Senator Chuck Grassley (R-IA) has asked the HHS Inspector
General to investigate the FDA's troubled approval of the Sanofi-Aventis
antibiotic Ketek based exclusively on allegedly “unreliable” foreign safety data.
In a letter to FDA commissioner Andrew von Eschenbach
Grassley recommended changes at the agency to ensure that it doesn't happen
“It is troubling, if FDA is approving new drugs based
primarily on questionable data in order to incentivize companies to develop new
antibiotics, especially when the drugs are for conditions that may not even
require antibiotic treatment,” he wrote.
Grassley's 22-page letter alleged that FDA knowingly
approved Ketek in 2004 exclusively on foreign safety data, an “unprecedented”
occurrence, that were called unreliable at the time by FDA reviewers.
The FDA never fully followed up on its own
recommendations against Ketek's approval, Grassley alleged, hinting that the
sponsor knew of the trial data deficiencies but submitted them anyway.