By Ed Silverman // May 31st, 2012
As for the letter, the FDA chastised the drugmaker for submitting a patient story that failed to match reality, at least as far as the agency is concerned. The proposed Vertex patient talk features “James M.,” a real guy who never quite says how he contracted hepatitis C, but portrays himself as an average sort who kicked around for awhile, had a good time and wound up with a diagnosis, a divorce and a four-year-old son to raise all around the same time (that’s James M. in the picture).
However, the FDA says Vertex went too far. The ad “misleadingly implies that most or all cirrhotic prior null responders (those who did not previously respond to treatment) who are infected with hepatitis C will successfully achieve Sustained Virologic Response (SVR) on Incivek combination therapy. FDA is not aware of substantial evidence or substantial clinical experience to support this implication. One patient’s treatment response does not constitute substantial evidence,” the agency writes in its May 25 letter.Continue Reading @ Pharmalot
Read the FDA warning letter here, and the Incivek promotional story here.
Continue reading the article here. More from the Boston Business Journal
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