FDA: Allergan Ad Misrepresents Acne Medicine's Effectiveness
August 21 2009 - 12:27PM
Dow Jones News
A journal advertisement for Allergan Inc.'s (AGN) acne cream,
Aczone, overstates the medicine's effectiveness and omits key
safety information, the U.S. Food and Drug Administration said.
The ad completely misrepresents the results of a study by
claiming it shows the medicine "Works fast 24% reduction in
inflammatory lesions at 2 weeks," according to the wording of a
letter the FDA sent the company on Monday. The agency posted the
letter on its Web site Friday.
"This claim is a complete misrepresentation of the results" of a
study involving Aczone, the FDA said. Aczone is a topical gel used
to treat mild to moderate acne.
The FDA said the ad, which ran in unidentified medical journals,
clearly claims the product has a substantial effect on acne after
two weeks of treatment, while studies show it has only a slight
benefit when compared to a placebo.
The ad in question hasn't been running since May, said Caroline
Van Hove. Hove said Allergan is working with the FDA to address all
of the agency's concerns.
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207;
jared.favole@dowjones.com