FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2025

On September 25, 2025, FDA posted an additional 11 Untitled Letters from the cohort of letters issued on September 9, 2025, bringing the total number of compliance letters directed toward prescription drug and biologic promotional communications to 60. For reference, this is a massive increase compared to the 5 letters (3 untitled letters and 2 warning letters) issued from January 1 – September 8, 2025.

As FDA Untitled & Warning Letters surge, what does FDA's 2025 enforcement mean for drug promotion?

Here's what we've learned from our analysis of all the FDA Untitled Letters and Warning Letters posted thus far.

Promotional Materials and Target Audience: Who is FDA Targeting with its Recent Untitled Letters & Warning Letters?

The initial round of posted FDA letters primarily focused on television ads and were entirely targeted at direct-to-consumer promotional communications. The newest batch of posted letters are exclusively targeted at HCP-directed materials and include websites, exhibit panels, a newsletter, and a sales aid. No additional TV ad letters were posted on September 25. Apart from the Keenan Thompson podcast videos cited in the September 16 round of letters, the Agency has yet to post any compliance letters directed at prescription drug and biologic promotion on social media.

Single-Arm Trials and Unsupported Time-to-Event Endpoints in FDA's Crosshairs

The newest batch of letters reiterate FDA's continued emphasis on efficacy presentations of time-to-event endpoints. Specifically, multiple letters cite false or misleading presentations of progression free survival (PFS), overall survival (OS), overall response rate (ORR), and disease control rate (DCR) based on data that is insufficient to support such claims. The Agency has once again reiterated single arm trials lack sufficient data to support time-to-event claims. As FDA has stated in previous letters, absent an appropriate comparator, which is needed to assess time-to-event endpoints, it is not possible to determine if the observed effect is attributable to the product or other factors. While the Sponsors attempted to reference additional data not included in the label in support of their claims and provided disclaimers highlighting the limitations of the time-to-event data, FDA noted the disclaimers did not mitigate the overall misleading impression of the presentations.

FDA Flags Limitations of Open-Label Studies in Superiority Claims

One of the letters posted in this week's release highlights the limitations of open label studies to support comparative claims of superiority. Specifically, the letter notes that open label study design "introduces bias and reduces internal validity of the study results." Overall, the FDA states that the referenced study was "inadequately designed to support conclusionary representations" of superiority. Additionally, the Agency also notes that a data limitation disclaimer stating "the open-label nature of this study may have influenced these results" was insufficient to mitigate the misleading impression of the comparative claims presentation.

Bad Ad Program Still Alive and Kicking

The Bad Ad Program has finally made an appearance – two letters posted on September 25 note that the subject websites were submitted as complaints to Bad Ad. A third letter notes the subject piece was reported via a complaint but does not note that it was submitted via Bad Ad suggesting that it was reported through another avenue.

FDA Enforcement Extends Reading Speed Standards to Benefit Claims

One letter posted on September 16 includes a false or misleading benefit presentation charge because of a 40-word benefit super that was displayed on-screen for six seconds. Per the calculation outlined in the letter, this would require viewers to read at 400 words per minute (wpm) to be able to read the entire super before it disappeared. The compliance letter cites the Marc Brysbaert article titled "How many words do we read per minute? A review and meta-analysis of reading rate." to support the charge. The Brysbaert paper states that the average silent reading rate for adults in English is 238 wpm for uninterrupted non-fiction reading, with most adults falling in a range of 175 to 300 wpm. This article was cited in another compliance letter earlier this year in relation to the scroll rate of a scrolling ISI presented on a social media post.

This citation is notable in its application to the presentation of benefit information and suggests that the FDA does not intend to limit the application of the Brysbaert wpm standard to risk presentations alone.

Influencer and Celebrity Spokesperson Training Essential for FDA-Compliant Drug Advertising

The three letters issued in relation to Keenan Thompson's appearances on multiple podcasts underlines the need for influencer and paid endorser training. Most influencers and paid endorsers with limited or no experience in the highly regulated prescription drug advertising space are not familiar with the regulatory requirements associated with the promotion of such products. It is important to ensure that influencers and paid endorsers are trained and prepared in advance of any public events or speaking engagements by or on behalf of the Sponsor.

ProPharma: Your Partner for Advertising & Promotional Compliance

Ensuring compliance in pharmaceutical advertising and promotion has never been more critical as FDA continues to intensify their crackdown on deceptive or misleading drug communications. Promotional content that omits key safety information, exaggerates efficacy, or fails to meet FDA standards can quickly result in Untitled or Warning Letters, triggering costly remediation efforts and potential reputational harm. Partnering with experienced experts in drug advertising compliance provides the strategic oversight needed to prevent violations before they occur is always the goal.

However, although avoiding any enforcement action is always the ideal situation, it is not always reality. Having a partner with the regulatory expertise to remediate issues effectively if enforcement actions are taken is critical. The right partner not only helps Sponsors maintain credibility and mitigate risk but also ensures a clear, compliant path forward in today's heightened enforcement environment.
ProPharma's team of regulatory consultants is the world's leading and first full-service global solution dedicated to Advertising & Promotional Review. Our team of advertising and promotional review experts have the knowledge and experience you need to help get your product on the market and stay there.

Bottom Line: With FDA's unprecedented surge in enforcement, Sponsors must prioritize compliant promotional practices and partner with experts who can both prevent violations and guide effective remediation when letters are issued. ProPharma's team has the experts you need.