Overview
- FDA is issuing about 100 cease‑and‑desist notices and thousands of warning letters to enforce existing rules on fair balance and side‑effect disclosures.
- The administration plans regulations to end the 1997 “adequate provision” approach, requiring more complete risk information within ads that could lengthen broadcasts.
- Scrutiny expands beyond traditional TV to social media influencers, online pharmacies and telehealth advertisers that have promoted drugs without proper disclosures.
- Officials cite a sharp drop in oversight, noting one enforcement letter in 2023 and none in 2024, and describe the action as the strongest step short of a ban.
- PhRMA stressed First Amendment protections for truthful advertising as officials declined to name letter recipients and referenced a criticized Hims & Hers Super Bowl spot as an example.