February 27, 2009
FDA on Wednesday halted its review of all pending applications from India's Ranbaxy Laboratories, citing fraudulent laboratory tests dating back to 2006, the Washington Post reports. This is the second sanction against Ranbaxy in six months -- officials in September 2008 blocked the company from importing some drugs made at its plants in Dewas and Paonta Sahib (Layton, Washington Post, 2/26). Ranbaxy manufactures generic antiretroviral drugs used in the U.S. and in the President's Emergency Plan for AIDS Relief, as well as other generic drugs (Kaiser Daily HIV/AIDS Report, 9/17/08).
According to the Post, FDA investigators said the current problems concern the company's plant in Paonta Sahib, which has produced 25 FDA-approved drugs. Most of those drugs are not believed to be carried in U.S. pharmacies, and FDA is not seeking a recall on the medications because regulators do not believe the drugs post a health risk. The affected drugs include medications for high cholesterol and an antihistamine, but FDA would not provide a specific list, the Post reports. Deborah Autor, director of compliance at FDA, said there is "no concern about the safety or efficacy of Ranbaxy's drugs on the U.S. market." However, federal officials said they were concerned enough by their investigation into the plant that they decided to stop approvals of any new or pending applications for Ranbaxy's drugs. If Ranbaxy improves its manufacturing process the agency will resume approvals, Autor said. Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research, said patients using the drugs should not stop their treatment (Washington Post, 2/26).
According to the Newark Star-Ledger, FDA said the company did not properly test the shelf-life and other safety measures of its drugs and then lied about the results. Ranbaxy said in a statement that it will "continue to cooperate with" FDA and that "[n]o effort or action will be spared to protect key (new drug applications) from Paonta Sahib" (Todd, Newark Star-Ledger, 2/26).
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