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From: Medical Marketing and Media

http://www.mmm-online.com/ddmac-warns-novartis-on-educational-websites/article/1\

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DDMAC warns Novartis on educational websites

Ben Comer

May 05 2010

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.