PEPFAR Drug Policies Slow to Embrace Generic ARV Drugs

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The President's Emergency Plan for AIDS Relief (PEPFAR) has been slow to allow the procurement of generic antiretroviral drugs (ARVs) to treat HIV/AIDS patients, instead favoring more expensive brand-name drugs, according to a new report by the Center for Public Integrity.

The President's Emergency Plan for AIDS Relief (PEPFAR) has been slow to allow the procurement of generic antiretroviral drugs (ARVs) to treat HIV/AIDS patients, instead favoring more expensive brand-name drugs, according to a new report by the Center for Public Integrity.

The latest update to the Center's "Divine Intervention" project, a year-long investigation into President Bush's $15 billion program to provide care, treatment and prevention for HIV/AIDS patients abroad, found that in 2004 and 2005, the plan allocated only about 5 percent of its overall ARV drug budget -- less than $15 million -- for generic drugs, according to estimates released by PEPFAR.

ARV treatment, which improves health and prolongs life, has been a major focus of PEPFAR. The plan's policy only allows the purchase of ARVs approved by the U.S. Food and Drug Administration (FDA) or given tentative approval through an expedited review process. In 2004, almost all ARVs administered through the program were from well-known companies that make name-brand drugs. By mid-October 2006, the FDA had approved 26 generic ARVs for use under PEPFAR, according to an agency spokeswoman.

The lack of significant approval for generic ARVs has drawn fire from critics, who say that their use over more costly brand-name medications would allow more patients to be treated for the same amount of money.

Government officials and HIV/AIDS activists in Kenya have argued that the number of people receiving treatment could be doubled or even tripled if more generic ARVs were made available under PEPFAR. In January 2002, Botswana became the first country to offer antiretroviral drugs to all citizens who needed them. The drugs, while costly, were distributed through the public health system and credited with largely transforming HIV/AIDS from a fatal condition to a manageable illness.

In addition to the Center's latest report, a new Divine Intervention Photo Gallery offers snapshots of life in several countries at the forefront of the HIV/AIDS epidemic: Ethiopia, Haiti, India, Kenya, Nigeria, South Africa, Thailand and Uganda.

The Center for Public Integrity is a nonprofit, nonpartisan Washington, D.C.-based organization that does investigative reporting and research on significant public issues. Since 1990, the Center has released more than 300 investigative reports and 15 books. It has received the prestigious George Polk Award and more than 20 other journalism awards from national organizations, including PEN USA and Investigative Reporters and Editors. In April 2006, the Society of Professional Journalists recognized the Center with a national award for excellence in online public service journalism for the fifth consecutive year. In October 2006, the Center also was honored with the Online News Association's coveted General Excellence award.

Contact:

Steve Carpinelli

Media Relations Coordinator

Center for Public Integrity

http://www.publicintegrity.org
(202) 481-1225 (office)

scarpinelli @ publicintegrity.org

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