Article Text
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.
- PEPFAR
- HIV
- AIDS
- ARV
- WHO
- prequalification
- PQP
- FDA
- USFDA
- tentative approval
- tFDA
- TA
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Footnotes
Handling editor Stephanie M Topp
Contributors HSC conceived the study, developed the methodology, designed the data collection instrument, oversaw data collection, analysed the results and played a leading role in writing the manuscript. PC and RP collected and verified data for US Food and Drug Administration drugs. PC, RP, JSM, MS and MLV reviewed, substantially edited and revised the manuscript. PGL helped refine the methodology, reviewed and substantially edited the manuscript and provided overall direction for the study. All authors contributed to discussion of the findings and policy implications.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Disclaimer The views expressed in this paper are those of the authors and not necessarily those of the US Food and Drug Administration. PGL is no longer with the US Food and Drug Administration.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available. All study data are provided in the supplement.