US Pays High Prices for Global AIDS Drugs, Study Says
2 articles sur la stratégie américaine de subvention déguisée aux labos pharmas américains (ndlr)
According to congressional investigators, the US government is paying twice as much for many of the drugs in its global AIDS program as other international aid groups pay because the Bush administration will not buy cheaper drugs from India.
The Government Accountability Office's draft report states that the lowest price available to the United States for the stavudine, lamivudine and nevirapine regimen is $562 per person annually. International aid groups not bound by US restrictions pay $215. The report's public release will not come until after the administration submits comments to GAO.
For months, administration officials have said they will buy the Indian-made drugs once they are certified safe by the Food and Drug Administration. The Indian drugs are cheaper and are administered as two pills daily instead of six. The administration says the issue is safety, not generics versus brand-name drugs. But a special FDA approval process, established in May, has yet to approve a three-in-one AIDS pill, in part because some companies have not submitted applications. AIDS advocates call the FDA review unnecessary and say the administration should treat the AIDS epidemic as an emergency.
Programs funded by the World Bank and the Global Fund to Fight AIDS, TB and Malaria are using Indian drugs prequalified by the World Health Organization. WHO has removed a few of the Indian drugs from the prequalified list due to data problems.
To secure FDA approval, foreign manufacturers must demonstrate that their generics are equivalent to brand-name products, and they must submit detailed information about chemistry and production. They cannot simply submit copies of the information given to WHO; they must also allow FDA to inspect their plants.
Bill Haddad, advisor to the Indian firm Cipla Ltd., said FDA has been helpful but the process is cumbersome, and the company is still evaluating whether applying is worthwhile.
Chuck Capariello, spokesperson for Indian drug-maker Ranbaxy Laboratories Ltd., said the company last week applied for FDA approval of one medication and plans to submit applications for 12 other products, including a combination drug, early in 2005. Aspen Pharmacare Inc. of South Africa said it will apply for FDA approval.
Dr. Mark Dybul, chief medical officer for the Office of the US Global AIDS Coordinator, said he is hopeful a three-in-one pill will win FDA approval early next year.
2 articles sur la stratégie américaine de subvention déguisée aux labos pharmas américains (ndlr)
According to congressional investigators, the US government is paying twice as much for many of the drugs in its global AIDS program as other international aid groups pay because the Bush administration will not buy cheaper drugs from India.
The Government Accountability Office's draft report states that the lowest price available to the United States for the stavudine, lamivudine and nevirapine regimen is $562 per person annually. International aid groups not bound by US restrictions pay $215. The report's public release will not come until after the administration submits comments to GAO.
For months, administration officials have said they will buy the Indian-made drugs once they are certified safe by the Food and Drug Administration. The Indian drugs are cheaper and are administered as two pills daily instead of six. The administration says the issue is safety, not generics versus brand-name drugs. But a special FDA approval process, established in May, has yet to approve a three-in-one AIDS pill, in part because some companies have not submitted applications. AIDS advocates call the FDA review unnecessary and say the administration should treat the AIDS epidemic as an emergency.
Programs funded by the World Bank and the Global Fund to Fight AIDS, TB and Malaria are using Indian drugs prequalified by the World Health Organization. WHO has removed a few of the Indian drugs from the prequalified list due to data problems.
To secure FDA approval, foreign manufacturers must demonstrate that their generics are equivalent to brand-name products, and they must submit detailed information about chemistry and production. They cannot simply submit copies of the information given to WHO; they must also allow FDA to inspect their plants.
Bill Haddad, advisor to the Indian firm Cipla Ltd., said FDA has been helpful but the process is cumbersome, and the company is still evaluating whether applying is worthwhile.
Chuck Capariello, spokesperson for Indian drug-maker Ranbaxy Laboratories Ltd., said the company last week applied for FDA approval of one medication and plans to submit applications for 12 other products, including a combination drug, early in 2005. Aspen Pharmacare Inc. of South Africa said it will apply for FDA approval.
Dr. Mark Dybul, chief medical officer for the Office of the US Global AIDS Coordinator, said he is hopeful a three-in-one pill will win FDA approval early next year.
posted by Dr Philippe Maslo at 08:11
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