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HelixTalk Episode #124 - The ABCs of EUAs: Understanding FDA Emergency Use Authorizations
Date posted: January 5, 2021, 6:00 am
In this episode, we discuss the FDA's Emergency Use Authorization (EUA) process and review the resources available to healthcare providers when an EUA for a drug therapy is approved.
- An emergency use authorization (EUA) is a special type of FDA approval only used in times of emergency in which a product MAY be effective to diagnose, treatment, or prevent a disease; the known/potential benefits outweigh the risks; and there are no adequate alternatives to treat the disease.
- All drug therapy EUAs are approved in conjunction with an EUA prescribing information document (along with many other useful documents). Healthcare providers should review these documents to learn about these new therapies.
- Not all EUAs result in a full FDA approval. In fact, the FDA has already revoked a COVID-19 EUA (hydroxychloroquine and chloroquine) due to a lack of benefit and potential risk of harm.
- A drug can be FDA approved and also have an EUA for an unapproved indication -- this is called an “unapproved use of an approved product”. Hydroxychloroquine (FDA approved for malaria, lupus, and rheumatoid arthritis) was an example of this type of EUA approval.
- Emergency Use Authorization. US Food & Drug Administration. December 13, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
- Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 10. doi: 10.1056/NEJMoa2034577. Epub ahead of print. PMID: 33301246.