A New Level of FDA Enforcement

After years of low-level enforcement by FDA in relation to promotional communications by the pharmaceutical industry, there has been huge change in the agency's approach. Not only have the numbers exploded, but the focus has shifted. What was, and exactly where was the action?

What happened? On September 9, 2025, FDA issued a press release - FDA Launches Crackdown on Deceptive Drug Advertising - making the case that the agency was moving into a new era of enforcement. On that same day the agency issued scores of enforcement letters that included both the most serious Warning Letters (letters addressed to the CEO of companies) and Untitled Letters (those sent to the heads of regulatory).

How many? Lots. Not only did the agency issue dozens of letters on the day of the press release, but since then enforcement has increased, with 10 letters issues so far in 2026. (See upcoming posting providing an overview of enforcement patterns for 2026 in coming days.) In 2025, FDA sent out more letters than were issued during the entire ten years prior, with 64 letters sent out on the same day as the press release. In 2024, FDA sent out only 5 letters, and the same for the year before. In addition, within the 64 letters sent out on September 9, were 8 Warning Letters (the balance were Untitled). Finally, FDA issued multiple letters to individual companies, sometimes regarding the same product. This was a departure from previous years when a single letter would cover multiple communications vehicles and multiple violations. Sending separate letters thereby inflated the overall effect somewhat. Nevertheless, it is undeniable, there was a marked increase in enforcement.

What did they say? While the press release headline refers to "advertising", the scope went beyond direct-to-consumer (DTC) advertising and included websites. With respect to the violations, the press release primarily focused on the issue of fair balance - saying that serious risks were being hidden or were hard to discern. However enforcement actions were also based on claims of efficacy, among other violations. In fact, 50 of the letters sent on September 9 were in relation to some type of DTC advertising, but other communications vehicles included websites, a newsletter, an exhibit panel, a sales aid and sponsored links.

What does it mean? It means that communications teams - both those focused on advertising and on public relations - need to be extra-vigilant and to audit their own practices for weaknesses in light of recent enforcement actions. In doing so, it should also be noted that the agency's press release also expressed specific concern regarding the use of social media and the use of influencers, implying perhaps that future regulatory focus will fall there and communications teams should consider that possibility. While some may view the enforcement spike of 2026 as an anomaly, the fact that enforcement has continued at a comparatively robust pace since then combined with the unaddressed social media/influencer component may mean that the events of that day were not an event, but the beginning of a process.

Bottom line: The change in the environment means that the approach to promotional communications must also likely be altered if a company wants to avoide facing the inconvenience caused by being the subject of a regulatory action letter. In addition to a thorough review current and planned promotional communications to assess potential vulnerabilities, it will be important for communications teams to be up to speed on the specifics of FDA's focus in these letters.