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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.

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INTRODUCTION: In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. DISCUSSION: USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. CONCLUSIONS: In this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource-constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example.

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OBJECTIVES: The role of the opioid OxyContin in the opioid abuse epidemic has been well documented. In 2010, OxyContin was reformulated to make it more difficult to abuse. We assessed past-year OxyContin nonmedical use among a nationally representative population and among nonmedical users of opioid pain relievers in the United States between 2006 and 2013. MATERIALS AND METHODS: Data are from the National Survey on Drug Use and Health. Prevalence estimates of past-year OxyContin nonmedical use overall and by sociodemographic, geographic, and substance use characteristics were calculated for each year, 2006 through 2013. Multivariable logistic regression was used to identify individual characteristics associated with past-year OxyContin nonmedical use before and after reformulation. RESULTS: In 2013, the of past-year nonmedical use of OxyContin among people 12 years and older in the United States was 0.5%. This was significantly lower than the prevalence in 2010 (0.7%; P<0.05), but was similar to that in 2006 to 2009 and 2011 to 2012. Among past-year nonmedical users of pain relievers in 2013, the prevalence of OxyContin nonmedical use was 13.0%. This was significantly higher than the prevalence in 2006 (10.5%; P<0.05), and was similar to that in 2007 through 2012. Groups with increased odds of using OxyContin nonmedically in the past-year were similar before and after reformulation (2009-2010 and 2012-2013, respectively). For 2012-2013, odds for past-year OxyContin nonmedical use after reformulation were greatest for: people reporting ≥200 days of pain reliever nonmedical use, adjusted odds ratio (aOR)=3.61 (95% confidence interval [CI], 2.47-5.28); past-year heroin users, aOR=3.45 (95% CI, 2.22-5.37); and people with past-year pain reliever abuse or dependence, aOR=2.57 (95% CI, 1.88-3.51). DISCUSSION: The prevalence of past-year OxyContin nonmedical use in 2013, 3 years after reformulation, was significantly lower than the prevalence in the reformulation year, but similar to other years before and after reformulation. The prevalence of OxyContin nonmedical use among nonmedical users of pain relievers was higher than or similar to historical prevalence rates before reformulation. Groups with increased odds of OxyContin nonmedical use were similar before and after reformulation.

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Distribution of naloxone, traditionally through community-based naloxone programs, is a component of a comprehensive strategy to address the epidemic of prescription opioid and heroin overdose deaths in the United States. Recently, there has been increased focus on naloxone prescription in the outpatient setting, particularly through retail pharmacies, yet data on this practice are sparse. We found an 1170% increase in naloxone dispensing from US retail pharmacies between the fourth quarter of 2013 and the second quarter of 2015. These findings suggest that prescribing naloxone in the outpatient setting complements traditional community-based naloxone programs.

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