The news: Dozens of pharma direct-to-consumer (D2C) TV ads are under fire as the FDA demands at least 40 commercials be pulled off the air or changed.

A spate of untitled warning letters posted on the FDA’s website charge that the TV ads—from Big Pharma companies including AbbVie, AstraZeneca, Novartis, and Pfizer—are false or misleading. It directs marketers to respond within 15 days with plans for corrective action or defend why the ads do not violate guidelines. The letters are dated Sept. 9, 2025.

How we got here: President Trump last week instructed the HHS and the FDA to crackdown on D2C drug advertising with rule changes and stricter enforcement.

• The FDA referred to the letters as “cease and desist” actions and said it sent about 100. 40 letters in the first batch specifically target TV drug ads.
• Along with the enforcement actions, FDA also plans to revoke a 1997 rule that let drugmakers shorten the risks in TV ads along with a link to an external resource. TV ads will now be compelled to disclose all risks resulting in longer commercials, adding media buying costs and production expenses.
• The administration will also expand social media ad regulations and oversight as part of the effort.