FDA Reverses Faulty Policy That Pushed Unreviewed Antibody Tests Into The Market

FDA Commissioner Stephen Hahn

WASHINGTON —  The Food and Drug Administration (FDA) has set new, tougher regulations on antibody test developers and manufacturers, after finding that previous rules that allowed firms to police their own quality control tests were not good enough.

Under the new policy, manufacturers of antibody tests must apply for an Emergency Use Authorization through the FDA within 10 business days of when the product was released to the market. If the product doesn’t meet the agency’s sensitivity and specificity performance threshold, the manufacturer must suspend distribution. Specificity measures how often the test correctly produces positive tests results, while sensitivity measures how often it correctly shows negative results.

The previous FDA policy on antibody tests, issued last month, was heavily criticized due to its lack of regulations and oversight. The agency said it was an effort to launch a discussion about when people should expect they could return to work and school, and to help identify an estimate of the population with antibodies to the new coronavirus, or COVID-19, that could help treat people currently infected by donating plasma or blood.

The former policy, however, allowed test developers to sell antibody tests as long as they validated their own data and notified the FDA, who didn’t conduct any additional testing. A recent House Oversight and Reform memorandum found that the FDA’s “unclear clarifications” on antibody tests policy showed the agency’s failure to police the coronavirus serological antibody test market that ended in allowing manufacturers to make fraudulent claims about their tests’ efficacy.

Officials have said “unscrupulous actors” took advantage of the previous policy to market fraudulent test kits. 

“Some test developers have falsely claimed their serological tests are FDA approved or authorized. 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,” FDA Medical and Scientific Affairs Deputy Commissioner Anand Shah and Device and Radiological Health Center Director Jeffrey Shuren said.

Last week, the American Medical Association sent a letter urging the Department of Health and Human Services to provide “additional guidance and educational materials around the use of serological testing to detect the presence of antibodies for SARS-CoV-2.” 

The letter emphasized the growing concerns of the medical community over the performance of many tests currently on the market, as they could influence individuals to limit physical distancing over a false negative test result.

Given the tests’ inherent limitations, the FDA said it “may be necessary for some individuals to have two serology tests performed to generate reliable results.”

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