Congress To Probe Ranbaxy Allegations
1 CommentBy Ed Silverman // July 16th, 2008 // 7:05 pm
The House Energy and Commerce Committee wants to investigate the FDA’s handling of allegations that the Indian generic drugmaker sold potentially adulterated meds, The Star-Ledger of New Jersey reports.
The move comes after the Department of Justice filed papers alleging employees at Ranbaxy’s plant in northern India used raw chemicals from unapproved sources, fabricated bioequivalency and stability data to meet FDA standards, and attempted to conceal the ruse from FDA inspectors. The feds also charge the scheme extended to AIDS drugs distributed by the President’s Emergency Plan for AIDS Relief program (PEPFAR) to foreign countries.
“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,” John Dingell, a Michigan Democrat, who chairs the House Energy and Commerce Committee, tells the paper. “I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”
An FDA spokeswoman declined comment, saying the case is the subject of a federal investigation. A Ranbaxy spokesman couldn’t be reached. Earlier this week, Ranbaxy filed a response in court saying it would release audits that may shed light on the allegations. The drugmaker, which denied the charges, previously refused to provide the audits, which were conducted by Paraxel, citing attorney-client privilege.
Anne
I don’t know what to think. I want to think Ranbaxy is the bad guy for doing something illegal, but then again, is this just the FDA acting on the behalf of Big Pharma and trying to take out the competitor?