commissioner of Food and Drugs,” September 2025, https://www.whitehouse.gov/presidential-actions/2025/09/memorandum-for-the-secretary-of-health-and-human-services-the-commissioner-of-food-and-drugs.

[2] U.S. Food and Drug Administration, “FDA Launches Crackdown on Deceptive Drug Advertising,” 2025, https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising.

[3] Jeremy A. Greene and Scott H Podolsky, “Reform, Regulation, and Pharmaceuticals—the Kefauver–Harris Amendments at 50,” New England Journal of Medicine 367, no. 16 (2012): 1481-3, https://www.nejm.org/doi/full/10.1056/NEJMp1210007.

[4] Ibid.

[5] Janelle Applequist and Jennifer Gerard Ball, “An Updated Analysis of Direct-to-Consumer Television Advertisements for Prescription Drugs,” Annals of Family Medicine 16, no. 3 (2018): 211-216, https://www.annfammed.org/content/16/3/211.

[6] Natasha Parekh and William H. Shrank, “Dangers and Opportunities of Direct-to-Consumer
Advertising,” Journal of General Internal Medicine 33, no. 5 (2018): 586-7, https://link.springer.com/content/pdf/10.1007/s11606-018-4342-9.pdf.

[7] Ibid.

[8] Martin A. Makary, “The FDA’s Overdue Crackdown on Misleading Pharmaceutical Advertisements,” JAMA 334, no. 19 (2025): 1701-1702, https://doi.org/10.1001/jama.2025.18197.

[9] U.S. Department of Health and Human Services, “Fact Sheet: Ensuring Patient Safety through Reform of Direct-To-Consumer Pharmaceutical Advertisement Policies,” Sep 9, 2025, https://www.hhs.gov/press-room/hhs-fda-drug-ad-transparency-fact-sheet.html.

[10] Central Hudson Gas & Elec. v. Public Svc. Comm'n, 447 U.S. 557 (1980).

[11] Zac Morgan, “There Is No ‘One Weird Trick’ Around the Constitution,” Washington Legal Foundation, August 4, 2025, https://www.wlf.org/2025/08/04/publishing/there-is-no-one-weird-trick-around-the-constitution-an-analysis-of-attempts-to-end-dtc-pharma-marketing.

[12] Kristen R. Klesh, “FDA’s Direct-to-Consumer Advertising ‘Crackdown’: Impacts to Brands, Agencies and Influencers,” Lexology, September 16, 2025, https://www.lexology.com/library/detail.aspx?g=360ccd10-5560-463c-af60-6345f9f142b1.

[13] Thompson v. Western States Medical Center, 535 U.S. 357 (2002).

[14] Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011).

[15] Abby Alpert, Darius Lakdawalla, and Neeraj Sood, “Prescription Drug Advertising and Drug Utilization: The Role of Medicare Part D,” NBER Working Paper 21714 (2015), https://doi.org/10.3386/w21714.

[16] Michael R. Law, et al., “Costs and Consequences of Direct-to-Consumer Advertising for Clopidogrel in Medicaid,” Archives of Internal Medicine 169, no. 21 (2009): 1969-74, https://doi.org/10.1001/archinternmed.2009.320.

[17] 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484 (1996).

[18] Va. Pharmacy Bd. v. Va. Consumer Council, 425 U.S. 748 (1976).

[19] 44 Liquormart, 517 U.S. 484 (1996).

[20] Matal v. Tam, 582 U.S. 218 (2017).

[21] Makary, “The FDA’s Overdue Crackdown.”