The FDA's marketing regulators have either been pulling their punches lately or drugmakers are complying with promo rules better than usual, because the number of warning letters about advertising and brochures and mailers last quarter could be counted on one hand--and so far this quarter, there hasn't even been one. As Eye on FDA notes, the letters can be mini-lessons in compliance, so here's the summary of the second quarter action:
- Pfizer was cited for a sildenafil citrate video that didn't include any risk information. The video referred viewers to that info on a web page, but the FDA didn't see that info. Lesson? Even online videos should include risk info, just like TV commercials.
- Zila Pharmaceuticals got tagged for a professional mailer about its oral rinse Peridex. The mailing included the rinse's package insert. But because that insert wasn't physically attached to the promotional brochure, it didn't count. Lesson? No detachable risk info.
- Novartis was cited for a Trileptal magnet because the risk info was on the back, where it couldn't be seen. Lesson? Risk info in view at all times.
- Shire got its hand slapped for a reminder ad that wasn't. A reminder ad, as you know, is supposed to just include the drug name--no indications, dosage, or other info. FDA said the Shire ad looked like a reminder ad, but contained language about indications. Lesson? Calling an ad a reminder ad doesn't make it one.
- read the post at Eye on FDA