AARP Eye Center
In the race to make COVID-19 treatments and vaccines available to the public, a little-known tool at the U.S. Food and Drug Administration (FDA) is suddenly getting a lot of attention. It's called Emergency Use Authorization, or EUA for short, and it lets the FDA allow the use of unapproved medical products that can diagnose, treat or — in the case of vaccines — prevent life-threatening diseases during public health emergencies, such as the coronavirus pandemic.
Just this week, the FDA issued an EUA for Regeneron's monoclonal antibody cocktail treatment to help prevent patients with mild to moderate cases of COVID-19 from getting sicker. Pharmaceutical companies Pfizer/BioNTech are awaiting word on whether the agency will do the same for its coronavirus vaccine.
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"You have these crises that require very fast action, so you need the ability to respond quickly,” says Joshua Sharfstein, M.D., vice dean for Public Health Practice at the Johns Hopkins Bloomberg School of Public Health and a former principal deputy commissioner at the FDA. “You may not have all the evidence you want, but the agency shows flexibility to do what makes sense.”
Here's what you need to know about the FDA's tool for fast-tracking much-needed medical products.
What's the difference between an EUA and regular FDA approval?
Time is a major one. The FDA's traditional approval process can take years, and that sort of time frame seems almost indefensible in the middle of a pandemic that's already claimed close to 260,000 lives in the U.S. alone.
As Francis Collins, M.D., director of the National Institutes of Health (NIH), explained in a recent AARP tele-town hall event, there are two notable differences between an EUA and a full FDA approval. One is the detail that the FDA requires in terms of manufacturing the medicine. “It's not quite as demanding for the Emergency Use Authorization,” he explains. The other difference has to do with the timetable.