FDA Moves to Disqualify Ketek Trial Investigator

Another investigator involved in a study of Sanofi-Aventis’ antibiotic Ketek is facing disciplinary action. The FDA sent Keith Pierce, who conducted a Ketek trial at the Michigan Institute of Medicine, a Notice of Initiation of Disqualification Proceeding and Opportunity to Explain letter March 17, claiming he submitted false information to the sponsor. The 2003 trial compared Ketek (telithromycin) with GlaxoSmithKline’s Augmentin (amoxicillin/clavulanate potassium) in outpatients with respiratory tract infections.
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