Dozens of companies making false claims about Covid-19 products meant to test if someone who has had the virus is now potentially immune to it face enforcement including possible product seizures, the FDA has warned.
Over 70 test developers have told the Food and Drug Administration they have these types of products—called serological tests— available. However, the agency has green lit only one company, Cellex Inc., through its emergency regulatory channel to use the tests in clinical labs. Going through that channel means the test has at least been reviewed by the FDA, that the agency believes it “may be effective,” and that the benefits of using it outweigh the risks.
But other companies are also claiming their tests have been approved or authorized by the FDA when they haven’t, the agency said Tuesday.
Companies can distribute serological tests that haven’t had FDA review but must follow certain guidelines, including providing instructions that explain the test hasn’t had an agency review and shouldn’t be used as a stand-alone diagnostic tool, according to FDA spokeswoman Stephanie Caccomo.
Saying the tests have been approved or authorized by the FDA—when they haven’t—gives people a false sense of security about the tests’ accuracy. Officials warned they’ll take action against firms “making false claims or marketing tests that are not accurate and reliable.”
The pandemic has forced the FDA into a regulatory juggling act of how best to reduce red tape to expand vital coronavirus testing capabilities while ensuring that regulatory gray areas aren’t exploited.
Accurate serological testing, which measures the level of antibodies or proteins in blood when someone is fighting an infection like Covid-19, is especially important because it’s a promising tool for, potentially, quickly reopening the U.S. economy. By pinpointing who has had Covid-19 and recovered, and may have immunity, such tests could help clear people to return to work as vaccines and treatments are developed. Serological tests could also verify which Americans could donate their plasma for potential Covid-19 treatments.
Issuing a warning letter to a company with fraudulent labeling is probably the first step the agency would take to stop bad actors, said Sonali Gunawardhana, a lawyer at Shook, Hardy & Bacon L.L.P. who used to work in the FDA’s medical device center.
If tests are giving false positives or false negatives, the agency might take more drastic action such as seizing products, she said. Any recalls would require a company to tell its customers that their test might have been inaccurate, she added.
—With assistance from Jeannie Baumann