Congress To Probe Ranbaxy Allegations
2 CommentsBy 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?
Janine
Believe it to be true! I have read a great deal about this. I am one who has experienced this problem first hand. About 4 months ago I was switched from one very reliable generic, which I took the same brand of for many years. This drug is to control very painful symptoms of a chronic bladder condition and now I am totally ill and in pain most of the time. I can’t prove that this exact generic drug came from this manufacturer, Ranbaxy, but I do know that one of my drugs was on the FDA blocked drug list; now I fear to take that one at all. This is sickening and should be immediately investigated. What is the FDA waiting for? They knew this about Ranbaxy for 2 yrs. I read the class action suit online. If a few of their plants are cheating on the active ingredients in their drugs, than who is to say they are not manufacturing from their other factories, even more defective or sub-standard drugs? I think this problem is more wide-spread than we even know. My doctor agrees with this article; she has had countless reports of generic drugs not working for her patients. What else can I say. For people suffering one needs to have faith in the drugs they take. If we continue to import sub-standard or defective drugs then we must oversee that operation with the utmost care for our safety.