Improving Access to Medicines for Children with HIV/AIDS

Through its public-private partnership for Pediatric AIDS, the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Government of Guyana have partnered to launch a novel drug regulatory mechanism called the Pre-approval Access for HIV/AIDS Therapies (the PaATH). The goal of the PaATH is to facilitate faster access to medicines for children with HIV/AIDS in countries with an unmet medical need. The PaATH serves as a ‘provisional’ approval of U.S. Food and Drug Administration (FDA)-approved pediatric medicines in countries where formal approval for full registration is pending.

What is the PaATH?

  • An abbreviated application provides the most salient information to demonstrate the drug has been deemed safe and effective by a stringent regulatory authority such as the FDA and verifies the authenticity of the product.
  • Harmonized requirements for the PaATH application avoids bottlenecks created by country-specific applications.
  • Eligible products for the PaATH mechanism are pediatric formulations of well-established adult antiretroviral products.
  • The PaATH ensures that the applicant agrees to submit a timely application for full registration.
  • The PaATH establishes clear lines of communication for pharmacovigilance and safety reporting.

The PaATH concept was conceived and developed as part of PEPFAR’s public-private partnership to expand access to pediatric AIDS treatment. It was developed jointly with representatives from the U.S. Government including the Department of State, U.S. Agency for International Development, and Supply Chain Management Systems, and Health and Human Services/ FDA; industry (Ranbaxy Laboratories Limited, Gilead Sciences, Inc., Bristol-Myers Squibb); and Civil Society groups.

The next critical step is to begin the launch of the PaATH in a limited setting. This is currently underway in Guyana, which has long been regarded as an innovator and global leader addressing regulatory issues specific to the developing world, particularly in the area of HIV/AIDS. In April 2011, Guyana will be the first country to assess PaATH applications submitted by Matrix Laboratories, Limited and by Emcure Pharmaceuticals, Ltd respectively. The direct outcome of the review and evaluation of the first PaATH applications will provide a framework for discussion and development of the PaATH and establish best PaATH review practices to share with other PEPFAR-supported countries. U.S. Government interagency website managed by the Office of U.S. Global AIDS Coordinator
and the Bureau of Public Affairs, U.S. State Department.
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