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美国热带病优先审评券:促进药物研发和可及性的经验教训。

​US Tropical Disease Priority Review Vouchers: Lessons In Promoting Drug Development And Access.

机构信息

David B. Ridley (

Pranav Ganapathy is an analyst at Evercore, in Menlo Park, California. He was a student in the Department of Economics, Duke University, when this work was conducted.

出版信息

Health Aff (Millwood). 2021 Aug;40(8):1243-1251. doi: 10.1377/hlthaff.2020.02273.

DOI:10.1377/hlthaff.2020.02273
PMID:34339239
Abstract

The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how critical it is to invest in preventing and treating infectious diseases. Until the COVID-19 pandemic, the largest US government-sponsored reward for infectious disease drug and vaccine development was the Tropical Disease Priority Review Voucher program. Under this program, the Food and Drug Administration awards a priority review voucher to the sponsor of a new drug or vaccine for tropical infectious diseases. The voucher then can be exchanged for the faster review of one drug. We provide case studies for tropical disease voucher recipients between 2007 and 2018, examine the effects of the voucher program on product innovation and access, and recommend that policy makers protect the voucher program while creating complementary incentives.

摘要

新冠疫情大流行摧毁了人们的生活和经济。它提醒人们,投资于预防和治疗传染病是多么重要。在新冠疫情大流行之前,美国政府资助的最大的传染病药物和疫苗开发奖励是热带疾病优先审评券计划。根据该计划,美国食品和药物管理局向热带传染病新药或疫苗的赞助商颁发优先审评券。然后,该券可用于加快一种药物的审评。我们提供了 2007 年至 2018 年期间热带疾病券受助人的案例研究,考察了券计划对产品创新和可及性的影响,并建议政策制定者在创造补充激励措施的同时保护券计划。

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​US Tropical Disease Priority Review Vouchers: Lessons In Promoting Drug Development And Access.美国热带病优先审评券:促进药物研发和可及性的经验教训。
Health Aff (Millwood). 2021 Aug;40(8):1243-1251. doi: 10.1377/hlthaff.2020.02273.
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BMJ Glob Health. 2024 Jan 30;9(1):e013686. doi: 10.1136/bmjgh-2023-013686.