Compounders’ catch-22

The National Review has a terrific article about the FDA’s recent crackdown on what it considers inappropriate or illegal direct-to-consumer drug advertising. In particular, we love how clearly it explains how compounders are caught between a rock … and another rock:

On one hand, they are prohibited from implying that their products are equivalent to FDA-approved medications. On the other, they’re now being criticized for omitting information that only exists in FDA-approved labeling. That regulatory catch-22 makes it especially challenging for platforms to navigate promotional claims without drawing scrutiny.

And when it comes to “drawing scrutiny,” the piece explains how it’s very, very easy to end up on the business end of an agency letter. Specifically, it goes into how FDA is using AI to flag offenses — including incredibly minor technical ones, such as “attention grabbing visuals” or “frequent scene changes” in videos. 

Even if you don’t think you’re advertising, you are — assuming you have a website, that is. There’s a good chance the FDA (or, more accurately, its AI) will be looking at it very carefully, along with any content you share via social media. In one case, the agency flagged an AstraZeneca video that showed teens discussing drugs without an adult present. That, per the agency, was implying “that the product could be self-administered by individuals aged 2 to 17.”

Translation: There’s basically zero wiggle room. So take a moment to read the National Review article to get a feel for what you’re up against — and then be sure you’ve also got APC’s “Best Practices for Marketing Compounded Medications” document on hand … and maybe your attorney’s cell number.