FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests

Bloated and unsubstantiated marketing claims about the capabilities of unproven serologic SARS-CoV-2 antibody tests have been a problem almost since the public health emergency began. After playing nice and calling on the test producers to police themselves, the FDA has and is now exercising its enforcement powers to crack down on companies for improperly marketing antibody tests. A 180-degree Pivot When the public health emergency first began, the FDA allowed producers to introduce antibody tests immediately upon self-validation without Emergency Use Authorization (EUA) via its newly created “Policy D” pathway. Predictably, the US market was soon awash with unproven tests deceptively touted as having FDA approval. The agency sounded the alarm and called on test makers to submit their products to federal labs for independent evaluation. Few did. The turning point came in early May when, in response to a scathing Congressional investigational report, the FDA put its foot down, ending Policy D and making independent evaluation mandatory for all SARS-CoV-2 antibody tests, including those with EUA. Less than two weeks later, nearly 30 Policy D tests were either delisted or voluntarily withdrawn by their manufacturers. On June 16, the agency revoked the EUA of one of the first serologic […]