In the United States, the rate of drug shortages has significantly increased over the last 10-15 years. The Food and Drug Administration passed the Food and Drug Administration Safety and Innovation Act in 2012, which requires pharmaceutical manufacturers to notify the administration of any changes to drug product production with the hope to prevent or mitigate any potential drug shortages. Various factors as to why drug shortages occur have been studied, including manufacturing difficulties, shortages of raw materials, voluntary recalls, natural disasters, supply and demand issues,
business and economic issues, and regulatory issues.