The White House, the Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) have announced that FDA has initiated “sweeping reforms” and “aggressive enforcement” to address “deceptive” and “misleading” direct-to-consumer (DTC) prescription drug advertising.
On September 9, 2025, the White House issued a memorandum to HHS Secretary Robert F. Kennedy, Jr. and FDA Commissioner Marty Makary directing both HHS and FDA “to ensure transparency and accuracy in DTC prescription drug advertising.” The memorandum also directs FDA to take appropriate action to enforce the prescription drug advertising provisions of the Federal Food, Drug, and Cosmetic Act (FDCA).[1] On the same day, HHS and FDA announced that FDA has launched a “crackdown on deceptive drug advertising”[2] and “will begin aggressive enforcement of DTC violations,”[3] with a focus on broadcast and social media advertising. As part of that effort, FDA has taken three significant actions:
- “Cease-and-desist” letters: FDA has issued approximately 100 “cease-and-desist letters” to pharmaceutical companies it alleges have “deceptive” DTC prescription drug advertisements.[4] FDA has not used the “cease and desist” terminology in previous letters to industry on purportedly violative DTC prescription drug advertisements. Instead, FDA typically issues so-called “warning letters” or “untitled” letters, which “request” that a letter recipient “cease any violations of the FD&C Act.”[5] Of note, courts have generally accepted FDA’s position that warning and untitled letters are advisory in nature and therefore not final agency action subject to judicial review.[6] FDA has not, as of yet, posted any of the 100 cease-and-desist letters on its website. As such, it is unclear whether the newly issued letters use language that would affect that determination of “finality.”
- “Dear Pharmaceutical Company” letters: FDA has issued a “Dear Pharmaceutical Company” letter to “all application holders” directing the removal of “any noncompliant advertising and bring all promotional communications into compliance.”[7] The letter outlines several concerns about “deceptive” and “violative” DTC prescription drug advertising, including that such advertising can “distort the patient-clinician relationship and create increased demand for medications regardless of clinical appropriateness” and that patients “are not seeing a fair balance of the information regarding a drug product,” including due to promotion of DTC prescription drug advertising on social media platforms. In the letter, FDA states that it “will no longer tolerate” “deceptive practices” around requirements to provide fair balance between safety and effectiveness information.
- Eliminating FDA’s “adequate provision” regulation: FDA has announced its intent to initiate rulemaking to eliminate FDA’s regulation on “adequate provision” of drug product information in consumer-directed broadcast advertisements. The “adequate provision” regulation allows for alternative means for provision of safety and efficacy information for consumer-directed broadcast advertisements, such as through a link to a website. FDA did not provide a timeline for the rulemaking, which does not appear in the Unified Agenda, the Administration’s official compilation of information about regulations under development.
The announcement of the enforcement push came on the same day that the Make America Healthy Again (MAHA) Committee published the MAHA Strategy Report, which calls on FDA, HHS, the Federal Trade Commission (FTC), and the U.S. Department of Justice (DOJ) to “increase oversight and enforcement” for violations of DTC prescription drug advertising laws, prioritizing “[e]gregious violations demonstrating harm from current practices,” including “by social media influencers and DTC telehealth companies,” and with respect to “dissemination of risk information and quality of life through misleading and deceptive advertising on social media and digital platforms.”[8]
Gibson Dunn is monitoring these developments closely. Our attorneys are available to assist clients as they navigate the changing landscape of prescription drug advertising.
[1]Mem. for the Sec’y of Health and Hum. Serv. And Comm’r of Food and Drugs re: Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements (Sept. 9, 2025).
[2]FDA News Release, FDA Launches Crackdown on Deceptive Drug Advertising (Sept. 9, 2025).
[3]HHS Fact Sheet: Ensuring Patient Safety Through Reform of Direct-to-Consumer Pharmaceutical Advertisement Policies (Sept. 9, 2025).
[4]FDA News Release, FDA Launches Crackdown on Deceptive Drug Advertising (Sept. 9, 2025).
[5]FDA, Regulatory Procedures Manual, Chapter 4, Advisory Actions, at 21.
[6] 5 U.S.C. § 704; 21 CFR 10.65(a); Holistic Candlers and Consumers Ass’n v. FDA, 664 F.3d 940, 946 (D.C. Cir. 2012).
[7]FDA, Dear Pharmaceutical Company Letter (Sept. 9, 2025).
[8]MAHA Committee, Strategy Report: Make Our Children Healthy Again (Sept. 9, 2025), at 9.