BioCentury
ARTICLE | Politics & Policy

Congress investigating Ranbaxy drug approvals

July 23, 2008 1:08 AM UTC

Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said on Tuesday they launched an investigation into whether FDA knowingly allowed Ranbaxy (NSE:RANBAXY; BSE:500359) to introduce adulterated and misbranded products into the U.S. market.

In a letter to FDA Commissioner Andrew von Eschenbach, the lawmakers said documents filed by the U.S. Department of Justice indicate FDA was aware of an alleged pattern of fraudulent conduct "for at least 18 months, yet did nothing to remove the suspect products from the market, or even notify the pharmacists in this country that Ranbaxy may have been distributing products that may have been obtained using fraudulent bioequivalence data and/or manufactured in a manner seriously out of compliance with current Good Manufacturing Practices." FDA said it cannot comment on an ongoing investigation. ...