availability of affordable drugs approved under the existing voucher
1. Lack of R& D in Voucher-eligible Diseases
In April 2009, the FDA granted Novartis a tropical disease voucher (and
the first-ever priority voucher) for Coartem, an artemisinin-based
combination therapy for malaria.
87 Artemisinin combination therapies are
consensually regarded as “generally highly effective and well tolerated” and
are the standard treatment recommend by the World Health Organization
(WHO) for uncomplicated malaria.
88 When Novartis sought regulatory
approval for Coartem in the U.S., the drug had been in use for close to a
decade and was already registered in 85 other countries.
89 Novartis stated that
it had been considering registering the drug in the U.S. before the creation of
the vouchers, citing “pressure from the U.S. Government and army to supply
traveling American citizens” as the main reason for registering the drug.
Similarly, in March 2014, Knight Therapeutics was awarded a neglected
tropical disease voucher after obtaining regulatory approval for Impavido, a
miltefosine-based drug used in the treatment of leishmaniasis.
91 The bulk of
miltefosine R& D took place during the 1990s with funding from the WHO
and other institutions.
92 Knight Therapeutics, while never involved in the
R& D process, went on to sell the voucher to Gilead for $125 million.
two examples illustrate the disjointed dynamics of the program, with the
incentive-benefit being appropriated by players that do not engage in drug-
related R& D.
87. Tatum Anderson, Novartis Under Fire for Accepting New Reward for Old Drug, 373
THE LANCET 1414, 1414 (2009).
88. See WORLD HEALTH ORG., GUIDELINES FOR THE TREATMENT OF MALARIA THIRD
89. See Anderson, supra note 87, at 1414.
90. See id.
91. Press Release, Knight Therapeutics, Inc., Knight Therapeutics, Inc., Announces FDA
Approval for Impavido (Miltefosine) for the Treatment of Visceral, Mucosal and Cutaneous
Leishmaniasis – Awarded Priority Review Voucher (Mar. 19, 2014), http://www.gud-
92. Bernard Pécoul & Manica Balasegaram, FDA Voucher for Leishmaniasis Treatment:
Can Both Patients and Companies Win?, PLOS BLOGS (Jan. 20, 2015),
93. Press Release, Knight Therapeutics, Inc., Knight Sells Priority Review Voucher to
Gilead (Nov. 19, 2014), http://www.gud-knight.com/en/knight-sells-priority-review-voucher-to-gilead.