Xenical Ads Skirt FDA Regulations

Roche Group's television advertising strategy for its weight-loss drug Xenical has "outwitted" the FDA's "complicated advertising rules" by dividing information about the drug into two separate commercials, allowing the company to avoid mentioning any "unpleasant side effects" associated with the product. The Wall Street Journal reports that FDA rules for pharmaceutical advertisements stipulate that a "full-length" commercial that advertises a product by name for specific medical conditions must include a list of that product's side effects. However, the Xenical advertisements feature two television spots separated by "unrelated commercial time." The first ad describes the condition Xenical is designed to treat -- "unhealthy" weight gain -- and shows an image of a baby morphing into a heavyset woman, although the name of the drug is not mentioned. The second ad uses the same images and music and names the drug, but says nothing about weight gain. The ad says, "Your doctor cared about your health then. He cares about it now. Ask about Xenical." The side effects of the drug, which can include "gas with oily discharge" and the inability to control bowel movements, are not mentioned in either commercial. Combined, the two commercials are 45 seconds long, as long as some full-length spots, but FDA lawyers have concluded that "without information to the contrary," the ads are "separate ... and don't constitute a violation of the regulations." The ads began airing in February.

Terry Hurley, a spokesperson for Hoffmann-La Roche, the U.S. pharmaceutical unit of Roche Group, said that the first Xenical ad is designed to "drive consumers into physicians' offices to talk about weight," while the second spot "is intended to build brand-name recognition for Xenical." Hurley added, "The message tends to get lost when combining it with mandatory side-effects language." He said that it is "critical" that the two ads run together, although they are separated by "at least one" commercial. While the Xenical commercials may be legal, the FDA says it is "exploring the issues surrounding the ads." Nancy Ostrove, an official with the FDA's Division of Drug Marketing, said, "Just because it may be legal doesn't mean we think it is appropriate. We are looking at it very closely." The FDA said it is not aware of any other drug maker using the same advertising technique on television, although Schering-Plough last year attempted a similar strategy in magazines and was told by the agency to halt the ads. The Xenical ads come as the FDA prepares to review its regulatory policy regarding pharmaceutical advertising. The agency said it plans to examine whether drug ads "confuse consumers and adversely impact the relationship between patients and their health care providers."