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The Food and Drug Administration announced on Monday that companies selling coronavirus antibody tests must submit data proving accuracy within the next 10 days or face removal from the market. The antibody tests are an effort to detect whether a person had been infected with the coronavirus, but results have been widely varied. Since mid-March, the agency has permitted dozens of manufacturers to sell the tests without providing evidence that they are accurate. (Kaplan, 5/4)

At least 160 antibody tests for Covid-19 entered the U.S. market without previous FDA scrutiny on March 16, because the agency felt then that it was most important to get them to the public quickly. Accurate antibody testing is a potentially important tool for public-health officials assessing how extensively the coronavirus has swept through a region or state. (Burton, 5/4)

“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. Blood tests for antibodies are used to determine who has been previously been infected with the virus. As the new coronavirus can be easily spread by people with no symptoms, widespread antibody testing is seen as a critical piece in the effort to get Americans back to work safely, as the presence of antibodies to the virus many indicate possible immunity to future infection. (Humer, 5/4)

The action was the latest about-face in the administration’s coronavirus effort as it seeks to fix a flawed testing response that has been criticized as either too restrictive or too lenient. Earlier this year, the FDA was hammered for moving too slowly in allowing academic medical centers and others to develop diagnostic tests for the virus that might have made them more widely available. Then, critics say, it swung too far in the other direction in allowing the antibody tests to go unvetted. (McGinley, 5/4)

A senior FDA official told POLITICO the policy change was not a direct result of pressure from Congress. Instead, the official said that having a dozen authorized tests on the market was a natural inflection point to reevaluate the agency’s approach to oversight. FDA Deputy Commissioner Anand Shah and device center chief Jeffrey Shuren wrote in a blog post Monday that the agency is aware of several commercial tests that are “being promoted inappropriately, including for diagnostic use.” “Some test developers have falsely claimed their [antibody] tests are FDA approved or authorized,” Shah and Shuren wrote. “Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.” (Lim, 5/4)