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FDA to Wyeth: Stop using flashcard

Pharma Compliance Alert, July 30, 2008

A flashcard for Wyeth’s BeneFIX presents unsubstantiated claims that suggest the drug is safer than it is, according to an FDA warning letter.

The flashcard presentation inaccurately suggests that BeneFIX contains no viral risk. The presentation also inaccurately implies that plasma-derived products such as Mononine are virally unsafe, according to the FDA.

Of the six citations referenced to support superiority claims of safety over Mononine, three simply reference the prescribing information for BeneFIX, Original BeneFIX, and Mononine. The other three contain no clinical or pharmacokinetic data from either product.

• Stop using the flashcard
• Provide written response to FDA allegations
• Offer a list of all promotional materials for BeneFIX that may present unsubstantiated claims
• Explain its plan for discontinuing use of such materials
• Submit notification of its intention to stop using the flashcard

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