consider not only the safety and efficacy of each component, but also the safety and efficacy of their simultaneous use and possible interactions—both favorable and unfavorable. The value of each component individually and in combined form must be clear. Inactive ingredients not present in single drugs may be a factor in the use of combinations as well.

Recommendation 5-6. The committee endorses as critical the use of the cheapest, safest, most effective high-quality antiretroviral drugs that can be procured. Fixed-dose combinations are recommended as most desirable if they are also of high quality, safe, effective, and inexpensive. The committee also strongly endorses a rigorous, standardized international mechanism to support national quality assurance programs for antiretroviral drugs. This mechanism should be timely, transparent, and independent of conflicts of interest; employ evidence-based standards; and provide ongoing assurance of consistent high-quality manufacture and handling. In particular, the pharmacological issues associated with fixed-dose combinations must be rigorously and rapidly addressed.

This Institute of Medicine (IOM) committee was asked to discuss the essential components and related general principles of a systematic framework to achieve a balance between the development of resistance and the need to scale up ART rapidly in resource-constrained settings. Yet it was not constituted with the particular technical expertise nor did it have the time to provide the sort of in-depth, independent, evidence-based examination necessary to critique or endorse specific drug quality assurance programs. Nevertheless, the committee commends the efforts of WHO, the U.S. government, and other international partners to facilitate and expedite the manufacture, procurement, distribution, and administration of consistently safe quality pharmaceuticals. Now that attempts to assure the quality of FDCs for AIDS treatment have highlighted the need for specific guidelines for particular component scenarios, publication of final expert consensus guidance is urgently needed. Organizations and governments working toward this goal should collaborate energetically and with the highest possible level of transparency to support each other’s efforts. The bottom line is that the approval process for ARVs must be swift while not compromising the quality and efficacy of the drugs.


Given the unprecedented magnitude of global ART scale-up and the paucity of data on how to provide ART safely and effectively in resourceconstrained settings, scale-up programs must be based on a learn-by-doing

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