The emergency use authorization (EUA) pathway that expedited availability of Covid-19 diagnostics for the past two years is narrowing for most new tests. The FDA said Tuesday it plans to review fewer new EUA requests and will instead direct diagnostics companies to submit applications through traditional review pathways.
Testing was a particular pain point as the pandemic unfolded in early 2020. Demand far outstripped the supply of the few available tests. Many labs that processed these tests were overwhelmed. The FDA’s issuance of EUAs for new tests was intended to help ease the testing problems.
The FDA now says that the current stage of the pandemic warrants changes. More than 430 distinct Covid-19 tests have received emergency authorization, and available information indicates that these tests are providing sufficient testing capacity throughout the country, the FDA said. Multiple over-the-counter tests are now available, and manufacturing capacity enables the production of hundreds of millions of tests per month, the agency added.
“Taking into account the current status of manufacturing capacity and consumer access given the administration’s important investments in tests, for most new tests, shifting to traditional premarket review would best meet the public health needs at the current stage of the COVID-19 public health emergency,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA policy change follows an Office of Inspector General (OIG) report issued last week that found testing failures from the beginning. While a test from the Centers for Disease Control and Prevention is typically the first to receive an EUA, that agency’s test was unusable for many weeks, during which no other test was available. The government oversight organization also found fault with the FDA, which did not readily recognize the testing capacity problem at public health labs. The report says the FDA tried to address testing problems by increasing the availability of Covid-19 tests, a decision that came at the expense of test quality.
“FDA’s decision to accept all EUA requests resulted in a record number of submissions—often low-quality and from developers lacking experience with FDA’s processes,” the report said. “In response, FDA took steps to support developers and ease its workload, which included issuing EUA guidance, updating templates (submission guides for developers requesting EUA), and adjusting its EUA review process, among others. Some developers still reported being frustrated and confused.”
The OIG’s recommendations include revising guidance for EUA submissions and developing EUA templates for future emergencies that involve novel pathogens. The report said that the FDA concurred with the recommendations.
The EUA requests that have already been submitted and are still pending may remain in the queue for review. But the FDA’s policy update appears to mean the end of a quicker path to the market for many diagnostics startups, as the FDA now says it is limiting EUAs to “experienced developers.” For such companies submitting new EUA requests and supplemental EUA requests, the agency will focus on:
- Diagnostic tests likely to have significant benefit to public health, such as those employing new technologies.
- Tests likely to fulfill an unmet need, such as diagnosing infection with a new variant or subvariant.
- Supplemental EUA requests that fulfill a condition of authorization include a modification that will significantly benefit public health or fulfill an unmet need.
- Tests for which the EUA request is from or supported by a U.S. government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics.
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