FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) took Novartis to school over educational websites the agency said went beyond disease awareness, and into brand promotion, according to a Warning Letter dated April 21.
Although Novartis' Gleevec was not mentioned by name on the two violative sites — www.gistalliance.com and www.cmlalliance.com — the websites "effectively promote this drug product for the treatment of GIST tumors and CML, respectively," the letter stated.
Brand promotion for Gleevec was implied on the websites in the following ways, according to the letter:
- websites discussed tyrosine kinase inhibitors (TKI) for first-line GIST and CML treatment, often in conjunction with the Novartis name. Gleevec is the only TKI indicated for first-line treatment of GIST and chronic phase CML.
- made numerous references to an organization and its oncology practice guidelines, which recommend the use of Gleevec exclusively for first-line treatment of GIST and CML.
- designed perceptually similar to the Novartis Gleevec product site, incorporating similar color schemes (including a distinct orange), design layouts and other presentation elements.
- clearly marked with the Novartis Oncology name and logo.
- a direct link to the Gleevec product website on one of the healthcare professional-directed pages. The consumer-directed version of the page linked to "My CML Circle Program," a website that discusses Gleevec as a treatment for CML.
- domain names registered to Novartis
- presented data from clinical studies that included Gleevec in the publication titles
Since the websites were considered to be brand promotions by DDMAC, other problems arose, including minimization and omission of risk, promotion of unapproved use of the drug, and unsubstantiated dosing claims, according to the letter. Novartis also failed to submit the website contents to FDA prior to dissemination, as required by law. Both websites had been removed from the web at press time.
GSK received an untitled letter in April regarding a disease awareness ad that alluded to its cancer treatment Arzerra, but left out the drug's side effects. Disease awareness ads are not required to include medication risks and other information that is required by product advertising, since they don't ostensibly promote a specific product, according to FDA's 2004 draft guidance. Where exactly disease education ends and brand promotion begins is a matter for debate, particularly in the case of one-product companies, Arnold Friede, a former Pfizer lawyer, told MM&M