August 30, 2010 » How NOT to Build an Unbranded Website

There’s a fundamental rule in marketing drug products: if you share positive information about your brand you also need to share the negative. This rule applies equally to branded sites as well as to unbranded or disease awareness sites in which there is a significant discussion of treatment class and products.

In February 2004, the US FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) drafted guidelines governing the creation of unbranded websites, which spelled out rules that marketers should follow. Breaking a number of these rules resulted in Novartis receiving warning letters from DDMAC back in April about two of the company’s unbranded sites: www.gistalliance.com and www.cmlalliance.com.

Where Did Novartis Go Wrong?

Both Novartis sites were deemed to be overtly promotional of the Novartis therapy, Gleevec. Here’s where the sites went wrong:

• Promoted the use of Gleevec outside its indication and made unsubstantiated dosing-related claims
• Were “perceptually similar” in terms of color schemes and layout to the Gleevec site
• Included “representation or suggestion relating to a particular drug,” including: direct links to the Gleevec product website; references within a publication on the site to a pivotal Gleevec trial; and footnotes on the site that referenced imatinib (Gleevec’s established name), and prominently featuring the Novartis logo
• Did not provide fair balance. While unbranded awareness and education programs are not subject to fair balance requirements, the FDA has taken the stance that it is required if the unbranded program “impliedly identifies a particular drug”
• Mentioned a tyrosine kinase inhibitor (”TKI”) for the first line treatment of GIST and CML. Gleevec is the only TKI indicated for first-line treatment of chronic phase CML, and the only TKI indicated for first-line treatment of GIST
• Contained registration opt ins without being clear they were opting into receive “product information” that delivered Novartis communications, promoting Gleevec

Following the Rules

If you’re looking to develop an unbranded or disease awareness website, be sure to adhere to the guidelines outlined by DDMAC:

• Be clear, accurate and reinforce a public health message
• Refer consumers to an HCP for more information
• Ensure the unbranded experience has its own creative identity
  • Use a separate color palate, as well as different visuals and models, from the branded experience
• Review treatment claims as if the piece was branded
• Follow the same strict regulatory guidance in the way the statements are crafted and substantiated
• Provide balanced treatment discussions
• Provide clear opt-in options for consumers, including a double opt in procedure

Following the rules not only helps you avoid a warning letter, it allows you to capitalize on an opportunity to better educate and enhance the value of your sites. In short, you can break through the clutter without breaking the rules!