Drugs

Steps Needed to Address Drug Shortages: Report

David McFarland

— 2 min read
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A Senate Homeland Security & Governmental Affairs Committee majority staff report, “Short Supply: The Health and National Security Risks of Drug Shortages,” lists six steps FDA, Congress, and others can take to help address the significant problem of drug shortages. The report notes that between 2021 and 2022, new drug shortages increased by nearly 30% to a five-year high of 295 active drug shortages at the end of 2022.

“However,” the report continues, “drug shortages are not a new problem. They are caused by a number of factors, including economic drivers, insufficient supply chain visibility, and a continued U.S. overreliance on both foreign and geographically concentrated sources for medications and their raw materials. These shortages have cascading effects on patient care, causing delays in treatment, increasing the risk of medication errors, and requiring the use of less effective alternative treatments. Hospitals have also experienced increased costs, medication waste, and limited staffing capacity to address and remedy shortages.”

The committee staff report, which updates a 12/2019 report by Sen. Gary Peters (D-MI), says it assesses the continued impact of drug shortages on patients, hospitals, and healthcare providers; evaluates federal and private sector efforts to address the shortages; and examines the threat posed by U.S. over-dependence on foreign and geographically concentrated sources for key drugs and their critical inputs, including key starting materials and active pharmaceutical ingredients. “The report finds that the federal government’s ability to comprehensively assess U.S. pharmaceutical supply chain vulnerabilities and address known cases of shortages for critical drugs continues to frustrate efforts to predict drug shortages and effectively mitigate their impact on patient care,” the document says.

The report contains these findings of fact:

  • drug shortages are increasing, lasting longer, and impacting patient care;
  • overreliance on foreign and geographically concentrated sources for critical drugs and their key starting materials and limited domestic manufacturing capabilities create health and national security risks;
  • FDA still lacks critical information that could help mitigate shortages;
  • while FDA retains certain data from manufacturers on the pharmaceutical supply chain, such as key starting materials needed to make drug substances, those data are currently not provided or stored in a useable format to aid supply chain visibility;
  • industry and the federal government lack end-to-end visibility into the pharmaceutical supply chain and efforts to map supply chains are not sufficiently coordinated; and
  • FDA lacks the authority to require manufacturer recalls for most drug products.

The committee staff makes these recommendations:

  • invest in domestic advanced manufacturing capabilities for critical generic drug products regularly in shortage;
  • conduct regular interagency medical supply chain risk assessments;
  • require manufacturers of life-supporting and life-sustaining drug products to report increased demand and export restrictions to FDA;
  • FDA should take steps to ensure its supply chain data can be used to monitor supply chain vulnerabilities and conduct predictive modeling;
  • streamline private and public efforts to predict and mitigate potential supply chain vulnerabilities; and
  • provide FDA with mandatory recall authority for all drug products.

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