FDA Issues Warning Letter to Pharmaceutical Company for Violative Promotion on Unbranded Websites

In a warning letter dated April 21, 2010, the Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising and Communications (DDMAC) cited a pharmaceutical company for improperly promoting its cancer drug in violation of the Federal Food, Drug, and Cosmetic Act (FDC Act). The agency concluded that the company’s sponsorship of two informational websites on gastrointestinal stromal tumors (GIST) and chronic myeloid leukemia (CML) was a veiled attempt to promote the use of its drug product for the treatment of these diseases. After deciding that the websites were product- specific promotional materials, the agency found that the websites were also false and misleading because they promoted an unapproved use for the drug, failed to disclose the associated risks and made unsubstantiated dosing claims that placed patients at increased risk for serious adverse events.

Click the link below to read the full alert.