The Food and Drug Administration announced on Monday that it would require new coronavirus tests to undergo a regulatory review after admitting that its lax policy led to fraudulent tests hitting the market, Reuters reports.
The FDA had only required companies to attest that the product worked and note on its label that it hasn’t been approved by the agency. The policy led to at least 170 tests making their way to market, many of which were sold with false claims about accuracy.
“Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” the FDA said in a statement.
FDA cracks down:
The FDA said it has stopped shipments of faulty test kits and vowed to take action against companies that falsely market their tests.
The earlier policy invited a number of shady characters with no background in medical supplies to start selling test kits.
Under the new FDA policy, manufacturers must submit their tests for emergency use authorization. Companies that have already released tests will have to submit their products to the FDA for authorization as well.
About a dozen tests on the market:
The FDA has already granted emergency use authorization to about a dozen tests. The FDA requires at least a 90% accuracy for the tests.
Former FDA chief Scott Gottlieb said that the tests are not accurate enough to determine whether people have antibodies that make them immune to the coronavirus.
Though it is assumed that those who were infected would develop immunity to the virus, that has not been proven in a lab setting and it is unclear how long any immunity would last.
Two Democrats have called for a congressional investigation into the tests and urged the FDA to do more to protect consumers from fraudulent tests.
