On September 9, 2025, President Trump signed a presidential memorandum that directs HHS to increase “the amount of information regarding any risks” associated with the use of prescription drugs and instructs FDA to “take appropriate action to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions.”Memorandum for the Secretary of Health and Human Services the Commissioner of Food and Drugs re: Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements (Sep. 9, 2025), https://www.whitehouse.gov/presidential-actions/2025/09/memorandum-for-the-secretary-of-health-and-human-services-the-commissioner-of-food-and-drugs/. HHS and FDA announced that same day in simultaneous news releases that FDA would begin a “crackdown on deceptive drug advertising.”FDA News Release, FDA Launches Crackdown on Deceptive Drug Advertising (Sep. 9, 2025), https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising (FDA News Release); HHS Press Office, HHS, FDA to Require Full Safety Disclosures in Drug Ads (Sep. 9, 2025), https://www.hhs.gov/press-room/hhs-fda-drug-ad-transparency.html (HHS News Release). HHS also published a fact sheet accompanying its news release, further detailing the actions FDA will take, which include conducting “rule-making to close the ‘adequate provision’ loophole to ensure risk disclosure” and “stepping up enforcement action of DTC pharmaceutical ads.”HHS, Fact Sheet: Ensuring Patient Safety Through Reform of Direct-to-Consumer Pharmaceutical Advertisement Policies, https://www.hhs.gov/press-room/hhs-fda-drug-ad-transparency-fact-sheet.html (Fact Sheet).
In the September 9 announcements, FDA promised “[a]ggressive enforcement of DTC violations.”Fact Sheet. Thereafter, FDA sent a letter to every sponsor of an approved drug or biologic directing them to “remove any noncompliant advertising from the market and bring all promotional communications into compliance.”See FDA, Ltr. to “Pharmaceutical Company,” Sep. 9, 2025, available at https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising (emphasis removed). Additionally, FDA issued approximately 100 “cease-and-desist” letters to companies regarding allegedly “deceptive ads.”Id. The cease-and-desist letters referenced in the September 9 announcements were initially nonpublic, but FDA has since made them available on its website as warning letters and untitled letters. While we will continue to evaluate these letters, our initial observations include:
FDA announced that its wave of enforcement against DTC advertisements used “AI and other tech-enabled tools to proactively surveil and review drug ads.”Id. Relying on AI could help FDA compensate for reduced staff in OPDP, but it may increase the risk that the enforcement letters contain errors and factual inaccuracies. Whether and how the Agency relied on these tools and implemented human oversight is unclear, but the simultaneous issuance of dozens of enforcement letters requiring responses to OPDP within 15 business days also means that OPDP will experience a significant influx of materials to review in the near-term. Time will tell whether OPDP will rely on AI and other technologies to facilitate its review of these responses, but companies should expect that closure letters may take additional time given resource limitations in OPDP.
Going forward, FDA has committed to continuing its use of AI and other tech-enabled tools and “aggressively deploy[ing] its available enforcement tools.” FDA’s news release suggests that the Agency plans to rely on untitled letters and warning letters as the primary mechanism of enforcement, stating that FDA anticipates ramping up enforcement activity to “hundreds of enforcement letters each year” if its initial actions do not “sufficiently alter DTC advertising behavior.”Fact Sheet. FDA has not specified what would constitute sufficiently altered DTC advertising behavior.
In general, FDA’s enforcement letters and Commissioner Makary’s statements suggest that FDA intends for its crackdown — and, in particular, its rulemaking to eliminate the adequate provision loophole — to deter companies from DTC advertising by making compliance impracticable.CNBC Television, FDA Commissioner Dr. Makary: Deceptive drug ads have ‘distorted the doctor-patient relationship’, YouTube, at 1:35-1:43, https://www.youtube.com/watch?v=Ow_uBPp9bg0.
Unlike print advertisements, broadcast advertisements that contain a major statement are not required to contain a brief summary of all necessary information related to the side effects and contraindications of the drug if “adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation.”21 C.F.R. § 202.1(e)(1)(i)(B). The major statement refers to the presentation of the advertised product’s most important risks, including its major side effects and contraindications.21 U.S.C. § 352(n). In 2007, Congress amended the FDCA to require that the major statement be presented in a clear, conspicuous, and neutral manner. Congress also directed FDA to issue regulations interpreting this standard.Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, title IX, § 121 Stat. 823, 940 (Sep. 27, 2007). In November 2023, FDA finalized a rulemaking to comply with this directive, establishing regulations specifying the criteria that must be met for a major statement to satisfy the clear, conspicuous, and neutral manner standard.See 21 C.F.R. § 202.1(e)(1)(ii).
