Last week, a little-noticed milestone was reached in the fight to save lives from AIDS with high-quality antiretroviral treatment.
The Food and Drug Administration in the U.S. Department of Health and Human Services (HHS/FDA) granted its 50th and 51st priority approvals for HIV/AIDS medications, making them eligible for purchase by the President”s Emergency Plan for AIDS Relief (PEPFAR/Emergency Plan) for use in some of the most impoverished countries in the world. One such product is a 3-in-1 drug combination for children, the complete twice-daily dose, and may be dissolved in water if the child cannot swallow pills.
President Bush captured the compassion and generosity of the American people when he announced PEPFAR, the largest international health initiative in history dedicated to a single disease. On a bipartisan basis, Congress has provided the resources to ensure we will exceed the initial $15 billion commitment over five years. Just as important as the resources was the commitment to massively scale up prevention, treatment and care in the developing world.
Many doubted the president”s ambitious goals could be achieved. In 2003, when PEPFAR was announced, only 50,000 people in all of sub-Saharan Africa were receiving treatment. As of March 2007, the U.S. supported treatment for 1.1 million people worldwide — more than 1 million of them in Africa. A transformation in the world”s response to the pandemic is under way — with the United States in the lead.
One of the many needs that had to be met was for a supply of inexpensive, high-quality antiretroviral drugs. In 2004, the HHS/FDA adapted and expedited its review process for generic antiretroviral drug products. Through this mechanism, products undergo the same rigorous scientific quality review that would make them eligible for use in the U.S. once patents expire. Families in Africa and other resource-poor areas deserve quality products, just as American families do.
Generic and innovator drug companies around the world have sought expedited review. The 51 approved medicines are products from companies in many countries, including India, South Africa and the United States. They include every major component of therapy for adults and children and the combination therapies used most commonly in the developing world. Due to the expedited review process and PEPFAR’s Supply Chain Management System (SCMS), our programs have access to the world’s lowest-priced products, including one of the lowest prices — $89 per year — for a commonly used 3-in-1 combination pill. Generic purchases increased to 91 percent of all PEPFAR drug purchases in the most recent quarter of 2007.
The benefits are not limited to programs supported by PEPFAR. Through SCMS, the lowest-priced products are now available for other programs serving the developing world as well. In addition, the expedited process has made three generic drugs originally approved under PEPFAR now available in the United States because their patents expired. In short, the process has benefited both Africans and Americans.
While much progress has been made, many challenges remain. Because there is no cure or highly effective vaccine in sight, the need for HIV/AIDS treatment likely will be with us for generations. And that means we will need a continuous stream of new, high-quality products to overcome the inevitable development of drug resistance.
HIV/AIDS drug resistance reduces the effectiveness of treatment and can lead to sickness and death. Even with high-quality drugs, resistance will develop: In California, 50 percent of HIV-positive persons on treatment show evidence of resistance. In the United States and Europe, as many as 10 percent of newly infected people become infected with resistant HIV, possibly limiting the effectiveness of treatment.
Low-quality products increase the risk of resistance and thereby exacerbate the very pandemic they are intended to control — a potential disaster in high-HIV prevalence areas of Africa. At the same time, the AIDS emergency makes it essential to treat as many people as quickly as possible.
The U.S. government’s approach balances current and future needs for high-quality drugs that are affordable in resource-poor settings. This effort plays a vital part in the American people’s long-term commitment and leadership in the global fight against HIV/AIDS — and it is something to celebrate.
Dr. Andrew C. von Eschenbach is the commissioner of the Food and Drug Administration and Ambassador Mark Dybul is the U.S. Global AIDS Coordinator.
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