Proactively preventing shortages: New FDA guidance spells out which drugs require risk management plans
By Zachary Brennan
Senior Editor, EndPoints
As the majority of drug shortages are still associated with manufacturing-related quality issues, the FDA on Thursday published new draft guidance spelling out how to proactively assess risks to manufacturing processes and supply chains, while understanding the market’s vulnerabilities.
While drug shortages peaked in 2011, the FDA says in its new 18-page draft guidance that the number of new drug shortages “has declined significantly since” that peak, reaching a low in 2015 and 2016, thanks in part to a new law’s enactment, known as FDASIA, which helped the agency better prevent or mitigate drug supply disruptions and shortages, and clarified cGMP requirements.
However, the FDA explains how this downward trend “did not continue in subsequent years,” noting:
Drug shortages continue to occur and at roughly the same levels since 2018. Further, drug shortages have grown more persistent (i.e., increased length of active drug shortages). Many of the reasons for drug shortages are, for example, issues related to drug quality, disruptions to supply chain manufacturing operations (e.g., caused by natural disaster or discontinuation of components by
