fee that would match or surpass that amount.
47 For fiscal year 2017 the fee
has been set at $2,706,000 for all types of vouchers.
Even if the user fee can compensate for the economic cost associated with
granting priority review in cases where the FDA might otherwise have denied
that status, it is still not enough to dispel all concerns about the impact the
program might have on the agency. These concerns are especially salient with
regard to autonomy in its agenda-setting, as described in Part IV.
In spite of potential direct and indirect costs, the voucher program quickly
gathered political support.
50 Senator Sam Brownback spearheaded the
incorporation of the program into the Food and Drug Administration
Amendments Act (FDAAA), which was signed into law on September 27,
2007, a mere year and a half after the concept of the vouchers was first
introduced in a scientific publication.
51 A second voucher program was
created in 2012, covering rare pediatric diseases, and the recently approved
21st Century Cures Act introduced a third voucher program, covering drugs
used to respond to bioterrorism or natural disasters (commonly known as
2. Development of the Voucher Program
The priority review voucher program was created in 2007 “to stimulate
new drug development” in neglected tropical diseases.
53 Eligible tropical
diseases are defined by a closed list, which originally encompassed 16
diseases, including tuberculosis, malaria, cholera and Human African
47. See Ridley et al., supra note 16, at 315, 318.
48. But see Zachary Brennan, Priority Review Voucher Fees to Decline in FY 2017, REG.
AFFS. PROF’LS SOC’Y (Sept. 29, 2016), http://www.raps.org/Regulatory-
(providing a comparison of 2016 to 2017 noting the decrease in fees for priority vouchers).
This is actually a decrease from FY 2016, in which the fee was set at $2,727,000. In 2011, the
fee for vouchers for tropical diseases was set at $4,582,000, rising to $5,280,000 in 2012 and
then declining to $3,559,000 in 2013. When pediatric disease vouchers were introduced (see
infra note 66) the fee was set to match the tropical disease fee at $2,325,000 in 2014, and there
has been fee parity for both programs ever since.
49. See infra Part IV.
50. See Sam Brownback, Eliminating Neglected Diseases: Impact of Published Paper,
26 HEALTH AFFS. 1505, 1509 (2007) (offering Senator Brownback’s support of a priority
review voucher program in Congress).
51. Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, § 1102,
121 Stat. 823 (2007).
52. What are Medical Countermeasures?, U.S. FOOD & DRUG ADMIN.,
boutMCMi/ ucm431268.htm (last visited Feb. 20, 2017); see also infra Part III. B.
53. Gaffney et al., supra note 34 (noting that section 1102 of the FDAAA created the l
Neglected Tropical Disease Voucher System).