• E-mail
• Print
• RSS

Congress: When did FDA know about problems with Ranbaxy drugs?

Pharma Compliance Alert, July 30, 2008

Representatives Bart Stupak (D-MI) and John Dingall (D-MI) are trying to determine when the FDA became aware of potential problems with drugs sold by Ranbaxy.

On July 3, the Department of Justice (DOJ) filed a motion in U.S. District Court in Maryland seeking documents from Ranbaxy. In its filing, the DOJ alleged some of the products Ranbaxy manufactured were too strong, too weak, or lacked the proper shelf life. The DOJ also claims the FDA knew about the alleged problems for 18 months and did nothing to remove the products.

In a letter to FDA commissioner Andrew Von Eschenbach, the Representatives said the allegations against the FDA, if true, “would call into serious question whether the leadership of the Agency . . . have met even the minimum requirements of due diligence.”

The Representatives requested all documents related to those drugs Ranbaxy is approved to market in the U.S. relating to:

• Pre-approval inspections
• “For-cause” inspections
• Findings by investigators during inspections

Inspections of laboratories performing bioequivalence studies

• Comment
• E-mail to a Colleague
• Print
• RSS
• Archive

Comments