Accord could speed distribution of generic AIDS drugs

JOHANNESBURG -- US Food and Drug Administration officials have agreed to share confidential information on their approvals of generic AIDS drugs with the World Health Organization, US and WHO officials said yesterday. The landmark deal is expected to speed the distribution of the lower-cost medications throughout poor countries.

The arrangement, negotiated over three months and quietly signed late last week, is also expected to clear the way for the first US purchases of generic AIDS drugs, which could arrive in countries in two or three months.

The officials said the deal stands to streamline the process: The FDA will pass on its files about the drugs; WHO will add them to its list of approved medicines; and poor countries will allow importation of the drugs, giving the United States the opening to buy and distribute them.

Just a few months ago, several African countries had said they would not accept the US regulator's findings on the drugs, insisting instead on WHO's stamp of approval.

While US officials have not figured out potential cost savings from using generics, the example of Nigeria is one yardstick. The US government now buys brand-name AIDS drugs for roughly 13,000 people in Nigeria at a cost of about $500 per patient a year; FDA-approved generic drugs, manufactured by Aspen Pharmacare in South Africa, cost about $300.

If the United States was now buying the generic Aspen drugs, the theoretical savings for Nigeria alone would be roughly $2.6 million a year -- enough to put another 8,666 people on the life-extending antiretroviral medicines. Around the world, an estimated 37 million people are infected with HIV, the virus that causes AIDS, and an estimated 25 million of them live in sub-Saharan Africa.

An estimated 5 million to 6 million people need life-extending antiretroviral medicine; less than 20 percent now receive the drugs.

The major reason that more poor people worldwide are not receiving the drugs is not cost or lack of supply, although both contribute to the problem. The main factor is that most people do not know they are infected. The cost of the drugs will greatly rise in importance in coming months and years, as large numbers of people begin to learn their HIV status because of more aggressive testing programs across Africa.

The deal ''is going to reduce the cost of AIDS drugs, and we also hope it decreases the confusion on the ground," Jim Yong Kim, WHO's director of the department of HIV/AIDS, said in a telephone interview from Botswana. ''Now you have the situation in many countries of one funder buying one kind of drug, and another funder buying another kind, and it makes things very complicated."

The US global AIDS program, by far the largest in the world in committing $15 billion over five years, will not purchase any generic AIDS drugs without FDA approval of those medicines. AIDS advocates strongly criticized the United States for not buying generics, but US officials said they wanted to make sure the drugs met the FDA's stringent conditions.

So far, since the FDA expedited review began about a year ago, the US regulator has approved nine generic AIDS medicines. The United States has not bought them because African countries would not allow the drugs.

Despite those approvals, several African countries, including Nigeria, Kenya, Ethiopia, and Uganda, still would not allow the medicines to be used. African regulators said they first wanted WHO's so-called ''pre-qualification" of the drugs. For years, they have recognized and trusted only the WHO system.

Those rejections spurred the FDA-WHO talks. Now, under the deal, the FDA will in the next few weeks ask the generic companies if they can pass test results and inspection reports to WHO's specialists. With the expected permission, WHO officials will then examine the files and quickly decide about whether to put the drugs on the prequalification list, officials said.

''The WHO promised us it is a matter of a week, two weeks, less than a month," before they approve the drugs, a senior US Health and Human Services official, speaking on the condition of anonymity, said in a telephone interview from Washington. ''We expect this to speed things up dramatically. Because of a big backlog of applications at the WHO, some of these drug companies' applications are way down the list. Now they will be dealt with quickly."

Kim, the WHO official, said: ''Now we have to have technical meetings, so we understand what we need to do. But the level of cooperation between the US government and WHO is really encouraging for everybody."

The senior US official said Aspen and two generic-drug companies based in India -- Ranbaxy Laboratories and Hetero Drugs -- could soon benefit from the WHO fast-track review, putting them in line for US contracts.

Before the FDA and WHO agreement, Nigeria's drug regulator, the National Agency for Food and Drug Administration and Control, had told Aspen several months ago that it needed WHO approval of the company's drug. But after the Globe published an article in June about African countries' rejection of the FDA-approved drugs, Nigeria did a turnaround.

On July 9, the regulator granted a waiver to Aspen's local agent to accept importation of the drugs, according to a document obtained by the Globe. Aspen still needs to reregister in Nigeria, but a senior official at the firm said the regulator's waiver should clear the way for delivery of the drugs to Nigeria as early as October.

In Uganda, Dr. James Makumbi, chairman of the National Drug Authority, had said in an interview in June that he needed WHO approval of the drugs before his board could consider the FDA-approved medicines.

Told last night of the FDA deal in a telephone interview from Uganda, he exclaimed, ''Oh, that's very good news for me! It simplifies my life so much. The absence of WHO approval has been the main hitch."

John Donnelly can be reached at donnelly@globe.com.