10.21.21

WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today urged Health and Human Services (HHS) Secretary Xavier Becerra and Acting Food and Drug Administration (FDA) Commissioner Dr. Janet Woodcock to help rapidly expand home COVID -19 tests. Durbin stressed that despite the dramatic expansion of vaccinations by the Biden administration, the country’s testing infrastructure remains an important and underdeveloped aspect of our response to public health emergencies.

“In September 2021, the United States averaged about 1.5 million COVID-19 tests per day, largely reflecting the strong capabilities of our public health and commercial laboratories. But as the pandemic moves to a new stage where vaccinations have reopened large segments of society but infections – whether revolutionary cases or among the unvaccinated – remain a major concern, the ability to have immediate and reliable testing is imperative ”, Durbin wrote. “Access to rapid antigen testing as a way to promote safety when returning to work, travel, education or other gatherings will be needed in this new phase of the pandemic. These home tests can supplement the gold standard of polymerase chain reaction (PCR) tests, which usually take several days to get results. “

In his letter, Durbin also praised the Biden administration for investing $ 1 billion in home tests earlier this month to help quadruple the market to 200 million tests per month by the end of the year. ‘year. He urged the FDA to explore flexibilities to bring rapid home tests to market faster and the HHS to continue to use US bailout funds (ARP) to allow states to expand testing.

“In order to maximize the public health benefits and utility of this rapid testing capability, the FDA and HHS should explore appropriate flexibilities in their regulatory standards to better enable the commercialization of additional precise and rapid tests. at home and be available over the counter (OTC) for the general public ”, Durbin continued. “I also urge the HHS to continue its efforts to use funds allocated by Congress from the US bailout and previous COVID-19 aid legislation, to ensure that the tests authorized by the FDA are widely disseminated. , accessible in high-risk communities and affordable so that cost is not a barrier to this public health tool, as many peer countries have done.

The full text of the letter is available here and below:

21 October 2021

Dear Secretary Becerra and Acting Commissioner Woodcock:

The spectacular efforts of the Biden administration to scale up vaccinations for 77% of eligible Americans have been an impressive and successful initiative. But more than a year and a half after the start of the COVID-19 pandemic, our country’s testing infrastructure remains an important and underdeveloped aspect of our response to public health emergencies. This is especially true following President Biden’s laudable immunization demands through the Occupational Safety and Health Administration (OSHA), which rely on rapid and reliable testing options to keep workers safe. work places. I am writing to urge the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to explore additional flexibilities in its regulatory framework for rapid home tests, to reflect the benefit for the public health to be accessible, reliable, affordable testing capacity.

Since the start of the pandemic, the FDA has used a range of tools to respond quickly and impressively to the testing needs of the country, issuing Emergency Use Clearances (EUA) for more than 400 COVID- tests. 19 and sampling devices. In September 2021, the United States averaged about 1.5 million COVID-19 tests per day, largely reflecting the strong capabilities of our public health and commercial laboratories. But as the pandemic moves to a new stage where vaccinations have reopened large segments of society but infections – whether revolutionary cases or among the unvaccinated – remain a major concern, the ability to have immediate and reliable testing is imperative.

Access to rapid antigen testing as a way to promote safety when returning to work, travel, education or other gatherings will be needed in this new phase of the pandemic. These home tests can supplement the gold standard of polymerase chain reaction (PCR) tests, which usually take several days to get results. I’m happy to see the Biden administration backing this premise by investing $ 1 billion in home testing earlier this month to help quadruple the market to 200 million tests per month by the end of the month. year.

In order to maximize the public health benefits and utility of this rapid testing capability, the FDA and HHS should explore appropriate flexibilities in their regulatory standards to better enable the commercialization of additional accurate and timely rapid tests. home and be accessible through a counter (OTC) for the general public.

Along with the clinical value of PCR diagnostics for confirming an individual’s infection, the ability to have faster notification times and home access is not just a matter of convenience, but of health benefit. public to specifically detect when someone is infectious and provide accurate and actionable information. information on the risk of transmission. Yet despite the different functions between clinical diagnosis and mitigation of transmission, the FDA sets the same validation standards for these rapid antigenic tests as for more extensive PCR diagnostic tests, which can remain positive even beyond the window of isolation of an individual. Currently, a rapid antigen test seeking an over-the-counter EUA for home use should demonstrate an 80% sensitivity, including in asymptomatic individuals, to a PCR test. Still, the Centers for Disease Control and Prevention (CDC) recognizes that people who have already recovered from COVID-19 may still have detectable virus samples for three months, suggesting that this reality could be taken into account when considering assessment of test sensitivity standards. Given the public health benefit of the immediate and actionable information that a home-based rapid can provide, it may be possible to maintain accuracy without applying a threshold of sensitivity commensurate with the window of positivity result longer than. ‘a PCR test can detect.

While I strongly support the work of the FDA to ensure the highest quality and confidence in the tests on the market, especially PCR diagnostics to confirm infection, there may be value and a credible way to ensure accuracy while exploring a flexible public health approach for rapid testing to demonstrate another threshold of sensitivity given the distinct role they can play. There are currently a few rapid antigen test products on the market which may be suitable as susceptibility predicates in such a public health standard.

Attention to the promise of rapid home testing is only one aspect of the country’s larger testing infrastructure, and it should not come at the expense of further support for PCR testing capacity. , which remains the most common and accurate form of testing. . In exploring a framework that reflects the reality of this public health testing capability, it remains important that home testing administration is properly authenticated and that relevant data results are shared with public health authorities to ensure a precise and complete picture of the transmission level. in a community. As the FDA and HHS work with manufacturers of rapid home tests, visibility of results will remain an important function.

I also urge the HHS to continue its efforts to use funds allocated by Congress from the US bailout and previous COVID-19 aid legislation, to ensure that the tests authorized by the FDA are widely disseminated, accessible in high-risk and affordable communities so that cost is not a barrier to this public health tool, as many peer countries have done. Thank you for considering this request to help promote our common public health and screening goals.

Truly,

-30-


Source link

Leave a Reply

Your email address will not be published.