US to approve generic drugs in anti-AIDS war

The US government has opened a new front in the battle over getting cheap AIDS drugs to the poorest countries that need them, saying it will...

The US government has opened a new front in the battle over getting cheap AIDS drugs to the poorest countries that need them, saying it will consider approving and providing cheap, multiple-dose generics.

US health and human services secretary Tommy Thompson said on Sunday, the Food and Drug Administration would give fast-track approval to new readymade, single dose cocktails — even their generic versions made in India.

US global AIDS coordinator Randal Tobias said any drugs approved under the program could then be used in programs across Africa and the Caribbean, under which the United States is targeting $15 billion in aid to the countries hardest-hit by the epidemic.

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Many groups, including some members of Congress, have been pressuring the US Government to use the cheap, multiple-dose combinations. Medecins Sans Frontiers, known also as ‘Doctors Without Borders’, has been distributing them in 20 countries and say that they are both cheaper and easier to take.

But the US government resisted, saying the generic versions may not be safe. AIDS groups have accused the government of catering to the pharmaceutical biggies that make the brand-name drugs under lucrative patents.

Sunday’s move could be seen as a big breakthrough in this battle. But some AIDS activists say they are suspicious, and note that the US government reserves the right to subject the drugs to its own regulatory approval process.

And just as Thompson was announcing the new guidance, brand-name drug makers said they were planning to make their own combination doses of anti-HIV drugs. — (Reuters)

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