Gottlieb Calls for Expansion of FDA Authorities to Fight IV Drug Shortages
FDA Commissioner Scott Gottlieb said the agency may ask Congress for more authority to deal with intravenous drug shortages but he also called for voluntarily collaboration by the industry.
Careful planning can reduce the fallout from shortages in the supply chain, but contingencies are needed in the short term, he said, calling the shortages an “inevitable consequence of an imperfect system.”
The agency is currently analyzing its authority for shortage prevention, he said. This could allow it to require for additional data from the industry when companies notify the FDA about possible shortages, to identify all manufacturing facilities associated with the affected drugs.