Priority Review Vouchers: An Innovative Approach To Accelerate New Product Reviews by the FDA and Encourage Development of Medicines For Neglected Diseases

STUDY OVERVIEW

Proposed by three Duke University professors in a 2006 Health Affairs academic paper, the FDA's priority review voucher was written into law in 2007. Under this law, developers of medicines for specified neglected or rare pediatric diseases receive a voucher for six-month priority review from the FDA to be redeemed with another product of choice or sold to another organization.

However, certain restrictions like the sunset clause have raised uncertainties around the value of priority review vouchers among biopharmaceutical companies. Moreover, for companies that are unsuccessful in their use of a priority review voucher, the cost of failure can be particularly high due to the cost to procure and use the voucher.

This study provides a brief overview of priority review vouchers, its benefits, recent developments and criticisms against the voucher program.

KEY TOPICS

• History of Priority Review Vouchers
• Working Benefits of Priority Review Vouchers
• Priority Review Vouchers are Benefiting Companies
• Recent Developments & Critics Against Priority Review Vouchers
• What Does the Future Hold?

KEY METRICS

• Number of approved orphan products by year
• Prices paid by priority review voucher buyers in millions

METHODOLOGY

This study was created using multiple secondary research sources.

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