The U.S. Food and Drug Administration has issued a warning letter to Vertex Pharmaceuticals (Nasdaq: VRTX) saying the company published a misleading “branded story” promoting its drug for hepatitis C, Incivek. The FDA is demanding that the Cambridge, Mass.-based company, which won FDA approval for the drug in May of 2011, stop disseminating the materials in question.
The warning letter reads in part, “The branded story is misleading because it overstates the efficacy, omits material facts and minimizes important risk information about the drug product.”
The branded Incivek story described the experience of a patient named James, who had stage 3 cirrhosis due to hepatitis C and failed to have a response on another drug regimen. He found the drug combination including Incivek to be effective.
The story included statements such as:
“And six months after treatment ended, I found out I’d cleared the virus. That made me feel so good. I was so happy to know I’d be around a little longer to see my son grow up.” [page 5]
“. . .I’m cleared, I can take my son to the batting cage. We go sailing on my boat and take nice vacations. I even retired from the railroad and started a successful cab business, which I really enjoy. I’m loving life.” [page 5]
The FDA found that while these statements might reflect this patient’s experience, it is misleading because it implies that all such patients will successfully achieve a Sustained Virologic Response (SVR).........
Read the FDA warning letter here, and the Incivek story from the man who had stage 3 cirrhosis here.
Continue reading the article here.....
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FDA Warning Letter................
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| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
Vertex Pharmaceuticals, Inc.
| NDA 201917 Incivik (telaprevir) Film Coated Tablets | 5/25/12 |
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