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Tom Bollyky testified before the U.S. Senate Appropriations Subcommittee on Agriculture, Rural Development, the Food and Drug Administration, and Related Agencies on June 23, 2010, about the FDA’s role in improving the development pathway for neglected disease therapies.
I am grateful for this opportunity to testify about ways in which the U.S. Food and Drug Administration (FDA) may expand its leadership role in supporting the development of products (drugs, vaccines, and diagnostics) for diseases that afflict the world’s poorest.
The essence of the problem is this: while philanthropists and private companies have increasingly seen the value in devising products for heretofore neglected diseases, the regulatory infrastructure necessary to develop and introduce these therapies to the developing world is sadly inadequate. Regulatory inefficiencies and gaps add costs to product development, deter private investment, and delay patients’ access to potentially life-saving treatments. Building the needed regulatory infrastructure is a substantial challenge and unprecedented opportunity to improve the lives of millions around the globe and promote the well-being of Americans at home and abroad. The United States government and FDA in particular should take a leadership role in improving the clinical development and regulatory pathways for neglected disease products.
First, I will summarize the burden that neglected diseases impose on affected people and their communities. Second, I will discuss the tremendous promise of the current pipeline of candidate products to address neglected diseases. Third, I will give an overview of how novel therapies are developed and approved for use in the developing world and the persistent regulatory gaps that undermine this process. Last, I will offer recommendations on how FDA can help bridge those gaps.