FDA Information on Immune Globulin Shortage

FDA says that since the demand for immune globulin (IG) products has increased in recent years, despite supply increases, there is an ongoing shortage of IG intravenous and IG subcutaneous products in the U.S. that could affect patient care. An agency statement says that in the setting of increased demand for IG, other factors that ordinarily might not affect availability may have a greater effect. Those factors could include uneven product distribution across different localities, logistics of contractual obligations, production delays, and other factors.

The agency says that while it cannot legally require a manufacturer to begin producing, continue producing, or increase production of drugs, it does work with manufacturers whenever possible to help mitigate shortages when it learns of them. It says it is working very closely with several applicants/manufacturers to help mitigate the supply situation for IG products as best as possible, and also is working with industry to explore ways to improve the manufacturing of IG products, which are derived from donor plasma.