Ensuring safe and effective health tools reach people in need

FDA’s role in enhancing access to life-saving global health products

The US Food and Drug Administration (FDA) is poised to heighten its role in global health. As the Obama Administration and other US leaders continue to prioritize global health issues, the FDA can play an increasingly 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. On September 23, a public hearing to examine this role will be hosted by the agency's newly mandated review group for neglected diseases of the developing world.

Next year, this review group is slated to deliver recommendations to Congress on FDA's role in ensuring that safe and effective global health products reach people in need worldwide. The group was formed under legislation passed as an amendment to the Department of Agriculture fiscal year 2010 appropriations bill, which directs the FDA to convene two new review groups. One of these review groups is mandated to recommend appropriate regulatory positions and solutions for the prevention, diagnosis, and treatment of neglected diseases in the developing world.

FDA's proven successes with global health

Though best known for its role in protecting the health of US consumers, the agency has a history of also leveraging its expertise to benefit communities abroad. Past activities and engagement include:

The FDA's program to review HIV/AIDS drugs delivered in the developing world through the US President's Emergency Plan for AIDS Relief.
The release of a guidance document which outlined FDA’s willingness to review vaccines for diseases not endemic to the United States.
The agency's partnership with global bodies, such as the World Health Organization, to assist other countries seeking to enhance their regulatory capacity.
The FDA's Priority Review Voucher program, which awards a voucher for future expedited product review to the sponsor of a newly approved drug or biologic that targets a neglected tropical disease.
The agency's administration of the Orphan Drug Act, which creates financial incentives for the developers of new drugs for rare diseases. This program also benefits neglected diseases, as drugs for the treatment of neglected diseases of the developing world generally also qualify as orphan drugs.

This month's public hearing marks the beginning of a new chapter for the agency as it determines how it can best play a role in facilitating access to life-saving global health products. It is truly an exciting time for the FDA and the millions of people worldwide who will eventually benefit from the agency's vast expertise.

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