Massachusetts: Promotion for Vertex Drug Would Mislead, FDA Says

The Food and Drug Administration's Office of Prescription Drug Promotion has issued a letter requesting that Vertex Pharmaceuticals Inc. not distribute promotional material that FDA says exaggerates the benefits of the hepatitis C drug Incivek.

Sent May 25, the letter said a Vertex-submitted "branded story" of a patient taking Incivek "is misleading because it overstates the efficacy, omits material facts, and minimizes important risk information."

The story was to be part of a promotion of a type common among drugmakers. Patients who are paid travel expenses and a modest honorarium by drug companies speak about their experiences in treatment; they are accompanied by nurses who discuss the therapy with prospective patients.

According to the "James 'J.P.' M, Hepatitis C Mentor" story posted on FDA's website: "Six months after the treatment ended, I found out I'd cleared the virus. That made me feel so good. I was happy to know I'd be around a little longer to see my son grow up."

In addition to noting the word "cleared" incorrectly implies eradication of the virus from the body, FDA regulatory review officials Sheetal Patel and Michael Sauers wrote, "This branded story misleadingly implies that most or all [patients] infected with hepatitis C will successfully achieve sustained virologic response" on Incivek.

Although the letter was not a formal warning, Vertex spokesperson Nikki Levy said the company is reevaluating the material. "We take the FDA's feedback very seriously," said Levy. "The material they're referencing hadn't been used publicly," she said, and will not be used "until we've addressed the FDA's concerns."

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