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Congress to Probe FDA Handling of Ranbaxy

Jul 17, 2008 | Parker Waichman LLP Members of Congress are getting ready to investigate the scandal surrounding generic drug maker Ranbaxy. The House Energy and Commerce Committee has scheduled a hearing to probe the Food and Drug Administration's (FDA) handling of allegations Ranbaxy sold potentially adulterated medicines.

Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995.  In February, federal agents raided the U.S. corporate offices of Ranbaxy in New Jersey, as well as a  manufacturing facility in the state.  The raid - and criminal investigation - was prompted, in part, by problems uncovered in FDA inspections a year earlier at the company’s plant in Paonta Sahib, India.  That inspection found inconsistencies in the company’s manufacturing processes and maintenance of data.

Earlier this month, US prosecutors filed a motion in federal court in Maryland alleging that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the this country.  The investigation is also looking into allegations that Ranbaxy  made weak or adulterated HIV drugs that were given to thousands of AIDS patients in Africa. Prosecutors have accused the company of concealing violations of good manufacturing practice regulations from FDA.

Ranbaxy was paid millions of dollars through U.S. government contracts to provide low-cost antiretroviral drugs under the president’s emergency plan for AIDS relief. Investigators at the Justice Department and the FDA allege that some of the drugs were poorly made, unstable or impotent. According to court filings  Ranbaxy fabricated documents to cover up the substandard products

"If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered twenty years ago," said Rep. John Dingell (D-Mich.), the committee chairman. "I would like to know whether FDA officials knew about these allegations and what, if any, action was taken."

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