Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation

The stresses of the COVID pandemic on the drug supply chain have thrown a spotlight on the importance of risk management plans (RMPs) in preventing and addressing drug shortages.

FDA is among regulatory agencies that have been emphasizing the benefit of RMPs, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed by the US Congress in March 2020, included an RMP requirement among its provisions intended to mitigate and prevent medical product shortages.

In addition to the existing FDA notification requirements where the supply of critical drugs could be disrupted, the Act broadened the reporting category to include drugs and active pharmaceutical ingredients (APIs) that are critical to public health during emergencies like the pandemic.

Accompanying the reporting requirements for these products, and for “any associated medical device used for preparation or administration,”  is a requirement that a redundancy risk management plan be developed, maintained, and implemented that “identifies and evaluates risks to the supply of the drug as applicable for each establishment in which such drug or active pharmaceutical ingredient of such drug is manufactured.”

The RMPs are subject to inspection, but are not required to be submitted and reviewed in drug approval applications.

Having arrived at the six-month implementation date of the CARES Act in late September, the dialogue has become more active between FDA regulators and industry at recent meetings on the expectations for RMPs and how they can be most effectively used in helping address the pandemic supply chain challenges.

Reflective of the experience with their value in addressing the supply chain stresses caused by disasters such as Hurricane Maria, FDA had already begun work on a draft guidance on the use of RMPs when CARES was enacted. The draft is now being completed for public release, which will incorporate the current expectations.

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