The Food and Drug Administration on Monday announced that antibody test developers must meet higher quality standards and seek authorization from the administration in order to keep their tests on the market.
The department previously allowed companies to validate their own data in bringing antibody tests to market, a controversial move that unleashed more than 100 tests with wildly variable degrees of quality. Under the new policy, coronavirus test developers will have to meet certain markers of accuracy and submit an application for emergency authorization within 10 days of submitting their data.
“Our expectation is that those that can't do that will withdraw their product from the market and we will be working with them to help them do that,” FDA Commissioner Stephen Hahn said on a call with reporters.
FDA officials said they are adapting their approach based on real-world experience and data. "The careful balancing of risks and benefits has shifted from where it was in mid-March," said a blog post by Anand Shah, FDA deputy commissioner for medical and scientific affairs, and Center for Devices and Radiological Health Director Jeff Shuren.
Hahn has said the pandemic necessitated the quick development of more testing capabilities as experts race to develop ways to identify and treat the virus.
The FDA faced criticism over its previous approach, which contributed to the chaos surrounding the nation’s testing situation.
“We’ve long been concerned that allowing tests on the market that have not been approved and authorized for use is a recipe for disaster,” Association of Public Health Laboratories Scott Becker said in a statement applauding the change. “This revised policy makes a lot of sense and should have been in place over the last six weeks.”
Other critics, such as Rep. Lloyd Doggett, D-Texas, said the revision still falls short.
“This announcement is mostly excuse-making without detailing sufficient steps being undertaken to assure consumer protection,” Doggett said in a statement. “This is much more than an import problem. The FDA has not outlined what oversight actions it will take to remove fraudulent tests and recoup payments made by abused consumers.”
The FDA has so far authorized 12 antibody tests, which look for evidence that a patient has been exposed to and recovered from the virus that causes COVID-19. Those authorizations expire once the national emergency ends, and none of the tests have earned full FDA approval.
Questions about accuracy of the data also persist, along with questions about what, if any, level of immunity antibodies offer against reinfection.
More data is needed to understand whether the presence of antibodies means it's safe for a person to return to work, Hahn said when asked if an antibody test is enough to consider that someone is immune.
"My opinion on that would be no, because again there are a lot of unanswered questions,” he said.