Biologic Product Shortages

Biologic Product Shortages
A biological product shortage occurs when a biological product is not commercially available in sufficient quantity to meet the demand.

A biological product is considered medically necessary when it is used to treat, cure, mitigate, prevent, or diagnose a serious or life-threatening disease or medical condition and there is no other available source or alternative therapy. A shortage situation occurs when the total supply of all licensed or approved product available at the market level will not meet the current demand and there is no adequate alternative therapy available that is judged by appropriate medical staff to be a suitable alternative. CBER's goal is to help prevent or alleviate shortages of biological products, and to work with all parties involved to make certain medically necessary products are available within the United States.

Manufacturing problems are the most common cause of biological product shortages. Manufacturing issues may be brought to FDA's attention by the manufacturer or as a result of an FDA inspection. Other activities that may cause product shortages include corporate decisions to discontinue the product, distribution disruptions, regulatory actions, or natural disasters.

Current Biological Product Shortages
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/default.htm