WASHINGTON (CN) — For months, companies have had free rein to market unapproved tests for the novel coronavirus as long as they notified the Food and Drug Administration and included disclaimers.
Officials said the unorthodox method created “flexibility” to respond to the urgent need for increased testing capacity.
But flexibility gave birth to fraud, leading the FDA to rescind the policy following heavy criticism from health experts and members of Congress.
"We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans,” Anand Shah, an FDA deputy commissioner, said in a statement issued Monday with Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
The FDA will now provide specific performance thresholds for test developers, giving commercial manufacturers 10 business days to submit emergency authorization requests with validation data.
The policy change came within hours of new modeling attributed to but disavowed by the Centers for Disease Control and Prevention that project new Covid-19 cases will soar to around 200,000 per day by the end of the month, with approximately 3,000 daily deaths by early June. That is double today’s death rate from the virus.
Publicly recognizing that false marketing has plagued the 160 coronavirus tests available, the FDA said Monday some companies have falsely claimed that their tests had been approved the agency, were made for at-home use or could cure coronavirus.
Nasal swabs are the most widely used to detect the presence of the novel coronavirus in a patient, while blood tests taken with a simple finger prick show whether the patient has antibodies that indicate a prior infection. While there are still many unknowns surrounding the virus, experts say the availability of widespread testing will be key to safely reopening the country after months of economic turbulence.
Monday’s shift on testing comes as “the careful balancing of risks and benefits has shifted from where it was in mid-March,” said Shah, the FDA deputy commissioner.
Shah stressed that one strategy to put a stop to the falsely marketed blood tests will be to detain illegitimate test kits at the border.
“We will keep up our work to stop illicit tests from entering the U.S., and we encourage states, hospitals and consumers to be on high alert and to make informed purchasing decisions regarding these tests,” he said.
The FDA plans to independently validate certain antibody tests in partnership with the National Cancer Institute.
Green-lighting one producer over the weekend, the agency approved Roche Holding AG to market its coronavirus antibody test. The Swiss-based company predicts its production will soar to the high double-digit millions by next month. The company said Sunday that its high-volume testing instrument churns out as many as 300 results in an hour.
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