THALIDOMIDE: FDA Warns Drugmaker to Curb Ads
The FDA is once again coming down on thalidomide-maker Celgene Corp., this time for the company's "unapproved promotion of the medication as a cancer fighter." In a "sharply worded warning letter" to Celgene, the agency ordered a halt to advertising of the drug as a cancer therapy and a plan for corrective action. The FDA criticized Celgene for promoting thalidomide's effectiveness against cancer without submitting peer-reviewed journal articles about the product to the agency and failing to get approval before distributing the articles to doctors. Preliminary testing of the drug has shown thalidomide as a "promising treatment for several forms of cancer." The leading theory on the drug is that it "reduces the growth of blood vessels, helping to starve fast-growing tumor cells." Excitement over the drug's potential was heightened after an article, published in the New England Journal of Medicine this November, concluded that thalidomide could "induce marked and durable responses in some patients with (bone cancer), including those who relapse after high-dose chemotherapy." Celgene has until today to comply with the FDA's mandates (Kaufman, Washington Post, 5/5).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.