FDA Issues Draft Guidance on Risk-Management Plans

The US Food and Drug Administration (FDA) has issued a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, which builds on the agency’s efforts to mitigate drug shortages and supply-chain disruptions, by assisting drug manufacturers and related manufacturers 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The draft guidance describes a framework for stakeholders to consider when developing risk- management plans that aligns with principles in the International Council for Harmonization (ICH) guidance, Q9 Quality Risk Management, and identifies risk factors to consider when developing the content of risk-management plans. The FDA notes in its guidance that 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. 

The guidance applies to applicants with an approved new drug application, abbreviated new drug application, or an approved biologics license application as well as to manufacturers of components, including active pharmaceutical ingredients (APIs), and to manufacturers of drug-led, drug-device or biologic-led, biologic-device combination products

The draft guidance contains an outline of products in which risk-management plans are required, where manufacturers of drug products, APIs, and associated medical devices must develop, maintain, and implement risk-management plans that identify and evaluate risks to the supply of a drug product.

Additionally, the draft guidance contains an outline of products in which risk-management plans are recommended. While certain types of drug products and APIs would be of particular concern to the FDA because of the potential effect on patient care, the FDA has found that certain drug products, such as those with less redundancy in their supply chains, are at higher risk of shortage.

The issuance of the draft guidance follows a 2019 report, by the FDA’s Drug Shortages Task Force, which called for the adoption of risk-management plans to assess risk and to predict and prevent supply disruptions that could potentially lead to a drug shortage. In 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act to require certain manufacturers to develop, maintain, and implement, as appropriate, risk- management plans that identify and evaluate risks to a drug’s supply.

Source: US Food and Drug Administration