Report: Feds allowed distribution of antibody tests after they knew many were flawed

It took 50 days for the FDA to reverse its course on antibody tests. In May, it began requiring test developers to apply for emergency authorization and submit data to show their tests worked. It was too late, says Rep. Raja Krishnamoorthi. He is investigating the FDA for not regulating the antibody tests. “Fraudulent tests flooded the market. Hundreds and hundreds of tests taken by hundreds of thousands, if not millions of people,” says the Illinois Democrat. All companies had to do to get their tests to the U.S. market was state they were self-validated. “When you open the floodgates to virtually any product being sold by anybody, well, guess what? Shysters, scam artists, and people who are preying on unsuspecting consumers enter the fray,” says Krishnamoorthi.

It took almost three months before the FDA started pulling tests off the market, but by then, many American municipalities had already used the tests to determine whether they could send essential workers like EMTs, policemen and firemen back to work. One of the more than 40 tests removed by the FDA was the one Dr. Gonzalez prevented from being used in Laredo. Suppose he hadn’t tested them? “We wouldn’t have a true indicator of the level of infection. The public deserves for us to give them something that’s valid,” he tells Alfonsi.