FDA comes under Congress scanner over Ranbaxy

FDA comes under Congress scanner over Ranbaxy
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First Published: Thu, Jul 17 2008. 02 48 PM IST
Updated: Thu, Jul 17 2008. 02 48 PM IST
New York: The US drug regulator FDA, which has charged Ranbaxy of selling unsafe medicines in the country, has come under the parliamentary scanner and will be probed for its conduct in approving the Indian pharma major’s products and other potential violations in the matter.
A Congressional Committee has said it would examine Ranbaxy’s drug approvals in the US and potential violations of manufacturing regulations, a media report said.
Besides, the House Energy and Commerce Committee would also “look at why the FDA continued to approve medicines made by the company and allow shipments into the US while it was questioning Ranbaxy’s manufacturing processes,” the Star Ledger newspaper reported.
The report said that the Committee “wants to find out whether the FDA knowingly allowed unsafe and ineffective medicine to enter the US.”
The inquiry stems from a federal court filing by the US Department of Justice, where it has been alleged that there have been “a pattern of systematic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information about stability and bio equivalence of the company’s generic medications.”
The Justice Department has also cited a failure by Ranbaxy to report in a timely fashion it distributed drugs that did not meet proper specifications, and has accused the company of concealing violations of good manufacturing practice regulations from FDA.
“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,” the Star Ledger report quoted House Energy and Commerce Committee chairman John Dingell as saying.
”I would like to know whether FDA officials knew about these allegations and what, if any, action was taken,“ the report further quoted Dingell as saying.
Earlier, Ranbaxy said that the current motion filed by the DoJ was “just a motion” seeking additional information and clarification, while asserting its deal with Daiichi Sankyo stands.
“We have been cooperating with them (DoJ) and will continue to do so. In the meantime, our business in the US continues as normal,” Ranbaxy CEO and MD Malvinder Singh said.
“There is no disruption as far as our business in the US is concerned. We continued to file for approvals from the US FDA and are also getting it,” Singh added.
Dispelling doubts about the deal with Daichii Sankyo after the motion filed by DoJ, he said: “They were aware of these issues while conducting due diligence. There is no change in the deal and there is no exit clause in it.”
He also clarified that the company’s plant Poanta Sahib, the genesis of probe by the US FDA, continued to supply existing drugs to the US market, while new drugs were being supplied from other manufacturing locations.
Singh also said Ranbaxy’s patent settlements with Pfizer for cholesterol lowering drug Lipitor and Astrazeneca for ulcer drug Nexuim would not be affected by the motion filed by the DoJ.
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First Published: Thu, Jul 17 2008. 02 48 PM IST
More Topics: Ranbaxy | USFDA | Lipitor | AstraZeneca | Pfizer |