Buying and Selling Prioritized Regulatory Review: The Market for Priority Review Vouchers as Quasi-Intellectual Property

Oulu Wang

ABSTRACT

Drug development is an expensive endeavor, and for decades, drug companies favored investing in drugs to treat diseases with commercially attractive markets rather than rare and neglected diseases. The U.S. Food and Drug Administration oversees numerous programs intended to incentivize the development of therapies for rare and neglected diseases, for example, by granting expedited review of applications and regulatory exclusivity periods. One such incentive program is the priority review voucher program. A priority review voucher may be awarded upon the approval of a treatment for a rare pediatric disease, a neglected tropical disease, or a bioterrorism threat. The priority review voucher entitles its owner to priority review of a subsequent application and is unique in that it does not attach to a particular product or sponsor, unlike expedited review and regulatory exclusivity. A priority review voucher is salable and transferable, much like ordinary property, and thus may be regarded and valued as quasi-intellectual property. This paper provides an analysis of the priority review vouchers that have been issued, transferred, and redeemed to date, as well as trends in the market for priority review vouchers.

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2018-09-18T11:19:53-04:00