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

Doctors want to know how CMS plans to display Sunshine payment data

Doctors want to know how CMS plans to ...

Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like ...

Pfizer Q2 sales slip, but still beat expectations

Pfizer Q2 sales slip, but still beat expectations

Patent losses and lost co-promotion agreements put a dent in sales.

Lack of marketing partner delays Afrezza launch

Lack of marketing partner delays Afrezza launch

Afrezza was heralded as one of the most innovative diabetes products of the last decade. So, why hasn't MannKind set a firm launch date for the product?