Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group.

Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts. They also increasingly have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. Moreover, the recent COVID-19 crisis has emphasized the need to adopt practices that better promote global supply chain resilience. In this paper, the USP Quality Advisory Group explores the various paradigm shifts currently impacting pharmaceutical quality and the approaches that are being taken to adapt to this new environment. Broad adoption of the Analytical Procedure Lifecycle approach, improved data management, and utilization of digital technologies are identified as potential solutions that can help meet the challenges of these quality paradigm shifts. Further discussion and collaboration among stakeholders are needed to pursue these and other solutions that can ensure a continued focus on quality while facilitating pharmaceutical innovation and development.

Im/Mobility at the US–Mexico Border during the COVID-19 Pandemic

In March 2020, the United States government began a series of measures designed to dramatically restrict immigration as part of its response to the global health crisis caused by the coronavirus pandemic. This included Title 42, which deported asylum seekers immediately and prevented them from applying for asylum. These measures worsened an already precarious situation at the US–Mexico border for an estimated 60,000 asylum seekers who were prevented, by the Trump administration’s ‘Remain in Mexico’ (aka MPP) policy enacted in January 2019, from remaining in the United States while they awaited their asylum hearings. In-depth interviews, participant observation, and social media analysis with humanitarian and legal advocates for asylum seekers living in a camp at the border in Matamoros, Mexico reveal that COVID-19’s impacts are not limited to public health concerns. Rather, COVID-19’s impacts center on how the Trump administration weaponized the virus to indefinitely suspend the asylum system. We argue that the Matamoros refugee camp provides a strategic vantage point to understand the repercussions of state policies of exclusion on im/mobility and survival strategies for asylum seekers. Specifically, we use the analytical lenses of the politics of im/mobility, geographies of exclusion, and asylum seeker resilience to identify how COVID-19 has shaped the im/mobility and security of the camp and its residents in unexpected ways. At the same time, our research illustrates that camp residents exercise im/mobility as a form of political visibility to contest and ameliorate their precarity as they find themselves in conditions not of their choosing.