Not the Time to Look at New Covid Approaches: Woodcock
As the omicron variant spreads out of control and related hospitalizations are breaking previous Covid-19 records, FDA acting commissioner Janet Woodcock told a Senate Health, Education, Labor & Pensions hearing 1/11 that this is not the time to think about different approaches to combat Covid-19 or determine how Americans will live with Covid in the future. She was responding to a question from senator Mike Braun (R-IN) about the need to look at different approaches to deal with Covid because the data on infections and hospitalizations are getting worse and not better since the public health emergency began two years ago.
Woodcock told lawmakers that it is “hard to process what’s actually happening right now, which is most people are going to get Covid, ... and what we need to do is make sure that hospitals can still function, and that transportation and other essential services are not disrupted while this happens. I think after that will be a good time to reassess how we’re approaching this pandemic... I think right now, we need to focus on continuity of operations for hospitals and other essential services as this variant sweeps through the population. I don't think that will last a really long time. But that’s where I think we are right now. So I don't think prior approaches reflect what’s going on right now.”
Addressing the frustration Americans are having with a lack of at-home Covid tests, Woodcock’s testimony noted that two recent emergency use authorizations (EUAs) could result in up to 400 million more at-home tests being available monthly to consumers early this year, based on projections by the manufacturers and dependent on federal subsidies. Currently, the agency has authorized 15 distinct at-home Covid-19 tests. She also said that FDA recently updated its review priorities to expedite at-home and point-of-care diagnostic tests that can be manufactured in high volumes. “These priorities help developers focus their prospective efforts where they are most needed, and reduce inefficient use of developer and FDA time on tests with less public health impact,” she said.
Additionally, Woodcock said FDA has worked with NIH to establish an Independent Test Assessment Program (ITAP) to streamline validation and authorization of antigen tests with potential for large-scale manufacturing. “This program is an extension of the RADx program which has already supported development of several authorized tests, including the first at-home OTC Covid-19 test,” she said. “ITAP goes further to conduct studies on over-the-counter tests and work with companies to help them provide complete, high quality submissions for FDA review. ITAP is conducting independent laboratory and clinical evaluations using protocols developed jointly with FDA. [The agency] uses information from these evaluations in deciding whether to grant EUAs. On 12/24, FDA authorized the first at home Covid-19 test where validation data were gathered through ITAP and the second followed shortly after on 12/29. We expect to continue shorter review times for such EUA requests due to our partnership with ITAP in establishing the evaluation program to address our regulatory needs.”