100th Antiretroviral Drug approved by FDA for PEPFAR

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Federal officials today celebrated the approval of the 100th antiretroviral drug authorized under an expedited regulatory framework created five years ago, as a way to fast-track the delivery of cheap HIV drugs to the developing world through the PEPFAR program. A panel discussion, held at the Pan American Health Organization Headquarters to mark the milestone, featured FDA Commissioner Margaret Hamburg, OGAC Director Ambassador Eric Goosby and ambassadors from Haiti and Tanzania.

The FDA process was launched in May 2004, in response to a call from activists, clinicians and members of Congress to use the WHO’s pre-certification drug list to make purchases of generic medications for PEPFAR-funded programs. Instead, a process was devised to allow the FDA to certify generic antiretrovirals (ARVs) for PEPFAR purchase, even if the branded drug was still protected by U.S. patent laws.

According to the first speaker, Dr. Mirta Roses Periago, director of the Pan American Health Organization, more than 4 million people now have access to lifesaving HIV medications, including 455,000 in Latin America and the Caribbean region. Periago noted that these numbers reflect only 42 percent of those who need ARVs and commented on the urgent need to bring down prices and increase availability of second-line treatments.

Dr. Hamburg highlighted the collaborative partnership between the FDA and the WHO to protect the public health by ensuring that these generic drugs and combination medications are safe and effective. The program allows USAID to buy the FDA-approved generic drugs for use in the developing world, but they cannot be sold in the U.S. Federal officials say the program has saved PEPFAR approximately $150 million a year.

This collaboration also allows drugs that have been approved by the FDA to immediately be added to the WHO pre-certification list. Hamburg noted that the FDA continues to work with developing country regulatory authorities to provide training and technical support with the aim of strengthening them. The list of 101 HIV medications includes 7 new pediatric formulations and 29 new adult formulations including combination drugs.

Ambassador Goosby said the program has been a resounding success, noting that 90 percent of the drugs procured in 13 PEPFAR countries are generic. In 2008, PEPFAR spent $202 million on antiretrovirals, 76 percent of them generic, at a savings of $197 million.

Ambassadors Joseph of Haiti and Sefue of Tanzania devoted more time extolling the benefits of PEPFAR to their respective citizenry than they did talking about the FDA process. Ambassador Sefue noted that in the early years of PEPFAR, after completely impoverishing themselves and their families to purchase the costly HIV drugs, people still died. He then outlined the contribution of PEPFAR to slowing the decline in life expectancy, reducing hospital admissions, softening the economic impact of AIDS on Tanzania, and stopping the exponential growth in the numbers of orphans, who now number some 1 million children ages 0-17. Both ambassadors made it clear that continuing support from PEPFAR was absolutely essential.

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