FDA Releases Enforcement Letters Related to DTC Advertising

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On September 16, the FDA publicly released several enforcement letters that were recently sent to pharmaceutical companies, telehealth companies, and drug compounding pharmacies as part of the agency’s crackdown on direct-to-consumer (DTC) advertising. The letters, which the agency referred to as “cease-and-desist” letters, included a mix of warning letters and untitled letters that cited a range of allegedly false and misleading promotional statements. 

These letters are notably different from FDA’s historic practice in that they were signed on behalf of George Tidmarsh, the Director of FDA’s Center for Drug Evaluation and Research (CDER), rather than CDER’s Office of Prescription Drug Promotion. According to the letters, the companies are required to correct the advertisements or provide the agency with adequate justification for their alleged violations, or else they risk escalated enforcement activity.

FDA Commissioner Martin Makary believes the agency’s enforcement drive is long overdue, according to an he recently authored. Makary blames the agency’s reduced oversight over the past two decades for unleashing a promotional “free-for-all” that has “distorted” the patient-doctor relationship and created an “increased demand for medications regardless of clinical appropriateness.” Makary pledged that the agency will now be taking a more proactive role in monitoring pharmaceutical advertising “across all media platforms.”

Many of the enforcement letters focus on the FDA’s approach to the presentation of the “major statement” about a prescription drug’s side effects, which must be presented in a clear, conspicuous, and neutral manner. Several letters highlighted FDA’s concern with attention-grabbing visuals and frequent scene changes that potentially distract from the major statement. One of the most common violations cited in the letters related to concerns about the presentation of efficacy, and FDA appears particularly concerned about visual presentations that may imply a higher or better quality of life than what patients using the drug could typically expect. 

These targeted areas of enforcement are consistent with concerns that Dr. Makary raised in his article. According to Makary, “Misleading impressions come straight from the ads themselves: glossy scenes of patients laughing, singing, and dancing dominate the screen, while fine print races past with warnings about seizures, addiction, or even death. That is not fair balance—it is a distraction by design.”

FDA’s crackdown also included letters to a number of compounding pharmacies for the unlawful compounding of glucon-like peptide-1 (GLP-1) drugs and for misleading promotional claims that imply that the compounded versions are the same as an FDA-approved product when they are not.

For more on the agency’s actions, Manatt on Health subscribers can see the September 15 of Insights this Week.

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