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FDA warns Johnson & Johnson about Natrecor mouse pad, pen

Pharma Compliance Alert, November 21, 2007

A mouse pad and pen used by Johnson & Johnson are not appropriate reminder labeling for Natrecor, according to an FDA untitled letter.

Reminder labeling calls attention to the name of the pharmaceutical product, but does not include its indication or dosage recommendations or other representations or suggestions relating to the product. Reminder labeling does not have to disclose risk and other information that is required in promotional material.

The pen and mouse pad show an older male patient in a hospital bed, submerged up to his shoulders in water, and connected to a heart monitor and a nasal cannula. The FDA ruled that the image, in conjunction with the Natrecor logo, suggests that Natrecor treatment would be appropriate for patients like this. The FDA ruled that the mouse pad and pen do not fit the requirements of reminder labeling because the image on the promotional items makes a representation or suggestion about Natrecor.

The FDA requested that Johnson & Johnson stop using the promotional materials.

Click here to read the warning letter.

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