AHA recommends legislative, regulatory actions to address drug shortages
The AHA today submitted to the Food and Drug Administration legislative, regulatory and best practice recommendations to address new and chronic prescription drug shortages that threaten the quality of patient care and increase hospital and health system costs. Responding to the agency’s request for comments as part of a September public meeting on the issue, AHA said Congress should strengthen drug shortage disclosure requirements for manufacturers; incentivize manufacturing contingency plans and/or redundancies; enhance production transparency requirements; enact shortage disclosure notification requirements for certain medical devices needed to administer drugs; assess drug shortages as a national security threat; and ask the Federal Trade Commission to consider the potential risk for shortages when it reviews drug company merger proposals. Among other actions, AHA recommended that FDA take additional steps to encourage manufacturers to produce drugs that are in shortage and prevent manufacturing shutdowns; establish a manufacturing quality rating system; disclose more information on the quality of outsourcing facilities that compound drugs in shortage; expand and improve its drug shortages list; and develop a list of critical drugs.