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The Global Health Technologies Coalition (GHTC), a group of more than 30 leading international health organizations, today released recommendations to elevate the role of the US Food and Drug Administration (FDA) in global health. The GHTC released its recommendations at a pivotal hearing hosted by the FDA to examine its role in regulating and reviewing crucial global health products, such as vaccines, drugs, microbicides, diagnostics, and other tools that save lives worldwide. The FDA is best known for its work to protect the health of US consumers, but the agency has a history of leveraging its expertise to benefit people around the world and is playing an increasingly vital role in global health issues. As the Obama Administration and other US leaders continue to prioritize global health and development, the FDA can play an important role in efforts to ensure the safety of health tools to prevent, diagnose, and treat infectious diseases that affect millions of people worldwide every year. The GHTC's recommendations call on the FDA to: Help build regulatory capacity in developing nations through increased collaboration with countries and regional regulatory networks. Strengthen its partnership with global regulatory stakeholders, such as the World Health Organization, that are working to enhance access to health tools for the developing world. Work more closely with groups and entities, such as public-private partnerships, developing the tools to prevent, diagnose, and treat diseases of the developing world. "The FDA has invaluable skills and expertise," said Kaitlin Christenson, coalition manager for the GHTC who testified at the FDA hearing. "The agency is now poised to share this knowledge and help introduce safe and effective health tools that can save millions of people worldwide every year. It is truly an exciting time for the FDA as it determines how it can best play a role in facilitating access to life-saving global health products, as well as the millions of people worldwide who will eventually benefit from the agency's vast expertise." The GHTC released its recommendations at today's public hearing to examine the FDA's role in global health hosted by the agency's newly mandated review group for neglected diseases of the developing world. Next year, this review group is scheduled to deliver recommendations to Congress on FDA's role in ensuring that safe and effective global health products reach people in need worldwide. "Many countries around the world do not have the resources to regulate health tools and ensure that only safe and effective products are distributed to people in need," said Dr. Mike Brennan, senior advisor for global affairs at the AERAS Global TB Vaccine Foundation and a GHTC member. "By taking three key steps—helping to build regulatory capacity in developing countries, strengthening its ties with global stakeholders like the World Health Organization, and working more closely with public-private partnerships and other groups developing the tools to prevent, diagnose, and treat diseases of the developing world—the FDA can help accelerate the delivery of the right health tools into the hands of people who need them most."

The Global Health Technologies Coalition (GHTC) recently released its first annual policy report, which provides recommendations for Congress and the Administration on how to position the United States as the leader in a worldwide movement to strengthen global health research and development (R&D). The report—titled Innovation in action: policies to accelerate the development and delivery of global health tools—focuses on how the United States can bolster coordination with domestic and international stakeholders to ensure that global health tools like vaccines, diagnostics, drugs, microbicides, and other products reach populations in need around the world. It makes recommendations in three areas: Public financing and coordination across the US agencies involved in global health research. Regulatory pathways to ensure that safe health products reach populations in need. Incentives to spur public sector involvement in global health research and innovative financing mechanisms to identify new ways of raising and allocating funds. The United States has long been at the forefront of efforts to develop tools to address global health diseases. US investment and innovation have contributed to remarkable progress in preventing, diagnosing, and treating conditions such as HIV/AIDS, malaria, tuberculosis, neglected tropical diseases, pneumonia, and diarrheal diseases. Despite these breakthroughs, existing technologies are not sufficient to address drug resistance or new infectious conditions, while only outdated or insufficient technologies exist for some of the most intractable diseases worldwide. For this reason, accelerating the development and delivery of global health tools is critical to reaching broader US global health goals. The United States is