Life Sciences

FDA: HUMIRA ad misleading

Pharma Compliance Alert, December 31, 2008

Abbott’s American Academy of Dermatology post meeting news ad for HUMIRA misbrands the drug in violation of the Food, Drug, and Cosmetic Act, according to an FDA warning letter.

The ad suggests HUMIRA is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience. In addition, risk information presented in the ad is small and hard to read, while the efficacy presentation uses a large font size. Risk information must be as prominent and readable as information relating to the effectiveness of the drug.

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