CBER warns Allergan again about Botox ads

ROCKVILLE, MD., June 25, 2003 -- In its second Warning Letter concerning allegedly violative promotion for Botox Cosmetic Botulinum Toxin Type A (Botox), the FDA's Center for Biologics Evaluation and Research (CBER cited Allergan Inc. for allegedly misrepresenting its product in three journal advertisements).

In addition to the recent June 23 Warning Letter, the agency previously expressed its concerns about Botox marketing in an Aug. 22, 2001, Warning Letter; in Untitled Letters issued Nov. 7, 2000, Feb. 14, 2000, April 12, 2001, and Sept. 5, 2002; and in Dec. 12, 1998, and Sept. 25, 2000, Review Memoranda.

CBER cited Allergan for allegedly misbranding Botox by advertising the product as "America's most popular cosmetic treatment," although it is classified as a combination drug and biologic product. Representing Botox as a cosmetic treatment "minimizes the risks associated with the use of this biological drug," the Warning Letter states. Furthermore, the FDA alleges that Allergan minimized Botox's risk by adding the phrase "if any occur" to the end of the fair balance statement in the journal ads, when data show almost 50 percent of Botox patients experience some form of adverse event associated with the biologic.

The FDA also objected to the ads for allegedly promoting Botox as a way to reduce frown lines, although the product only is approved for temporary improvement in the appearance of glabellar lines -- wrinkles that form between the eyebrows. According to the Warning Letter, Allergan previously agreed to modify this claim in future ads in its Oct. 18, 2002, response to CBER. The FDA ordered Allergan to immediately cease using the allegedly violative ads and to provide a written action plan for disseminating corrective information to those who might have seen the allegedly misleading promotions.

For more details about the Botox Warning Letter and other advertising enforcement news, see the August 2003 issue of the FDA Advertising and Promotion Manual. www.thompson.com/libraries/fooddrug/sell/index.html

Source: FDA Regulatory News  www.thompson.com/libraries/fooddrug/index.html

Posted: June 2003


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