Premier Weighs in on FDA Draft Guidance on Drug Shortage Risk Mitigation

Premier submitted comments in response to the Food and Drug Administration (FDA) draft guidance to help manufacturers put in place risk management plans (RMPs) to proactively mitigate drug shortages.

The draft guidance is designed to implement provisions that Premier advocated for in the CARES Act that require certain manufacturers to carry out measures that identify and evaluate risks to a drug’s supply, with a focus on quality issues. The draft guidance describes a framework for stakeholders to consider when developing RMPs that aligns with principles for high-quality manufacturing.

Premier’s comments on the draft guidance focus on three major areas:

1. The list of “other stakeholders” who can access RMPs should be expanded to include group purchasing organizations (GPOs) given the significant role GPOs play in contracting and supply chain resiliency
2. The list of drugs recommended to have a RMP should be streamlined to all drugs on the FDA List of Essential Medicines, Medical Countermeasures, and Critical Inputs
3. The requirements associated with development of a RMP should not create undue burden on manufacturers, which can result in increased drug costs that are then passed on to providers