Coalition of leading international health groups releases recommendations to elevate FDA's role in global health

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."