Emergency use authorization

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An emergency use authorization (EUA) in the United States is an authority granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act added or amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). [1] It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.[1]

To be considered for an EUA requires a finding that it is "reasonable to believe" that the drug "may be effective" "to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a [chemical, biological, radiological, and nuclear] agent(s)" or to mitigate a disease or condition caused by an FDA-regulated product ... used to diagnose, treat, or prevent a disease or condition caused by" such an agent.[1]

The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals, using a risk-benefit analysis based on "the totality of the scientific evidence available", it is "reasonable to believe" that the product may be effective for the specified use.[1]

EUAs end once the Secretary of Heath and Human Services determines that the precipitating emergency has ended (in consultation with the issuer of the appropriate state of emergency as necessary), or once the product or unapproved use is approved through normal channels.[1]

Examples[edit]

In response to requests from the U.S. Centers for Disease Control and Prevention, on April 27, 2009 the FDA issued Emergency Use Authorizations to make available diagnostic and therapeutic tools to identify and respond to the 2009 swine flu pandemic under certain circumstances. The agency issued these EUAs for the use of certain powerful antiviral drugs, and for the quantitative PCR Swine Flu test.[2]

On April 22, 2013, the FDA issued an EUA for the CDC Human Influenza Virus quantitative PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus.[3]

On June 5, 2013, the FDA issued an emergency use authorization for the CDC Novel Coronavirus 2012 quantitative PCR Assay. This test is for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012.[3]

The FDA issued an EUA for CDC test kits for COVID-19 in February, 2020.[4] In May 2020, the FDA issued an EUA for remdesivir, also for COVID-19.[5][6]

References[edit]

  1. ^ a b c d e "Emergency Use Authorization of Medical Products and Related Authorities". US Food and Drug Administration. January 2017. Retrieved May 14, 2020.
  2. ^ "FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans. FDA News, April 27, 2009".
  3. ^ a b Health, Center for Devices and Radiological (April 6, 2020). "Emergency Use Authorizations". FDA – via www.fda.gov.
  4. ^ Bruce Japsen. "U.S. Approves Abbott Labs Coronavirus Test For Hospital Use". Forbes. Retrieved 2020-04-07.
  5. ^ "Emergency Use Authorization (EUA) of Remdesivir for Coronavirus Disease 2019 (COVID-19)". U.S. Food and Drug Administration. 1 May 2020.
  6. ^ Holland S, Mason J, Maler S (1 May 2020). "FDA Authorizes Remdesivir Drug for COVID-19". The New York Times.

External links[edit]

Emergency Use Authorization by the FDA