Emergency use authorization
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 as added to and amended by various Acts of Congress, including 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]
After initial authorizations for serious diseases such as pandemic influenza and emerging diseases, EUS's were also authorized for medical countermeasures (MCM's) principally in response to public health emergencies such as bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats. Subsequent legislative authorities expanded the latitude of the class of drugs eligible for consideration, and the range of testing to which the drug or therapy has been subjected. The scope and applicability of EUA's is also affected by presidential executive orders (Title 3 of the Code of Federal Regulations), which may affect the definition of the situations considered to be public health emergencies, and under which the authority of the FDA to issue EUA's may be exercised.
Consideration of a drug 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]
History of Legal Authority for EUA’s
In the United States, EUA’s are authorized by Section 564 of the Federal Food Drug and Cosmetic Act (FDCA) of 1938 (Public Law 75-717) as added and subsequently amended by the Project BioShield Act of 2004 (S. 15, Public Law 108-276) for funding of the development and procurement of medical countermeasures against CBRN threats, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307, Public Law 113-5), the 21st Century Cures Act of 2016 (H.R. 34, Public Law 114-255) and Public Law 115-92 of 2017 (no short title).
Applicability and the Animal Efficacy Rule
EUA's may be applied to drugs, devices or biological product. EUS's may either permit the emergency use of an unapproved drug, device or biologic product, or permit an unapproved use of an approved drug, device or biologic product. Furthermore, drugs, devices or biologic products may or may not have undergone human efficacy trials, due to risk, feasibility or ethical considerations. Drugs, devices or biologic products which have only been tested or approved under the animal efficacy rule are loosely known as animal products. Under certain conditions, an EUA may authorize the emergency use in humans, of drugs, devices or biologic products approved under the animal efficacy rule. EUA's may also only be implemented during the period of a public health emergency as defined by a declaration of the Secretary of Health and Human Services. Conditions determining the applicability of such declarations may be specified by federal statute. Code of Federal Regulations or an presidential executive order (Title 3 of the Code of Federal Regulations).
Examples
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
- "Emergency Use Authorization of Medical Products and Related Authorities". US Food and Drug Administration. January 2017. Retrieved May 14, 2020.
- "FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans. FDA News, April 27, 2009".
- Health, Center for Devices and Radiological (April 6, 2020). "Emergency Use Authorizations". FDA – via www.fda.gov.
- Bruce Japsen. "U.S. Approves Abbott Labs Coronavirus Test For Hospital Use". Forbes. Retrieved 2020-04-07.
- "Emergency Use Authorization (EUA) of Remdesivir for Coronavirus Disease 2019 (COVID-19)". U.S. Food and Drug Administration. 1 May 2020.
- Holland S, Mason J, Maler S (1 May 2020). "FDA Authorizes Remdesivir Drug for COVID-19". The New York Times.