The Congressional subcommitte Oversight and Investigations will be issuing subpoenas to FDA investigators over the antibiotic Ketek. They are looking for more information into fraudulant clinical data that was used to gain approval for the drug. Last year the FDA issued a black box warning label for Ketek, the highest safety warning. The subcommittee is investigating drug safety and whether the FDA and the drug’s manufacturer knew of the bad data.
Sanofi-Aventis SA says one of its predecessors, Aventis, was not aware of fraud connected with a key Ketek study until after the study was submitted to the FDA. The agency has also said there was no intention to deceive the public. It did not know then that the entire study should not be relied upon.
The Department of Health and Human Services says that it is working with Congress in a way that will not compromise it’s staffs ability to do their job. The subcommittee will hold another hearing on Ketek on February 12th.