Drug Shortage Reporting Rules Prompt Questions as Deadlines Loom

The meaning of a “life-saving” drug and how quickly supply chain data can become available are among the questions pharmaceutical companies are raising as they work to comply with expanded reporting rules aimed at combating pandemic-fueled shortages.

The goal of the updated rules is to bring efficiency to drug shortage reporting so that the Food and Drug Administration can be better equipped to handle public health crises in the future. But concerns remain that the scope of the requirements, along with the timelines for meeting them, are becoming too arduous a task for drugmakers that are already working to meet ...