WASHINGTON (AP) – US regulators overturned a decision Monday that allowed dozens of coronavirus blood tests to hit the market without first proving their effectiveness.
The Food and Drug Administration said it took action because some vendors had made false statements about the tests and their accuracy. Companies will now have to show that their tests work well or risk withdrawing them from the market.
Under pressure to increase testing options, the FDA in March essentially allowed companies to start selling tests as long as they informed the agency of their plans and provided disclaimers, including that they were not approved by the FDA. The policy was intended to allow the “flexibility” needed to quickly speed up production, officials said.
“However, flexibility never meant that we would allow fraud,” said Dr. Anand Shah, an FDA deputy commissioner, in a statement. “Unfortunately, we see unscrupulous players marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of the Americans. “
Blood tests are different from the nasal swab tests currently used to diagnose active COVID-19 infections. Instead, tests look for blood proteins called antibodies, which the body produces days or weeks after fighting an infection. Most use a blood test on a test strip.
The revised policy follows weeks of criticism from doctors, laboratory specialists and members of Congress who said the lack of FDA oversight had created a Wild West of unregulated testing.
The agency admitted on Monday that there were misleading and deceptive marketing issues among the 160 tests launched in the U.S. Some companies have claimed that their tests can be used at home, although the FDA has not not allowed this use. Others claim their accuracy is baseless. Some US hospitals and local governments have reported purchasing tests that have been shown to be inaccurate or fraudulent.
So far, the FDA has authorized 11 antibody tests, which means their methods, materials and accuracy have been approved by regulatory agencies. Companies whose test kits are currently on the market without FDA approval will now have to submit formal requests to regulatory authorities within 10 business days. Companies launching at a later date will have 10 days to return their applications after validating their tests.
Health officials in the United States and around the world have suggested that testing could be useful in identifying people who have already had the virus – with or without getting sick – and who have developed some immunity. But researchers have not yet been able to answer essential questions that are essential to their practical use: what level of antibody does it take to be immune and how long does this protection last?
“We’re spending a lot of time and resources on something that isn’t really a panacea for reopening,” said Kamran Kadkhoda, laboratory director at the Cleveland Clinic.
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For now, the tests are primarily a research tool for scientists trying to determine the extent of the spread of the coronavirus in the American population. These studies are ongoing but have produced very different preliminary results, in part due to variations between tests. Even high-performance tests can produce biased results when used in a large population where few people have had the virus.
The National Institutes of Health and other federal agencies are also examining the tests and conducting research to find out if they can successfully predict immunity.
FDA Commissioner Stephen Hahn said in a statement that the government’s approach to “balance risks and benefits has changed from what it was in mid-March” based on new data from FDA and NIH reviews.
Monday’s decision is the latest in the Trump administration’s heated attempt to deploy an effective and comprehensive approach to testing. Although testing has intensified since the start of the epidemic, state and local governments continue to report shortages of testing supplies needed to screen for the virus and safely alleviate social distancing. A “test plan” released last week by the White House said states are responsible for developing their own test plans.
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The Associated Press’s Department of Health and Science is supported by the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.