poised to address these issues head on. With the release of the US Global Health Initiative (GHI), US policymakers have the opportunity to ensure that a commitment to research and innovation to develop new products and tools is a central part of the nation's efforts to improve health worldwide. The GHTC's report examines the financing and regulatory issues that affect global health R&D, highlighting why innovation and product development are critical to the overall US global health strategy. By pursuing the policy actions outlined in the GHTC’s report, Congress and the Administration have the opportunity to boost the critical research and innovation needed to address global health diseases and to ensure that the most effective tools are available both today and tomorrow. Global health experts call for US leadership during GHTC event The report was released at the GHTC's first annual Congressional briefing, which highlighted how the United States has long been a leader in R&D for global health diseases. Keynote speaker Dr. Nils Daulaire, director of the Office of Global Health Affairs at the US Department of Health and Human Services, highlighted the critical role that R&D plays in reaching the overall US global health goals. Dr. Maria Freire, president of the Albert and Mary Lasker Foundation and the second keynote speaker, called for the United States to lead a worldwide movement to elevate global health R&D. “We must deepen our funding of research for health and ensure that it remains not only a national priority, but a global imperative. Millions of lives, our own and those of our neighbors, depend on it." Dr. Freire said at the briefing. She added, "As the leader in biomedical research, our country can spearhead a global movement for increased and sustainable funding for research that will transform the world." Panelists at the event included Dr. Christy Hanson, chief of the Infectious Disease Division at the US Agency for International Development's Bureau for Global Health, and Sylvie Kwedi, president and founder of CLEAR, Inc. (Capacity for Leadership Excellence and Research).  View individual speeches at the links listed below: GHTC expo introduction Dr. Nils Daulaire at the GHTC expo (part 1) Dr. Nils Daulaire at the GHTC expo (part 2) Dr. Maria Freire at the GHTC expo Dr. Christy Hanson at the GHTC expo Sylvie Kwedi at the GHTC expo

GlaxoSmithKline (GSK) and Pfizer today announced that they have joined the first Advance Market Commitment (AMC), a unique funding effort to bring pneumococcal vaccines to millions of children worldwide. The Global Health Technologies Coalition (GHTC) commends increased involvement in the AMC and calls on the United States to participate in innovative health financing mechanisms, including a future AMC, to maximize the life-saving potential of immunizations worldwide. The first AMC was launched by the GAVI Alliance, the World Bank, the World Health Organization (WHO), the United Nations Children’s Fund (UNICEF), the Bill & Melinda Gates Foundation, and five national governments in June 2009. The introduction of a pneumococcal vaccine through the AMC is projected to prevent an estimated 900,000 deaths by 2015 and more than seven million deaths by 2030. In addition, the long-term price of a vaccine will be lowered from more than US$70 per dose to $3.50 under the AMC. "Today’s landmark announcement promises to make new vaccines available affordably, where they are urgently needed, and faster than ever before. Through this AMC, and thanks to the political will demonstrated by donors and least developed nations and the participation of the pharmaceutical companies, prevention against the world’s biggest childhood killer is now within reach,” said GAVI Alliance CEO Dr. Julian Lob-Levyt. These benefits underscore why the United States should consider engaging with future AMCs. The vaccine research pipeline is more promising than ever, with late-stage trials beginning on vaccines for diseases ranging from meningitis to malaria. It is crucial that this promising pipeline receives support from a wide range of partners to ensure success. US engagement in efforts to stimulate the development and delivery of immunizations is crucial to sustaining and building on this momentum. The Lantos-Hyde Act of 2008 directs the United States to invest in a future AMC, and the GHTC strongly urges policymakers to begin exploring how to engage in future AMC opportunities. "As these new partnerships demonstrate, the pharmaceutical industry and other global health stakeholders are increasingly recognizing the AMC's role in spurring the development and delivery of vaccines for the developing world," said R. Gordon Douglas, Jr., MD, Executive Chairman of the Aeras Global TB Vaccine Foundation. "US support for AMCs would guarantee that recent successes in creating vaccines are sustained and extended going forward, saving the lives of even more children in the developing world." Read the GAVI Alliance press release on the organization's website.