US to rein in flood of virus blood tests after lax oversight
Source: Associated Press
WASHINGTON (AP) U.S. regulators Monday pulled back a decision that allowed scores of coronavirus blood tests to hit the market without first providing proof that they worked.
The Food and Drug Administration said it took the action because some sellers have made false claims about the tests and their accuracy.
Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA approved. The policy was intended to allow flexibility needed to quickly ramp up production, officials said.
However, flexibility never meant we would allow fraud, Dr. Anand Shah, an FDA deputy commissioner, said in a statement. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans.
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By MATTHEW PERRONE
17 minutes ago
Read more: https://apnews.com/238af56283754cd19d1966ff1681f5ae