FDA’s current regulatory framework for broadcast advertisements enables sponsors to communicate this content in a manner that is both practical and informative. The adequate provision regulation, coupled with the major statement framework, informs viewers of the drug’s most important risks while instructing them where to find more information about the drug in its PI.FDA, Basics of Drug Ads, https://www.fda.gov/drugs/prescription-drug-advertising/basics-drug-ads. Although FDA’s adequate provision regulation has been in effect for many decades, FDA attributes its origin to 1997 — the year FDA published draft guidance outlining FDA’s interpretation of how industry could fulfill the adequate provision requirement.FDA, Draft Guidance for Industry; Consumer-Directed Broadcast Advertisements (July 1997); FDA, Guidance for Industry: Consumer-Directed Broadcast Advertisements (Aug. 1999), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/consumer-directed-broadcast-advertisements. Commissioner Makary characterizes the publication of this draft guidance as a “regulatory change,”Martin A. Makary, MD, MPH, JAMA, The FDA’s Overdue Crackdown on Misleading Pharmaceutical Advertisements, JAMA (Sep. 12, 2025), https://jamanetwork.com/journals/jama/fullarticle/2839061 (JAMA Article). although it is unclear why given that the guidance is interpretive. Notably, the guidance is still operative; it was finalized in August 1999 and, to date, has not been rescinded.
FDA’s news release and the HHS fact sheet indicate that FDA plans to amend its regulation at 21 C.F.R. § 202.1(e)(1)(i)(b) to remove the text that allows sponsors to make “adequate provision ... for the dissemination of the approved or permitted product labeling in connection with the broadcast presentation.”See HHS Fact Sheet. As a result, broadcast advertisements would be required to contain a “brief summary of all necessary information related to side effects and contraindications.”See 21 C.F.R. § 202.1(e)(1)(i)(B). Broadcast advertisements would thus need to disclose each specific side effect and contraindication contained in the product’s approved labeling, a result that both HHS and FDA have acknowledged would likely make the advertisements prohibitively long and expensive.Fact Sheet.
FDA announced that it will close digital loopholes by expanding its oversight of DTC advertising to encompass all social media promotional activities.Fact Sheet. This effort, according to FDA, will include monitoring “algorithm-driven targeted advertising” and “dark ads,” “platform-specific promotional strategies designed to evade detection,” “influencer partnerships and sponsored content across all platforms,” “AI-generated health content and chatbot interactions,” and “emerging digital technologies and promotional methods.”Id. It remains to be seen whether FDA will follow its existing guidance under any such expansion of its social media oversight, such as its guidance discussing the use of social media platforms with character space limitations or on correcting independent third-party misinformation, and whether FDA will update any of these guidances.
Prescription drug advertisements are required to present a “fair balance” of risk and effectiveness information.21 U.S.C. § 352(n); 21 C.F.R. § 202.1(e)(5)(ii). FDA’s regulations describe numerous ways in which an advertisement may violate this requirement, such as by suggesting that a drug has less serious side effects or contraindications than its labeling indicates.21 C.F.R. § 202.1(e)(6)(i). FDA’s regulations are also clear that an advertisement is not lacking in fair balance “if the presentation of true information relating to side effects and contraindications is comparable in depth and detail with the claims for effectiveness or safety.”Id. § 202.1(e)(5)(ii). Similarly, broadcast advertisements are not false and misleading if they include a major statement of key risks in a clear, conspicuous, and neutral manner under FDA’s regulatory framework that became effective last year.Id. § 202.1(e)(1)(ii).
Prescription drug advertisements and promotional communications are thus subject to a detailed and well-established statutory and regulatory framework to which FDA must adhere so long as the framework remains. Stakeholders will want to closely observe whether FDA tries to expand its authorities via enforcement letters before it has changed the existing regulatory architecture, as this would present a predicament for companies. On the one hand, courts have held that warning letters and untitled letters are not final agency action and cannot be challenged judicially.See Holistic Candlers & Consumers Ass’n v. FDA, 770 F.Supp.2d 156, 160-62 (D.D.C. 2011), aff’d 664 F.3d 940, 945-946 (D.C. Cir. 2012). At the same time, these letters are generally publicly available and can have significant knock-on effects for companies who receive them.
