FDA Enforcement Action on Comorbidity & Linking Strategies
September 13, 2011
Analyst: Dale Cooke
The FDA has taken enforcement action against promotional activities by Pfizer that further clarifies FDA’sview on website linking strategies. This action also has implications for the cross-promotion of other productstreating comorbidities and franchise marketing efforts. Companies should scour existing promotionalactivities to ensure there are no mentions of products and indications without relevant risk information, andavoid mention of specific products as part of their linking strategies.In addition, this violation was reported via the Bad Ad Program. FDA’s initiative to encourage health careprofessionals to report allegedly violative materials is clearly increasing those reports and industry needs totake heed.
On August 31, 2011, the Food and Drug Administration’s Division of Drug Marketing Advertising andCommunications (DDMAC) issued an untitled letter to Pfizer for its marketing of CADUET
(amlodipinebesylate/atorvastatin calcium) Tablets, CHANTIX
(varenicline) Tablets, and NORVASC
(amlodipine besylate)Tablets. Specifically, Pfizer had placed on the Lipitor.com website a link to the product sites, along with amention of the product names, and an abbreviated description of the product indications. On the webpage,there was risk information provided for the use of LIPITOR
(atorvastatin calcium) Tablets, but there was norisk information provided for Caduet, Chantix, or Norvasc.Another item worth noting about this enforcement activity is that FDA again attributed the action to a“complaint to the DDMAC Bad Ad Program.”
The Bad Ad Program, which was launched in May 2010,encourages healthcare professionals to report allegedly violative promotional materials to the FDA. FDA hastaken steps to educate healthcare professionals about advertising regulations for prescription drugs and haspromoted the program via webinars, press releases, and promotional videos.
So far in 2011, five of DDMAC’s 21 enforcement actions have been attributed to the Bad Ad Program. Clearly,this is now a major source for enforcement actions and all members of industry should assume that healthcare professionals are more aware of the advertising regulations, and because FDA has made it easier toreport allegedly violative materials, health care professionals are more likely to report them.
It’s also worth noting that the use of links has been an ongoing area of interest for the FDA, dating back atleast to the 1996 hearings on the FDA and the Internet.
This topic was again on the docket for the November2009 Part 15 hearings on the use of the Internet and social media tools to promote medical products.
One of the detailed questions the FDA was seeking information about was “Should parameters be established forlinks to and from Web sites?”