III. RECENT EXPANSION OF THE VOUCHER PROGRAM
A. Expansion of Eligible Tropical Diseases in the Wake of the Ebola and
As described in Part II, the FDA has the authority to expand the list of
tropical diseases that qualify for priority review vouchers by administrative
order.105 On two separate occasions, though sharing the same motivation,
Congress also added Ebola and Zika to the list. First, in December 2014, all
strains of filoviruses—the family that includes the Ebola virus—were made
voucher-eligible.106 This was accomplished a short four months after the
WHO declared the 2014 West Africa Ebola outbreak a public health
emergency. In April 2016, Congress again expanded the list to include the
Zika virus, only two months after the WHO declaration of public health
The addition of Ebola and Zika to the list of voucher-eligible neglected
tropical diseases is noteworthy for two reasons. First, it showcases the
goodwill associated with the voucher program. While Congress disagreed on
many aspects of the response to Ebola and Zika, delaying funding to address
both public health emergencies,108 it made each disease eligible for a priority
review voucher within months of the beginning of each outbreak.109 Second,
the inclusion of Ebola and Zika in the voucher program offers new evidence
of the misalignment between the incentives offered by the voucher program
and their impact on R& D in neglected diseases.110
For the purposes of the voucher program, Ebola and Zika are treated
similarly; both are tropical diseases lacking a vaccine111 and endemic to areas
105. See supra Part II. FDA added Chagas and neurocysticercosis to the list in 2015. See
Additions to Tropical Diseases, supra note 56, at 50, 559.
106. 21 U.S. C. § 360n(a)( 2).
107. Press Release, Kaiser Family Found., House Approves Bipartisan Bill Adding Zika
To FDA’s Priority Review Voucher Qualifying Diseases List; President Obama Expected
To Sign (Apr. 13, 2016), http://kff.org/news-summary/house-approves-bipartisan-bill-adding-zika-to-fdas-priority-review-voucher-qualifying-diseases-list-president-obama-expected-to-sign/; see also Sarah Ferris, House Approves Bill to Speed Up Zika Drugs, THE HILL (Apr. 12,
108. See Alison Kodjak, Congress Ends Spat, Agrees to Fund $1.1 Billion to Combat
Zika, NPR (Sept. 28, 2016), http://www.npr.org/sections/health-
109. See S.2917 - Adding Ebola to the FDA Priority Review Voucher Program Act, infra
note 124; see Kaiser Family Foundation, supra note 107.
110. Kesselheim, supra note 86.
111. See WORLD HEALTH ORG., Ebola Virus Disease,
http://www.who.int/mediacentre/factsheets/fs103/en/ (last updated Jan. 2016); see also
WORLD HEALTH ORG., Zika Virus, http://www.who.int/mediacentre/factsheets/zika/en/ (last
updated Sept. 6, 2016).