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Law360 (May 4, 2020, 9:10 PM EDT) -- The U.S. Food and Drug Administration announced Monday that commercial manufacturers of antibody tests for COVID-19 will now be required to submit emergency use authorization requests, a change from a March policy that had more lax oversight for the tests.
Commercial manufacturers must submit emergency use authorization requests with their validation data to the agency within 10 business days of either the publication of the policy or their notification to the FDA of their validation testing, whichever comes later.
In a call with reporters Monday, FDA Commissioner Stephen M. Hahn said the tests, which are a kind of serologic test, are important in the fight against the coronavirus outbreak, noting that high-quality tests can provide insights into a person or population's exposure.
Serologic tests look for the presence of certain antibodies in blood samples and can be used to see if someone has been exposed to a particular disease. The serologic tests for COVID-19 check for antibodies to the SARS-CoV-2 virus, the novel coronavirus that causes the illness.
"When we issued our original serologic test policy in mid-March, it was critical for the FDA to provide regulatory flexibility for serologic test developers given the nature of this public health emergency and an understanding that the tests were not to be used as the sole basis for COVID-19 diagnosis," Hahn said.
"I just want to emphasize that fact remains true today," Hahn added. "These tests are not to be used as the sole basis for COVID-19 diagnosis."
The FDA also gave serologic test developers specific performance threshold recommendations for their tests' sensitivity and specificity and provided emergency use authorization templates for antibody tests to help streamline the process.
According to Hahn, almost half of all the commercial manufacturers offering serologic tests are already interacting with the FDA.
The agency's site says that more than 200 antibody tests are "currently the subject of a pre-EUA or EUA review" and that 12 tests have been authorized by the agency under an individual emergency use authorization — most of those in the past few days.
Dr. Jeff Shuren, the director of the Center for Devices and Radiological Health, also noted on the call that the emergency use authorizations would expire when the national emergency ended.
He also said they had identified test developers who were improperly marketing tests, many for use at home — something never allowed under the policy unless authorized by the FDA — and others falsely claiming to have agency approval.
In some cases, the agency has removed tests from the market or modified their marketing, and other cases have been referred to the agency's criminal investigators, Shuren said.
Hahn said in a statement that the FDA will continue to modify its approach "based on real-world experience and data."
"As the FDA has authorized more antibody tests and validation data have become available, including through the capability at [the National Cancer Institute], the careful balancing of risks and benefits has shifted to the approach we have outlined today in our policy update," Hahn told the reporters Monday.
--Additional reporting by Jeff Overley. Editing by Orlando Lorenzo.
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