US House representatives probe FDA approval of Ranbaxy drugs

Mumbai: Close on the heels of an English Crown Court giving a clean chit to Ranbaxy Laboratories Ltd on Tuesday (See: UK Crown court rejects charges against Ranbaxy),  in a case relating to alleged price rigging in drug supplies to UK's National Health Services (NHS) between 1996-2000, US lawmakers have started investigations into  the Indian pharma major's drug sales in that country.

Democrats John Dingell and Bart Stupak said they are investigating whether the Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data.

The House representatives will look into whether Ranbaxy submitted false data to support generic drug applications and tried to hide manufacturing violations.

The current investigations are part of a larger probe initiated by by US law enforcement authorities – the justice department and the attorney's office – which filed a legal motion on the FDA's behalf on 3 July.

In letter to FDA, the authorities have sought documents to look into allegations that the pharma sector regulator was aware of ''fraudulent conduct by Ranbaxy'' but did nothing to remove suspect products from the market.

They also sought documents relating to its inspections of Ranbaxy facilities and its suppliers as also other related information.

The FDA is alleged to have colluded with Ranbaxy by "knowingly allowing drugs suspected of being fraudulently approved and manufactured in violation of good manufacturing practices,'' it was alleged.

Ranbaxy, which has agreed to a $4.6 billion takeover offer from Japan's Daiichi Sankyo, has denied allegations that it sold misbranded or adulterated drugs and said it was cooperating with the three-year-old probe by US authorities.