A new report says the Department of Health and Human Services’ inventory planning reports failed to communicate risks.
The Strategic National Stockpile (SNS) is a multibillion dollar inventory of drugs, vaccines, supplies, and other medical countermeasures that can be used in emergencies. The Government Accountability Office (GAO) reports that to guide inventory purchases from 2015 through 2019, the Department of Health and Human Services (HHS) used a multi-step process involving interagency experts, resulting in annual SNS reviews with inventory recommendations. This process was suspended when the expert group underwent a reorganization, and annual reviews were not completed to inform inventory decisions for fiscal years 2020 through 2022, resulting in purchases based on past reviews and HHS discretion. HHS has since completed reviews to inform inventory decisions for fiscal years 2023 and 2024. However, GAO has found that these reviews did not meet most statutory requirements—such as by including the amount of additional medical countermeasures procured—because HHS did not update its procedures to account for changes enacted in 2019.
From fiscal years 2015 through 2021, HHS obligated nearly $5 billion in non COVID-19 appropriations to purchase medical countermeasures, mostly for anthrax and smallpox.
GAO’s analysis of SNS reviews shows the SNS contained most medical countermeasure types recommended, but often not in the recommended quantities. HHS officials noted that gaps in quantities are due to budget constraints and acknowledge these gaps present risks. However, GAO found the reviews lack key information needed for managing these risks and communicating them to stakeholders, including to Congress.
HHS obligated $6.1 billion in COVID-19 relief funds for supplies for the SNS that significantly increased the amount of certain medical countermeasures and expanded the types of countermeasures in the SNS inventory. According to GAO’s report, most of the funding went toward ventilators and personal protective equipment, which resulted in substantial increases in the amount of these medical countermeasures in the SNS relative to what was held prior to the COVID-19 pandemic.
The SNS inventory now contains additional finished pharmaceutical products, such as sedatives for use with ventilators. In response to recommendations from HHS, the Office of the Assistant Secretary for Preparedness and Response also took steps to add testing supplies to the SNS inventory in late 2020, including nasal swabs and transfer media. Prior to the COVID-19 pandemic, the SNS did not hold these medical countermeasures
GAO noted that the COVID-19 response has been a catalyst for HHS to re-examine SNS operations, including the role, responsibilities, expertise, and inventory needed moving forward. As such, HHS is working to develop a strategic plan to guide future SNS efforts.
To help HHS in its efforts, GAO has made three recommendations to the Assistant Secretary for Preparedness and Response:
- Update procedures for how SNS reviews will be conducted in accordance with statutory requirements, including a description of the roles and responsibilities of its interagency partners in the development of the SNS reviews.
- Develop and document an approach—whether through the standard operating procedures for the SNS reviews or some other mechanism—for ensuring that medical countermeasures under consideration for SNS procurement receive the same consideration regardless of whether they received development funding from the Biomedical Advanced Research and Development Authority, in accordance with statutory requirements.
- Develop and document an approach for regularly managing the risks associated with the gaps between SNS medical countermeasure inventory levels and recommended quantities. Such an approach, which could occur as part of the SNS reviews, should clearly prioritize risks, track progress made in addressing the risks, and estimate resources needed to address risks. This approach should involve communicating this information to key decision makers, including Congress.