Originator drugs that are drug or biological products approved by FDA through an Abbreviated New Drug Application (ANDA) or a biologics license application (BLA) ( FDA, 2017a, 2021a, 2022 WHO, 2008) 2. Medical product supply chains deliver a diverse array of products, including the four main categories described in this report 1: 1. Given these complexities, regulatory oversight plays a particularly important role in the medical product supply chain to ensure patient safety. For example, the share of newly approved devices that contain software increased from approximately 10 percent in 2002 to nearly 18 percent in 2016, and devices containing such software increasingly include cybersecurity content ( Stern et al., 2019). The manufacture of medical products is an increasingly complex process. Food and Drug Administration (FDA) plays critical roles in the regulation of development, manufacture, sale, and distribution of drugs, biologics, and medical devices. As a result, medical products-which for the purpose of this report is an all-encompassing term that includes drugs, biologics, medical devices, and medical equipment-and manufacturing processes are subject to more government oversight and regulation than supply chains for many other consumer goods. Failure in medical product supply chains can result in serious harm to patients or even death. Consequently, maintaining resilient medical product supply chains is not only about delivering products and generating profits, it is also about saving lives and protecting public safety. Unlike supply chains for consumer goods, where profit motives and competition provide effective incentives to meet customer needs, medical product supply chains serve profit and public health objectives, which may be in conflict ( Shah et al., 2021). At the same time, medical product supply chains are also integral to the health care system. These entities are subject to variation in supply and demand, and they are powerfully influenced by profit motives. They involve multiple stages and steps, with different entities in different locations frequently being responsible for different portions of those stages rather than being performed within a single vertically integrated organization. Medical product supply chains share many characteristics with other modern supply chains. medical product supply chains and their inability to deliver essential medical products to patients who need them, both in so-called normal times and during disasters or public health emergencies ( Accenture, 2021 Phuong et al., 2019). These disruptions are the result of a lack of resilience and security of U.S. health care system, costing medical facilities millions of dollars per year ( Vizient, 2019), threatening the clinical research enterprise ( McBride et al., 2013), and most importantly, impacting the health and lives of patients ( Phuong et al., 2019). Over the past several decades, supply chain disruptions and drug shortages have repeatedly plagued the U.S. medical product supply chains predate the current public health crisis. Shortages of personal protective equipment for health care workers, medical devices, supplies, and drugs used to treat conditions associated with COVID-19 have put the lives of Americans at risk and have compromised the U.S. The coronavirus disease 2019 (COVID-19) pandemic has exposed the fragility of U.S. Medical product supply chains are essential for the national security and the health security of the United States, and ultimately, the continuity of society.
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