Investigator to Congress: Ketek data was known to be fraudulent

A subpoenaed FDA criminal investigator has told Congress that Aventis should have known that data it submitted to support the approval of antibiotic Ketek was fraudulent.

James G. Dickinson

April 1, 2008

7:13 pm

A subpoenaed FDA criminal investigator has told Congressthat Aventis should have known that data it submitted to support the approvalof antibiotic Ketek was fraudulent. Agent Douglas Loveland testified that therewere so many “red flags” in one study that the company should have notified theFDA.

From the April 01, 2008 Issue of MM+M - Medical Marketing and Media

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