FDA Issues Warning Letter to Amgen Over Enbrel Ad

The FDA has cited drugmaker Amgen for running a television commercial that includes an unsubstantiated claim for its TNF inhibitor Enbrel.

The letter from the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) stated that the Enbrel (etanercept) promotion -- a 60-second commercial entitled "Freedom" -- is misleading because it refers to the drug as a "breakthrough" treatment. "Enbrel is not a breakthrough therapy for moderate to severe plaque psoriasis because it does not offer any documented material difference that offers a significant advantage over other drugs already available for this condition," DDMAC said.

Amgen was also warned for failing to communicate the drug's limitations. According to the letter, the television advertisement shows 12 people, presumed to be patients on Enbrel, whose skin shows no signs of psoriasis, giving the impression that Enbrel completely clears up the skin condition. However, DDMAC said Enbrel has never been shown to completely clear skin of psoriasis.

The agency also objected to the lack of risk information in the ad. Only patients with moderate-to-severe psoriasis should use the drug, the letter said, because Enbrel carries a risk of serious toxicity. The ad, however, suggests the drug is useful for a broader range of patients, including ones with milder symptoms that can be managed with therapies that carry less risk than Enbrel.

DDMAC ordered Amgen to respond in writing to the warning letter by March 7. To view a copy of the letter, go to http://www.fda.gov/cder/warn/2005/Enbrelwl.pdf (http://www.fda.gov/cder/warn/2005/Enbrelwl.pdf).