US to approve generic drugs in anti-AIDS war

May 19, 2004

WASHINGTON, MAY 17 : 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 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.

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 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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