I was very pleased FDA accepted our invitation to speak at our DTC National in 2026. It is encouraging that we can have some open dialog with them. I will be moderating a session with a senior representative from FDA. After their critical communications on DTC advertising last year it will be fascinating to see if they since moderated their views.

We know that OPDP has ramped up the untitled letters citing about 30 ads as misleading. We also know their stated goal of ending the adequate provision clause which allowed the 60-90 second television ads. That of course if achieved would make the standard ad impractical and force branded DTC off air.

We know that most ads cited addressed the OPDP concerns and either tweaked their ads of launched a new campaign. My guess is that FDA achieved its goal of being seen as tougher on ad claims. Industry certainly can adapt to a stricter standard on television ads. Agencies may have to give up on some of the typical happy patient scenes used in DTC. FDA is using a totality of the impression approach which says that even if claims are technically correct the overall impression may be misleading.

My hope is that FDA recognizes that forcing ads off air is not likely constitutionally sound under the first amendment. I also am encouraged that drug makers can still make good ads even under stricter OPDP interpretation. FDA wants ads to convey the true nature of improvement after taking a drug based on clinical studies.

The session with FDA should be interesting and hopefully collaborative. Consumers like knowing which drugs are available and DTC helps make consumers aware of what is available. Given that payers want to control which drugs consumers can get and always prefer cheaper drugs, DTC puts pressure on payers to cover the newer and usually more expensive drugs.

FDA seems interested in making drug ads more sober and less glitzy. The untitled letters make clear their expectations and we as advertisers must accept the reality of stricter oversight.

Bob Ehrlich

CEO

DTC Perspectives