U.S. Investigating Indian Pharmaceutical Company Ranbaxy Over Generic Drugs, Including Antiretrovirals Used In PEPFAR

Main Category: HIV / AIDS
Also Included In: Pharma Industry / Biotech Industry
Article Date: 16 Jul 2008 - 12:00 PDT

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U.S. investigators are looking into whether Indian pharmaceutical company Ranbaxy Laboratories manufactured substandard generic drugs, including HIV/AIDS medications provided to thousands of HIV-positive people in Africa, the Wall Street Journal reports. Ranbaxy under a U.S. government contract was paid "millions of dollars" to provide low-cost antiretroviral drugs under the President's Emergency Plan for AIDS Relief, according to the Journal. Investigators at the Justice Department and FDA have said that some of the drugs were substandard, impotent or unstable. In addition, court filings and lawyers close to the investigation indicate that Ranbaxy manufactured documents to cover up the poorly made drugs, the Journal reports.

Ranbaxy on Monday issued a statement acknowledging the investigation, and the company in a federal court filing said that it is cooperating with investigators and that it will provide documents sought by the U.S. Ranbaxy in the court filing acknowledged some "serious allegations concerning compliance with U.S. law." The filing added that "except for issues that have been fully aired with the government, Ranbaxy knows of no evidence to support these allegations." Company spokesperson Chuck Caprariello declined to comment (Wilke, Wall Street Journal, 7/15). The drugmaker in the court filing also said that federal prosecutors have not revealed the scope of the investigation. "The government has chosen not to share such information yet," it said, adding, "If and when the government chooses to share the details of its concerns, Ranbaxy commits to responsibility (to) respond to, and resolve, those concerns." In the separate statement, Ranbaxy said that the "allegations are baseless" (Jordan, Newark Star-Ledger, 7/15).

U.S. investigators in a July 3 court filing said that the investigation involves a "pattern of systematic fraudulent conduct," including allegations of health care fraud, contract fraud, false claims and fabrication of documents. The filings aimed to compel Ranbaxy to release audits of its plants conducted by a consultant that the company had said were privileged. In addition, prosecutors told the court that Ranbaxy consistently lied to FDA about the formulation of its generic drugs. FDA agents in February 2006 inspected a Ranbaxy plant in India and discovered quality issues, according to warning letters from the agency to the company. FBI and FDA agents in February 2007 raided Ranbaxy's U.S. offices in Princeton and South Brunswick, N.J. (Wall Street Journal, 7/15).

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