Grassley seeking FDA reform over Ketek issues
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 again.
“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.