Press Release - New HHS Actions Add to Biden Administration Efforts to Increase Access to Easy-to-Use Over-the-Counter COVID-19 Tests

NIH to Invest $70 Million from American Rescue Plan to Accelerate Test Developers Progress Through Regulatory Authorization Process

FDA Updates Regulatory Path Which Could Lower Costs, Make Tests More Available

FDA Authorizes Additional Over-the-Counter COVID-19 Test

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 actions to help reduce costs, make tests more available, and support bringing more tests to market in the U.S.

"Access to easy-to-use, affordable and reliable COVID tests is key to bringing peace of mind to our families, especially as we approach winter. Thanks to President Biden's American Rescue Plan, we are boosting the supply of at-home tests and the number of test options for Americans nationwide," said HHS Secretary Xavier Becerra. "As we pursue our path out of this pandemic under President Biden, we will continue doing 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 onto the market in the U.S. in coordination with the Food and Drug Administration (FDA). NIH's new Independent Test Assessment Program (ITAP) will establish an accelerated 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 manufacturers of high quality tests and encourage them to bring those tests to the U.S. market, increasing options for people and overall supply and potentially lowering costs. In this new program, NIH, FDA, and other CDC and HHS experts will assess and conduct studies on over-the-counter tests and work with companies to compile proper data, work towards the right benchmarks for performance, and support other needs that will help ensure they are providing the best submissions possible for FDA's regulatory review. NIH will provide reliable, independent laboratory and clinical data to FDA for test manufacturers that can scale up quickly. If tests meet FDA's performance and quality standards, FDA will use this information to grant emergency use authorization (EUA). In this new program, HHS will prioritize new over-the-counter test applications that have the potential for manufacturing 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 FDA, NIH will produce the precise data needed to make authorization decisions quickly," said NIH Director Francis S. Collins, M.D., Ph.D. "This close partnership will streamline the process to generate the data for FDA review."

Separately, the FDA is further streamlining the regulatory pathway for manufacturers developing over-the-counter at-home tests. FDA is providing recommendations for labeling updates to facilitate over-the-counter single-use testing for symptomatic individuals for tests currently authorized only for serial testing. The developers of those tests will now be able to request authorization to add single-use testing for symptomatic individuals without submitting additional data. For example, right now when people go to a pharmacy to buy an over-the-counter test, they are sold in two-packs. This change would let tests be sold in singles, meaning more individual tests for sale potentially at a lower price.

Additionally, FDA announced it has authorized another over-the-counter rapid antigen test. FDA has granted an emergency use authorization to Celltrion Diatrust for its COVID-19 Home Ag Test for over-the-counter single-use testing for symptomatic adults and over-the-counter serial testing for all adults. This brings another easy-to-use rapid COVID-19 test to market, the tenth over-the-counter test FDA has authorized. This means that when people go to their pharmacy or a store to buy a test they can take at home, they will soon have an additional option, increasing supply and making more tests available on shelves for people. In line with the new update to its regulatory pathway, FDA has also reauthorizedthe Quidel QuickVue at-home test to add over-the-counter single-use testing for symptomatic adults and children.

"These actions demonstrate our continued commitment and flexibility to providing a streamlined approach to developers to increase the availability of rapid at-home tests," said Jeff Shuren, M.D., J.D., 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 and reliable tests they can count on, while also increasing access and availability."

These actions will help put more tests on shelves when people go to buy an at-home test, unlocking more options and potentially lowering prices. They follow President Biden's recent announcement to quadruple 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.