The U.S. Food and Drug Administration (FDA) recently released its long-awaited Drug Shortages Task Force report, “Drug Shortages: Root Causes and Potential Solutions.” ACEP has been involved in this effort from the beginning, including calling for the creation of this task force, urging the FDA to find solutions to the drug shortage crisis, and working with congressional partners. In its report, the task force identifies three root causes of drug shortages: 1) lack of incentives to produce less profitable drugs; 2) the market’s failure to recognize or reward manufacturers for mature quality management systems; and 3) logistical and regulatory challenges that make it difficult for the market to recover after a disruption.
Explore This IssueACEP Now: Vol 38 – No 12 – December 2019
The report also provides three potential solutions: 1) create a shared understanding of the impact of drug shortages and the contracting practices that may contribute to them; 2) create a rating system to incentivize drug manufacturers to invest in achieving quality management system maturity; and 3) promote sustainable private sector contracts. The report includes several ACEP priorities, including the need to enhance transparency to ensure adequate competition in the marketplace and better supply chain monitoring and response so as to guarantee the availability of lifesaving emergency medications.
ACEP President William Jaquis, MD, FACEP, had a call with the nominee for FDA commissioner, Stephen Hahn, MD, FASTRO, on Nov. 15 to discuss the report and the impact drug shortages have had on emergency medicine. ACEP will continue to work alongside Congress and the FDA on this issue. Stay apprised of our progress.