US FDA role in Ranbaxy case comes under scanner
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17/07/2008
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Economic Times (New Delhi)
AUS Congressional Committee is launching an investigation into whether US Food and Drug Administration (FDA) was lenient in allowing Ranbaxy to sell new drugs in the US market when it was still investigating discrepancies at the Indian pharma major's manufacturing facility in India. The committee will also examine whether the USFDA took timely action against Ranbaxy.
"If these allegations are true, Ranbaxy has imperilled the safety of Americans in a manner similar to the generic drug scandal we uncovered twenty years ago. I would like to know whether FDA officials knew about these allegations and what, if any, action was taken,' a New Jersey-based newspaper quoted The House Energy and Commerce Committee chairman John Dingell as saying. The committee will also examine Ranbaxy's drug approvals in the US and potential violations of manufacturing regulations.
In a court filing, the US government's Department of Justice (DoJ) has alleged "a pattern of systematic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information about stability and bioequivalence' of the company's generic medications. DoJ also believes that violations "have resulted and continue to result in the introduction of adulterated and misbranded products' into the US.
A Ranbaxy spokesperson said, "The company is not aware of any Congressional Committee inquiry and has not received any communication. Ranbaxy is a highly regarded company that has always believed in upholding the highest standards of quality. All our plants are CGMP compliant and produce medicines that meet global norms.' Ranbaxy CEO and MD Malvinder Singh on Wednesday said the company was getting approvals from multiple plants and will be launching products in the US. However, Ranbaxy shares dropped 3.87% (Rs 18) on Thursday to close at Rs 452.50 on the BSE on a day the Sensex moved up 4.26%.
According to Ranbaxy's website, the Gurgaon-based company filed 28 Abbreviated New Drug Applications (ANDA) and received marketing nod for 18 new drugs from the FDA in 2007. Since 2006, the FDA has been investigating whether Ranbaxy's facility at Paonta Sahib in Himachal Pradesh adhered to the US standards and had put on hold the compliance status of the unit since mid-2006. In 2007, US sales accounted for 23% of Ranbaxy's over $1.5-billion global sales, up 2% from 2006. The Congress move against FDA is expected to further strengthen the drug regulator's scrutiny on Ranbaxy.
Earlier, to allay the concerns of its investors, Ranbaxy and Daiichi Sankyo together reiterated in a separate press release that the deal for Daiichi Sankyo to buy out Ranbaxy was "binding and final.' "Daiichi Sankyo, Ranbaxy and the Singh family stand by the deal and confirm that the terms of the deal remain unchanged,' the press release said.
Sector experts say that a political intervention in the US was on the cards. The allegations against Ranbaxy of selling adulterated drugs comes at a time when the US presidential elections are just around the corner. Also, the development puts the US healthcare at stake and would lead to questions as to why the US government did not take timely action. There are already concerns in the US about sourcing drugs from low-cost destinations like India and China, especially after 149 people died in the US after consuming heparin, a blood thinner, made in China. A US senator recently wrote to the FDA seeking details about outsourcing details of drugs by pharma majors such as Pfizer.