What is FDA emergency use authorization?

The United States Food and Drug Administration (FDA) is responsible for the safety and efficacy of all pharmaceuticals, medical devices, edible products, and cosmetics in the United States. There’s a long, arduous road to full FDA approval. It usually takes months or even years before a product truly earns its stripes.

In the face of an international emergency, however, the official process is much too time-consuming to protect people on a national scale.

What is an emergency use authorization? What’s the difference between an EUA and full FDA approval?

What is an FDA emergency use authorization?

EUA approval is essentially a temporary approval that allows emergency countermeasures to see the light of day well before they would be able to under ordinary circumstances. 

The most obvious application of this process in recent years is COVID-19 vaccines and testing devices. The truth, though, is that FDA emergency use actually predates the pandemic by several decades.

The history of FDA EUA

The original motion took effect in 1998, but its use has been relatively uncommon until the coronavirus became an international issue. 

To compare, only 38 EUAs total were authorized for Zika, Ebola, MERS, and avian flu combined. Mostly, the desire to detect COVID on a global scale and to prevent the spread quickly is what allowed the maelstrom of EUAs that the pandemic catalyzed to come to fruition legally.

You’ll find the formal language outlining the acceptable use of this practice under 360bbb–3 of the Food, Drug, and Cosmetic Act (FD&C Act). The act was then later clarified and built upon under section 564—on March 10, 2020, COVID-19 officially became a part of the FDA EUA canon. 

The amendment sought to ensure that healthcare providers everywhere had “full access to the products they need.” The COVID pandemic was declared a major public health emergency the February just before—desperate times inevitably lead to desperate measures. 

Originally, this clause concerned general use respirators, not new vaccines. This development did, however, pave the way for the new COVID-19 tests and the vaccine releases we all remember from early on in the pandemic. This clause is the precursor to the EUAs we’re all more than familiar with today.

FDA emergency use authorization examples under COVID-19

As of October 21, 2020, the FDA had temporarily approved 337 emergency use authorizations related to COVID-19 prevention and treatment:

  • 284 of these FDA EUAs concerned in vitro diagnostic tests and tools
  • 26 concerned ventilators and other equipment for COVID treatment
  • 22 involved PPE and other preventative devices
  • 5 of these were COVID-related drugs

Since October 2020, at least six of these EUAs have been rescinded. Many of them, however, still stand strong to this day. 

This type of legal event is not one employed lightly, and the evolution of the original code means that its modern use differs significantly from EUAs of the past—in fact, we may never have seen EUAs like these in our lifetimes if COVID-19 had never emerged as an international threat.

What warrants an FDA emergency use authorization?

To justify this extreme emergency measure, the secretaries of the Department of Homeland Security, the Department of Defense, or the Department of Health and Human Services all need to determine that a true emergency and an existential risk to society exists. 

In order for the issuance to prevail, the following conditions must all be met:

  • The product to be authorized must stand as an objectively viable solution against a given emergency
  • The potential, utilitarian benefits the product has to offer must outweigh any negative consequences that may result from its use on a national scale
  • There are no other FDA-approved alternatives currently on the market

An EUA isn’t exactly permanent, either—any emergency use authorization at play can be altered or revoked entirely by the FDA at any time.

Emergency use authorization vs. FDA approval

Is an EUA equivalent to FDA approval? It is not, nor should it be. 

EUAs exist as a temporary emergency measure, a last resort in the face of real danger. While EUA products and devices can’t exactly be called “unsafe,” the approval process under ordinary circumstances is much more intensive, allowing little room for something potentially harmful.

With that being said, though, EUAs are, of course, held to plenty of academic and scientific standard. If the alternative is truly dangerous enough, though, a few more months in the lab may simply not be worth the lives at risk during an emergency. It’s a difficult line to toe, but if the hundreds of thousands of lives saved are anything to go by, traversing this juncture responsibly is totally worth the risk.

FDA EUA definition: for emergency use only

The FDA was founded in 1906 as a means of consumer protection from misleading and defective products made available to the public. Thanks to the COVID-19 pandemic, however, that same division of experts have had to supersede their own professional code, all for the greater good.

We trust the experts. Calls like these are never easy to make, which is why we salute those at the helm of life-saving initiatives like the ones we’ve seen over the last couple of years. With any luck, we won’t have to deal with a catastrophe that demands an EUA any time soon. Onward and upward.

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