Sam Waksal, A Hepatitis C Medicine And An FDA Warning Letter

As a new batch of hepatitis C treatments emerges from the pharmaceutical pipeline, drugmakers are scrambling to position themselves to grab a chunk of what Wall Street estimates could be a $15 billion market. And Kadmon Pharmaceuticals is no exception, although its prized possession is an older treatment called Ribasphere that is currently used as part of a combination treatment and is being tested with forthcoming medicines. Kadmon, however, may have been a bit too eager to ensure the medical community is aware of Ribasphere, a name for ribavirin. The FDA has issued a scathing warning letter in response to a letter the drugmaker wrote to physicians. In its own missive, the agency writes that the numerous violations are “concerning from a public health perspective” and that one violation was “particularly egregious.” Specifically, the agency chastised Kadmon because its letter suggests that Ribavirin can be used in a broader range of patients and conditions than has been substantiated; material facts were omitted; unsubstantiated effectiveness claims were made and evidence was provided that indicate Ribavirin is intended for a new use that has not been approved (here is the Kadmon letter to physicians). The ceo at Kadmon, by the way, is Sam Waksal. If the name is not familiar, Waksal is the former ImClone Systems ceo who was convicted of insider trading in a scandal that also snared his friend, Martha Stewart. After leaving federal prison three years ago, he raised a ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs