The PDUFA legislation includes Title X, which is specifically dedicated to addressing the national shortages of anesthetic and other drugs. Title X would require drug manufacturers to notify the FDA in a timely manner if there is a stall in the production of key drugs, including sterile injectable products and drugs used in emergency medical care and during surgery.
Title X would also authorize the Secretary of the Department of Health and Human Services to process expedited inspections and reviews of drug applications and manufacturing facilities to help alleviate pending drug shortages.
“We applaud the Senate’s passage of PDUFA re-authorization,” said American Society of Anesthesiologists President Jerry A. Cohen, MD. “This legislation marks an important step in ongoing efforts toward addressing drug shortages.”
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