FDA Updates Regulatory Pathway That Could Reduce Costs and Increase Testing Availability
FDA authorizes additional over-the-counter COVID-19 test
The following press release was issued by the U.S. Department of Health and Human Services Press Office, contact: 202-690-6343, media@hhs.gov
As part of the Biden-Harris Administration’s commitment to increasing access to COVID-19 testing, the U.S. Department of Health and Human Services (HHS) is taking several new steps to help reduce costs, make testing more available, and support the commercialization of more tests in the U.S.
“Access to easy-to-use, affordable and reliable COVID tests is key to providing peace of mind for our families, especially as we head into winter. Thanks to President Biden’s American Rescue Plan, we are increasing the supply of at-home testing and the number of testing options for Americans across the country,” said HHS Secretary Xavier Becerra. “As we move forward on our path out of this pandemic under President Biden, we will continue to do everything we can to keep people safe and healthy.”
The National Institutes of Health (NIH) is investing $70 million from the American Rescue Plan to help bring more high-quality at-home tests to the U.S. market in coordination with the Food and Drug Administration (FDA). NIH’s new Independent Test Assessment Program (ITAP) will establish an expedited pathway to support FDA evaluation of tests with potential for large-scale manufacturing. The program is an extension of the NIH Rapid Acceleration of Diagnostics (RADx) initiative.
This new program will help identify high-quality test manufacturers and encourage them to bring those tests to the U.S. market, increasing options for individuals and overall supply and potentially reducing costs. In this new program, NIH, FDA, and other experts from CDC and HHS will evaluate and conduct studies on over-the-counter tests and work with companies to collect appropriate data, work to achieve the right benchmarks for performance, and support other needs that will help ensure they provide the best possible submissions for FDA regulatory review. NIH will provide independent, reliable clinical and laboratory data to the FDA so test manufacturers can scale up quickly. If the tests meet FDA quality and performance standards, the FDA will use this information to grant emergency use authorization (EUA). In this new program, HHS will prioritize new over-the-counter testing applications that have the potential to be manufactured at significant scale. The goal is to accelerate the availability of more high-quality, accurate and reliable over-the-counter tests to the public as quickly as possible.
“Working hand in hand with the FDA, NIH will produce the accurate data needed to make authorization decisions quickly,” said NIH Director Francis S. Collins, MD, Ph.D. “This close partnership will streamline the process of generating data for FDA review.”
Separately, the FDA is further simplifying the regulatory pathway for manufacturers developing over-the-counter home tests. The FDA is providing recommendations for label updates to facilitate non-prescription, single-use testing for symptomatic individuals for tests currently authorized for serial testing only. Developers of those tests will now be able to request authorization to add single-use tests for symptomatic people without submitting additional data. For example, right now, when people go to a pharmacy to buy an over-the-counter test, it is sold in packs of two. This change would allow tests to be sold individually, which would mean more individual tests would potentially be sold at a lower price.
Additionally, the FDA announced that it has authorized another over-the-counter rapid antigen test. The FDA has granted emergency use authorization to Celltrion Diatrust for its COVID-19 home agriculture test for single-use, over-the-counter tests for symptomatic adults and serial over-the-counter tests for all adults. This brings another easy-to-use rapid COVID-19 test to market, the 10th FDA-authorized over-the-counter test. This means that when people go to their pharmacy or store to buy a test they can take at home, they will soon have an additional option, increasing supply and putting more tests on shelves. In accordance with the new update to its regulatory pathway, the FDA has also reauthorized the Quidel QuickVue home test to add single-use, over-the-counter tests for symptomatic adults and children.
“These actions demonstrate our continued commitment and flexibility to provide a streamlined approach to developers to increase the availability of rapid at-home testing,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We will continue to work with developers and our government colleagues to ensure the public has access to accurate, reliable testing they can count on, while also increasing access and availability.”
These actions will help put more tests on shelves when people go to buy a test at home, unlocking more options and potentially lowering prices. They follow President Biden’s recent announcement to quadruple the supply of at-home tests by the end of the year by investing a total of $3 billion in rapid testing – up to 200 million at-home tests per month by the end of the year.
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