There are more warning letters from the FDA on various pharma-marketing schemes, and it's not even Friday yet. As the agency continues to pick up the pace of marketing enforcement, it released warnings sent to Novartis and GlaxoSmithKline over promotions for two different products.
The warnings themselves aren't super-significant: The FDA chided GSK for a sales piece on its impetigo drug Altabax. The brochure suggests that the ointment can treat impetigo caused by bacterial strains the drug doesn't actually combat, the agency says. GSK says it will stop using the brochure and that's it's "carefully reviewing" the agency's issues with it.
Novartis got warnings on two websites it sponsors; the site content wasn't submitted for the required prior approval, the agency says. What's more, the sites promoted the drug Gleevec for an unapproved use and they failed to disclose the risks involved.
What's most striking about this latest set of warnings is that they add to a newly apparent--and burgeoning--pattern. The "new FDA" of the Obama administration did promise to tighten up regulation of the industries it supervises. The handful of marketing warnings we're seeing every week is just a part of that. We'll have to wait and see if the pace of warnings picks up even more.
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