In addition to its gatekeeping function, the FDA also has explicit and
implicit roles in innovation policy, as demonstrated by Rebecca Eisenberg.172
For example, FDA regulation has become “an important adjunct to the patent
system in protecting innovating firms from competition in product
markets.”173 The types of market exclusivity that FDA regulation layers on
top (or, in some cases, in lieu of) patent rights directly impacts decision-making processes in the pharmaceutical industry, particularly at the level of
funding and R& D strategies.
But while the combined roles played by the FDA may and do effectively
shape the types of pharmaceutical innovation that we get,174 never has the
agency been called to partake in an incentives scheme as it does under the
voucher program. It is one thing to acknowledge that FDA regulation and
rulemaking is informed by policy and will, which in turn affect industry
behavior; it is another to use agency review as an integral component of the
As described in Ridley’s 2006 paper and subsequently implemented, the
program purports to have no impact on the Agency because it is cost-
neutral—that is, the economic cost of resource displacement is absorbed by
the fee paid by drug sponsors wishing to redeem the voucher. Moreover, the
90-day notification requirement ensures that the agency will have the time
necessary to adjust to an expedited timeline.175 Yet a simple budgetary
balancing act does not truly depict the extent of the impact of the voucher
program on the agency, which has been vocal about not endorsing the
vouchers.176 The GAO Report, albeit focused solely on pediatric vouchers,
made the agency’s position abundantly clear:
FDA officials stated that, while they strongly support the goal of
incentivizing drug development for rare pediatric diseases, they have seen
no evidence that the program is effective. The program’s authorization, as
amended, is set to terminate October 1, 2016, and FDA officials said they
do not support the program’s continuation. They expressed concern that
the program adversely affects the agency’s ability to set its public health
priorities by requiring FDA to provide priority reviews of new drug
applications that would not otherwise qualify if they do not treat a serious
condition or provide a significant improvement in safety or effectiveness.
Additionally, FDA officials said that the additional workload from the
program strains the agency’s resources.177
172. See Eisenberg, supra note 5, at 346.
173. Id. at 347.
174. Id. at 346.
175. 21 U.S. C. § 360n(b)( 4).
176. See Carroll, supra note 156.