In the fact sheet accompanying the joint news releases, FDA and HHS describe the major statement as “vague” and assert that, even when it is combined with instructions for how patients can access an advertised product’s full PI, it “denies patients vital safety information required for them to make an informed decision.”Fact Sheet. According to Commissioner Makary, the issue is that neither Congress nor FDA have defined “major,” allowing companies to “choose what to include or omit.”JAMA Article.
These statements represent a dramatic change in position from FDA’s description of the major statement in the final rule that went into effect last year. As part of that rulemaking, FDA established requirements that would ensure DTC broadcast advertisements “convey a truthful and non-misleading net impression about the advertised drug, including its risks, and that consumers are better informed when they participate in healthcare decision making.”88 Fed. Reg. 80960. In fact, FDA stated that it intended for these new regulations to “convey a truthful and non-misleading net impression about the advertised drug” and to “remedy the lack of business incentive for prescription drug firms to effectively communicate the risks of their products to consumers.”Id. at 80959-80960. In order to change its position on the major statement framework, FDA will need to both acknowledge and offer a reasonable basis for such a change.
More fundamentally, requiring broadcast advertisements to disclose information in brief summary conflicts with the statutory provision that expressly permits major statements in broadcast advertisements, which Congress enacted in 2007.Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, § 901(d)(3)(A), 121 Stat. 823, 940 (2007) (codified at 21 U.S.C. § 352(n)). The information to include in brief summary includes “each specific side effect and contraindication ... contained in required, approved, or permitted labeling.”21 C.F.R. § 202.1(e)(3)(iii). By contrast, the information in a major statement includes the “presentation of the drug’s most important risks.”FDA, Drug Advertising: A Glossary of Terms, https://www.fda.gov/drugs/prescription-drug-advertising/drug-advertising-glossary-terms#major_statement. Requiring both would thus likely affect viewer comprehension, conflicting with the statutory provision that implicitly indicates that summarizing risk information is permissible. It would also be at odds with FDA’s carefully considered regulatory framework for major statements. Indeed, FDA has said that including exhaustive, lengthy lists of all the risk information from a drug’s prescribing information in an advertisement “detract[s] from, and make[s] it difficult for, consumers to comprehend and retain information about the more important risks.”FDA, Revised Draft Guidance: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Aug. 2015), Rev. 2, at 4, available at https://www.fda.gov/files/drugs/published/Brief-Summary-and-Adequate-Directions-for-Use---Disclosing-Risk-Information-in-Consumer-Directed-Print-Advertisements-and-Promotional-Labeling-for-Prescription-Drugs.pdf (FDA Revised Draft Guidance).
Under the Supreme Court’s Central Hudson framework, the government may impose restrictions on commercial speech that directly advance a substantial government interest and are no more extensive than necessary to serve that interest.Central Hudson Gas & Elec. Corp. v. Public Svc. Comm'n, 447 U.S. 557, 566 (1980). Courts also evaluate compelled commercial speech under the more relaxed standard in Zauderer,Zauderer v. Off. Of Disciplinary Couns. Of Sup. Ct. of Ohio, 475 U.S. 626, 651 (1985). but HHS and FDA seem to recognize that a court would likely review any final rule under Central Hudson. Specifically, in the fact sheet, they state that the proposed rulemaking “goes to the core government interests of protecting the public from deception and protecting public health—as supported by voluminous evidence of public harm under the current system; and does not unduly burden advertisers, by preserving their right to engage in commercial speech under the standards that existed prior to 1997.”Fact Sheet.
As HHS and FDA acknowledge, however, requiring information in brief summary previously deterred pharmaceutical companies from broadcast advertising altogether.Id. Further, and as noted above, FDA has said that it believes overwhelming consumers with all of the risk information and technical language in a drug’s PI “may serve to detract from consumers’ comprehension of the information or from the likelihood of consumers reading material in its entirety.”FDA Revised Draft Guidance. FDA will likely need to address these points to satisfy the four-part test under Central Hudson.
Companies should prepare for heightened scrutiny of DTC advertisements and promotional communications more generally. Given the downstream effects that can follow receipt of an untitled letter or warning letter, companies may consider taking a fresh look at existing and planned DTC advertisements and promotional communications to ensure they are aligned with the company’s risk tolerance given FDA guidance in the recently issued letters.