GAO highlights continued PPE shortages in COVID-19 report

Regulatory NewsRegulatory News | 23 September 2020 |  By 

The United States continues to struggle with shortages of personal protective equipment (PPE) and testing supplies due to high global demand and the fact that most supplies are made outside of the US, according to new findings from the US Government Accountability Office (GAO).
In a wide-ranging report on the US federal response to COVID-19, the GAO issued 16 new recommendations for federal agencies spanning the medical supply chain, vaccines and therapeutics, COVID-19 data, economic impact payments, the Coronavirus Relief Fund, guidance for K-12 schools, tracking contract obligations, and cybersecurity weaknesses.
In preparing the report, issued 21 September 2020, the GAO reviewed data, documents and guidance from federal agencies, and interviewed federal and state officials and industry representatives.
PPE Supply Chain
The GAO noted that the US Department of Health and Human Services (HHS), the Federal Emergency Management Agency (FEMA) and other federal partners have made strides in responding to the need for medical supplies. But as supply shortages continue, GAO said the agencies have not developed response plans with sufficient specificity.
“Until HHS and FEMA develop and communicate to stakeholders – such as state, local, tribal, and territorial governments – plans outlining specific actions the federal government will take to help mitigate remaining medical supply gaps, uncertainly will persist regarding whether the federal response will align with needs,” the GAO wrote. “Further, such plans would provide needed clarity to federal partners and nonfederal entities on priority needs and ongoing efforts to address those needs.”
Among its recommendations, the GAO called on HHS and FEMA to devise guidance and best practices to help states enhance their ability to track the status of supply requests and plan for supply needs throughout the COVID-19 pandemic response.
As of 1 September 2020, the US federal government had provided about 92.4 million N95 respirators, 28.1 million non-surgical gowns, 79.7 million gloves, 228.4 million face masks, as well as other PPE to state, tribal, and territorial entities, according to GAO. As of 10 September 2020, the US federal government had also distributed more than 95 million swabs and 76 million units of test tubes and transport media.
However, the US Food and Drug Administration has cited a number of areas of critical shortages, including examination and surgical gowns, various types of gloves, surgical respirators, ventilator-related products, and various testing supplies and equipment, such as transport culture medium, sterile swabs, and general purpose reagents, among others.
Additionally, FEMA told GAO officials that the agency had open requests from state and local governments for more than 139 million nitrile gloves, 11 million surgical gowns, and 6 million N95 respirators, as of 4 August 2020. “FEMA also notes that the supply of N95 respirators for medical use is not expected to catch up to demand until January 2021,” GAO reported.
Vaccine Distribution
The GAO also reported on federal efforts to distribute a COVID-19 vaccine. HHS and the Department of Defense (DoD) have announced that McKesson Corporation will be a central distributor of vaccines and related supplies under the government’s Operation Warp Speed initiative. Additionally, HHS has said it will pursue a tiered approach to distribution of an authorized vaccine. The federal government has also invested more than $12 billion in funding to accelerate development, manufacturing, and distribution of COVID-19 vaccines and therapeutics, as of 1 September 2020.
On 16 September 2020, HHS and the DoD released two documents outlining the federal strategy for distributing a vaccine. Since the reports were released after the GAO’s audit work was completed, the plans were not evaluated. GAO is set to evaluate them in future reports.



© 2023 Regulatory Affairs Professionals Society.

Tags: coronavirus, GAO, HHS, US

Discover more of what matters to you

No taxonomy