Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by executive order on his first day in office, and he pledged to work with Donald Trump to end drug commercials after he left the race and endorsed Trump.
Secretary Kennedy has argued that drug commercials contribute to overutilization of prescription drugs and drive up federal health care costs. This concern is echoed in the May 2025 MAHA Report, which states that “studies suggest that [direct-to-consumer (DTC) ads of prescription drugs] have a strong influence on those who view them, potentially increasing inappropriate prescriptions.”
Secretary Kennedy has expressed support for a bill to remove tax deductions for the costs of drug advertising. There are also legislative proposals to ban drug advertising and to require that DTC drug ads include the drug’s price.
Food and Drug Administration (FDA) Commissioner Marty Makary has reportedly said, “We don’t have any plans to ban direct-to-consumer advertising, but there are some things we can do to make sure that the information being presented … in those ads … is a complete picture.”
Whatever the political imperative for such approaches to DTC drug ads, they may be challenged based on the free speech protections of the First Amendment and even under FDA statutory authority.
FDA’s statutory basis for regulating DTC drug ads
Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA) gives the FDA exclusive jurisdiction over prescription drug ads; yet, that authority is limited.
FDA may require by regulation that advertisements include “information in brief summary relating to side effects, contraindications, and effectiveness.” FDA’s regulation, at 21 C.F.R. 202.1(e)(1), defines the “brief summary” as “a true statement of information in brief summary relating to side effects, contraindications, and effectiveness” with further specifications set out in 21 C.F.R. 202.1(e)(3)-(5). In medical journals and magazines, this requirement translates into a page or two of fine print.
For broadcast ads, the regulation requires instead the “major statement” (that is, “information relating to the major side effects and contraindications”) and “a brief statement of all information related to side effects and contraindications, unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation.” A 1999 FDA guidance allows “adequate provision” through (1) a toll-free number, (2) reference to a print advertisement, (3) an internet link with the drug’s labeling, and (4) disclosure that pharmacists and other health care providers may provide information about the drug.
In 2007, Congress amended section 502(n) to provide that, for television and radio ads, “the major statement relating to side effects and contraindications” must be “presented in a clear, conspicuous, and neutral manner.” The regulation defining “clear, conspicuous and neutral manner” is found in 21 C.F.R. 202.1(e)(1)(ii). In this 2007 amendment to section 502(n), Congress arguably endorsed the FDA’s approach to broadcast advertising, albeit with clarification about how the major statement is to be presented.
FDA may require “prior approval” of drug ads only “in extraordinary circumstances,” but section 503C of the Federal Food, Drug, and Cosmetic Act (FDCA) does permit FDA to require prereview of television drug ads, though FDA may not order changes to an ad except to add specific disclosure about a serious safety risk or, within the first two years of approval, the drug’s date of approval.
Section 502(n) does not give the FDA the authority to ban prescription drug advertisements.
The First Amendment limits on drug ad regulation
Drug ads are commercial speech because they propose a commercial transaction, the purchase of a prescription drug. As such, they are regulated under the test from Central Hudson Gas and Electric v. Public Service Commission, 447 U.S. 557 (1980), which poses four questions: As a threshold matter, does the commercial speech concern unlawful activity or is it misleading? If so, the speech is not protected. If not, is the governmental interest in regulating the speech “substantial”? If the government’s interest is substantial, does the regulation “directly advance” the government’s interest? And, is it “no more extensive than necessary” to serve that interest?
It is challenging to predict the interest the government will assert under Central Hudson to defend a law or regulation affecting DTC drug ads, and so whether that interest is directly advanced by the law or regulation and whether it is no more extensive than necessary. Yet, the Supreme Court in Thompson v. Western States Medical Center, 535 U.S. 357 (2002) and Sorrell v. IMS Health Inc., 564 U.S. 552, 564 (2011), has provided insight into how that test may play out for regulation of drug ads, especially if the government were to assert certain interests.
In Western States, the Supreme Court held that a ban on the advertising or promotion of “the compounding of any particular drug, class of drug, or type of drug” but not of “compounding service[s]” in section 503A of the FDCA violated the First Amendment rights of pharmacies, licensed pharmacists and licensed physicians. In doing so, the court rejected “an interest in prohibiting the sale of compounded drugs to patients who may not clearly need them.” Western States at 373 (quotations omitted):
[If the] speech-related restrictions were motivated by a fear that advertising compounded drugs would put people who do not need such drugs at risk by causing them to convince their doctors to prescribe the drugs anyway, that fear would fail to justify the restrictions. Aside from the fact that this concern rests on the questionable assumption that doctors would prescribe unnecessary medications … , this concern amounts to a fear that people would make bad decisions if given truthful information about compounded drugs …. We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.
Western States at 374 (citations omitted).
Western States also addressed the government’s interest in preventing misleading advertisements: Instead of banning the ads for compounded drugs, “this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown.” Western States at 376 (emphasis added). So, there may be First Amendment limits as to what the government can require in DTC drug ads when that information is readily available elsewhere, such as in the online FDA-approved labeling or the summary patient insert of that labeling provided by pharmacies with dispensed drugs.
