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 (HHS) Secretary Tommy Thompson said on Sunday the Food and Drug Administration would give fast-track approval to new ready-made, single dose cocktails -- even to copycats 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 US is targeting US$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 they are both cheaper and easier to take.
But the US government has resisted, saying the copycats may not be safe. AIDS groups have accused the government of catering to big pharmaceutical companies that make the brand-name drugs under lucrative patents.
Sunday's move could be seen as a big breakthrough in the 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 drugmakers said they were planning to make their own combination doses of HIV drugs.
Bristol-Myers Squibb, Gilead Sciences and Merck said they are in talks to develop a once-daily, fixed-dose combination of three anti-HIV drugs.
GlaxoSmithKline and Germany's Boehringer Ingelheim said they were discussing a similar option.
The AIDS virus infects 43 million people globally and has killed more than 25 million. There is no cure, but expensive cocktails of drugs can control the virus and keep patients relatively healthy.
These cocktails, called highly active antiretroviral therapy or HAART, are expensive. But the World Health Organization (WHO) and some groups have negotiated cheaper prices from some companies that make them.
They have also bought and are distributing cheap copycat versions made by two Indian companies -- Cipla and Ranbaxy Laboratories.
The US has said there is no proof that these Indian-made generics are either safe or effective -- although the WHO and Doctors Without Borders say they are.
The new HHS guidance opens up the possibility for a change in US policy.
"For companies making products where another firm owns the US patent rights, the FDA could issue a tentative approval when it finds the product meets the agency's normal safety and efficacy standards," HHS said in a statement.
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