Woodcock Sets High Priority for OTC Covid Tests

Increasing the availability of over-the-counter (OTC) Covid-19 home tests is a top priority at FDA, according to acting commissioner Janet Woodcock. In 11/4 testimony provided to the Senate Health Education Labor & Pension Committee, Woodcock said the agency prioritizes the review of emergency use authorization (EUA) requests for at-home rapid antigen tests and is actively engaging with test developers to increase their availability.

Woodcock’s testimony said the agency has increased staffing on the antigen test review team as resources permit. “FDA is actively working to increase the pipeline of at-home tests by engaging with companies to obtain data that can be used to support their EUA, and encouraging developers with authorized [point-of-care] POC tests to add at-home test claims,” she said, adding that the agency is also continuing its engagement with international regulators, and targeted outreach to manufacturers of home tests in non-U.S. markets. 

Woodcock told the hearing that FDA to date has authorized 10 rapid at-home tests. Three of these were authorized within one week. FDA also has authorized 31 EUAs for rapid tests for use at point-of-care, including schools. She noted that In March, FDA obtained results from an NIH-sponsored study that supported further streamlining of FDA’s at-home test recommendations. “Based on these data, on 3/16, FDA created a streamlined pathway for the agency to authorize tests with at least 80% sensitivity in symptomatic individuals, with sensitivity falling in a range as low as 70% in certain circumstances, to offer their test for OTC serial screening without additional data collection,” she said. “Multiple tests were authorized under this approach within weeks.”

To illustrate improvement in OTC testing, Woodcock said that on 10/25, FDA provided labeling updates to allow OTC single-use testing for symptomatic individuals for tests currently authorized only for serial testing. “For example, right now when people go to a pharmacy to buy an over-the-counter test, they are sold in two-packs,” Woodcock said in her testimony. “This change would allow tests to be sold in singles, meaning more individual tests for sale potentially at a lower price.” Last month, she continued, the agency authorized the ACON Laboratories Flowflex COVID-19 Home Test, which Woodcock said should increase the availability of rapid, at-home tests; by the end of 2021. The manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February.

Going forward, Woodcock said FDA is supporting NIH’s new Independent Test Assessment Program (ITAP) which will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing. The program is intended to 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,” she said. “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.”