Ranbaxy accused of gaming FDA rules to thwart rivals

Ranbaxy Laboratories Ltd was accused in a lawsuit of conspiring with a web of lawyers and consultants to manipulate the US Food and Drug Administration (FDA) and block competition in the generic drug business.

Ranbaxy for years filed false or incomplete paperwork with the FDA to win 180 days of marketing exclusivity for generic drugs that the Gurgaon, India-based company wasn't ready to make, according to a complaint filed Tuesday in a Boston federal court.

The proposed class action was brought by Michigan retailer Meijer Inc. and its distribution arm. They are seeking to represent buyers of Roche Holding AG's Valcyte, which treats a virus afflicting transplant patients and people with AIDS, and Novartis AG's blood-pressure drug Diovan.

The lawsuit also names Sun Pharmaceuticals Industries Ltd, which completed its acquisition of Ranbaxy this year. A call to Sun's press office in India after regular business hours wasn't answered.

Ranbaxy's actions broke US antitrust law and amounted to a racketeering scheme that blocked competitors from getting generic medicines to market faster, the retailer alleged.

Generics makers race for "first-to-file" status to win 180 days of exclusivity, during which a drug's price plummets and generics makers reap the bulk of their profit, according to the complaint.

'Intentionally deceive'
Ranbaxy "stands out as one willing to intentionally deceive the FDA in order to win that race," the buyers said in the complaint. "The speed and volume of Ranbaxy's numerous filings came at the expense of truthfulness and accuracy."

Ranbaxy could also use its first-to-file status "as a valuable bargaining chip with its brand and generic competitors," the plaintiffs said.

The drugmaker allegedly carried out the scheme with a group of lawyers and a "purportedly independent regulatory consultant" to dodge FDA scrutiny and give the appearance of prompt action and truthful reporting, according to the complaint.

THIS INJECTION MIGHT HURT

• Ranbaxy Laboratories Ltd was accused in a lawsuit of conspiring with a web of lawyers and consultants to manipulate the US Food and Drug Administration (FDA) and block competition in the generic drug business.
   
• Ranbaxy for years filed false or incomplete paperwork with the FDA to win 180 days of marketing exclusivity for generic drugs the firm wasn't ready to make, according to a complaint filed Tuesday in Boston federal court