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Feds scrutinize generic maker.


by Anderson, Jane
Internal Medicine News • August 15, 2008 • POLICY & PRACTICE

India's Ranbaxy Inc., 1 of the top 10 generic drug makers in the world, is being investigated by various arms of the federal government for allegedly introducing "adulterated or misbranded products" into the U.S. market. The company's auditor, Parexel Consulting, is also under scrutiny. According to a subpoena for documents filed in the U.S. District Court for the District of Maryland by the federal Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy submitted false information to the Food and Drug Administration on sterility and bioequivalence, covered up violations of good manufacturing practice, and defrauded Medicare. "If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago," said Rep. John Dingell (D-Mich.). "I would like to know whether FDA officials knew about these allegations and what, if any, action was taken."


COPYRIGHT 2008 International Medical News Group Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2008 Gale, Cengage Learning. All rights reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.


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