Woodcock defends COVID test review priorities to Congress

Regulatory NewsRegulatory News | 11 January 2022 |  By 

Facing questions from members of the Senate Health, Education, Labor & Pensions Committee, Acting FDA Commissioner Janet Woodcock defended the agency’s move to prioritize the review of at-home and point-of-care tests based on manufacturing capacity.
The agency has so far granted emergency use authorizations (EUAs) to more than 400 COVID-19 tests and sample collection devices, including more than a dozen over-the-counter tests for at-home use.
“The agency’s been closely monitoring the potential impact of the omicron variant on the currently available vaccines, diagnostics and therapeutics,” Woodcock said. Amid concerns about the ability of at-home tests to detect the omicron variant, she added, “We believe all of them detect omicron, we simply feel they are somewhat less sensitive than they were to some of the previous variants.”
When asked whether at home tests could be converted to using a throat swab instead of a nasal swab to boost sensitivity, Woodcock said that the biggest barrier to doing so would not be in FDA’s review, but rather the effort it would take for the manufacturer to modify the test configuration to accommodate a larger swab.
In an exchange with Ranking Member Richard Burr (R-NC), Woodcock defended the agency’s move to prioritize the review of tests based on several factors, including the ability of at-home and point-of-care test makers to scale up manufacturing.
“FDA issued revised guidance stating it would focus its review efforts on at-home tests and point-of-care COVID test applications from developers with the capacity to manufacture more than 500,000 tests per week of being authorized. Why did the FDA move the goalpost at this particular time and suggest to companies that can’t ramp up to that manufacturing that they’re not going to get an accelerated EUA pathway?” Burr asked.
Woodcock replied that there is “an urgent need for high-volume home-based tests. We have a queue; we have moved heaven and earth to get as many done as possible. We’ve authorized over 400 different kinds of tests or test collection devices during this pandemic. As far as what the queue is, the priority, we’re prioritizing the highest volume and putting them to the front so that we can get home test kits into the hands of people.”
Burr questioned Woodcock on whether the move would discourage innovation by smaller companies, to which Woodcock responded that the agency’s policy only prioritizes certain submissions, and does not mean it won’t get to other applications.
“It’s capacity we’re talking about here, production capacity,” Woodcock said.
Later in the hearing, Woodcock said that the agency is facing resource constraints due to the unprecedented volume of submissions for devices during the pandemic.
“We could do more with more resources. We have authorized over 2,000 different device products, including the 400 test-related products in two years. That’s an incredible increase in the workload and we really appreciate the funding that Congress has provided,” she said, adding that the recently established Independent Test Assessment Program (ITAP) program with the National Institutes of Health for home testing will improve the development of at-home tests “tremendously”.


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