BioCentury
ARTICLE | Regulation

Political science

December 18, 2006 8:00 AM UTC

Last week's FDA advisory committee meeting on Ketek can only be understood in the context of Sen. Chuck Grassley's ongoing investigation of FDA's approval of Ketek as well as an ongoing review by the Government Accountability Office of all antibiotic approvals based on non-inferiority studies.

Grassley's investigation is focused on Study 3014, a large trial that sanofi-aventis Group (Euronext:SAN; SNY, Paris, France) undertook after the agency's Anti-Infective Drugs Advisory Committee recommended in April 2001 that telithromycin not be approved unless the company demonstrated safety in a large trial. ...