Two days ago, the Coronavirus Aid, Relief, and Economic Security (CARES) Act entered its 10th month, and a US Government Accountability Office (GAO) report today says 27 of 31 previous implementation recommendations have not been resolved.
This is the fifth report regarding the CARES Act, and as such, it covers similar topics as in its previous editions, including medical supply chains and program integrity, although its 13 new recommendations reflect the pandemic's progression.
"While GAO recognizes federal agencies continue to take some steps, GAO underscores the importance of developing a well-formulated plan to address critical gaps for the remainder of the pandemic, especially in light of the recent surge in cases," the authors write.
Still, they add, "GAO is pleased that the Consolidated Appropriations Act, 2021—enacted in December of 2020—requires a number of actions that are consistent with several of GAO's prior recommendations, including those related to the medical supply chain, vaccines and therapeutics, and COVID-19 testing."
End-to-end supply chain data and strategy
The office continues to recommend the Department of Health and Human Services (HHS), with help from the Department of Defense (DOD), fully implement a coordinated COVID-19 vaccination plan with set timelines and communication strategies built in.
"Effective coordination and communication among federal agencies, commercial partners, jurisdictions, and providers is critical to successfully deploying COVID-19 vaccines and managing public expectations, especially because the initial supply of vaccine has been limited," the authors write.
Similarly, medical supply chain issues also need better communication and coordination between HHS, Congress, and nonfederal stakeholders to improve supply chain strategies. In December, for instance, the Association of Public Health Laboratories reported that 28% of surveyed public labs would run out of reagents or other testing supplies within the week.
Perhaps one of the largest supply-chain hurdles is the lack of manufacturing and supply chain information available to federal agencies, the authors note. To fully identify vulnerabilities in the supply chain, they say, the US Food and Drug Administration (FDA) needs to have access and visibility to what occurs.
Some of the authority the FDA does have rests in its inspections, but GAO notes the drop in on-site inspections since the pandemic began. While other methods were used such as foreign regulatory reviews and record requests, GAO recommends that the FDA fully assesses its alternatives to inspections and account for the consequences of backlogged inspections as it moves forward.
Work needed on US drug making, national stockpile
One effort to shore up supply chain vulnerabilities is to buy more domestic products. Despite bipartisan executive orders emphasizing this, GAO cautions that the orders alone would not be enough to fix the problem. DOD officials reportedly said that 86% of critical drugs rely on non-domestic manufacturers that hold the active pharmaceutical ingredient (API), and pharmaceutical companies can find loopholes around regulations as the Buy American Act and Trade Agreements Act may still count a product with a non-domestic API as made in America.
Even if drug companies are given the right incentives, the report says, long-term supply chain changes will take time. "According to one stakeholder's estimate, building an FDA-approved drug manufacturing facility in the U.S. could cost as much as $2 billion and take 5 to 10 years to build," the authors write, noting that other countries may compete to bring drug manufacturers to their nations. "The federal government has initiated other efforts to increase domestic manufacturing in addition to the Executive Order."
National medical countermeasure security also lies within the role of the Strategic National Stockpile (SNS), and GAO says more improvement is needed to strategy and stakeholder engagement. In GAO's discussion with the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), ASPR suggested a possible transition away from warehouse stockpiles of supplies to private sector distribution models. This might give greater flexibility to move and distribute stock as needed.
As the nation thinks about future pandemics, ASPR also says it needs to decide whether the SNS should continue to be a "stopgap" for state's supply depletions or if it should also act as a type of first-response pandemic relief.
Better tracking, surveillance are crucial
Improved surveillance and tracking is a theme across multiple areas in the GAO report, besides supply chain, though, including monetary relief, COVID testing, and Occupational Safety and Health Administration's (OSHA's) COVID guidelines.
A big part of the CARES Act is financial support to people and organizations affected by the pandemic. Fisheries were one of the named stakeholders, and as such the act allotted $300 million to the Department of Commerce to aid them as disruptions affected the demand for seafood products. However, GAO's research showed that as of Dec 4, 2020, approximately 18% of those funds had been disbursed. To help efficiency, GAO recommends that a better tracking system be used so that the department can reach its goal of distributing the majority of funds early this year.
In the government's efforts to assist people affected by the pandemic, the researchers found multiple agencies actually gave too much financial aid to certain parties. The Department of Labor overspent $1.1 billion in Pandemic Unemployment Assistance payment, the authors state, and the Small Business Administration (SBA) may have approved approximately $156 million to ineligible businesses such as real estate development and insurance. Both cases necessitate better data tracking, as well as more loan analysis in regards to the SBA.
Additional data tracking will also be needed to form and execute a national COVID testing strategy, says GAO. HHS already has some documents that outline some strategy, but they have to be synthesized, expanded as needed, and made public. "Overall testing numbers are unknown in part because those data are incomplete as reported to HHS by the states," the authors write.
"As the use of antigen and other point-of-care tests continues to increase, including with increased availability of home-based testing, it will be important to capture such use in metrics used for public health decision-making."
As for OSHA, GAO recommends that it expand and improve its employer data requirements to better assist public health surveillance. The organization has already adapted many of its regulation methods to the pandemic, but further assessment of their effectiveness would be beneficial as well, the report says.