neglected tropical diseases.
With most companies engage in pharmaceutical R& D in the developed
world, particularly in the United States and Europe,
19 Ridley et alia reasoned
that a way to bolster the development and commercialization of new drugs
and therapies for tropical diseases would be to tie the incentives for orphan
drugs to strategic and financial benefits for “blockbuster” drugs which
receive most funding for R& D. The scheme would partially add to R& D
funding for diseases prevalent in economically unattractive markets (the
markets of the developing world) from the traditional patent-based model in
which innovator companies recoup R& D costs through the sale of drugs
priced for more affluent populations.
To implement the program in the United States, Congress created a list of
21 When the sponsor of an eligible drug obtains
FDA approval, a voucher is issued granting “priority review” to a second
drug for which the sponsor might seek regulatory approval at a later time.
Under standard review, the FDA takes around ten months23 to review and
either grant or deny approval of new drugs and therapies.
24 When a priority
18. Ridley et al., supra note 16, at 313.
19. Andrew Witty, New Strategies for Innovation in Global Health: A Pharmaceutical
Industry Perspective, 30 HEALTH AFFS. 118, 124 (2011). The Ridley et al. paper suggested the
adoption of a similar mechanism for Europe and, in 2011, David Ridley & Afonso Calles
Sánchez specifically described and proposed a European priority review voucher system.
David B. Ridley & Alfonso Calles Sánchez, Introduction of European Priority Review
Vouchers to Encourage Development of New Medicines for Neglected Diseases, 376 THE
LANCET 922, 922 (2010).
20. See Ridley et al., supra note 16, at 315 (describing the proposal’s goal to create a
market for financially “unattractive” diseases).
21. See infra Part II. B. 2 (discussing drug affordability).
22. Gaffney et al., infra note 34.
23. See U.S. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY EXPEDITED PROGRAMS FOR
SERIOUS CONDITIONS – DRUGS AND BIOLOGICS
http://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf (comparing the FDA’s
expedited goal to action within six months of receiving the application with its standard ten-month framework) [hereinafter GUIDANCE FOR INDUSTRY]; see also U.S. FOOD & DRUG
ADMIN., TROPICAL DISEASE PRIORITY REVIEW VOUCHERS GUIDANCE FOR INDUSTRY 6 (2016),
ces/ucm080599.pdf (stating, “FDA commits to a goal to review and act on 90 percent of
standard applications for N[ew] M[olecular] E[ntity] and original B[iologics] L[icense]
A[pplications] submissions within 10 months of the 60-day filing date.”) [hereinafter
TROPICAL DISEASE PRIORITY REVIEW VOUCHERS].
24. Average review times also vary depending on type of drug and drug complexity. A
2014 study examined review times at FDA’s Center for Drug Evaluation and Research
(“CDER”) and found “wide variance” among divisions, with Oncology and Antivirals
approving new drugs approximately three times quicker than the agency’s least efficient
divisions. Oncology and Antivirals took on average under 200 days to approve a new drug,
whereas the slowest division, Neurology, took close to 600 days. JOSEPH
A. DIMASI ET AL.,
AN FDA REPORT CARD: WIDE VARIANCE IN PERFORMANCE FOUND AMONG AGENCY’S DRUG