For Immediate Release: May 19, 2022
Statement From: Patrizia Cavazzoni, M.D., Director – Center for Drug Evaluation and Research
Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act.
To further assist manufacturers with these requirements, we are issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans.
The draft guidance describes a framework for stakeholders to consider when developing risk management plans that aligns with principles stated in the International Council for Harmonisation guidance for industry, Q9 Quality Risk Management, and identifies risk factors to consider when developing the content of risk management plans. The steps needed to reduce risks of a disruption in drug supply may vary among the different manufacturers in the supply chain for a given drug.