As the 21st Century Cures Act is implemented, the FDA will continue to
be part of an incentives scheme that the Agency finds contrary to its mission.
The impact and consequences of allowing private parties to influence Agency
goal setting has yet to be fully addressed in the literature and raises questions
that exceed the scope of the Article. Nevertheless, as new vouchers are
granted and redeemed, this is an area that deserves close monitoring.
Although Congress acted with good intentions, the efficacy of the program
is questionable. GAO’s evaluation of the pediatric voucher program was
inconclusive, but evidence seems to suggest that most, if not all, drugs that
have received a voucher were already in development before each of the
voucher categories was implemented. In this sense, the incentive provided by
the vouchers is perversely diverted towards areas where there are fewer, if
any, shortages of R& D incentives. The current design of the program also
fails to ensure that drugs for which a voucher is redeemed are available to
patients at affordable prices.
Despite these shortcomings, the recent additions of filoviruses and Zika to
the list of voucher-eligible diseases, as well of the expansion of the program
to cover medical countermeasures, indicate that Congressional support for
the vouchers will likely endure. The 21st Century Cures Act is poised to
improve the parameters for evaluation of the program in future GAO reports,
but does little to solve the incentives problem at the core of the voucher
mechanism, or to address its affordability issues.
Finally, while it has been widely documented that current incentives for
R& D in low-burden diseases are subpar, co-involving the FDA in
experiments with alternative incentives models is not without its risks. The
program displaces Agency resources, arguably impacting the Agency’s
overall implicit and explicit innovation policies. It also brings into question
whether the FDA is the best locus for anchoring prize-type incentives, even
in indirect forms such as the voucher program.