Life Sciences

FDA warns five companies for incomplete or false advertising

Pharma Compliance Alert, October 1, 2008

Shire, Johnson & Johnson, Novartis, Mallinckrodt, and Eli Lilly all received warning letters from the FDA about their marketing for attention deficit hyperactivity disorder (ADHD).

In its letter to Shire, the FDA said the company overstated the efficacy of Adderall XR, omitted important safety information, and suggested uses of the drug that were not FDA approved. The agency cited Shire’s YouTube video featuring Extreme Makeover Home Edition’s Ty Pennington and a company Web site in its letter.

Johnson & Johnson overstated the efficacy of Concerta and omitted facts about its use on professional convention panels and on a consumer Web page, according to an FDA letter.

Novartis received a warning letter about its professional slide deck and Web page for Focalin XR. The FDA said the materials overstated the efficacy of Focalin XR and broadened the indication for the drug.

A patient brochure for Mallnckrodt’s Methylin overstated the efficacy of the drug, omitted and minimized risks associated with Methylin, and contained unsubstantiated claims about the drug, according to an FDA letter.

A professional sales ad for Lilly’s Strattera broadened the indication for and overstated the efficacy of Strattera, omitted material facts, and minimized important risks, the agency warning letter states.


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