While not using the established name of the Novartis drug product - Gleevec - the two Novartis-sponsored websites, www.gistalliance.com and www.cmlalliance.com, effectively promote this drug product for the treatment of GIST tumors and CML, respectively.
—FDA Warning Letter to Novartis, 4/21/10
Although devices don't fall under DDMAC's authority, this is a story with an important lesson: your clever efforts to skirt and dodge the letter of the law may not be enough. FDA may actually expect you to behave the way you're supposed to.
These "alliance" web sites were already down by the time I heard about them, so I can't vouch for how similar they were to established Novartis branding. What may be more interesting about this warning letter is that the obviousness of the brand tie-in is only one of many reasons they're holding Novartis' feet to the fire.
FDA cites several factors in considering these alliance web sites part of Novartis' promotional efforts. These two paragraphs are particularly worth reading:
The websites discuss the use of tyrosine kinase inhibitors (TKIs) for the first line treatment of GIST and CML, often in conjunction with the Novartis name. Gleevec is the only tyrosine kinase inhibitor (TKI) indicated for first-line treatment of chronic phase CML; the only TKI indicated for first line treatment of GIST; and the only TKI made by Novartis that is indicated for both GIST and CML. These product details are well known in the oncology community.
The websites contain numerous references to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, which recommend the use of Gleevec exclusively for the first-line treatment of CML and GIST.
Novartis seems to have gone out of their way to appear (or be) impartial, but that's not a big enough fig leaf. These are still promotional activities and as such, Novartis is way out of line.
There's a larger issue at play here regarding the relationships between manufacturers and disease advocacy groups. Those alliances are problematic, but unlikely to disappear any time soon.
But FDA isn't taking on that elephant, they're bagging far smaller prey: the use of "astroturf" advocacy groups. As FDA's warning letter makes clear, these "alliances" were sufficiently dependent on Novartis that Novartis is included on the domains' registration records. That makes it pretty clear who's making these claims.
My advice, generally, is that if you think you're getting away with something, you're probably operating at risk. FDA may be slow to react, but they aren't stupid. Sooner or later, they'll clear enough of their workflow to catch up with your clever ruse.
Tags: Advertising and Promotion, Best Practices, Enforcement, FDA, Warning Letters
