Regulatory Alert Unbranded Promotions Targeted by FDA Enforcement Actions

May 5, 2010 Analyst: Dale Cooke

EXECUTIVE SUMMARY

According to the FDA, simply excluding a brand name does not obviate the need for risk information, especially with unique brands or when the brand has yet to launch. Novartis and GSK learned this recently as recipients of warning letters. Care is needed with unbranded initiatives, as well as “vanity” URLs and redirects, to ensure they don’t become product-specific promotions.

BACKGROUND

In the past two weeks, the FDA has issued letters to Novartis and GSK that have targeted Gleevec (imatinib mesylate) and Arzerra (ofatumumab). The letters affect launch and post-approval promotions, affect use of a “vanity” URL re-direct, and discuss what constitutes tying disease awareness communications too closely to a brand.

RELEVANT FACTS The letters reaffirmed that simply excluding the brand name does NOT automatically make a promotional piece into a disease awareness piece not requiring presentation of risk information and other regulatory mandatories applicable to branded promotional messages. None of the promotional pieces that generated the enforcement actions included the word "Gleevec" or "Arzerra".

IMPLICATIONS

In the case of Arzerra, the promotional piece was a journal ad that sent readers to a “vanity” URL (cllinformation.com) that re-directs to Arzerra.com. Quoting from the letter:

"The characteristics of the product promoted in the ad can only describe Arzerra. Not only is Arzerra the only recently approved drug marketed by GSK for CLL, but no other product approved for the treatment of CLL has an indication that is limited to this specific population. Consequently, this presentation is a product-specific prescription drug ad for Arzerra."

Hence, the letter re-affirms the long-standing FDA position that the mere omission of a brand name does not in itself eliminate the obligation to provide risk information. In addition, the journal ad ran during the 120-day window following FDA approval. During that period, no promotional materials may be used unless they were submitted before product approval. So, this letter is particularly relevant to people working on launch products. This also is the first explicit statement by the FDA addressing the use of a redirecting URL (though note that the letter does not indicate that use of a redirecting URL is in and of itself a violation). With regard to the Gleevec materials, the websites that prompted enforcement actions were www.cmlalliance.com and www.gistalliance.com. Neither site mentions Gleevec by name (and note that the promotional materials themselves have not yet been posted to the FDA website), but according to the FDA letter:

May 5, 2010 Unbranded Promotions Targeted by FDA Enforcement Actions Page 2 of 2

"The websites are perceptually similar to the Novartis Gleevec product website, incorporating similar color schemes (including a distinct orange), design layouts and other presentation elements."

and

"The websites present data from imatinib clinical studies, and provide the corresponding literature references, which include the drug name in the listed publication titles."

The FDA letter also notes that the two websites have links to Gleevec.com and MyCMLcircle.com, though the letter doesn't explicitly mention those links as violations, they are included as factors contributing to the FDA conclusion that "these websites are product specific promotions for the drug Gleevec." It's also worth noting that the appropriate use of links was also one of the five questions from the FDA's hearings on Social Media in November 2009. Finally, note that Novartis is being required to provide corrective communications because of these violations. This is also a growing trend in FDA enforcement as corrective communications are being requested more often.

RECOMMENDATIONS

Among the lessons from these letters are:

1. Not using the brand name does not automatically mean a site qualifies as disease awareness and does not mean that it's OK to omit risk information.

2. Use of “vanity” URLs and redirects is now on the FDA's radar.

3. Promotional materials intended as disease awareness cannot be too closely connected visually or descriptively to a company’s product.

4. Use of studies including the brand to support claims on an unbranded site are viewed as suspect by the FDA.

5. Linking disease awareness websites to product websites is viewed by the FDA as a contributing factor to turn a communication into a product-specific promotion requiring full risk information.

SUPPLEMENTAL MATERIAL Links for further info: Novartis letter on the FDA website: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm210191.htm Arzerra letter on the FDA website: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM208798.pdf Arzerra promotional material on the FDA website: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM208799.pdf