ProPublica Examines U.S. Investigation Into Pharmaceutical Company Ranbaxy Over Antiretrovirals Used In PEPFAR, Other Drugs

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 19 Aug 2008 - 8:00 PST

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ProPublica on Thursday examined a U.S. investigation into whether Indian pharmaceutical company Ranbaxy engaged in a "pattern of systemic fraudulent conduct" by concealing its drug manufacturing process violated FDA standards, including HIV/AIDS medications used in the President's Emergency Plan for AIDS Relief (Andrews, ProPublica, 8/14).

U.S. investigators last month announced that they are looking into whether Ranbaxy manufactured substandard generic drugs. Ranbaxy under a U.S. government contract was paid to provide low-cost antiretroviral drugs under PEPFAR, and 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 (Kaiser Daily HIV/AIDS Report, 7/15).

According to ProPublica, PEPFAR in 2007 allocated $9 million in funding to Ranbaxy for its generic antiretrovirals, and more than 1.8 million packages of the Ranbaxy-produced drugs were sent to PEPFAR's 15 focus countries. Ranbaxy has not been formally charged, and some of its drugs remain on FDA's list of generic antiretrovirals approved for PEPFAR despite the investigation. ProPublica reports that it is not clear how the drugs maintained their approval status and continued to be purchased through PEPFAR. An FDA spokesperson said FDA is not involved in the purchase or distribution of antiretrovirals through PEPFAR. "We only expedite the approval process," the spokesperson said, adding, "Another agency pulls the trigger."

According to a spokesperson for the Office of the Global AIDS Coordinator, the U.S. embassy in each PEPFAR country is responsible for developing a "country operational plan" for each fiscal year that describes how funding will be spent. ProPublica reports that it is not clear whether the U.S. embassies were told of the Ranbaxy investigation or any potential substandard manufacturing (ProPublica, 8/14).

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