March 17, 2020
ASA Urges Congress to Include Legislation to Address Drug Shortages in COVID-19 Legislative Packages
The American Society of Anesthesiologists (ASA) applauds U.S. Senators Dick Durbin (D-IL), Lamar Alexander (R-TN), and a group of Senate leaders for introducing the Commission on America’s Medical Security Act. The bipartisan legislation would develop measures to address U.S. dependence on foreign produced medical equipment, including medications and devices sourced from or manufactured in foreign countries, and boost domestic supply and production. This bill aligns with an ASA recommendation to enact legislation requiring a risk assessment of foreign source active pharmaceutical ingredients (APIs), which stemmed from a 2018 health care Summit hosted by ASA, “Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Healthcare Critical Infrastructure.”
U.S. Senators Patty Murray (D-WA), Mitt Romney (R-UT), Doug Jones (D-AL), Roy Blunt (R-MO), Tina Smith (D-MN), Tammy Baldwin (D-WI), Jack Reed (D-RI), Amy Klobuchar (D-MN), and Richard Blumenthal (D-CT) also joined in introducing the legislation.
ASA has been working with Congress to include legislation to address drug shortages into upcoming COVID-19 legislative packages.
ASA is pleased the legislation addresses shortages in light of the recent Food and Drug Administration (FDA) announcement of the first coronavirus-related drug shortage. Approximately 80 percent of APIs and 40 percent of finished drugs are manufactured overseas, particularly in China and India. The ongoing COVID-19 outbreak has highlighted vulnerabilities arising from our nation’s reliance on foreign manufacturing and the deficiencies in our regulatory oversight of the global supply chains.
ASA has long raised concerns on the nation’s dependency of foreign-made active pharmaceutical ingredients, particularly from China. At a drug shortages stakeholder meeting in 2013, the topic was discussed extensively. ASA has also recommended (link to Summit recs) to the FDA that the agency work with drug manufactures to ensure they have contingency or redundancy production plans for their products and that back-up plan include increasing production and inventory for API and finished goods. Several of these recommendations were incorporated into FDA’s Drug Shortages Task Force report in 2019, titled Drug Shortages: Root Causes and Potential Solutions.
In addition to this newly introduced legislation, Senators Collins and Smith introduced S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act in October 2019. ASA and other stakeholders worked closely with the Senators to ensure the bill included recommendations from ASA’s September 2018 Summit. This bill provides increased authority to the U.S. Food and Drug Administration (FDA), enhanced manufacturing reporting requirements and new market-based incentives to help mitigate the risks drug shortages pose to both patients and the health care system.
ASA applauds these bipartisan efforts in the Senate to address U.S. dependence on foreign-made medical supplies and prevent further drug shortages. ASA will continue to work with Congress to ensure measures to address drug shortages are included in any upcoming COVID-19 legislative packages.