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Business & Regulation Business Practice, Supply Chain, Quality & Compliance, Ingredients

Greater Transparency; Fewer Shortages

In 2011, the number of new drug shortages in the US spiked at 267, but the regulatory response was thorough and prompt, including the 2012 FDA Safety and Innovation Act and the 2013 Drug Supply Chain Security Act. Industry consortiums also leapt into action. To name a few initiatives, the Parenteral Drug Association (PDA) established preventive end-to-end controls for drug shortage risks based on criticality of the drug product, patient impact, and overall product risk evaluation. And Xavier University published Good Supply Practices for the 21st Century.

But after three years of relative stability in the US, the number of new drug shortages rose to 186 in the year 2018; the highest number since 2012 and up 26 percent from 2017. There are a number of complex dynamics and market forces implicated in drug shortages, and the issue is amplified by rapid pipeline growth and the push for geographic expansion. The same factors are leading to increased investments in global biopharmaceutical manufacturing capacity. Growth and expansion results in an increase in the length, depth and breadth of supply chains, which in turn, increases their vulnerability to disruptions.

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About the Author

Dawn MacNeill

Head of Supply Robustness, Process Solutions, MilliporeSigma

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