investments to tropical or rare pediatric diseases. For instance, Sanofi,
which was involved in the purchase of 2 vouchers, reported revenues of
more than $43 billion in 2014.153
Against this backdrop, prolonging the life of the voucher program not only
reinforces the market failures that are left unsolved by the patent system;154
it also perpetuates a system that is nominally cost-neutral to the FDA but that
in practice entails resource displacement and affects the agency’s priority-setting agenda.155
Nevertheless, political support for the voucher system—rooted in a
misconstruction of the vouchers as cost-neutral drivers of increased R& D in
neglected diseases—does not appear to wane. Calls for the program to sunset
or be cancelled are likely to be futile, as they have been in the past.156 The
21st Century Cures Act supports this view, as described in the following
section. Given this scenario, if and when Congress revisits the voucher
program, it would be critical to at least mitigate the R& D and affordability
problems triggered by current practices. In particular, a requirement
establishing that a modicum of the revenue generated by the sale of a voucher
be redirected towards a voucher-eligible disease would be a first step, and
potentially not impossible to negotiate from a political standpoint.
Restrictions on the ability of sponsors to obtain a voucher by gaining FDA
approval for drugs already commercialized abroad should also be put in
place, although it might be harder to compromise on these restrictions.
Finally, making the vouchers conditional on price negotiations guaranteeing
affordability of drugs would also be desirable, although probably another
2. Impact of the 21st Century Cures Act
The 21st Century Cures Act has been a controversial piece of legislation
throughout its drafting history, having been dubbed “one of the most-lobbied
health care bills in recent history, with nearly three lobbyists working for its
passage or defeat for every lawmaker on Capitol Hill.”157 The Act allocates
153. See Aaron S. Kesselheim, Experience With the Priority Review Voucher Program
for Drug Development, 314 JAMA 1687, 1688 (2015).
154. Trouiller et al., supra note 17.
155. See Witty, supra note 19.
156. In the past, some of these calls have come from the FDA itself. See John Carroll,
That Priority Review Voucher Program? The FDA Hates It, FIERCEBIOTECH (Mar. 3, 2016),
157. Sydney Lupkin, Legislation That Would Shape FDA and NIH Triggers Lobbying
Frenzy, NPR (Nov. 25, 2016), http://www.npr.org/sections/health-
frenzy; see also Michael Hiltzik, The 21st Century Cures Act: A Huge Handout to the Drug
Industry Disguised as a Pro-Research Bounty, L. A. TIMES (Dec. 5, 2015),