Pharmaceutical Technology - September 2021


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22 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m Drug Safety pandemic issues. For example, hurricanes and other natural disasters have demonstrated that single sourc- ing can be problematic. If a manufacturing or sourc- ing facility is damaged and there is no other alterna- tive, shortages happen. VanTrieste (Civica RX): In identifying risks, we should ask: which products are essential, which have a history of shortages, which ones are produced largely within a single country or geography? Drugs that seem espe- cially vulnerable include penicillin and cephalosporin antibiotics. These are absolutely essential to modern medicine—from out-patient prescriptions to intensive care medicine—and we no longer make them in the US. What's more, global production is heavily con- centrated in China. And in a future pandemic, trade war, or another event, we could be left with no source to serve our own population. The role of regulatory authorities PharmTech: What role do/can governments or regula- tory authorities play in addressing drug shortages? Patel (Clarkston Consulting): In general, the industry will rely on FDA more heavily to open up channels for collaboration and communication both between the regulatory authorities and manufacturers and also amongst manufacturers together. VanTrieste (Civica RX): Government has an impor- tant role to play in identifying the products most at risk or most essential to have on hand, ensur- ing there is adequate inventory in the system and adequate manufacturing redundancy, creating public-facing quality data, and (in some cases) making targeted investments to shore up domes- tic manufacturing capacity. Since the start of the pandemic, FDA has developed an essential drugs list and the government has made some targeted investments, including an end-to-end domestic manufacturing capacity through a project that Civica has partnered on with Phlow Corporation. The White House and Congress have proposed to make additional investments to further shore up supply chains. Predictions for the future PharmTech: Any predictions for trends in drug shortages or the supply chain going forward? VanTrieste (Civica RX): What we can say is that the risk factors that have contributed to shortages still exist: quality problems, the concentration of pro- duction to just a few manufacturers or a restricted geographical area, low prices and small margins, and lack of transparency on quality. Patel (Clarkston Consulting): With increased focus from stakeholders in the value chain, including patients and consumers, we will likely see sustain- ability rising as a focus for supply chains moving forward. Also, as the past 18 months have shown, more and more businesses will begin to focus on digitalization through data analytics, advanced technological manufacturing, etc. References 1. FDA, Report to Congress: Drug Shortages for Calendar Year 2020, Re- port,, Feb. 21, 2020. 2. EMA, "Availability of Medicines," regulatory/post-authorisation/availability-medicines#impact-of- covid-19-pandemic-section, accessed Aug. 4, 2021. PT "The rush to develop and manufacture vaccines has resulted in major raw material shortages in the industry for other drugs." —Swati Patel, Clarkston Consulting

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