������ý

On June 23, 2020, ASM provided the following response to the House Energy & Commerce Committee Hearing: “Oversight of the Trump Administration’s Response to the COVID-19 Pandemic.”

On behalf of our 30,000 members in the ������ý States and around the world, the American Society for ������ý (ASM) thanks Chairman Frank Pallone, Ranking Member Greg Walden and members of the House Energy & Commerce Committee for holding this hearing with federal health agency leaders to provide an update on the response to and efforts toward recovery from the COVID-19 pandemic. We appreciate steps taken by Congress in recent months to provide emergency funding for public health agencies, to supplement funding for research and development towards better diagnostics for SARS-CoV-2 and novel vaccines and treatments, and to enact provisions to address the needs faced by clinical laboratories, whether in public health departments or in hospitals and academic medical centers.

At this time, we offer the following specific points to the Committee:

• We urge the Secretary of Health and Human Services (HHS) to renew the public health emergency declaration before it expires on July 25. It is imperative that the federal government continue to deploy all resources and authorities necessary to protect the public and assist states and localities as they continue to respond to this urgent situation.
• FDA must provide appropriate oversight and enforcement of diagnostic and antibody tests that come to market. We thank FDA leadership for maintaining an open dialogue with ASM leadership and adapting its diagnostic and antibody testing policies and guidance as the pandemic has evolved. However, this situation brought to light current shortcomings of the EUA process and had the unintended consequence of erecting barriers to timely and accurate testing at the point of patient care. At the same time, the current crisis has highlighted challenges of balancing the need to foster innovation while ensuring oversight of newly developed serology tests.
• The federal government must continue to assist states and stakeholders to track, communicate and help resolve laboratory testing supply issues. ASM and its members have been advising the White House Coronavirus Task Force on the needs of public health and clinical microbiology laboratories and around the country. These efforts point to the need for a large scale and coordinated system to connect the public, clinical, commercial and industry sectors to ensure sufficiently robust supply lines, transparency about when and where shortages exist and for what materials, and cross-sector communication about supply levels, so that we can leverage the power of testing to reopen our economy. In order to carry out this important mission, clinical labs should have the supplies (e.g. reagents, swabs, buffers) and testing kits they need to meet the demands in their area. Laboratory clinicians should have access to personal protective equipment (PPE) due to the risk of exposure to infectious material.
• We must deploy a national testing strategy and national plan to study COVID-19 interfaces, its spread and levels of exposure in communities to mitigate the ongoing pandemic and better prepare our country for the next one. State and local plans are important components, but leadership and coordination needs to occur at the federal level.

Broad access to accurate and reliable diagnostics and reporting of test results continues to be fundamental to addressing the pandemic.  Testing and tracking of the virus are essential elements for fully reopening the U.S. economy. Sustained, robust funding for multiple public health agencies such as CDC, NIH, BARDA and FDA, including funding for preparedness, response, laboratory capacity, surveillance and infrastructure, also is required to meet the ongoing demands placed on the system by the pandemic, and to provide the medical countermeasures to help us move beyond it.

ASM reiterates our commitment to assisting the Committee, its members, the Congress, the White House Coronavirus Task Force and the agencies as the U.S. continues to respond to the COVID-19 pandemic.

Find more information from ASM on nCov2019.