“FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. The agency works closely with manufacturers of drugs in short supply to communicate the issue and to help restore availability. FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage. Manufacturers are not required to report information, such as reasons for shortages or the expected duration of shortages. However, many companies voluntarily provide shortage information that FDA posts on its website.”
- Obama Administration Takes Action to Reduce Prescription Drug Shortages, Fight Price Gouging
- Obama Administration Takes Action to Reduce Prescription Drug Shortages in the U.S. (fact sheet)
- Executive Order — Reducing Prescription Drug Shortages
- Letter to Industry
- Graphic – A Drug Supply Chain Example
- Economic Analysis of the Causes of Drug Shortages (HHS)
- FDA Report: A Review of FDA’s Approach to Medical Product Shortages
- Center for Drug Evaluation and Researchs (CDER) Drug Shortages Action Plan
- Current Drug Shortages
- General Drug Shortages Questions and Answers
