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

Abstract

BackgroundSince 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.MethodsWe 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.FindingsOverall, 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)).ConclusionsThe 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.

Access to unauthorized hepatitis C generics: Perception and knowledge of physicians, pharmacists, patients and non-healthcare professionals

“…Just as with the WHO prequalification programme, the FDA will inspect facilities manufacturing generic drugs. [39–41] Indian generic manufacturers are significant players in the global generic drug market; for instance, India supplies more than 80% of drugs to treat AIDS in developing countries and might also play a crucial role in the fight against HCV. [42, 43] Notably, Mylan Pharma, an Indian pharmaceutical company, introduced the first generic in the Swiss market in December 2018.…”

An Evaluation of US Food and Drug Administration’s Program to Register HIV Drugs for Use in Resource-Constrained Settings

“…Continued efforts to reduce duplication of drug reviews between FDA and the WHO drug review mechanism (prequalification of medicines program), as identified by previous research, 8 are needed. As an initial step, to reduce duplication and increase timely access to ARTs in countries of greatest need, FDA and WHO have initiated a joint pilot program in which FDA will share its completed drug reviews, to determine whether this will expedite reviews of the same products by WHO’s prequalification of medicines program.…”

“…8 In addition, FDA-reviewed ARTs can also be used to support HIV treatment guidelines developed by WHO and the HIV community, which includes recommendations on first-line or second-line ARTs, depending on patient needs. 8,9…”

“…Previous literature 4,8,10 has analyzed the outcomes of FDA PEPFAR ARTs on treatment costs and the downstream effects of FDA-reviewed drugs via WHO and the Global Fund. This study provides an in-depth quantitative analysis of the ART applications and products reviewed by FDA to better understand the agency’s PEPFAR contributions and to identify potential areas for improvement.…”

“…Other global entities, such as the World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund), also use FDA-reviewed ARTs to enhance their respective lists of quality-assured ARTs, thus amplifying the downstream outcomes of the FDA program. 8 In addition, FDA-reviewed ARTs can also be used to support HIV treatment guidelines developed by WHO and the HIV community, which includes recommendations on first-line or second-line ARTs, depending on patient needs. 8,9 Previous literature 4,8,10 has analyzed the outcomes of FDA PEPFAR ARTs on treatment costs and the downstream effects of FDA-reviewed drugs via WHO and the Global Fund.…”