review voucher is redeemed, the agency must attempt to bring that period
down to six months.
25 Pharmaceutical companies benefiting from a voucher
are therefore able to enter the market four months earlier, reaping the
corresponding financial gains.
26 The incentive to engage in R& D for
neglected diseases thus materializes in the form of sales of a second
(potentially blockbuster) drug.
27 Short as this window of time may seem, for
the pharmaceutical industry, “four months of earlier market access could
translate into hundreds of millions of dollars.”
In addition to the possibility of direct use, Ridley et alia suggested that the
vouchers should be transferable.
29 As an alternative to entering the market
ahead of time, a voucher holder would be allowed to transfer or sell it to
30 In the first iteration of the program, Congress chose to
restrict the number of times a voucher could be transferred, but the law was
amended to remove that limitation in 2014.31 To date there have been five
confirmed sales, ranging from $67 to $350 million.
The combined transfers and sales of vouchers that have occurred since the
program was implemented in the United States provide an idea of the de facto
economic value of the vouchers. By extension, they should also help
delineate the profile of the incentive for companies to engage in R& D in
voucher-qualifying areas. For instance, Praluent, an injectable cholesterol-lowering treatment, and Odefsey, used to treat HIV- 1 infections, have entered
the market with a voucher.
33 In both cases, the voucher had been acquired
25. See U.S. FOOD & DRUG ADMIN., FAST TRACK, BREAKTHROUGH THERAPY,
ACCELERATED APPROVAL, PRIORITY REVIEW,
http://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm (last updated Sept. 14,
2015) [hereinafter FAST TRACK] (“
A Priority Review designation means FDA’s goal is to take
action on an application within 6 months.”).
26. U.S. FOOD & DRUG ADMIN., FDA’S EFFORTS ON RARE AND NEGLECTED DISEASES:
HEARING BEFORE THE SUBCOMM. ON AGRIC., RURAL DEV., FOOD & DRUG ADMIN., AND
RELATED AGENCIES, COMM. ON APPROPRIATIONS, UNITED STATES SENATE
GoodmanJ-20130627.pdf [hereinafter HEARING] (recording the statement of Jessie L.
Goodman, Chief Scientist and Deputy Commissioner for Science and Public Health, Food and
28. FDA’s Efforts on Rare and Neglected Diseases, U.S. FOOD & DRUG ADMIN,
https://www.fda.gov/NewsEvents/Testimony/ucm216991.htm (last updated June 23, 2010).
29. Ridley et al., supra note 16, at 322.
30. Id. at 317.
31. See infra Part III. B.
32. Infra Table 1.
33. FDA Approves Praluent to Treat Certain Patients with High Cholesterol, U.S. FOOD
& DRUG ADMIN. (July 24, 2015),
Sciences, Gilead Sciences Says U.S. FDA Approves Odefsey, REUTERS (Mar 1, 2016, 2: 16