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Akron Univ. School of Law

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Wednesday, June 22, 2005

FDA's Approval Not Enough For Some African Countries

Four African countries - Nigeria, Uganda, Ethiopia and Tanzania - are refusing to allow delivery of generic AIDS drugs that the US Food and Drug Administration has approved.  According to the Boston Globe, these countries have told South African generic drug maker Aspen Pharmacare that "its FDA approval for antiretroviral drugs have no standing in their regulatory review of medicine, and that they have long required a study of the drug's safety and quality from the WHO. " The effect of this is a delay of delivery of the lower cost medicine to patients. 

Many US, UN, and African officials are now asking the WHO to immediately approve the FDA-tested drugs and Dr. Kim, WHO's head of HIV/AIDS program, says he will approve the drugs quickly.  He adds that the Africans' reliance on WHO standards "shows the importance of our process, and the strength of our relationship with the countries."

This conflict stems from the lack of coordination between parallel US and UN drug regulators, which makes it difficult for the US to rapidly increase treatment in regions hardest hit by the AIDS/HIV virus.  Last year US officials said they would buy generic AIDS drugs for Africa as long as those medicines met the same safety standards established for sale in America.    They said WHO standards would not ensure the same quality standard, and the US rejected an option to send US scientists to Geneva to assist the WHO.  US officials argue that confusion over safety and quality of certain generic medicines caused by the WHO in its approval and disapproval process has caused several African countries to switch treatment regimens. 

Paul Zeits, head of the Global AIDS Alliance, criticizes the US, arguing that if US officials had "started a regulatory system that everyone could have agreed to more than a year ago, we would have been much farther along...[the US] has created the controversy." 

Establishing a parallel review system between WHO and the US global AIDS program has proven to be difficult.  Dr. Mark Dybul, deputy coordinator of US global AIDS program says that "we've been blamed by quite a few people about delaying procurement of drugs by going through a stringent regulator before we make the drugs available.  And now we have the premier stringent regulatory agency in the world..or one of them..find that the drugs meet all the requirements, and then we have the inability to use the drugs."  Dr. James Makumbi, chairman of the National Drug Authority in Uganda defends their position by saying that "asking for WHO approval is partly historical and because of our membership in the organization...This is how we've been doing things for time immemorial.  We don't ask for FDA approval.  I think this is basically a problem with the FDA interacting with the WHO, because the WHO can always endorse the US regulator's review." 

The FDA tentatively approved two generic versions of a major AIDS drug on Monday.   According to the AP, the two tentative approval applications for neviraprine tablets go to two companies in India, Ranbaxy Laboratories Limited and Aurobindo Pharma LImited in Hyderabad.   The drugs can be used by relief organizations outside the United States funded by the US AIDS relief plan.  Last year some criticized the administration for refusing to purchase drugs that hadn't been reviewed by the FDA, and in effect, were bolstering the sales of US drug makers at the expense of AIDS patients in the developing world. 

Thanks to Lindley Bain for her work on this post.  [tm]

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