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originally posted by: Sillyolme
a reply to: tadaman
Then you must be for holding gun manufacturers responsible for the harm their products do. .
originally posted by: intrepid
originally posted by: Gothmog
a reply to: Sillyolme
So what happened? The drug company agreed to the price then supplied inferior drugs
Hillary probably asked for cheaper. Then agreed to the cheaper "watered down" version . Then used the savings to help fund her campaign.
When people use the words "probably", "if" or "but" they really have no leg to stand on. As for funding her campaign, this was resolved 3 years ago.
From 2002 to 2010, as an initiative of the Clinton Foundation, 4 million patients were able to access CHAI-negotiated ARV drugs and as of today, CHAI’s work, as a separate 501(c)(3), has over 11.5 million patients accessing treatment. ]Clinton Health Access Initiative (CHAI)
During 2004–2005, Dinesh Thakur and Rajinder Kumar, two Indian employees of Ranbaxy, blew the whistle on Ranbaxy's fabrication of drug test reports. Thakur's office computer was soon found tampered with. Ranbaxy then accused Thakur of visiting pornographic websites using his office computer, forcing him to resign in 2005. Thakur left India for the USA and contacted the Food and Drug Administration which started investigating his claims. As a result, on 16 September 2008, the Food and Drug Administration issued two warning letters to Ranbaxy Laboratories Ltd. and an Import Alert for generic drugs produced by two manufacturing plants in India.
By 25 February 2009 the US Food and Drug Administration said it halted reviews of all drug applications including data developed at Ranbaxy's Paonta Sahib plant in India because of a practice of falsified data and test results in approved and pending drug applications.
On 8 February 2012, three batches of the proton-pump inhibitor Pantoprazole were recalled in the Netherlands due to the presence of impurities.
On 9 November 2012, Ranbaxy halted production and recalled forty-one lots of atorvastatin due to glass particles being found in some bottles. Also in 2012, an apparent dosage mistake was reported in which 20 mg tablets were found in a bottle of atorvastatin labeled as containing 10 mg tablets; this led in 2014 to the voluntary recall in the United States of some 64,000 bottles.
In May 2013 the US fined the company US$500 million after it was found guilty of misrepresenting clinical generic drug data and selling adulterated drugs to the United States.
In September 2013, further problems were reported, including apparent human hair in a tablet, oil spots on other tablets, toilet facilities without running water, and a failure to instruct employees to wash their hands after using the toilet. Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility until the company complies with US drug manufacturing requirements.
CHAI announced in October 2003 it was going to distribute generic, low-cost HIV drugs from four foreign drug manufacturers: Ranbaxy; Cipla of Mumbai, India; Matrix Labs of Hydrabad, India; Aspen Pharmacare of Johannesburg, South Africa.
CHAI’s endorsement also allowed Ranbaxy to manufacture HIV drugs that would be bought by the U.S. government under the President’s Emergency Plan for AIDS relief — a $15 billion initiative proposed by former President George W. Bush.
The flow of U.S. funds combined with Clinton’s endorsement allowed the four foreign drug manufactures to become “good acquisition targets,” according to the report.
The companies enjoyed great financial profits and they “exploded as they partnered with the Foundation for several years,” the report states.
Blackburn says the worst part of the story were the “false hopes” offered by the Clinton Foundation.
“You think about the emotional state of health care workers as they are dealing with these individuals and the emotional state of the patients. To me it’s disturbing and very sad,” she said.
After the FDA's 2008 import alert, CHAI stopped sourcing drugs from Ranbaxy with the exception of two small batch medications, of which Ranbaxy was the sole supplier.
By ET Bureau | Apr 11, 2013, 11.15 AM IST
MUMBAI: Former US president Bill Clinton praised Indian generic drug companies such as Ranbaxy and Cipla for their stellar contribution in the fight against the HIV/AIDS scourge, saying their cheap drugs saved millions of lives.
originally posted by: Xcathdra
a reply to: Gryphon66
The first warning letter went out in 2002. The second went out in 2006. The Whistle blowers notified the FDA / DOJ in 2006.
CHAI used the company from 2003 to the present as I have not seen anything showing they cut contact with the Indian company.
ETA - what are the small batch medications and what are they used for?
Ranbaxy USA admitted to introducing into interstate commerce certain batches of adulterated drugs that were produced at Paonta Sahib in 2005 and 2006, including Sotret, gabapentin, and ciprofloxacin. Sotret is Ranbaxy’s branded generic form of isotretinoin, a drug used to treat severe recalcitrant nodular acne; gabapentin is a drug used to treat epilepsy and nerve pain; ciprofloxacin is a broad-spectrum antibiotic.
For consumers currently taking a Ranbaxy product affected by this action, FDA strongly advises these consumers not to interrupt their drug therapy, which could have serious implications for their health.
To date, FDA has no evidence of harm to any patients who have taken drugs made in these two facilities. Today’s actions are being taken as a preventive measure because the manufacturing processes at these two Ranbaxy facilities do not meet FDA’s regulatory standards. By focusing on the process used to make these drugs, FDA is working to prevent the possibility that a product that does not meet its specifications could get into the hands of U.S. consumers.
Additionally, consumers should know that products from Ranbaxy’s other plants are not affected by this action. FDA has inspected those facilities and to date they have met FDA standards for drug manufacturing.