April 12, 2021
By Naomi Lopez
For more than a year now, the United States’ fight against COVID-19 has frequently felt like a game of whack-a-mole—as we struggle to keep on top of COVID case surges, treatments, and the distribution of vaccines across the country. Now, with the news that several COVID tests will now be available over the counter, we’re reminded yet again that we have it in our power to ensure that regulatory obstacles and barriers never stand in the way of health and economic recovery.
The U.S. Food and Drug Administration (FDA) recently announced emergency use authorizations (EUA) for three previously authorized COVID-19 tests that will now be available for over-the-counter (OTC) use without a prescription for use in serial screening. According to the FDA, “Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test.”
These authorizations came as a result of the FDA’s recently created new pathway for OTC authorization for tests that already had EUA status. The impact of these new authorizations will be an integral part of the nation’s ongoing response to COVID-19. According to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, “Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country’s pandemic response—many schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19.”
While this is a welcome development, we should remember that the United States has not been leading the way in embracing scientific innovation during this pandemic, instead lagging most of the developed world in administering COVID-19 tests and making adequate personal protective equipment (PPE) available to frontline workers. It remains illegal for states to validate and use their own COVID-19 tests without prior federal approval, and existing rules and regulations continue to pose similar obstacles for states to manage their own production and certification of PPE.
In our newly released blueprint for healthcare reform, the Goldwater Institute offers up a proposal that would allow states to validate and use their own tests and personal protective equipment (PPE) during times of national or state-declared emergencies. Under this proposal, state departments of health will have the authority to certify tests and equipment. This approach establishes the presumption that state health departments can and should be empowered to act more quickly when time is of the essence and lives are at stake. States would still be required to submit for federal approval but would do so without delaying their ability to respond in an emergency.
And state flexibility in responding to public health emergencies will continue to be important going forward, as COVID evolves and threatening variants continue to appear, posing an ongoing threat to the nation’s full restoration of health and economic recovery. With an unpredictable future about the effectiveness of our current vaccines against new and emerging variants, an important priority for lawmakers should be in ensuring that we have as many options for responding to what remains unknown and unpredictable threats to public health.
Our battle against COVID-19 is no game—lives are on the line. Our nation needs the ability to leverage of the full capacity of our scientific potential going forward—unfettered by bureaucratic red tape and delay. Part of the response should include allowing states, when possible, to launch their own responses in times of public health emergencies. Empowering states to act quickly and flexibly is absolutely key to keeping the COVID threat at bay in the future.
Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute and a contributor to the Goldwater Institute’s new blueprint, Putting Patients First: Unleashing Innovation in American Healthcare.