DDMAC Digs Deep to Link Unbranded Websites to Violative Promotional Practices

By Carrie S. Martin –

FDA just released the Warning Letter it issued to Novartis Pharmaceuticals Corporation (“Novartis”) in April regarding two purportedly unbranded websites, www.gistalliance.com and www.cmlalliance.com (the “alliance websites”), which included disease-state information and clinical data about gastrointestinal stromal tumors (“GIST”) and chronic myeloid leukemia (“CML”).  DDMAC concluded that the websites promoted the use of Novartis’s product Gleevec (imatinib mesylate)—despite the fact that the websites do not specifically mention the drug’s name—in violation of the Federal Food, Drug, and Cosmetic Act (“FDC Act”). 

Gleevac is approved for several indications, including the treatment of different types of CML and GIST.  Some of these indications received accelerated approval via Subpart H.

DDMAC’s detective work to link the alliance websites to Gleevec included the following: comparing the alliance websites to Gleevec’s product website and finding them “perceptually similar” in terms of color schemes and layout, locating Novartis logos on the alliance websites, finding direct links to the Gleevac product website on the alliance websites, reviewing the publications referenced and finding one that “recounted” a pivotal trial from one of Gleevac’s approvals, noticing that footnotes referenced imatinib (Gleevec’s established name), and—somewhat surprisingly—looking into the registration of the alliance websites and finding them registered to Novartis AG. 

The Agency further noted that the alliance websites mention a tyrosine kinase inhibitor ("TKI") for the first line treatment of GIST and CML.  Gleevec, DDMAC explained, is the only 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 indicated for both GIST and CML.  According to DDMAC, these facts are “wellknown” [sic] in the oncology community.  In other words, the alliance websites were thinly veiled attempts to improperly promote Gleevec.

FDA concluded that the alliance websites promoted Gleevec in violation of the FDC Act in several ways.  For example, DDMAC found that the websites minimized and omitted risk information (indeed, the websites contained none), and, more seriously, contained unsubstantiated dosing claims that could put patients at increased risk for serious adverse events.  For example, the alliance websites suggested that low plasma levels might necessitate an increase of Gleevec to achieve efficacy.  DDMAC noted that these dosing instructions are not contained in the Gleevec Prescribing Information (“PI”) and that the PI warns that adverse events are dose-related.  The alliance websites further recommended that physicians test their patients for “suboptimal” plasma levels through Avantix Laboratories.  To add insult to injury, DDMAC determined that the Avantix website, www.bloodleveltesting.com, was registered to Novartis, its content referred to Novartis, and it contained logos for and links to the CML and GIST Alliances. 

As evidenced by this Warning Letter, FDA is clearly concerned that companies may be masquerading promotional material as “disease-state” information via websites with unbranded web addresses.  Companies, therefore, should be wary of registering websites for any third parties with which they would like to work (but remain independent).  They should also be more conscientious of how “connected” unbranded or disease state material is to the company’s branded material.  DDMAC has shown that it is ready to go to significant lengths to pull back the proverbial curtain to find violative promotional content in otherwise “innocent” and unbranded contexts.