PHARMACEUTICALS: FDA Cracks Down On Claims
As drugmakers rush to tap the ever-growing market of preventive treatments for breast cancer, osteoporosis and heart disease among postmenopausal women, competition is heating up between pharmaceutical manufacturers and the FDA is cracking down on what it says are misleading claims. The FDA has issued warning letters to two companies for what it alleges are "inaccurate assertions [that] could endanger women's health" in their advertising. Zeneca, the manufacturer of tamoxifen, which is approved for lowing the risk of breast cancer in high-risk postmenopausal women, was told by the FDA to halt ads in consumer magazines because "it had wrongly omitted mention" of side effects, including blood clots and a slightly increased risk of uterine cancer. And Eli Lilly & Co., the manufacturer of Evista, which is approved for the treatment of osteoporosis, "was said to have implied that Evista could prevent breast cancer." In addition, Zeneca has filed suit against Lilly, charging that "Lilly's sales representatives had falsely told doctors that Evista could prevent breast cancer and has created a widespread misperception that Evista could be used in place of" tamoxifen. Lilly has countersued and demanded that Zeneca cease making the accusations. The New York Times reports that the "warnings to Libby and Zeneca are striking because the companies are the first to jockey for position in an enormous and potentially lucrative new market: cancer prevention" (Grady, New York Times, 3/28).
The warning letters to Lilly and Zeneca are only a few of the crackdowns by the FDA since the surge of direct-to-consumer advertising. The New York Times reports that the FDA has "repeatedly reprimanded drug companies in recent months after finding that they have made false or misleading claims in television commercials and magazine advertisements." However, the Times reports that "an exhaustive review of more than 100 agency letters asserting violations of federal drug-advertising standards shows that, in practice, the agency often operates as an editor, criticizing the text and the design of advertisements, including details like the size of type." The agency often objects to ads in which information is presented in a confusing manner or in which the benefits of the drug are overstated (Pear, 3/28).