Talkin’ Bout a Revolution in Drug Advertising: What FDA’s DTC Crackdown Means for Pharma

Channeling Tracy Chapman’s 1988 hit, the Food and Drug Administration and the Department of Health & Human Services (“HHS”) are “talkin’ bout a revolution” in drug promotion. While many have described the latest actions as revolutionary, they are better understood as an escalation in enforcement and a clearer insistence on full risk disclosure.

On September 9, 2025, FDA announced a broad enforcement initiative targeting direct-to-consumer (“DTC”) pharmaceutical advertising. Building on the 2024 Clear, Conspicuous, and Neutral (“CCN”) Final Rule, this effort goes further in both scope and emphasis. FDA Commissioner Marty Makary, M.D., M.P.H. sent letters to more than 1,500 NDA holders — every company with an approved drug application — directing them to review and correct noncompliant advertising.

In addition, approximately 100 companies received Untitled Letters and Warning Letters, unusually signed not by OPDP but by the directors of CDER and CBER, underscoring the visibility of this effort.¹ The message is clear: compliance with promotional requirements is a baseline obligation for all application holders, whether or not they actively advertise.

Context and Rationale

The commissioner and HHS leadership described this as a crackdown on “deceptive drug advertising.” The agency has expressed concerns that it believes DTC advertising:

• Distorts the doctor-patient relationship by driving demand regardless of clinical appropriateness;
• Consumes disproportionate industry budgets that, in FDA’s view, could otherwise reduce drug prices (as Commissioner Makary emphasized in a CNBC interview); and
• Fails to provide full safety context, especially in short-format TV, radio, and digital ads.

The CCN Final Rule, effective in 2024, requires television and radio ads to present risks in clear, consumer-friendly, and neutral language. Specifically, risk information must avoid technical jargon and may not be overshadowed by distracting visuals, background audio, or insufficient screen time. With the September letters, FDA has now signaled that abbreviated disclosures or “adequate provision” references to other sources will no longer be tolerated.

Enforcement Updates

• Letters to NDA Holders: More than 1,500 letters sent to all application holders.
• Untitled/NOV-Style Letters: Approximately 100 letters issued. To date, it does not appear that all have been made public. These were signed by CDER/CBER Directors, not OPDP, signaling a policy-level push.
• Cease-and-Desist Language: While not styled as formal orders, the letters make clear FDA expects corrective action, which may include removing ads.
• AI Monitoring: FDA has acknowledged leveraging artificial intelligence to detect misleading promotion, compensating for reduced staff resources.
• Focus Areas: Online pharmacies, biologics, social media influencers, and products recently launched are expected to face the highest scrutiny.
• Form FDA 2253: Submission obligations extend to social media and even personal accounts of company executives if used for promotional purposes.

AGG Observations

• Tone and Intent: FDA’s latest communications reflect a sharper tone than in prior initiatives, emphasizing vigilance around promotional compliance.
• Lack of Clarity: Companies still lack guidance on what constitutes “more fair balance.” For example, whether a 15-second ad can satisfy FDA’s expectations is unclear and may raise questions about commercial viability.
• AI-Driven Oversight: The scope and speed of letter distribution suggest FDA is already using enhanced monitoring systems and may issue additional waves of enforcement letters.
• NDA Holder Responsibility: In co-promotions, the NDA holder remains ultimately accountable for all promotional content.
• Influencers and Endorsers: Training and oversight must extend to all endorsers, especially in digital campaigns.
• Repeat Offenders: Companies with prior OPDP enforcement actions should exercise particular caution, as FDA has shown a pattern of escalating penalties for repeat violators.
• Practical Continuity: Compliance obligations remain fundamentally the same before and after these pronouncements. The difference lies in FDA’s emphasis on transparency and visibility. Companies do not need to dismantle existing SOPs or MLR processes. Rather, the same systems should be reinforced and applied with added scrutiny.
• Regulatory Leverage: The letters provide regulatory affairs and legal more weight in promotional review discussions, reinforcing the need to scrutinize materials closely.

Next Steps for Industry

• Audit Existing Materials: Prioritize high-visibility campaigns (TV, social media, websites, core visuals), Boxed Warning products, and recent launches. Consider targeted audits rather than a wholesale review of all materials.
• Reconsider Past-Debated Materials: Re-review materials where there was some internal debate about fair balance and determine whether changes might be made now.
• Evaluate Ad Formats: Assess whether short ads remain commercially viable if FDA expects comprehensive safety disclosure.
• Revisit Advisory Comments: For recently launched products, re-review OPDP advisory comments to determine whether changes are advisable.
• Enhance Review Processes: Continue using MLR/PRC committees, but reinforce scrutiny on fair balance, risk prominence, and financial disclosures.
• Train Influencers and Staff: Update training for influencers, endorsers, and internal teams on disclosure obligations.
• Align Co-Promotions: Ensure co-promote partners coordinate messaging, as the NDA holder is liable.
• Analyze Published Untitled Letters and Warning Letters: Review the publicly available Untitled Letters and Warning Letters for common themes of non-compliance.²
• Plan for Ongoing Monitoring: Expect continued FDA surveillance, additional letters, and further rulemaking clarifications.

Bottom Line

FDA may be “talkin’ bout a revolution,” but for industry, the fundamentals remain unchanged: compliance requires presenting a fair balance of risks and benefits, avoiding misleading claims, and ensuring clear disclosures. The recent actions emphasize the importance of revisiting current materials with a renewed focus, supporting internal review teams with additional context from FDA’s communications, and preparing for heightened oversight going forward.

[1] Many of the Untitled Letters and Warning Letters have been published on FDA’s website, available here: https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters and https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters.

[2] Id.