The page cannot be found

Recently, the 34 members of the Presidential Advisory Council on HIV/AIDS (PACHA) unanimously passed the resolution that would ensure antiretroviral therapies purchased for Africans with U.S. federal funds are verifiably safe and effective. The resolution will now go to Health and Human Services Secretary Tommy Thompson next month, and, if approved, would reach the President's desk by early summer.

"I am pleased that every member of this committee stands behind giving Africans what they deserve -- the same standard of care we would insist on for Americans. U.S. taxpayers should be sure their money is buying the best treatments for Africans. Ineffective drugs will promote resistant strains of HIV, and we must be certain that our decisions do not perpetuate the pandemic. Buying unproven treatments for Africans with American dollars, as some are currently advocating, would be a mistake. For AIDS, the maxim must be, 'First, verify,'" said Mason, a member of the PACHA and author of the resolution.

President Bush, through the Emergency Plan for AIDS Relief (PEPFAR), has committed $15 billion over 5 years to provide drugs to 2 million people infected with HIV in 14 African and Caribbean nations.

The resolution states that PEPFAR funds must purchase only drugs that "meet comparable standards for safety, quality and effectiveness as would be necessary for drug approval in the United States or any other country with drug approval standards of comparable scientific rigor."

The committee also voted in favor of establishing an "outside technical advisory panel to advise the [administration] on clinical outcomes, quality standards and diagnostic and drug treatment guidelines" for triple-combination therapies.

Such drugs, also known as fixed dose combinations, are manufactured by two Indian generic companies, and have not been subject to FDA approval or equivalent stringent regulatory agency review in Europe, Japan, Australia, Canada or New Zealand. Those countries act as referral agencies for developing countries that may lack sufficient expertise or resources for rigorous product reviews.

ARP was founded in 2003 to educate key policy makers and the general public to the unique needs of traditionally underserved HIV/AIDS-affected populations and to develop strategies and solutions to overcome barriers to treatment.

In 2002, Mason was appointed to serve as a member of the PACHA, where he is chairman of the International Subcommittee. The PACHA provides advice, information and recommendations to the President and the Secretary of Health and Human Services regarding policies to promote the effective prevention, treatment and research and care of HIV disease and AIDS in the U.S. and around the world.

International Subcommittee Resolution #2: Ensuring the Safety, Quality and Effectiveness of Drugs Procured by the President's Emergency Plan for AIDS Relief Funds

Whereas, the President's Emergency Plan for AIDS Relief (PEPFAR) has as its major goal the implementation of a plan to provide lifesaving drug treatment to 2 million people infected with HIV in the 14 targeted countries; and

Whereas, the Office of the Global AIDS Coordinator has been given the responsibility and authority to fund the purchase of drugs, and to determine what drugs will be procured either directly or indirectly with Emergency Plan funds; and

Whereas, the people of Africa and the Caribbean who will receive drugs procured directly or indirectly with Emergency Plan funds deserve drugs that meet a high standard for safety, quality and effectiveness; and

Whereas, even with the best of intentions, allowing a compromised standard of drug safety, quality and effectiveness for Emergency Plan drug procurements will allow, if not ultimately encourage a lower standard of care for African and Caribbean drug recipients; and

Whereas, FDA approved ARV drugs and their generic equivalents have demonstrated their capacity to effectively manage HIV disease; and

Whereas, poor quality, counterfeit, mismeasured, or ineffective drugs can speed development of resistant virus, sicken or harm patients or simply fail to help them, thus jeopardizing the success of the Emergency Plan,

Be it resolved, that the Presidential Advisory Council on HIV/AIDS recommends that the President direct the Office of the Global AIDS Coordinator to require that any drug procured directly or indirectly with Emergency Plan funds must meet comparable standards for safety, quality and effectiveness as would be necessary for drug approval in the United States or any other country with drug approval standards of comparable scientific rigor; and

In addition, the Office of the Global AIDS Coordinator should be directed to create an outside technical advisory panel to advise the Office on clinical outcomes, quality standards and diagnostic and drug treatment guidelines, and

Be it further resolved, that PACHA recommends that the Secretary of HHS take all necessary steps to expedite clinical trials on new drugs and formulations, including fixed dose combinations (FDC's) that hold promise for simplifying treatment regimens, decreasing treatment costs, and thereby expanding safe effective treatment.

UNANIMOUSLY APPROVED.