The $15 billion U.S. program to combat AIDS in poor countries won approval yesterday to buy inexpensive combination drugs made by foreign companies, rather than more expensive brand-name products, opening the way to treat many more patients.
The Food and Drug Administration decision to approve a package of generic drugs by Aspen Pharmacare of South Africa effectively ends a bitter fight over whether President Bush's ambitious AIDS initiative would be limited to buying patented drugs from drugmakers in wealthy countries.
FDA official Murray Lumpkin said the foreign drug manufacturer meets U.S. standards.
(Andrea Bruce Woodall -- The Washington Post)
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"It's hard to exaggerate the importance of this announcement," said Mark Isaac, vice president at the Elizabeth Glaser Pediatric AIDS Foundation, which uses money from the president's AIDS initiative to treat patients in Zambia, South Africa, Tanzania and the Ivory Coast.
"For a large number of people in Africa and beyond, this could be a true turning point," he said. "This offers low-cost drugs for people who would otherwise face certain death . . . we estimate we could serve two to three times as many people taking the same regimen."
Other generics, especially from manufacturers in India, are in the same pipeline, and fixed-dose combination drugs are expected to become the mainstay of AIDS treatment in poor countries. By combining drugs made by different manufacturers into single pills, the generic companies offer easy-to-use formulations that are not available even to patients in wealthy countries, and at a fraction of the cost.
Yesterday's approval brings the U.S. AIDS treatment initiative more into line with international treatment programs that have long advocated the use of cheaper generics. The drugs will not be sold in the United States because the combination pills violate U.S. patents.
"It's wonderful news," said Richard Feachem, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, an independent foundation that is, along with the United States, among the largest funders of AIDS treatment programs in poor countries.
"This is an extremely significant step and very good news for the international effort to fight the global HIV-AIDS pandemic," he said. "If one stream of money has one set of rules and another stream of money has another set of rules, it puts people on the front lines in an impossible position."
The pharmaceutical industry has long raised concerns about the safety of such medications, but yesterday's announcement set concerns about Aspen Pharmacare's package to rest, said Mark Grayson, a spokesman at the Pharmaceutical Research and Manufacturers of America.
Grayson rejected the notion that the industry had voiced safety concerns as a way to keep less expensive drugs from being purchased with U.S. money: "It wasn't a way to keep the drugs off the market. It was a way to make sure people got the appropriate medicines. . . . People in Africa deserve safe and effective medicines."
Murray Lumpkin, acting deputy commissioner of the FDA for international and special programs, said that the approval process included inspections of Aspen's facility in South Africa. "It meets all of our safety, efficacy and manufacturing standards," he said.
The drug package combines three AIDS drugs. Two of them, 3TC and AZT, are already being sold as a combination drug called Combivir by Glaxo SmithKline in the United States. The Aspen package includes a generic version of Combivir and a third drug called nevirapine, which is sold in the United States by Boehringer-Ingelheim as Viramune. The set of two tablets will have to be taken twice a day, for a total of four tablets.
The price of Combivir in the United States is around $19 per person per day or about $7,000 a year, according to its manufacturer. Isaac said that the combination of Combivir and Viramune being used in Africa, purchased at discounted rates from patent-holders, runs around $55 a month per patient, or about $660 a year. Isaac expected that generic combinations like the Aspen package would sell for around $20 to $30 a month per patient, or around $240 to $360 a year.
Mark Dybul, assistant global AIDS coordinator in the State Department program that administers the U.S. AIDS initiative, said that there was every reason to expect that the U.S. program would be able to buy generic drugs at the cheapest rates available anywhere.
Feachem said an agreement between the Global Fund and the Clinton Foundation last year had brought the price of some AIDS drug treatment packages as low as $150 per person per year.
The praise for the FDA action was not unanimous: The humanitarian group Doctors Without Borders questioned the need for FDA's stamp of approval because the generic products had already been widely endorsed by international health groups.
Rachel Cohen, U.S. director of the group's Campaign for Access to Essential Medicines, described the FDA process as duplicative and dismissed the safety concerns raised by U.S. drug companies as disingenuous.
"It sends a strange signal that the FDA should be the arbiter of drug safety for African governments," she said. She suggested the United States should instead support the generic drug certification program of the World Health Organization.
"We should not have had to go down this road to begin with," she said. "It is a curious time for the FDA to be boasting about its ability to monitor drug safety given recent scandals around Vioxx and other products."