FDA Issues Draft Guidance on Priority Review Vouchers
Washington, D.C. – October 20, 2008
BIO Ventures for Global Health (BVGH) today announced its support of the US Food and Drug Administration's (FDA) release of Draft Guidance for Industry on Priority Review Vouchers. The Priority Review Voucher (PRV) program is designed to encourage industry investment in the development of drugs and vaccines for neglected tropical diseases. Enacted as part of the FDA Amendments Act, the program awards a Priority Review Voucher to any sponsor obtaining FDA approval for a product preventing or treating diseases such as malaria, tuberculosis and leishmaniasis. The voucher, which can be traded or sold, can be used to obtain priority review on a future product of the company's choosing, shaving months off the standard FDA review.
Barriers such as insufficient markets, funding, and information have largely deterred industry from applying their technologies to research and development in this arena. PRVs can help industry overcome some of these barriers.
"Priority Review Vouchers are valuable incentives that leverage industry expertise and encourage greater investment in innovation for neglected tropical diseases," said Christopher D. Earl, president and CEO of BVGH. "By taking advantage of existing market forces, patients in the developing world can have faster access to lifesaving products that may not otherwise be developed. And sponsors of neglected disease drugs can be rewarded for their innovations."
Some economists estimate that a voucher may be worth hundreds of millions of dollars - an amount sufficient to offset the substantial risk and investment required for discovery and development of a new neglected disease product.
"Industry and investors alike are keenly following the implementation of the PRV program," said Wendy Taylor, founder and vice president of strategy and operations at BVGH. "The timely release of this guidance reinforces FDA's support of this important program."
A key aspect of the voucher is its ability to be traded or sold. The guidance confirms that contractual agreements directing the right to transfer vouchers can allow for an unlimited number of transfers before the voucher is used.
BVGH's support for PRVs stems from the organization's core mission in developing market-based incentives for investment in global health. BVGH is continuing its advocacy with industry and communication with all stakeholders to ensure that the PRV program grows into a powerful incentive for building the arsenal of new medicines for global health.
About BIO Ventures for Global Health
BIO Ventures for Global Health is a non-profit organization whose mission is to save lives by accelerating the development of novel biotechnology-based drugs, vaccines, and diagnostics to address the unmet medical needs of the developing world. The organization spurs biotech industry involvement in global health product development by increasing biotech and global health partnerships, designing and advocating for compelling market-based incentives, and synthesizing and disseminating critical information and quantitative analysis. For more information, please visit www.bvgh.org.
For additional information, contact:
Molly Polen, Director of Communications, BIO Ventures for Global Health 202-470-6232