FDA Issues Warnings to Drug Makers for ‘Misleading’ Ads
Drug makers AstraZeneca, Pharmacia Corp., Abbott Laboratories and ICN Pharmaceuticals have received FDA warning letters about using "misleading" advertising to promote their drugs to consumers and physicians, Bloomberg News/Los Angeles Times reports. According to the FDA, the ads "downplayed risks and lacked balance." The FDA cited AstraZeneca for ads for the breast cancer treatment Nolvadex, or tamoxifen, saying they suggested "greater efficacy than demonstrated by substantial evidence." Advertisements for Efudex, ICN's treatment for precancerous lesions, were deemed "unbalanced" because they de-emphasized risks "spelled out" in the drug's warning label, including potential miscarriage when used during pregnancy. The FDA said consumers were "confused" by ads for Pharmacia's Genotropin, used to treat stunted growth, because the drug maker did not "clearly note caveats," including the drug's approval for children "only up to age 2." In addition, the FDA warned Abbott's Knoll division for distributing promotional materials in the Detroit area for its obesity drug Meridia that contained "before" and "after" pictures of "individuals said to have lost weight" on the drug (Bloomberg News/Los Angeles Times, 1/16).
The FDA also issued a warning to Icos Corp. and Eli Lilly, its marketing partner, for "premature[ly]" promoting Cialis, an experimental impotence drug that has not yet been approved. The FDA cited "numerous" references in company news releases that "foreshadow the marketing battle to come" between Cialis and Pfizer's Viagra. Lacy Fitzpatrick, Icos spokesperson, said, "The FDA asks that companies be careful in statements they make prior to a drug's approval. These types of statements wouldn't have received attention if the drug was approved." She added that the company is removing two news releases about Cialis from its Web site. John McCamant, Medical Technology Stock Letter editor, said a warning from the FDA Division of Drug Marketing, Advertising and Communications is "fairly common" and typically "a slap on the wrist." He added that with "more and more direct-to-consumer ads for drugs, [t]he FDA wants to get better control over that. (Lilly/Icos) did something wrong, but it's not egregious. It is marketing getting ahead of itself" (Timmerman, Seattle Times, 1/15). Bloomberg News/Los Angeles Times reports that critics of direct-to-consumer ads say they "spur consumers to demand drugs they don't need." The FDA is currently conducting a physician survey examining how the ads influence behavior (Bloomberg News/Los Angeles Times, 1/16).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.