January 22, 2019
ASA Submits Comprehensive Drug Shortage Solutions to the FDA
ASA submitted formal solutions to the Food and Drug Administration (FDA) to address drug shortages. The comments were in response to FDA’s solicitation for comments, which were issued with an announcement of a public stakeholder meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions.
ASA attended the public meeting in November 2018, where stakeholders discussed how to prevent and mitigate drug shortages. The purpose of the meeting and the solicitation for comments is to assist the Inter-agency Drug Shortages Task Force as they work to develop recommendations on drug shortages and submit a report to Congress. FDA created the Task Force in July 2018, as health care providers and others saw drug shortages on the rise. In a May 2018 letter, more than 130 bipartisan, bicameral Members of Congress urged FDA to convene such a meeting. ASA was pleased to join the American College of Emergency Physicians (ACEP) in support of this effort.
In comments to the FDA, ASA submitted 19 recommendations to address the ongoing shortages of critical medications affecting patient care across the country. The recommendations are the product of a summit of healthcare leaders, “Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Healthcare Critical Infrastructure,” which was held in September 2018 at ASA’s Washington, DC office. The summit was jointly convened by ASA and ASHP (American Society of Health-System Pharmacists), with support by the American Hospital Association (AHA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP). It brought together representatives from clinician groups, industry and supply chain entities, and government officials to examine vulnerabilities in the supply chain, U.S. dependence on foreign-sourced pharmaceutical ingredients, disaster planning and response efforts, and risk factors associated with pharmaceutical manufacturing and distribution.
The recommendations include regulatory, legislative, and marketplace solutions to stem drug shortages. In the communication to the FDA, ASA also shared information collected from ASA’s Drug Shortages Registry, where members and others can report shortages to ASA and provide information about how they are impacting patient care. ASA was able to identify the top five shortages reported over a six-month period and whether individuals reporting shortages knew why there was a drug shortage. The hope is that the FDA will find the information valuable to its efforts to mitigate shortages and emphasize the need for increased transparency and communication regarding drug shortages.
ASA is pleased to be a leader in examining the implications of drug shortages and looks forward to working with the FDA Drug Shortages Task Force as it develops lasting solutions to drug shortages.
Learn more about the September 2018 Drug Shortages Summit
Report a Drug Shortage to ASA