was legislatively expanded over time in both scope and duration.
Congress recently passed the 21st Century Cures Act, which provides funding
for early-stage and “high-risk, high-reward” biomedical research and further
expands the priority review voucher program.
Part I of the Article introduces the voucher program in the context of
innovation policy. Part II surveys the genesis, growth and shortcomings of
the program. Part III shows how the expansion of the program—following
the recent Ebola and Zika outbreaks, and into new fields—accentuates
misalignments between the vouchers and R& D incentives strategies. Part IV
explores the future of the program as affected by recent legislative changes,
as well as the emerging role of the FDA as a catalyst for innovation policy as
dictated by the voucher program.
II. THE FDA’S VOUCHER PROGRAM AS AN INCENTIVES
A. The Priority Review Voucher Program
1. The Voucher Program in the Context of Incentives Mechanisms
David Ridley, Henry Grabowski, and Jeffrey Moe first proposed the
priority review voucher program in Health Affairs article in 2006.16 The
catalyst for the proposal was the generalized lack of medicines available to
patients with infectious and parasitic diseases in the developing world.
authors suggest that the FDA could be the touchstone of an incentives scheme
that would have pharmaceutical companies self-fund increased R& D in
14. See infra Part III.
15. See 21st Century Cures Act, Pub.L. No. 114 – 255, § 2036 (2016) [hereinafter 21st
Century Cures Act]; see also Elaine Schattner, Why Patients Support the 21st Century Cures
Act, FORBES (Nov. 30, 2016, 9: 54 AM),
century-cures-act/#9143ceaac373 (citing funding for Precision Medicine Initiative and the
Cancer Moonshot as one of the main reasons for supporting the 21st Century Cures Act).
While both initiatives have been regarded favorably by patient advocacy groups and the
general public, the potential and actual efficacy of the Precision Medicine Initiative and the
Cancer Moonshot has been contested. Tabitha M. Powledge, That ‘Precision Medicine’
Initiative? A Reality Check, GENETIC LITERACY PROJECT (Feb. 3, 2015),
reality-check/; Jamie Condliffe, The Best—and Worst—Things About Joe Biden’s Cancer
Moonshot, TECH. REV. (Oct. 17, 2016), https://www.technologyreview.com/s/602679/the-
16. David B. Ridley et al., Developing Drugs for Developing Countries, 25 HEALTH AFF.
313, 313 (2006).
17. Id. For a discussion of the market failures surrounding R& D for neglected diseases,
see Patrice Trouiller et al., Drug Development for Neglected Diseases: A Deficient Market and
A Public-Health Policy Failure, 359 THE LANCET 2188, 2188