FDA addresses drug shortages during COVID-19 pandemic

The Food and Drug Administration (FDA) has been monitoring the medical product supply chain during the COVID-19 pandemic. The FDA’s Drug Shortage Staff within the Center for Drug Evaluation and Research works with key stakeholders, including manufacturers, to help prevent, mitigate and resolve shortages of drugs, prioritizing medically necessary drugs.

Communication with manufacturers, health care professionals and the public is an essential component of the FDA’s efforts to prevent and mitigate drug shortages during the pandemic. The FDA provides health care professionals and patients with up-to-date information about drugs in short supply at https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm and through a mobile app called DrugShortages. The app, available on the App Store and Google Play, allows users to receive notifications about shortages of specific drugs or drugs within selected therapeutic categories.

The FDA also engages with other federal agencies and outside organizations, including the AAP Committee on Drugs and the American Society of Health-System Pharmacists, to communicate drug shortage information.

In addition, the FDA recently added products to the Search List of Extended Use Dates to Assist with Drug Shortages at https://bit.ly/3eOp1bV. This list provides information that is based on stability data provided by manufacturers and that may support a patient’s or provider’s choice to use a drug that is or has the potential to be in shortage after its labeled expiration date.

Finally, the FDA communicates with manufacturers in order to develop and facilitate mitigation strategies to help restore product availability. These strategies may include expediting review of requests to add manufacturing lines and suppliers and expediting review of new applications for drugs that may address the medical need.