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GlaxoSmithKline

FDA Review of Altabax Promotional Material

Date: 04/19/2010 (Date of FDA Warning Letter)

Misconduct Type: Health

Enforcement Agency: Health and Human Servs.

Contracting Party: None

Court Type: N/A

Amount: $0

Disposition: Investigative Finding

Synopsis: In April 2010, the U.S. Food and Drug Administration issued a warning letter to GlaxoSmithKline about the promotion of its Altabax skin infection ointment. The FDA reviewed a sales brochure known as a “slim jim” sales aid which discussed Altabax and found it “false or misleading.” The FDA said the brochure “broadens the indication of Altabax, makes unsubstantiated superiority claims, and omits and minimizes important risk information associated with Altabax. Thus, the slim jim misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act….These violations are concerning from a public health perspective because they suggest that Altabax is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience.”