House Members Send Letter To Secretary Of State Rice Requesting Information On Antiretrovirals Supplied To PEPFAR By Ranbaxy

Main Category: HIV / AIDS
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 23 Sep 2008 - 6:00 PDT

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Rep. John Dingell (D-Mich.) and members of the House Committee on Energy and Commerce on Friday sent a letter to Secretary of State Condoleezza Rice requesting information about alleged safety problems with antiretrovirals manufactured by the Indian generic pharmaceutical company Ranbaxy and distributed through the President's Emergency Plan for AIDS Relief, the AP/International Herald Tribune reports (AP/International Herald Tribune, 9/19).

FDA last week announced that it has banned imports of more than 30 generic drugs -- including antiretrovirals -- that were manufactured by Ranbaxy, citing manufacturing deficiencies at two of the company's plants. According to Deborah Autor, director of FDA's compliance office, FDA inspections earlier this year found violations at Ranbaxy factories that could lead to contamination, allergic reactions and other problems, and the company has not taken proper steps to correct them (Kaiser Daily HIV/AIDS Report, 9/17).

The lawmakers in the letter requested a list of all nongovernmental organizations that have received antiretroviral drugs from Ranbaxy, as well as details of all medications the company supplied to PEPFAR, the Business Standard reports (Business Standard, 9/21). The lawmakers also asked Rice whether any countries or groups participating in PEPFAR have contacted the State Department with concerns about the safety or efficacy of antiretrovirals manufactured by Ranbaxy.

FDA officials said they are communicating with the World Health Organization and other representatives of groups responsible for antiretroviral distribution in Africa. In addition, the Department of Justice has launched an investigation into whether antiretrovirals manufactured by Ranbaxy were "weak or adulterated." Dingell in a statement said, "It is important that the recipients of PEPFAR drugs know the FDA has done everything it should be doing to ensure the safety and effectiveness of these life-saving medications" (Favole/Mundy, Dow Jones, 9/19).

Ranbaxy has received an estimated $8.9 million from PEPFAR, the Business Standard reports (Business Standard, 9/21).

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