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GAO-12-897R 1 (2012-08-01)

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        Accourtbility * Integrity * Reliability
United States Government Accountability Office
Washington, DC 20548




              August 1, 2012

              The Honorable G.K. Butterfield
              House of Representatives

              The Honorable Don Manzullo
              House of Representatives

              The Honorable Gregory W. Meeks
              House of Representatives

              The Honorable Dave Reichert
              House of Representatives

              Subject: Ensuring Drug Quality in Global Health Programs

              The United States supports global health programs primarily through the U.S. Agency for
              International Development (USAID) and the Centers for Disease Control and Prevention (CDC)
              and by providing contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria
              (Global Fund). USAID and CDC implement the President's Emergency Plan for AIDS Relief
              (PEPFAR), which provides antiretroviral treatment to more than 3.9 million people, and the
              President's Malaria Initiative (PMI), which has procured and distributed over 67 million malaria
              treatments. In addition, the Global Fund provides antiretroviral drugs to about 3.3 million people,
              has supported tuberculosis treatment for 8.6 million, and enabled treatment of 170 million
              malaria cases.

              Concerns have been raised about the potential for substandard drugs to enter the supply chains
              of global health programs. Substandard drugs, which may be caused by poor manufacturing
              practices, improper storage or distribution, or tampering, can have serious public health
              consequences. These include ineffective treatment of diseases, adverse reactions in patients,
              and drug resistant strains of pathogens.

              Given these concerns about substandard drugs, we were requested to review safeguards in
              place to ensure drug products procured with U.S. foreign aid funds are of assured quality.1 We
              examined (1) the regulatory and policy requirements intended to ensure the quality of drugs



              1This review was conducted in response to a 2010 request from Representative Gregory Meeks-then Chairman,
              House Financial Services Subcommittee on International Policy and Trade-to review the safety and effectiveness of
              prescription medicines being purchased by USAID. By 2012, other Members had joined on as requesters and we
              commenced the review when staff with the required skills were available.


GAO-1 2-897R Global Health

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