sustain interest and moderate funding for R& D for a while, domestic and
international focus will shift towards the next infectious disease.141 That
leaves the question of whether the vouchers are sufficiently powerful to
stimulate additional innovation around Zika and Ebola. As discussed in Part
IV, the economic footprint of the program appears to be too small to achieve
B. The 21st Century Cures Act and Vouchers for Medical
The FDA defines medical countermeasures as “products (biologics, drugs,
devices) that may be used in the event of a potential public health emergency
stemming from a terrorist attack with a biological, chemical, or
radiological/nuclear material, a naturally occurring emerging disease, or a
natural disaster.”143 The 21st Century Cures Act (“the Act”) creates a third
type of voucher program covering these products.144 The Act defines a
“material threat medical countermeasure application” as an application for a
drug that is intended “to prevent, or treat harm from a biological, chemical,
radiological, or nuclear agent identified as a material threat;”145 or “to
mitigate, prevent, or treat harm from a condition that may result in adverse
health consequences or death and may be caused by administering a drug, or
biological product against such agent.”146 Similar to the pre-existing
programs, vouchers for medical countermeasures are transferable, and there
is no limitation on the number of times they may be sold or otherwise
transferred.147 Drugs qualifying for the new voucher program may
cumulatively benefit from “any other incentive programs.”148 A temporal
limitation applies, however, as the program is scheduled to sunset on October
was completed, for instance.
141. Before Ebola and Zika, the WHO had issued two emergency declarations, one for
H1N1 (swine flu) in 2009 and another for polio in 2014. Other infectious disease outbreaks
never achieved that status, such as Chikungunya.
142. See infra note 153.
143. What are Medical Countermeasures?, U.S. FOOD & DRUG ADMIN.,
outMCMi/ ucm431268.htm (last updated Oct. 12, 2016).
144. 21st Century Cures Act, § 3086.
145. 21st Century Cures Act, § 3086 (a)( 4)( A)(i).
146. 21st Century Cures Act, § 3086 (a)( 4)( A)(ii).
147. 21st Century Cures Act, § 3086 (b)( 2).
148. 21st Century Cures Act, § 3086 (e).