A Change Is Gonna Come: OPDP Continues to Focus Its Attention on DTC Advertising

As Sam Cooke famously sang, “It’s been a long, a long time coming.” In the latest sign that the Food and Drug Administration is maintaining its focus on direct-to-consumer (“DTC”) advertising, the Office of Prescription Drug Promotion (“OPDP”) issued multiple Untitled Letters this fall regarding television advertisements and other consumer-facing promotional materials.¹ The letters highlight that the level of regulatory scrutiny on promotional communications remains elevated, particularly for materials presenting complex approved indications to a broad audience. Most recently, OPDP posted three new letters, although with dates matching the first round of letters.

Background

• On September 23, 2025, OPDP posted an Untitled Letter concerning a 45-second television advertisement for an SGLT2 inhibitor approved for chronic kidney disease and heart failure.² The agency noted that the ad could be misleading because it emphasized certain benefits without fully presenting the scope of the approved indications and composite endpoints. Specifically, the ad stated that the SGLT2 inhibitor “can help you keep living life by reducing the risk of cardiovascular death” in patients with chronic kidney disease or heart failure, without fully communicating other potential risks.
• On September 30, 2025, OPDP issued two additional Untitled Letters.
  1. One involved a DTC television advertisement for a seizure medication, where the agency highlighted that serious risk information was not presented in a dual-modality format (simultaneous audio and on-screen text), which could affect consumer understanding of key safety information.³
  2. The other letter involved a generic drug company webpage for a ketamine hydrochloride injection, where OPDP flagged concerns that the promotional materials appeared to misrepresent the FDA-approved indication (suggesting broader pain or surgical-management use), and failed to submit the materials under the required advertising transmittal form — issues the agency deemed sufficient to render the communications misbranded under the FD&C Act.⁴

AGG Observations

• Elevated regulatory attention: These letters demonstrate a sustained enforcement focus on DTC promotional oversight. Industry tracking indicates that FDA has issued a substantial number of Untitled and Warning Letters recently, signaling continued scrutiny of promotional compliance.
• Complex messaging requires balance: Promotional materials covering multi-component indications or products with significant safety considerations must present information in a way that accurately reflects the approved label. Emphasizing benefits, without fair balance, or isolating favorable outcomes without appropriate context, will attract agency attention.
• Mass-media channels remain a focus: Broadcast TV and other consumer-facing media continue to be prioritized by OPDP. These platforms require careful attention to clarity, balance, and accuracy for both benefit and risk messaging.
• Presentation and modality are critical: The letters reinforce that how information is presented matters, including dual-modality for risk information (audio + on-screen text) and visually accessible communication of composite endpoints or other important data.
• Review and refine existing DTC assets:
  • Audit TV, webcast, and print materials to ensure statements about benefits and risks reflect the full approved indication and endpoints.
  • Confirm that risk information and endpoint context are presented clearly and visually accessible, including dual-modality, where applicable.
  • Where an indication involves multiple endpoints or safety considerations, promotional statements should not isolate one element in a way that implies approval solely for that outcome.
  • See our September 2025 Bulletin for other AGG recommendations.

Bottom Line

As Sam Cooke’s song reminds us, “a change is gonna come.” OPDP’s recent actions indicate that heightened scrutiny is here to stay, and companies can use this as an opportunity to review internal processes and ensure promotional practices align with evolving regulatory expectations.

[1] AGG’s Bulletin on these letters can be found at Talkin’ Bout a Revolution in Drug Advertising: What FDA’s DTC Crackdown Means for Pharma.

[2] The Untitled Letter can be found here.

[3] The Untitled Letter can be found here.

[4] The Untitled Letter can be found here.