Grassley seeking FDA reform over Ketek issues

Share this article:

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. 
Share this article:
close

Next Article in News

Email Newsletters

More in News

Star Group merges with Vox Medica, Calcium NYC

Star Group merges with Vox Medica, Calcium NYC

The newly formed group will be known as Calcium with Steve Michaelson, formerly of Rosetta Wishbone, at the helm.

Survey finds pay doesn't make doctors happy

Survey finds pay doesn't make doctors happy

Medscape's survey of over 24,000 physicians found that a paycheck is not necessarily linked to a physician's professional satisfaction.

CDC sees declines in some diabetes complications

CDC sees declines in some diabetes complications

Centers for Disease Control data shows that diabetes complications including heart attack and amputation fell in the twenty years between 1990 and 2010. The bad news: the number of diagnosed ...