Pharmaceutical Technology - September 2021


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18 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m Drug Safety The pandemic's impact on drug shortages PharmTech: To date, how has the COVID-19 pandemic impacted drug shortages? VanTrieste (Civica RX): The global coronavirus pandemic has highlighted weaknesses in the US supply chain for essential medicines and other medical supplies. In- creased demand—both within the United States and among our trading partners—is an important fac- tor but has largely served to exacerbate supply chain shortcomings that are pre-existing and longstanding. It is important to emphasize that drug shortages have been a chronic problem for more than a decade. Dur- ing the pandemic, numerous products have remained in shortage and there have been some additional short- ages of drugs, such as dexamethasone, which are used to manage patients with COVID-19. However, early in the pandemic, numerous countries restricted pharma- ceutical exports, some manufacturing facilities experi- enced workforce shortages, and international air cargo was curtailed. This suggests that the system came closer than we may realize to breaking down. Patel (Clarkston Consulting): COVID-19 has caused drug shortages in all areas within the supply chain. The rush to develop and manufacture vaccines has resulted in major raw material shortages in the in- dustry for other drugs. Drug manufacturers are struggling to keep production running, while sup- pliers are maxed and unable to keep up with demand. This has occurred because vaccine manufacturers were prioritized to receive any materials needed to manufacture doses. As a result, other drug manu- facturers either didn't receive what they ordered on time, or no supply was available when they did place an order. In addition, consumers are stocking up on supply [the finished drug product], further depleting supplies [both the finished drug product and the raw materials used to make them]. McDonald (Proactive Worldwide): The COVID-19 pan- demic has impacted drug shortages in a variety of ways, from sourcing initial materials to manufacture drugs and biologics, to reducing the capacity of the manufac- turing lines themselves as production is shifted to man- ufacture and produce potential COVID-19 drugs. For companies and [contract development and manufac- turing organizations] CDMOs that are being used, this manufacturing bottleneck runs from both upstream and downstream all the way to fill and finish. A lot of the source materials for drugs and biologics are sourced from China. As the world economies open back up, the shortages have improved but dependence on foreign country production of materials demonstrates the need for redundancy and local supply. Addressing drug supply: what changes were made? PharmTech: In what ways has the bio/pharmaceutical industry pivoted to address the COVID-19 pandemic and drug supply? McDonald (Proactive Worldwide): A few years ago, the idea of creating a vaccine or other technologies in under a year was unthinkable. The rise of [messenger RNA] mRNA vaccines and improved manufactur- ing (single-use technologies for the production of a variety of biologics) have allowed for the rapid manu- facturing of potential vaccines. Gene therapy tech- nology improvements over the last six–eight years, including dedicated internal and CDMO expertise, allowed for a pivot during the pandemic. Moderna, for example, has been working on mRNA vaccines for more than 10 years as a result of several BARDA contracts awarded to explore the potential of mRNA vaccines. Better manufacturing technology combined with intentional exploration of alternatives via govern- ment contracts allowed for the rapid development of COVID vaccines. The FDA played a pivotal role as

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