USA – Why FDA’s Issuance of EUAs are Not ‘Approvals’ and Why That Matters

You may have read that some drugs are now “approved” to treat COVID-19, or as the New York Times reported yesterday, that the US Food and Drug Administration (FDA) “approved” the first serology test for COVID-19, or that the dozens of marketed COVID-19 diagnostics are “approved” by FDA.

But in reality, FDA still has not approved any treatment or test for COVID-19 and has instead issued what are known as emergency use authorizations, or EUAs. From an outsider’s perspective, the difference between an approval and an EUA may seem like semantics, but EUAs and full approvals are significantly different.

For instance, EUAs have been issued by FDA for in vitro diagnostic (IVD) tests, personal protective equipment and therapeutics during this pandemic, but these authorizations are only in effect for as long as the public health emergency lasts. When a company wins approval for a drug or a device, the approvals remain in place unless a safety or efficacy issue comes up, and even then, FDA usually has to request the removal of such a product.

The type of review that FDA conducts for an EUA is also considerably less rigorous than how the agency would normally review a product for an approval. As each of the EUAs for the COVID-19 IVD tests makes clear, “An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD.”…