let me extend my warm greetings to you from the

Geneva headquarters of the World Health Organization.

You are commemorating the 100th antiretroviral drug

granted tentative approval by the FDA.

This is an achievement welcomed by WHO on many

levels.

The HIV/AIDS epidemic changed international

thinking about diseases and the need for care in

significant ways.

It brought unprecedented attention to the issue of

fair access to medicines.

When effective antiretroviral treatments

became available, an ability to pay became

equivalent to an ability to survive for many

millions of patients.

The work done by the FDA, in support of the

President's Emergency Program for AIDS Relief,

promotes the expedited approval of generic

products that meet the high standards of the FDA.

The benefits of this work are extended through

collaboration with the WHO prequalification of

medicines program.

This program gives quality medical products a

seal of approval that guides purchasing

decisions, whether by national governments, aid

programs, or UN agencies.

Established in 2001, the WHO program pioneered

work on the assessment and pre-qualification of the

first generic antiretroviral medicines

and the first triple fixed-dose combination

product for HIV/AIDS.

At the time, this was a breakthrough in regulatory

thinking.

The program also established a framework

for working with regulatory authorities and

assisting industry in ways that ultimately benefit

patients.

The authorization procedures followed by FDA

operate as an incentive for generic manufacturers

to enter the market for antiretroviral medicines.

Purchase by USAID adds an economic incentive.

Competition among generic manufacturers brings

prices down.

By special arrangement, products approved by the

FDA are added by the Program to its list of

pre-qualified medicinal products.

In the case of therapies for HIV/AIDS, what this

means is first-rate medicines, from multiple

manufacturers, at lower prices, in a process that

is efficient, inclusive, and widely accessible.

Everyone benefits, but most especially people in

need of these life-prolonging medicines.

This work further shows that public health can

indeed achieve greater efficiency without

sacrificing quality.

Improving access to good quality medicinal products

is a core objective of public health efforts, and

one with a direct and measurable impact on

health.

I am sure that many millions of people in the

developing world are equally grateful to the

FDA for its work in this area.

Thank you and congratulations.