USA plans speedy "gold standard" review of fixed-dose combination ARVs for LDCs

The USA is introducing an expedited review process to ensure it provides safe, effective drugs to developing countries under President George W Bush's $15 billion Emergency Plan for AIDS Relief. New guidance proposed by the Food and Drug Administration will enable lower-cost drugs to be provided to millions of people in Africa and the Caribbean, it said.

Announcing the plan in Geneva, Switzerland, ahead of the World Health Assembly, May 17-22, US Health and Human Services Secretary Tommy Thompson said drug patent issues applying in developed nations should not impede purchase of these drugs for developing countries. The guidance will apply to new products that combine already-approved individual HIV/AIDS therapies into single-dosage, fixed-dose combinations, as well as to new co-packaging of existing therapies. Drugs approved in this way will meet all FDA standards for safety, efficacy and quality, said the agency's Acting Commissioner, Lester Crawford.

The process will provide a solid foundation for purchasing drugs that work, said US Global AIDS Coordinator Randall Tobias. "We will have a gold-standard assurance that a combination product will be safe and effective," he added.