Actelion Pharmaceuticals US, San Francisco, July 20 (DDMAC).After reviewing the Actelion website, CDER's Office of Medical Policy Division of Drug Marketing, Advertising and Communications (DDMAC DDMAC Division of Drug Marketing, Advertising and Communications ) issued the firm a warning letter for advertising claims for Tracleer (bosentan) tablets.The letter said the webpage was false and misleading because it omitted material facts regarding important risk information associated with the drug, over stated efficacy, made unsubstantiated superiority claims and contained claims that broadened the indication of Tracleer. Further, the product page was not submitted to FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 30 days prior to dissemination of the promotional material as required by 1 CFR CFR See: Cost and Freight 314.550. The letter said these claims presented "serious public health and safety concerns." Tracleer is an endothelium endothelium /en·do·the·li·um/ (-the´le-um) pl. endothe´lia the layer of epithelial cells that lines the cavities of the heart, the serous cavities, and the lumina of the blood and lymph vessels. receptor antagonist approved under Subpart H regs, with a risk management program that includes restrictions on distribution and a boxed warning for potential liver injury and major birth defects. FDA noted in the warning letter that DDMAC expressed similar concerns to the firm via an untitled letter Oct. 30, 2002, for false or misleading representations made about the use of Tracleer in congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , as well as failure to disclose information regarding risks associated with the drug. At that time, the agency told the firm to discontinue promotional materials containing similar representations. A further meeting was held with the firm and FDA on Jan. 27, 2003, to resolve areas of disagreement, which progressed to a formal dispute resolution meeting by Janet Woodcock woodcock: see snipe. woodcock Any of five species (family Scolopacidae) of plump, sharp-billed migratory birds of damp, dense woodlands in North America, Europe, and Asia. , M.D., on May 27, 2003. As a result of the dispute resolution meeting, the firm agreed on indication and usage and presentation of risk information to be included on all promotional material. However, the website clearly violated the agreement with FDA; and, the agency requested that Actehon immediately cease "dissemination of violative promotional materials for Tracleer." F-B F-B Forward - Backward (radar image analysis) , Web; Doc: Doc. 13534W |
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