The FDA must clear the market of junk antibody tests without delay

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A coronavirus antibody rapid serological test kit showing a negative result for no antibodies is displayed at an antibody testing site on July 26 in San Dimas, California, 30 miles east of Los Angeles.

If you’re one of the hundreds of thousands of Americans who have received a test for COVID-19 antibodies, the Food and Drug Administration has some bad news for you: you may have been the victim of a scam the FDA enabled. That’s why I’m calling on the FDA to immediately clean up the mess it created when it allowed a sea of fraudulent antibody tests to flood the market.

The U.S. House Oversight Subcommittee on Economic and Consumer Policy, which I chair, has spent the past three months investigating makers of COVID-19 antibody tests, also known as serology tests. My colleagues and I uncovered that the FDA, in an apparent effort to avoid the criticism it received for its frustratingly slow development and approval of diagnostic tests in the critical early weeks of the coronavirus crisis, effectively chose not to exercise its regulatory authority over antibody tests at all. Instead of verifying these tests worked and were safe for consumers – the core functions of the agency – the FDA took manufacturers’ word for it that their tests were reliable and accurate. And guess what: they weren’t.

The FDA, which is tasked with keeping bogus medical devices off the market, effectively opened the door to scam artists and others who saw an opportunity to make a quick buck. Hundreds of fraudulent tests flooded the market, many from abroad, and thousands of Americans who received the tests drew misinformed conclusions about their risks of contracting COVID-19. Although public health officials have warned that the presence of antibodies does not guarantee immunity from the disease, the common perception that this is the case makes the issue of bogus tests nothing short of a matter of life and death. If someone wrongly believes a positive antibody test means he or she can resume life as usual, without social distancing, masks, or other measures to slow the spread, this wrong approach puts everyone at risk of catching the virus at a time we need to be more diligent than ever.

After my subcommittee called on FDA Commissioner Stephen Hahn to reverse this reckless “hands-off” policy, the FDA changed course – partially. Manufacturers of antibody tests must now submit their tests to FDA review by applying for Emergency Use Authorization, or permission to sell under special circumstances like a pandemic. So far, the FDA has put several dozen tests on a do-not-sell list, apparently after finding they were unfit for sale in the United States. There are, however, still over 170 unreviewed tests on the market, the makers of which can continue to earn profits and spread false security while awaiting FDA review. This is unacceptable.

The FDA must immediately root out each and every one of these remaining tests that are fraudulent and pose a danger to public health. The new application requirements are meaningless if weeks or months go by before a bogus test, currently enjoying the glow of contingent FDA approval, is pulled from the shelves. With the U.S. approaching 60,000 new cases of COVID-19 per day, allowing Americans to continue making decisions based on faulty tests will contribute to the already uncontrolled spread of this pandemic.

We know that manufacturers and shady importer-distributors have been pushing doctor’s offices and clinics to purchase their antibody tests with the full knowledge that they do not work. Meanwhile, less scrupulous operators masquerading as health care providers have been pushing these tests onto consumers, making scientifically unsound claims about immunity. Individual Americans, a record number of whom are unemployed and seeking assurance that they can safety return to work, have been paying in some cases over $100 for each test that is just as likely to give a false positive as a true positive. We cannot let this situation fester, further imperiling public health.

The health and lives of the American people are too important to be handed over to opportunists. The FDA must act much more quickly to prevent further harm from its lax policies, and if the FDA does not, we in Congress must.

Raja Krishnamoorthi, a Democrat from Schaumburg, represents the 8th District of Illinois.

Tags Antibody tests Coronavirus Food and Drug Administration Raja Krishnamoorthi

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