E-DRUG: Africa prefers WHO prequalification over FDA registration
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[Interesting complication for FDA-approved generic ARVs that are not (yet) WHO pre-qualified. USA did not recognize WHO PQ as stringent enough to certify the quality of ARVs, but now African countries do not recognize the FDA registration...
Also, the African countries want to have the drugs registered in their own countries, but this registration is not enough to convince the Global Fund to pay for them, as it considers African Drug Regulatory Authorities as "not stringent" enough.... Three million AIDS patients are waiting for the life-saving drugs and wonder why they have to die this year... Can the world please agree on one joint quality system for ARVs, and make sure it works effectively and has enough funds to perform its work? Copied as fair use. WB]
AIDS drugs hit roadblock in Africa - Dispute over generics stalls treatment efforts
By John Donnelly,
Boston Globe
June 20, 2005
PRETORIA -- 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 drug's safety
and quality from the World Health Organization, officials confirmed in
interviews last week.
This roadblock, unanticipated by US officials, has set off a flurry of
anxious discussions in recent weeks among US, UN, and African officials,
including a phone call from US global AIDS coordinator Randall L. Tobias
to WHO's director general, Dr. Lee Jong-wook, requesting immediate
approval of any FDA-tested drugs.
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 a year per patient. The United States is now buying and
distributing brand-name drugs costing between $500 and $800 a year.
It is unclear when the United States 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 in
telephone interviews 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'll approve those drugs very quickly. We're more than happy to have
that kind of relationship" with the FDA, said Dr. Jim Yong Kim, WHO's
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, in a telephone interview from Mozambique, where he
was visiting US-funded programs. ''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."
Stavros Nicolaou, Aspen's 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 an
interview in Cape Town during the recent Africa Economic Summit. ''It's
baffling. You go to these countries, say, 'Here's 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, in a telephone interview from
Kampala. ''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.
Dr. John Idoko, chairman of Nigeria's national antiretroviral committee,
said registering Aspen's drugs ''could be fast-tracked."
''It shouldn't take nine months to a year," he added. ''It's a lot
faster, I can assure you."
Makumbi agreed, saying Aspen could be registered within four months.
Regulators in Ethiopia and Tanzania did not return phone messages last
week.
Dybul said in a second interview from Washington late last week he has
had no indications that the delay in US purchase of the generic
medicines resulted in denying AIDS therapy to patients. He also said he
hoped the US program would begin buying some generic AIDS drugs in the
next six 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.
''Each country needs to make their own decision about approving the
drugs," Dybul said. ''We have raised this issue with ministers of
health, and wherever else we can. This is an urgent matter. We should be
pushing as hard as we can."
John Donnelly can be reached at donnelly@globe.com