GAO makes recommendations on the federal public health response to COVID-19
The Government Accountability Office (GAO) announced it has issued five comprehensive reports with 44 recommendations to help improve the federal response to the COVID-19 pandemic.
The GAO testimony summarized 16 of these recommendations in selected public health areas—testing, vaccines and therapeutics, medical supply chain, health disparities, and data. GAO recommended that the government establish a time frame for a coordinated national vaccine distribution and administration plan following best practices.
More than a year after the U.S. declared COVID-19 a public health emergency, the pandemic continues to result in catastrophic loss of life and substantial damage to the economy. It also continues to lay bare the fragmented nature of our public health sector, the fragility of the nation's medical supply chain, and longstanding disparities in health care access, treatment, and outcomes.
Only one of these 16 recommendations has been implemented. The Secretary of Health and Human Services should direct the Commissioner of the U.S. Food and Drug Administration (FDA) to identify ways to uniformly disclose to the public the information from FDA’s scientific review of safety and effectiveness data— similar to the public disclosure of the summary safety and effectiveness data supporting the approval of new drugs and biologics—when issuing emergency use authorizations (EUA) for therapeutics and vaccines, and, if necessary, seek the authority to publicly disclose such information (November 2020 report on vaccine and therapeutics). FDA did develop a process for working with drug sponsors to disclose its scientific review documents for therapeutic EUAs and has released this information for the EUAs it has already issued. For vaccine EUAs, FDA is holding public Vaccines and Related Biological Products Advisory Committee meetings, through which FDA and sponsors are making information from scientific reviews publicly available. The agency also released decision memos with detailed information about the agency’s review of safety and effectiveness data for the two vaccines authorized to date.
Of these recommendations, 16 relate to the following public health topics:
· COVID-19 Testing. GAO has made two recommendations to date to improve the federal government's efforts in diagnostic testing for COVID-19, critical to controlling the spread of the virus. In January 2021, GAO recommended that the Department of Health and Human Services (HHS) develop and make publicly available a comprehensive national COVID-19 testing strategy.
· Vaccines and Therapeutics. GAO has made two recommendations to improve transparency, communication, and coordination around the government's efforts to develop, manufacture, and distribute vaccines and therapeutics to prevent and treat COVID-19. For example, in September 2020, GAO recommended that HHS establish a time frame for a national vaccine distribution and administration plan that follows best practices, with federal and nonfederal coordination.
· Medical Supply Chain. GAO has made seven recommendations for the federal government to respond to vulnerabilities highlighted by the pandemic in the nation's medical supply chain, including limitations in personal protective equipment and other supplies necessary to treat individuals with COVID-19. In January 2021, GAO recommended that HHS establish a process for regularly engaging with Congress and nonfederal stakeholders as the agency refines and implements its supply chain strategy for pandemic preparedness, to include the role of the Strategic National Stockpile.
· COVID-19 Health Disparities. GAO has made three recommendations to improve COVID-19 data by race and ethnicity, as available data show communities of color bear a disproportionate burden of COVID-19 positive tests, cases, hospitalizations, and deaths. In September 2020, GAO recommended that the Centers for Disease Control and Prevention involve key stakeholders to help ensure the complete and consistent collection of demographic data.
· COVID-19 Data. GAO has made two recommendations to improve the collection of data needed to respond to COVID-19 and prepare for future pandemics. GAO recommended in January 2021 that HHS establish an expert committee to help systematically define and ensure the collection of standardized data across the relevant federal agencies and related stakeholders; the absence of such data hinders the ability of the government to respond to COVID-19, communicate the status of the pandemic with citizens, or prepare for future pandemics.
Although the responsible agencies generally agreed with the majority of the 16 recommendations, only one has been fully implemented. GAO maintains that implementing these recommendations will improve the federal government's public health response and ability to recover as a nation. The country also continues to experience serious economic repercussions.
Five relief laws, including the CARES Act, have appropriated $3.1 trillion to address the public health and economic threats posed by COVID-19. The CARES Act also includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to COVID-19.
