Watchdog says HHS reviews of emergency medicine stockpile did not meet most statutory requirements

A federal watchdog found that the Department of Health and Human Services (HHS) did not meet a number of requirements in maintaining the Strategic National Stockpile (SNS) of medical countermeasures.

The Government Accountability Office (GAO) conducted a review of the SNS’s operating procedures, requirements, inventory and obligatory data. The agency’s report was first issued in August but was made public on Monday.

The SNS is a multibillion-dollar reserve of drugs, vaccines and other medical supplies meant to supplement medical countermeasures among states and local jurisdictions. During the COVID-19 pandemic, medical supplies such as N95 respirators and other personal protective equipment were deployed.

The stockpile also held the U.S.’s initial supply of smallpox vaccines such as Jynneos and ACAM2000 that have been used to stem the spread of monkeypox.

As the GAO noted in its report, inventory decisions for the SNS were led by prior reviews from the assistant secretary for preparedness and response (ASPR) from 2015 to 2019.

However, this process was suspended after the agency was reorganized, resulting in no SNS reviews being conducted for three years beginning in 2017. The reviews meant to be conducted during those years would have informed inventory decisions made between 2020 and 2022.

“Instead of completing annual reviews, SNS officials told us they used recommendations from a previously completed review to inform inventory decisions for these years,” the GAO report stated.

“We have concerns about ASPR’s ability to prepare for, and respond to, public health emergencies given recent management challenges related to the SNS,” the GAO report said. “If left unaddressed, these deficiencies will continue to hamper ASPR’s ability to be prepared for, effectively respond to, and recover from future threats.”

Several of the medical countermeasures in the SNS were developed through the support of the Biomedical Advanced Research and Development Authority (BARDA). However, not all BARDA-supported products are included in the SNS, and the report found that the stockpile has had difficulty in purchasing such products in recent years.

The GAO’s analysis of the stockpile determined that most medical countermeasures were accounted for, but they were often not present in recommended amounts. HHS officials told the agency that this was due to budget constraints.

The agency recommended that ASPR update the procedure on how SNS reviews were conducted and develop a method to manage risks associated with gaps in the SNS’s inventory levels and to ensure that products being considered for the stockpile receive equal consideration regardless of whether they were supported by BARDA.

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