On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a torrent of untitled letters, 40 in total, just days after rumblings that FDA would be cracking down on direct to consumer (“DTC”) advertising of pharmaceuticals.[1] This enforcement flurry—which we will digest in a later blog post, given its complexity—did not stop there as just a week later, on September 16, 2025, FDA released about 80 warning letters. We have forecasted this for months, and now, we believe this wave of action to be the tip of the enforcement iceberg.[2]
Latest Post
More Posts
Key Takeaways from FDA’s Latest Social Media Warnings
Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?
Krazati Untitled Letter: A Cautionary Tale for CFL Promotion of Accelerated Approval Drugs
FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company
FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI®
2024 Top-of-Mind Issues for Life Sciences Companies
FDA’s Office of Prescription Drug Promotion Issues Second Untitled Letter of the Year to Exeltis for Misleading Statements Relating to SLYND®
FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements
FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information
Subscribe: Subscribe via RSS
Blogs