Eleven months ago, an FDA warning letter was a rare event. Enforcement letters had fallen from more than 130 a year in the late 1990s to just five in all of 2024. Then came last September, when the FDA’s Office of Prescription Drug Promotion (OPDP) sent more than 60 warning and untitled letters in a single day, a number that climbed past 100 within weeks as thousands of additional notices went out to sponsors industry wide.
OPDP has not slowed down since, but this is not just a tightening of compliance. It is about protecting patients and doing right by them as they navigate one of the hardest journeys in their lives. Patients should be able to rely on what they are told about their medications, no matter where they encounter that information. The letters are just the visible part of that effort.
That is why OPDP scrutiny now reaches HCP websites, corporate webpages, influencer content, earned media, and patient testimonials, channels that were barely part of the conversation two years ago but are increasingly where patients form their understanding of a drug’s risks and benefits. Enforcement is now extending beyond pharmaceutical brands to telehealth platforms and compounding pharmacies over GLP-1 marketing claims. When a patient or creator’s story is part of a paid relationship, OPDP wants that partnership spelled out very clearly.
What this shift means for DTC marketers
In practice, this means the questions DTC marketers should already be asking are the ones OPDP is now asking too. Who is this patient, and how was the story found? Was consent documented before the story was captured, or requested after the fact? Is it clear that the story only reflects one person’s experience and experiences may be different for others? When a creator or patient’s voice is part of a paid relationship, is that relationship spelled out clearly?
These used to be formalities nobody thought twice about. Now getting them right is critical and could be the difference between a clean review and a warning letter. Beyond that, getting them wrong can cost patient trust, and that shows up in the marketing numbers that matter more than reach. It is the difference between a patient understanding their options well enough to talk to their doctor, and whether they stick with treatment once they start.
How to build patient storytelling that stands up to this new compliance reality
Snow’s Patient Ambassador® process has led the industry for 25 years, built on real patient experiences and authentic relationships. It is a proprietary approach that has evolved over the years to meet the latest compliance standards and is customized based on client needs.
For organizations evaluating their own patient storytelling programs, now is the time to ask whether their recruitment, consent, documentation, and review processes would hold up under this new era of compliance review. That’s the work Snow does with marketing teams every day, navigating the complexities of this enforcement landscape and using our proprietary process to find the right patients and bring their stories to life.
