ASA commends FDA for identifying root causes and solutions to drug shortages

On October 29, the inter-agency Drug Shortages Task Force led by the U.S. Food and Drug Administration (FDA) issued a report titled "Drug Shortages: Root Causes and Potential Solutions" at the request of Congress. The American Society of Anesthesiologists (ASA) commends the FDA for its analysis of the underlying causes of drug shortages and its recommendations to solve them, many of which align with recommendations offered by ASA and other health care stakeholders last year.

Many shortages are due to manufacturing quality issues. ASA has recommended greater transparency surrounding the source of raw materials and manufacturing locations so providers can more easily assess pharmaceutical product quality. We are pleased the FDA report recommends creating a quality rating system to better inform decision making,"

Mary Dale Peterson, M.D., MSHCA, FACHE, FASA, ASA President

In 2018, ASA with other medical specialty groups, urged Congressional action on drug shortages which resulted in 130 lawmakers from both chambers requesting the FDA Commissioner to examine critical shortages. Ultimately, the Commissioner created the inter-agency Task Force. In 2018, ASA hosted a summit of health care leaders, "Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation's Health Care Critical Infrastructure," which resulted in 19 recommendations that were shared with the FDA.

"We are gratified to see the report come to realization and applaud the Task Force for its thoughtful work," Dr. Peterson continued. "Shortages of critical drugs remain a health care safety and quality issue for the nation's physician anesthesiologists."

ASA commends the Task Force's recommendations that include (1) creating a shared understanding of drug shortages' impact and the contracting practices that may contribute to them; (2) creating a rating system to incentivize drug manufacturers to invest in quality management system maturity; and (3) promoting sustainable private sector contracts.

Additional potential progress on the drug shortages front include the introduction of the ASA-endorsed bipartisan Mitigating Emergency Drug Shortages (MEDS) Act by Senators Susan Collins (R-ME) and Tina Smith (D-MN). This bill would enhance manufacturer reporting requirements. In another recent development, Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Rep. Brett Guthrie (R-KY) introduced H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, which would allow the FDA to partner with universities across the country to designate them as National Centers of Excellence in Continuous Pharmaceutical Manufacturing.

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