In the fall of 2025, the FDA quietly issued a huge number of compliance letters to the drug industry. This incredible level of enforcement went under the radar, shocking the space with more than 1000 warnings and over 100 letters of violation for noncompliance in relation to misleading direct to consumer pharmaceutical advertising.
Using AI, the FDA is utilizing advanced technology to identify violators, which has resulted in a 50% increase in warning letters. Also being scrutinized is the widespread issues with supplier qualifications, data integrity, and quality unit authority within manufacturing.
These unanticipated letters have come forward after the FDA found concern in deceptive drug advertising, noting a spike in misleading or unapproved claims on DTC channels, social media and telehealth networks. The FDA united with the HHS are aggressively targeting online, influencer and TV advertising that are lacking parity, failing to disclose safety risks, or providing unapproved claims promoting their products.
Amidst these infractions, companies are expected to strengthen their internal medical-legal-regulatory (MLR) review processes as well as audit third party content creators to immediately align with the new data driven FDA expectations.
Following these letters, the FDA published Complete Response Letters, which detailed why a drug has not been approved. While these violation letters and CRLs are routine for the FDA, the unexpected volume may have caught the industry off guard.
Our organization can help the life science industry navigate the negative impact on corporate image, corporate communications, and public relations these actions might cause. We welcome your inquiry and request support in these matters.