Healthy Skepticism Library item: 1681

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

FDA hits Elan, Pharmacia and Roche on ad practices
FDA news Daily Bulletin 2002 Feb 26

Full text:

The FDA last week posted three new untitled letters on its website, reflecting common concerns of the agency’s Division of Drug Marketing, Communications and Advertising (DDMAC), according to food and drug attorneys.

Elan Jan. 16 received an untitled letter regarding a visual aid promoting its Zanaflex, a drug intended to manage spasticity. The visual aid implied an overly broad indication for the product by failing to convey its limitations, according to the letter. The promotional material described Zanaflex as the “#1 antispasticity agent.” This claim “fails to communicate that Zanaflex is a short-acting drug,” the agency wrote. View the document at http://www.fda.gov/cder/warn/2002/10596.pdf . Untitled letters also were issued to: *Pharmacia: A journal ad for the ophthalmic product Xalatan minimized its risks, the FDA charged. Specifically, the ad featured efficacy claims on the front page while relegating risk information to the back of the ad. The letter is available for download at http://www.fda.gov/cder/warn/2002/10562.pdf . *Roche: A direct-to-consumer print ad stated, “Finally, oral chemotherapy for metastatic colorectal cancer.” The ad didn’t mention any product by name. However, the only oral chemotherapy for metastatic colorectal cancer is Roche’s Xeloda. Therefore, the ad constitutes a product-specific ad and should have included risk information, the FDA wrote. Download the letter at http://www.fda.gov/cder/warn/2002/10521.pdf .