Why FDA’s Issuance of EUAs are not ‘approvals’ and why that matters

Regulatory NewsRegulatory News | 03 April 2020 |  By 

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.”

And when FDA issued an EUA to allow states to receive donated doses of potential, but still unapproved COVID-19 treatments, known as chloroquine phosphate and hydroxychloroquine sulfate, the agency said “optimal dosing and duration of treatment for COVID-19 is unknown,” which is not a phrase one would expect to see with an approved product.

FDA also told health care providers: “Although limited scientific information is available, it is reasonable to believe that chloroquine phosphate [and hydroxychloroquine sulfate] may be effective for treatment of adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible.” Again, FDA would not say that a product “may be effective” if that product were receiving a full approval.

Patricia Zettler, assistant professor of law at Ohio State University and a former FDA lawyer, explained to Focus via email: “I think it’s really important that patients, healthcare professionals, and the public understand that emergency use authorizations are *not* the same as standard FDA approvals or authorizations.

“Typically we think of FDA authorization as meaning that there is data and information that in the agency’s view shows the product is safe and effective for its intended use. For example, to approve a drug, FDA must determine that there is ‘substantial evidence’---consisting of adequate and well-controlled investigations---that the drug will have the effect it is intended to have.  An EUA, on the other hand, can be authorized if ‘it is reasonable to believe that . . . the product may be effective.’ The EUA standard is simply a lower standard, and everyone should understand that.”


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