FDA Warns Vertex About Misleading Incivek Marketing Claims

Posted on May 31, 2012

The Food and Drug Administration has issued a warning letter concerning potential marketing materials of a drug meant to treat hepatitis C.

The drug in question is called Incivek, and it is manufactured by Vertex Pharmaceuticals.  The FDA took issue with a potential marketing event in which a patient would be extolling the virtues of the drug.  These types of events usually consist of patients telling their stories and nurses talking up the item to prospective patients.  At this particular get-together, the patient was set to speak about how the virus was cleared from his system six months after treatment with the drug.

The FDA believes this story to be misleading.  Although they don’t question this one patient’s experience with the drug, they don’t believe that the story gives an accurate assessment of what the majority of patients could expect to have happen.  They also take umbrage with the word “cleared,” which suggests that the hep C virus was removed from the body completely, which wouldn’t technically be true.

The safety organization went so far as to say that facts were omitted, potential risks were minimized, and the effectiveness as the drug was overemphasized by the claims in the story.  This promotional material had yet to be used in public, according to Vertex.  They said they wouldn’t release the marketing materials until the FDA’s warnings were addressed.

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