The Priority Review Voucher Program at the FDA:
From Neglected Tropical Diseases to the 21st
Century Cures Act
Ana Santos Rutschman*
The priority review voucher program at the Food and Drug Administration
(FDA) was established in 2007 to incentivize research and development
(R& D) in traditionally underfunded diseases.
1 While shrouded in controversy
and criticism, the program has recently been bolstered by the passage of the
21st Century Cures Act,
2 which prevented the vouchers from sunsetting in
late 2016 and furthered the overall scope of the program.
3 As it reaches the
end of its first decade, this Article discusses the impact of the program, with
a focus on recent developments. The Article builds on literature suggesting
that the voucher program has been ineffective in incentivizing research in
neglected diseases. It is the first to consider the expansion of the vouchers to
cover R& D on Ebola and Zika, arguing that the expansion was attributable
to misguided bipartisan political support and is likely to result in further
cross-subsidization benefiting R& D on mainstream diseases. Finally, this is
also the first scholarly piece to describe and assess the likely impact the 21st
Century Cares Act has on the program.
The process of developing and getting regulatory approval for a drug is
4 The default mechanism for incentivizing innovation in
* Jaharis Faculty Fellow in Health Law and Intellectual Property, DePaul University College
of Law. For helpful comments, I would like to thank Wendy Netter Epstein, Sam Halabi,
Katherine Macfarlane, Josh Sarnoff and Nadia Sawicki, as well as the participants in the Tenth
Annual Symposium on Health Law & Policy at Loyola University Chicago School of Law.
All errors remain my own.
1. Ridley et al., infra note 16, at 313; Priority Review Vouchers: Overview,
http://priorityreviewvoucher.org/ (last visited Apr. 6, 2017).
2. Jennifer Steinhauer & Robert Pear, Sweeping Health Measure, Backed by Obama,
Passes Senate, N.Y. TIMES (Dec. 7, 2016),
3. Infra, Part IV. A. 1.
4. A 2015 study puts this number at as high as $2.56 billion. See TUFTS UNIV., CTR. FOR
THE STUDY OF DRUG DEV., OUTLOOK 2015, 3 (2015),
http://csdd.tufts.edu/files/uploads/Outlook-2015.pdf [hereinafter TUFTS]. This might be an
overestimation. There is however no consensus on what the exact figures are, and the numbers