The FDA sent a warning letter to Sanofi's CEO Gregory Irace accusing the company of knowingly having submitted clinical data had "multiple and significant violations of FDA regulations… that affected the integrity of data submitted".
After the FDA required more information on Ketek following fears that it could cause liver damage, data obtained as part of a postmarketing study by Pharmaceutical Product Development was submitted on behalf of Aventis prior to its merge with Sanofi-Synthelabo.
At the heart of the matter is Dr Anne Kirkman-Campbell who in 2004 was convicted of fraud regarding patient enrollment and fake consent forms during the Ketek study. The issue also raised concerns in Congress and a former Pharmaceutical Product Development employee testified that both her former employee and Aventis were aware of the problems with the clinical data but took no action.
Since its approval in 2004 Ketek appears to be responsible for 37 cases of liver injury or failure. The drug is still available but is only prescribed for the treatment of pneumonia. The original approval was not based on the data from the study in question.
[Source: DrugResearcher]
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