African nations are refusing to accept US Food and Drug Administration approval of generic AIDS drugs, delaying the delivery of the less costly medicine to patients, according to US, UN, African, and drug company officials.
The problem highlights the lack of coordination between parallel US and UN drug regulators, which is frustrating US efforts to rapidly expand treatment in regions hardest-hit by the deadly virus.
Four countries – Nigeria, Uganda, Ethiopia, and Tanzania – have told South African generic drug maker Aspen Pharmacare that its FDA approval for antiretroviral drugs had no standing in their regulatory reviews of medicine, and that they have long required a study of the drugs safety and quality from the World Health Organization.
US officials said no one has been denied AIDS drugs so far because of their inability to deliver less expensive generic medicines, which can cost under 200 US dollar (1.800 DKR) a year per patient. The US is now buying and distributing brand-name drugs costing between 500 and 800 dollar a year.
It is unclear when the US will begin buying the less expensive drugs, although officials plan to start purchasing generic medicine in some countries within six months.
But if the process takes longer and AIDS treatment programs continue to rapidly register more patients as expected, activists say US reliance on brand-name drugs could mean growing numbers of people on waiting lists for the life-extending medicines.
Essentially, they argue, the cost of the more expensive drugs will eventually exceed budgets.
If US officials ”started a regulatory system that everyone could have agreed to more than a year ago, we would have been much farther along,” said Paul Zeitz, head of the Global AIDS Alliance, an advocacy group based in Washington, D.C. ”They created the controversy.”
A year ago, 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 rejected an option to send US scientists to Geneva to bolster the WHO staff.
Establishing a parallel review system for AIDS drugs created tension between WHO and the US global AIDS program. But WHO officials said from Geneva that they are working with FDA scientists to speed exchange of information on any drugs approved by the US regulator. WHO regulators have declined, however, to give a rubber stamp to FDA-approved drugs.
– We will approve those drugs very quickly. We are more than happy to have that kind of relationship with the FDA, said Dr. Jim Yong Kim, WHOs head of HIV/AIDS programs. He added that the Africans reliance on WHO standards ”shows the importance of our process, and the strength of our relationship with the countries.”
But US officials are barely concealing their impatience on relying on WHO approval, which they had earlier rejected as not stringent enough. In the last year, the WHO process also has had its share of difficulties, delisting 18 drugs that previously had been approved.
Although many of those drugs are once again approved, such confusion over safety and quality of certain generic medicines has caused several African countries to switch treatment regimens.
– It is ironic, said Dr. Mark Dybul, deputy coordinator of the US global AIDS program, from Mozambique, where he was visiting US-funded programs.
– We have 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, added he.
Stavros Nicolaou, Aspens senior executive in charge of strategic trade development, expressed even more frustration.
– After we got FDA approval, we thought all the red tape would be waived, and there would be a flurry of orders, Nicolaou said in Cape Town during the recent Africa Economic Summit.
– It is baffling. You go to these countries, say, “Here is FDA approval”, and they say, “Sorry, we want WHO prequalification first”. What is Nigeria, Ethiopia, Uganda, and Tanzania, or the WHO going to do that is better than the FDA?”
In addition to WHO requirement, Nicolaou said the four countries also require registration of Aspen and of its drugs before allowing distribution. Nicolaou estimated that process could take nine months to a year.
Both Nigerian and Ugandan officials defended their reliance on the WHO process and said that registration of Aspen and its drugs could take as little as one to four months.
– I think our asking for WHO approval is partly historical and because of our membership in the organization, said Dr. James Makumbi, chairman of the National Drug Authority in Uganda.
– This is how we have been doing things for time immemorial. We do not 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 regulators review.
Dr. John Idoko, chairman of Nigerias national antiretroviral committee, said registering Aspens drugs ”could be fast-tracked”. – It should not take nine months to a year. It is a lot faster, I can assure you, he added.
Makumbi agreed, saying Aspen could be registered within four months.
The FDA has approved four generic AIDS drugs in the last seven months. At least one of the generic drug makers, Ranbaxy of India, has registered its drug with some African countries. WHO officials said they are now reviewing some of the FDA-approved drugs.
Kilde: The Push Journal
