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Rep. Schrier Urges President Biden to Use Executive Order to Make More Rapid COVID Tests Available

October 8, 2021

ISSAQUAH, WA – Today Congresswoman Kim Schrier, M.D. (WA-08) sent a letter to President Joe Biden urging him to issue an executive order to streamline the process for approving rapid, at-home COVID tests. So far, the U.S. has approved eight tests, with only three tests currently available for purchase, compared to 36 in the UK and 34 in Germany.

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Rapid tests available

In her letter, Rep. Schrier said, "While I hope to see even more tests authorized in the coming weeks and months, we need a plan now to bridge the gap until supply can meet demand. The most efficient way to ramp up supply is to provide access to the dozens of tests that have already received approval from an equally rigorous approval process. The European Union has recognized 138 rapid antigen tests that provide accurate results… I urge your Administration to make more tests available in the United States by issuing an executive order providing an expedited approval pathway that recognizes tests already approved in the European Union."

Rep. Schrier has been pushing for more than a year to make rapid tests more available on the market. In March, at Rep. Schrier's urging, the Food and Drug Administration (FDA) put forward an Emergency Use Authorization Template to help streamline approval of rapid antigen tests. It is this EUA template that allowed the new FlowFlex test to be approved earlier this week.

Rep. Schrier continued, "Right now, to test the over 50 million K-12 students in America two times a week, we need over 100 million tests- a week. This means, for a full school year, we need over 4 billion tests. And that does not factor in higher education or take into consideration other congregate settings, employer based testing or private sector use."

The news this week of FlowFlex's approval and the Biden Administration's purchase of 180 million more tests will allow more tests to be on the market soon. But there is still work to be done, and that can be done singularly by President Biden, to make more tests available to Americans who want to test themselves before work, school, or going out to eat.

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The text of the letter to President Biden is as follows:

Dear President Biden:

I commend this week's announcement to scale-up access to rapid at-home COVID-19 tests. For over a year, I have urged the adoption of a testing strategy that prioritizes frequent, at-home testing to help individuals make informed decisions and markedly curb the spread of COVID-19 in our workplaces, schools, and communities. Today, I am pleased to see that strategy put into action. The new investments in rapid tests will make a meaningful difference in Americans' ability to access tests.

However, I write today to raise caution: even with the surge of newly authorized FlowFlex tests in addition to the rapid tests currently on the market, we will still lack the capacity to truly optimize the use of these tests as they are intended. While I hope to see even more tests authorized in the coming weeks and months, we need a plan now to bridge the gap until supply can meet demand. The most efficient way to ramp up supply is to provide access to the dozens of tests that have already received approval from an equally rigorous approval process. The European Union has recognized 138 rapid antigen tests that provide accurate results. The United Kingdom has 36 at-home tests that have passed validation. Germany has 36 tests approved for self-use. The United States has 8 -- only 3 of which are currently available for consumers to purchase. I urge your Administration to make more tests available in the United States by issuing an executive order providing an expedited approval pathway that recognizes tests already approved in the European Union.

In March, the FDA put forward an Emergency Use Authorization Template for serial testing to help streamline approval of screening tests.[1] It is this EUA template that allowed FlowFlex to be approved. Having a test work through this process, with immediate contracts and commitments to scale up production is exactly how the system can and should work. Expediting approval of tests that are globally recognized and already approved by rigorous regulatory entities is the next logical step to streamline approvals and break the gridlock at the FDA.

As we scale up, there needs to be a steady eye on the math: to keep our schools and economies open and free from outbreak, asymptomatic screening testing needs to happen frequently. Testing all students 2-3 times a week will catch cases before they can spread. The NIH found earlier this year, that "with schools and businesses reopening, an individual's risk of infection can change from day to day. Serial antigen testing can help people manage this risk and quickly take action to prevent spread of the virus."[2]

Right now, to test the over 50 million K-12 students in America two times a week, we need over 100 million tests- a week. This means, for a full school year, we need over 4 billion tests. And that does not factor in higher education or take into consideration other congregate settings, employer based testing or private sector use.

Even with FlowFlex joining the other handful of rapid antigen tests companies available in the US market, and the promise millions more accessible and purchasable tests, we will still be far short of that goal. We need inexpensive, accessible tests to truly utilize our testing potential. In the United Kingdom, tests are available free to pick up at local pharmacies and can be delivered to residents. In Germany, consumers pay less than a dollar per test.

Ideally, the US would also subsidize screening tests. But we still need the supply. That is why I encourage you, President Biden, to help us turn the corner on this public health emergency and issue an executive order to recognize tests already approved in the European Union.

Thank you for the hard work of the COVID-19 Task Force to create a comprehensive COVID-19 strategy to safeguard the American public and our economy. I look forward to continuing to work together to develop a powerful and effective national testing strategy that can be employed to fight the health crisis now and in the future.

Sincerely,

Kim Schrier, M.D.

MEMBER OF CONGRESS