When the FDA first relaxed the regulations on antibody tests back in mid-March, the agency itself acknowledged the risks of failing to regulate the products in any way. “Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients,” the FDA stated, urging companies to “take all necessary steps” to ensure the accuracy of their tests. The policy, however, tasked companies entirely with validating their own tests.
The stricter FDA policy change came after the chair of the House Oversight Economic and Consumer Policy Subcommittee announced a congressional investigation of the policy, writes Politico. Last week, the American Medical Association also urged the Department of Health and Human Services to restrict who can administer the tests to medical professionals after doubts have grown about the accuracy of some tests. Some companies have also made false claims about their tests being FDA-approved or appropriate for at-home use, which was never part of the FDA guidelines.
According to FDA Commissioner Stephen Hahn, close to half of the companies with an antibody test on the market are now seeking appropriate authorization through the updated policy.
But confusion in the marketplace was bound to be the result of Trump and his allies pushing to get a bunch of unproven tests on the market as part of their reckless push to reopen the economy.