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Foreign Drugs Approved For Anti-AIDS Program

This Washington Post story of January 26 reports that the Bush Administration’s $15bn program to fight HIV in the developing world can now by inexpensive generic drugs from foreign companies rather than buy brand names. The FDA approved a package of generic drugs by Aspen Pharmacare of South Africa. There had been some concern that these generics were not as safe, given that several drugs are often combined into a single pill. An Indian company Cipla had their drugs temporarily de-licensed last year because of those kinds of concerns. However, the South African firm seems to have its act together. The cost savings are large, allowing U.S. and international money to go much further to treat more people:

“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.”

The reaction by Doctors without Borders was interesting. They argue that because the World Health Organization already certifies generics that FDA approval was superfluous. That’s probably true, but if it is a hoop that had to be cleared to placate U.S. pharmaceuticals, and if the issue is permanently resolved as it appears, it may have been a political price that had to be paid. Some have suggested that because the WHO is not a regulatory body like the FDA, it may not reach the FDA’s gold standard for safety. There’s probably a fair measure of American pharmaceuticals jockeying for position, but this recent announcement is very good news. My intuition is that this decision had less to do with pharmaceuticals and more to do with the Bush Administration’s mistrust of the WHO and general aversion to international institutions.

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