美国食品药品监督管理局对抗逆转录病毒药物的注册对全球获得艾滋病治疗的影响。

Impact of the US Food and Drug Administration registration of antiretroviral drugs on global access to HIV treatment.

作者信息

Chahal Harinder Singh, Capella Peter, Presto Ryan, Murray Jeffrey S, Shimer Martin, Valdez Mary Lou, Lurie Peter G

机构信息

Office of Public Health Strategy and Analysis, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.

Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

出版信息

BMJ Glob Health. 2018 May 17;3(3):e000651. doi: 10.1136/bmjgh-2017-000651. eCollection 2018.

DOI:10.1136/bmjgh-2017-000651

PMID:29862054

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5969730/

Abstract

BACKGROUND

Since 2004, the US Food and Drug Administration's (USFDA) dedicated drug review process in support of President's Emergency Plan for AIDS Relief (PEPFAR) has made safe, effective and quality antiretrovirals (ARVs) available for millions of patients. Furthermore, the WHO and Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) can add the USFDA-reviewed products to their respective formularies, through a novel process of 'one-way reliance'. We assessed the number of ARVs made available through WHO and Global Fund based on the USFDA review.

METHODS

We conducted a cross-sectional study of all the USFDA-reviewed PEPFAR drugs between 1 December 2014 and 20 March 2017 to determine 1) the percentage that are included on the WHO and Global Fund formularies; 2) the number of the USFDA ARVs supporting the WHO HIV treatment guidelines, and their uptake by WHO and Global Fund and 3) time between the USFDA review and WHO review of the same ARVs.

FINDINGS

Overall, 91% (204/224) of the USFDA products appeared on either the WHO/Prequalification of Medicines Programme (PQP) or the Global Fund ARV lists. Forty-five per cent (100/224) and 83% (184/224) appear on WHO/PQP and Global Fund formularies through one-way reliance, respectively. Forty-one per cent (91/224) of the USFDA products support the WHO-preferred first-line HIV treatment options. Of these 91 products, 38% and 85% of products were adopted by WHO/PQP and Global Fund through one-way reliance, respectively. Sixty-six products that were fully reviewed and registered by WHO (vs one-way reliance) had also undergone the USFDA review; 46 of these were registered by WHO after the USFDA review was complete (median delay of 559 days (IQR 233-798 days)).

CONCLUSIONS

The USFDA's PEPFAR process is making safe and effective ARVs available worldwide, in part because the major global ARV procurement organisations rely on the USFDA registration as proof of quality. There is room for improved information sharing and collaboration to reduce duplication of effort, save resources and further expedite access to ARVs.

摘要

背景

自2004年以来，美国食品药品监督管理局（USFDA）为支持总统艾滋病紧急救援计划（PEPFAR）而设立的专门药物审评程序，已为数百万患者提供了安全、有效且质量可靠的抗逆转录病毒药物（ARV）。此外，世界卫生组织（WHO）和抗击艾滋病、结核病和疟疾全球基金（全球基金）可通过一种“单向依赖”的新颖程序，将经USFDA审评的产品纳入各自的药品目录。我们基于USFDA的审评，评估了通过WHO和全球基金提供的ARV数量。

方法

我们对2014年12月1日至2017年3月20日期间所有经USFDA审评的PEPFAR药物进行了横断面研究，以确定：1）被纳入WHO和全球基金药品目录的药物所占百分比；2）支持WHO艾滋病治疗指南的USFDA抗逆转录病毒药物数量，以及WHO和全球基金对这些药物的采用情况；3）同一种抗逆转录病毒药物经USFDA审评与经WHO审评之间的时间间隔。

结果

总体而言，91%（204/224）的USFDA产品出现在WHO/药品预认证计划（PQP）或全球基金的抗逆转录病毒药物清单上。分别有45%（100/224）和83%（184/224）的产品通过单向依赖程序出现在WHO/PQP和全球基金的药品目录上。41%（91/224）的USFDA产品支持WHO推荐的一线艾滋病治疗方案。在这91种产品中，分别有38%和85%的产品通过单向依赖程序被WHO/PQP和全球基金采用。经WHO全面审评和注册（与单向依赖程序不同）的66种产品也经过了USFDA的审评；其中46种产品在美国食品药品监督管理局审评完成后由WHO注册（中位延迟时间为559天（四分位间距233 - 798天））。