FDA works to mitigate shortages of I.V. drugs and shorten supply disruptions

FDA Commissioner Scott Gottlieb discusses new steps the agency is taking to address the root causes of drug shortages. "While the causes of drug shortages vary, most shortages are due to disruptions in supply chain availability of actively marketed products," he states.

FDA Commissioner Scott Gottlieb discusses new steps the agency is taking to address the root causes of drug shortages. "While the causes of drug shortages vary, most shortages are due to disruptions in supply chain availability of actively marketed products," he states. "Among these interruptions, manufacturing and quality issues are the leading causes of drug shortages. This includes outdated equipment in need of repair or replacement, unexpected issues with a product's composition, and a manufacturer's inability to maintain facility and product quality." Gottlieb also notes the availability of raw materials can also be a key factor in creating supply disruptions. "In cases where alternative manufacturing is not available in the U.S., or the manufacturers of U.S.-marketed products are not able to expand production, we may explore importation of a product from a foreign manufacturing source until the shortage is resolved," says Gottlieb. "We're also taking steps to bring on new technology that can improve manufacturing, to help reduce the chance that supply disruptions will occur. FDA has implemented an emerging technology program and established an emerging technology team to engage with companies about new production technologies that could, in the long run, prevent drug shortages caused by product quality and manufacturing problems."