FDA's role over Ranbaxy issue to be probed

This follows the US drug regulator FDA, which has charged Ranbaxy with selling unsafe medicines in America, coming under the Congress scanner.      

Democrats from Michigan on the House Energy and Commerce Sub-Committee John Dingell and Bart Stupak are questioning whether FDA officials knew about the potentially fraudulent information but approved Ranbaxy's products anyway.      

"If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago," said Dingell.      

"I would like to know whether FDA officials knew about these allegations and what, if any, action was taken," he added.     

"One of the great reforms to come out of the generic drug scandals was the institution of pre-approval inspections," said Stupak.     

"We learned from investigating contaminated heparin that such inspections were dispensed with in the case of the active pharmaceutical ingredient manufactured in China, which resulted in a public health disaster."      

Now it appears that such inspections in India, the second largest supplier of drugs to the US, may be another example in which FDA found it inconvenient to assure the safety and effectiveness of drugs before approving them for marketing to American patients.      

"If that is the case, then the American people should not have to wait until January for change and this Administration should clean house at the FDA now," he added.      

The law-makers have said that the Committee will soon commence a formal probe into the Ranbaxy drug approvals.