Sorrell involved a Vermont law that prohibited, without prescriber consent, health insurers, pharmacies and others from selling prescriber-identifiable information (e.g., which drugs a provider prescribed) and from allowing the use of such information for marketing. The law also prohibited the use of such information for marketing by drug manufacturers and marketers.
The Supreme Court said the law “disfavors marketing, that is, speech with a particular content. More than that, the statute disfavors specific speakers, namely pharmaceutical manufacturers.” Sorrell at 564. Because of this “specific, content-based burden on protected expression, … heightened judicial scrutiny is warranted,” Sorrell at 565, and these “content-based burdens must satisfy the same rigorous scrutiny as its content based bans,” Sorrell at 566. Though incidental burdens on commercial speech may be permitted, a law “directed at certain content and … aimed at particular speakers” directly burdens speech. Sorrell at 567.
One of Vermont’s justifications for the law was that it would “lower[] the costs of medical services and promot[e] public health.” Sorrell at 577. The Supreme Court, while noting these goals “may be proper,” determined that the law did “not advance them in a permissible way,” that is, it used “the indirect means of restraining certain speech by certain speakers.” Sorrell at 577. Although the Vermont law’s premise was that “the force of speech can justify the government’s attempt to stifle it, … [t]his reasoning is incompatible with the First Amendment …. That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.” Sorrell at 577-78.
A DTC TV drug ad ban
A direct ban on DTC drug ads, or even just DTC drug ads on TV, is surely unconstitutional. In Western States, the Supreme Court found a statutory ban on advertising or promotion of a compounded drug unconstitutional. When applying the Central Hudson test in both Western States and Sorrell, the Supreme Court rejected concerns about overprescribing, over-medication and drug spends that are too high—concerns frequently articulated by Secretary Kennedy and others to justify a ban.
Increased disclosures in drug ads
FDA Commissioner Makary has suggested changing required disclosures of drug risks and side effects to make the information “complete.”[i] As noted above, prescription drug ads on TV that state a drug’s indicated use are currently able to direct consumers to “brief summary” information elsewhere. This information—even “complete” information in the form of the drug’s labeling—can readily be found using a laptop or smartphone from one’s couch, and pharmacies dispense drugs with summaries of a drug’s benefits and risks. As such, under Western States, FDA may be challenged to justify changing its current approach to require more disclosure in the body of DTC drug ads, let alone “complete” information. Nor is it clear that section 502(n) of the FDCA would permit such an approach.
Eliminating the DTC tax deduction
A bill eliminating the tax deduction for DTC drug advertisements (and not for other consumer goods) “disfavors marketing, that is, speech with a particular content. More than that, [it] disfavors specific speakers, namely pharmaceutical manufacturers,” Sorrell at 564, and so must pass heightened scrutiny. As with a DTC drug ad ban, then, under a Central Hudson analysis, eliminating the tax deduction for DTC drug ads would likely fail unless the government can identify an interest other than seeking to reduce drug expenditures or usage.
Price disclosure in ads
Legislation to require a drug’s list price in DTC ads also raises First Amendment concerns. In Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985), the Supreme Court held that the government may require “purely factual and uncontroversial information about the terms under which … services [or goods] will be available” … “as long as disclosure requirements are reasonably related to the [government’s] interest in preventing deception of consumers.” Zauderer at 651. Although the list price of a prescription drug is arguably factual information, it is also arguably not “uncontroversial.” Even if the disclosure includes information that some patients will not pay list price for the drug, is requiring this disclosure “reasonably related to an interest in preventing deception of consumers”? As the sponsors of some iterations of this legislation have identified its purpose as “reduc[ing] bloated spending on medications,” it may face constitutional hurdles if enacted.[ii]
Next Steps
We will monitor the next steps on DTC prescription drug advertising and provide additional commentary as developments warrant.
[i] Increased disclosures could make drug TV ads longer or less informative, yet they likely would not eliminate them altogether (and if they were to, they would likely be considered tantamount to a ban). The Wall Street Journal, in a presciently titled article from 1997, FDA Clears the Way for Blitz of Drug Ads on Television (https://www.wsj.com/articles/SB870991429202636000?mod=article_inline), observed that drug ads already appeared on TV with nearly a minute of several screens of small print disclosures, or with no risk information at all by not mentioning the drug’s indicated use (what FDA calls “reminder ads”).
[ii] In 2020, a federal appeals court overturned the 2019 regulation issued by the Centers for Medicare and Medicaid Services (CMS) to require, in television ads for certain prescription drugs, disclosure of the drug’s list price for a typical course of treatment and a statement that, if a patient has health insurance, the cost may be different. Although the regulation was challenged on both statutory and First Amendment grounds, the court addressed only the statutory argument, concluding that CMS lacked the authority to require such disclosures under the Medicare and Medicaid statutes.
