FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. FDA is aware that in 2010 there was a record number of shortages and in 2011 FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs.
When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients.
FDA works with other firms who manufacturer the drug, asking them to ramp up production, if possible, in order to prevent or mitigate a shortage.
FDA works to communicate information about shortages based on information provided by the manufacturers. Companies voluntarily provide the shortage information posted on the FDA website. Manufacturers are not required to report information about shortages to FDA, and are not required to report the reasons for shortages or the expected duration of shortages on the FDA website. FDA encourages and appreciates all reporting of shortages by manufacturers. Shortage notifications and updates may be reported to FDA at drugshortages@fda.