FDA issues draft guide to tackle supply chain disruptions

The FDA says that implementing risk management principles should be applied throughout the drug supply chain to help mitigate the risk of shortages.

“Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply,” the US Food and Drug Administration (FDA) said in a statement.

“For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should take every step available to reduce risks and threats to the drug supply chain.”

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While the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 included measures to prevent and mitigate against drug supply disruptions and drug shortages, the number of drug shortages have grown more persistent since 2018.

“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 65 discontinuation of components by suppliers), limitations in forecasting future demand, and market withdrawals of drug products,” the Agency wrote in it’s the draft guidance document, entitled ‘Risk Management Plans to Mitigate the Potential for Drug Shortages.’

“Additionally, in recent years, FDA has observed a rise in number of cyberattacks on drug manufacturers and is increasingly concerned about the effect of such attacks on the drug supply chain.”

As such, the FDA calls for holders of new drug application (NDA) or biologics license application (BLA), contract manufacturing organizations (CMOs), and other stakeholders in the supply chain to adopt risk management plans (RMPs) to proactively assess risk and to predict and prevent disruptions.

“RMPs are a useful tool to facilitate compliance with a firm’s regulatory requirements. As a general matter, the Agency believes that RMPs are a good practice to help ensure reliability of supply of drug products and APIs,” the guidance states.

The document provides a RMP framework for stakeholders and calls for industry’s comments to be submitted in the Federal Register within 60 days.