trypanosomiasis (commonly known as sleeping sickness).
54 As detailed in
Part III, Ebola and Zika were not part of the initial list. The FDA has the
authority to add “[a]ny other infectious disease for which there is no
significant market in developed nations and that disproportionately affects
poor and marginalized populations,”
55 a prerogative that the agency first used
in August 2015 to add Chagas and neurocysticercosis to the neglected
tropical disease voucher program.
56 At the time, the FDA also created a
docket for public recommendations for further additions to the list.
Additionally, the statute gives the FDA the authority to enforce
requirements and limitations on the use of vouchers. During the first seven
years of the program, the statute required drug sponsors to notify the FDA at
least 365 days before redeeming a priority voucher, a period that was
shortened in 2014 to a minimum of 90 days.
58 Initially, transfers of vouchers
were also limited and could only take place once. In 2008, the FDA clarified
that “contractual arrangements such as the use of an option or transfer of the
right to designate the voucher’s recipient” were within the terms of the
59 Since 2014, there have been no limits to the number of times a
voucher may be transferred,
60 but a letter of transfer is required.
The tropical disease vouchers may be used in combination with other
incentives initiatives or programs. For instance, a drug might qualify
simultaneously for the voucher and for orphan drug designation,
would make it eligible for “marketing exclusivity and tax credits for qualified
clinical testing,” as well certain fee exemptions.
54. 21 U.S. C. § 360n(a)( 3).
55. TROPICAL DISEASE PRIORITY REVIEW VOUCHERS GUIDANCE, supra note 23, at 4.
56. Designating Additions to the Current List of Tropical Diseases in Section 1102 of the
Food and Drug Administration Amendments Act, 80 Fed. Reg. 50559, 50559–65 (Aug. 25,
2015) (to be codified at 21 C.F.R. p. 317), https://www.gpo.gov/fdsys/pkg/FR-2015-08-
20/pdf/2015-20554.pdf [hereinafter Additions to Tropical Diseases].
57. DEP’T OF HEALTH & HUMAN SERVS., U.S. FOOD & DRUG ADMIN., FDA-2008-N-0567
(Nov. 5, 2008), http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0567-nhc.pdf.
58. 21 U.S. C. § 360n(b)( 4).
59. TROPICAL DISEASE PRIORITY REVIEW VOUCHERS GUIDANCE, supra note 23, at 5.
60. 21 U.S. C. § 360n(b)( 2); see also TROPICAL DISEASE PRIORITY REVIEW VOUCHERS
GUIDANCE, supra note 23, at 8 (explaining the FD& C Act and modifications).
61. TROPICAL DISEASE PRIORITY REVIEW VOUCHERS GUIDANCE, supra note 23, at 8.
62. Aarti Sharma et al., Orphan Drug: Development Trends and Strategies,
PHARMACY & BIOALLIED SCI. 290, 291 (2010),
(An orphan drug can be defined as “is one that has been developed specifically to treat a rare
medical condition, the condition itself being referred to as ‘orphan disease.’”); see also
U.S. C. § 360bb (explaining voucher designation for rare diseases by the Secretary of Health
and Human Services).
63. TROPICAL DISEASE PRIORITY REVIEW VOUCHERS GUIDANCE, supra note 23, at 10; 21
U.S. C. § 335a(o)( 2)(a).