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Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health
American Journal of Law & Medicine ( IF 0.694 ) Pub Date : 2018-08-14 , DOI: 10.1177/0098858818789430
Michael S Sinha 1 , Nina Jain 2 , Thomas Hwang 3 , Aaron S Kesselheim 4
Affiliation  

The U.S. federal government awards a priority review voucher (“PRV”) to a pharmaceutical manufacturer after the Food and Drug Administration (“FDA”) approves a product for one of a list of voucher-eligible indications. The voucher, which can be transferred or sold, allows the company to accelerate the review timeline of another product for any indication. The PRV program was proposed in 2006 as an incentive for research and development for neglected diseases, such as dengue and leishmaniasis.Neglected tropical diseases (“NTDs”) predominantly affect the world’s poorest populations and are associated with significant morbidity and mortality. Despite their global public health importance, neglected diseases were estimated to account for less than 1% of pharmaceutical research and development expenditures. The voucher program was intended to address this gap between investment and disease burden: “[t]he major obstacle to stimulating the R&D of new medicines for neglected diseases is lowincome nations' inability to pay for such medicines.” The voucher would provide an additional financial incentive to fund clinical development of these products without requiring additional appropriations from Congress.

中文翻译:

根据 21 世纪治愈法案扩大优先审查券计划:对创新和公共卫生的影响

在美国食品和药物管理局 (“FDA”) 批准产品符合优惠券资格的适应症列表后,美国联邦政府会向制药商颁发优先审查优惠券 (“PRV”)。可以转让或出售的代金券使公司可以加快对另一种产品的审查时间表,以获取任何指示。PRV 计划于 2006 年提出,作为对登革热和利什曼病等被忽视疾病研究和开发的激励措施。被忽视的热带病 (“NTDs”) 主要影响世界上最贫困的人口,并与显着的发病率和死亡率相关。尽管对全球公共卫生具有重要意义,但据估计,被忽视的疾病在药物研发支出中的占比不到 1%。代金券计划旨在解决投资与疾病负担之间的差距:“刺激被忽视疾病新药研发的主要障碍是低收入国家无力支付此类药物的费用。” 该代金券将为这些产品的临床开发提供额外的经济激励,而无需国会额外拨款。
更新日期:2018-08-14
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