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FDA knows there are constitutional limits on its power to make ads overly difficult to craft. Instead, the agency seems satisfied with ramping up enforcement.
OPDP is expecting ads that present clinical benefits in a more sober and balanced manner. They are cracking down on scenes that imply greater benefits than have been proven. Happy patients who appear dramatically transformed are now a no-no. That means the typical active lifestyle scenes we associate with DTC are under scrutiny if they imply superior efficacy.
Industry has been put on notice that what was acceptable in the past will no longer be acceptable in 2026 and beyond. The odds of receiving a letter have gone from almost zero to roughly 25–40%. Any ad that is not pre-cleared is at risk.
Companies have historically been willing to risk a letter since there was no meaningful penalty and most violations were resolved with minor re-edits. Dr. Makary said the FDA is looking at putting greater teeth into enforcement. That could mean statutory penalties tied to regulatory letters. For example, a letter could trigger corrective advertising, which is both embarrassing and costly.
My advice is to pre-clear ads if they contain claims or scenes that mirror the themes raised in recent letters. Simply running ads and hoping to get past OPDP scrutiny seems to be a losing strategy. They are well staffed and ready to challenge ads.
The good news is that the 60–90 second ad format still appears safe, albeit somewhat toned down.
Dr. Makary was a talented and capable leader. I hope the administration finds someone with solid credentials who can successfully take the reins.
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