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. by 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 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 to the public as quickly as possible.
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.
