FDA’s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued a letter to Pfizer’s vice-president of US Regulatory Affairs regarding its online resources page for Lipitor (atorvastatin calcium) tablets. The letter, which was brought about as part of the agency’s Bad Ad program, cites that the webpage is misleading because it makes representations and/or suggestions about the efficacy of Caduet (amlodipine besylate/atorvastatin calcium) tablets, Chantix (varenicline) tablets, and Norvasc (amlodipine besylate) tablets without communicating risk information associated with the use of these drugs.
The letter reviews the FDA-approved indications and side effects for these products and notes that DDMAC sent Pfizer a letter in 2009 regarding sponsored links on Internet search engines for several of its products, including Caduet and Chantix. Those links were deemed misleading as well and “DDMAC is concerned that Pfizer is continuing to promote its products in a similarly violative manner,” states the current letter.
Promotional materials that include the name of a drug but not its indications are required to disclose risk and other information, states the letter. Otherwise, the materials are considered misleading.
Chantix in particular has a boxed warning, which was omitted in the webpage, and the lack of risk information about all the products noted on the webpage “suggests that these drugs are safer than have been demonstrated,” states the letter.
DDMAC has asked Pfizer to immediately stop disseminating the promotional materials and to submit a response letter to the agency by Sept. 14, 2011.