Processing Magazine

FDA calls Glaxo ad for prostate drug ''misleading''

March 2, 2009
The Associated Press reports that a marketing campaign for a GlaxoSmithKline prostate drug has drawn complaints from federal regulators, who said the space-themed advertisement is misleading. The drugmaker''s Avodart capsules treat symptoms of enlarged prostate, including frequent urination. In the company''s advertisement, a man working on a model of the solar system is forced to stop painting to make frequent trips to the bathroom. A colleague then recommends he take Avodart, adding that "other medicines, they don''t treat the cause, because they don''t shrink the prostate." But FDA regulators say that claim is false. In a letter to the company''s U.S. management, the FDA said Merck & Co. Inc.''s Proscar also reduces the size of the prostate, and has a similar indication. In a letter posted on the FDA Web site, says that the labeling for Avodart does not suggest any specific advantages of the drug. Regulators also take issue with the visuals used to promote the drug. At one point the ad shows a man holding a model of a planet, which is quickly replaced with a much smaller planet, to demonstrate Avodart''s prostate-shrinking power. The FDA says the visual exaggerates the drug''s effect, which has been shown to reduce the prostates size about 25-percent after two years. The FDA''s letter calls on the company to respond to the agency''s concerns. A company spokeswoman said in a statement the ad has not aired since last fall, and that the company "is committed to responsible marketing."