FDA Tells Baxter To Tone Down Aralast Claims

Law360, New York (September 1, 2010, 3:31 PM EDT) -- The U.S. Food and Drug Administration has issued a warning letter chastising Baxter International Inc. for overstating the effectiveness of Aralast, a lung therapy for patients at risk for a form of hereditary emphysema.

The FDA said in a letter sent Aug. 3 and released Wednesday that the physician brochure misbrands the drug under the Federal Food, Drug and Cosmetic Act because it makes misleading efficacy claims.

“Moreover, we are very concerned by your continued violative promotion of your products,” said Mary A. Malarkey, director of...
To view the full article, register now.