FDA Crackdown on Pharma TV Ads Targets Pfizer, Novartis, BMS, Lilly & Others
On September 9, 2025, the FDA launched a sweeping crackdown on deceptive direct-to-consumer (DTC) pharmaceutical advertising, specifically targeting TV ads and digital promotions by major companies including Pfizer, Novartis, Bristol Myers Squibb (BMS), Lilly, AstraZeneca, and others34.
The FDA issued more than 100 warning and untitled letters, alongside thousands of notices to approved drug sponsors, directing them to remove non-compliant promotional materials and comply with stricter risk disclosures in all consumer-facing ads134.
A primary focus is closing the 'adequate provision' rule loophole from 1997, which lets companies mention only major risks in broadcast ads while diverting viewers to prescribing information for complete risks; new measures signal all key safety details must be included in advertising going forward4.
FDA Commissioner Marty Makary described the ads as a 'public health crisis' and criticized heavy industry spending on marketing instead of lowering drug prices54.
The crackdown extends beyond TV to digital platforms and paid influencer campaigns, with more aggressive enforcement of fair balance in presenting both drug benefits and risks48.
This marks a major regulatory turning point for pharma marketers, with real risk of TV ad bans and increased scrutiny of DTC promotional practices, requiring sponsors to pivot toward compliant digital and social media channels24.
Sources:
1. https://www.raps.org/news-and-articles/news-articles/2025/9/fda-posts-more-than-100-warning-and-untitled-lette
2. https://www.liveworld.com/pharma-chaos-fda-crackdown/
3. https://www.fiercepharma.com/marketing/fda-targets-lilly-novartis-bms-and-more-deluge-marketing-letters
4. https://www.propharmagroup.com/thought-leadership/fda-launches-crackdown-on-deceptive-drug-advertising
5. https://pharmaphorum.com/news/fdas-makary-explains-overdue-pharma-ads-crackdown
8. https://trial.medpath.com/news/338d06b591347c72/fda-launches-major-crackdown-on-misleading-pharmaceutical-advertising-under-trump-administration