Updated August 13, 2018
Emergency Use Authorization and FDA’s Related Authorities
Under most circumstances, drugs, medical devices, and
biologics may only be introduced into interstate commerce
if they have been approved, cleared, or licensed by the Food
and Drug Administration (FDA). Under certain
circumstances, however, FDA may permit a medical
product to be provided to patients outside the standard
regulatory framework. One of these circumstances is if the
Secretary of Health and Human Services (HHS) declares,
pursuant to §564 of the Federal Food, Drug, and Cosmetic
Act (FFDCA), that an emergency or threat exists due to a
chemical, biological, radiologic, or nuclear (CBRN) agent,
in which case the HHS Secretary may temporarily authorize
the emergency use of an unapproved product or the
unapproved use of an approved product. P.L. 115-92,
signed into law on December 12, 2017, amended this
authority to allow for emergency uses of medical products
for threats in addition to CBRN agents, to include agents
that may cause or are associated with an imminently lifethreatening and specific risk to the United States military.
The four-step process required to authorize the emergency
use of a medical product—referred to as Emergency Use
Authorization (EUA)—is shown in Figure 1 and described
in the following sections.
Figure 1. Steps in Emergency Use Authorization
the emergency use of certain medical products upon one of
the following determinations:
A determination by the Secretary of the Department of
Homeland Security (DHS) that there is an actual or
significant potential for a domestic emergency involving
a heightened risk of attack with one or more CBRN
agents;
A determination by the Secretary of the Department of
Defense (DOD) that there is an actual or significant
potential for a military emergency involving a
heightened risk of attack with either with one or more
CBRN agents, or with one or more agents that may
cause or are associated with an imminently lifethreatening and specific risk to United States military
forces;
A determination by the HHS Secretary that there is an
actual or significant potential for a public health
emergency that affects or has significant potential to
affect national security or the health and security of
United States citizens living abroad, and that involves
one or more CBRN agents; or
The identification by the DHS Secretary of a material
threat pursuant to Public Health Service Act §319F-2.
The HHS Secretary may fulfill both the determination and
declaration functions. Each of the secretarial determination
mechanisms have been used as the basis for an EUA, and
EUAs have been issued for a variety of uses and products.
The emergency declaration must terminate on the earlier of
(1) a determination by the HHS Secretary that the
emergency no longer exists or (2) a change in the approval
status of the product such that the EUA would not be
necessary.
Issuance of an EUA
Following the HHS Secretary’s declaration, the FDA
Commissioner, in consultation with the Assistant Secretary
for Preparedness and Response (ASPR) and the Directors of
the National Institutes of Health (NIH) and Centers for
Disease Control and Prevention (CDC), may authorize the
emergency use of a specific drug, device, or biologic, by
issuing an EUA, provided that certain criteria are met:
Source: Developed by CRS based on FFDCA §564.
Secretarial Determination and
Declaration
the CBRN agent that is the subject of the EUA can
FFDCA §564, established by the Project BioShield Act of
2004 (P.L. 108-276) and amended by the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013
(PAHPRA, P.L. 113-5) and P.L. 115-92, allows the HHS
Secretary to declare that the circumstances exist justifying
the product may be effective in diagnosing, treating, or
cause a serious of life-threatening disease or condition;
preventing such disease or condition, based on the
totality of the available scientific evidence;
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Emergency Use Authorization and FDA’s Related Authorities
the known and potential benefits of the product
outweigh its known and potential risks; and
there is no adequate, approved, and available alternative
to the product.
during an emergency for its approved indication because
certain preparedness and response activities (e.g.,
dispensing without a prescription) otherwise could have
violated the FFDCA. Section 564A authorizes FDA to:
Extend expiration dating of an eligible product for use in
Conditions of Authorization
FFDCA §564 directs FDA to impose certain required
conditions in an EUA and allows for additional
discretionary conditions where appropriate. The required
conditions vary depending upon whether the EUA is for an
unapproved product or for an unapproved use of an
approved product. For an unapproved product, the
conditions of use must: (1) ensure that health care
professionals administering the product receive required
information; (2) ensure that individuals to whom the
product is administered receive required information; (3)
provide for the monitoring and reporting of adverse events
associated with the product; and (4) provide for
recordkeeping and reporting by the manufacturer. For an
unapproved use of an approved product, only the first two
conditions listed above are required and additional
conditions regarding monitoring, reporting, and
recordkeeping may be imposed. For both types of EUAs,
FDA may waive or limit Good Manufacturing Practice
(GMP) requirements (e.g., storage and handling) and
prescription requirements.
a CBRN emergency if the extension is supported by
appropriate scientific evaluation;
Allow deviations from GMP requirements to
accommodate emergency response needs;
Issue emergency use instructions to inform health care
providers or individuals to whom the product is being
administered about the product’s conditions of use; and
Waive Risk Evaluation and Mitigation Strategies
(REMS) requirements for an eligible product based on
the same emergency conditions that allow an EUA.
Section 564A also waives the applicability of certain
requirements to allow for emergency dispensing without a
prescription, provided that such dispensing occurs as
permitted by state law in the state in which it is being
dispensed, or it is in accordance with an emergency
dispensing order issued by FDA.
Products Held for Emergency Use
In general, an EUA will remain in effect for the duration of
the emergency declaration made by the HHS Secretary,
unless revoked at an earlier date. In either case, the product
that was subject to the EUA may continue to be used by a
patient who began treatment before revocation or
termination, as deemed necessary by the patient’s attending
physician.
PAHPRA established new FFDCA §564B, which allows
government entities and their agents to preposition or
stockpile an unapproved medical product intended for
emergency use, provided the product is held and not used
until it is approved, cleared, or licensed; authorized for
investigational use; or authorized for use under an EUA.
The HHS Secretary (FDA by delegation of authority) must
promptly publish in the Federal Register a notice of each
EUA, along with reasons for issuance, a description of
intended use, and any contraindications of the product. The
issuance of an EUA authorizes the emergency use of an
unapproved product or an unapproved use of an approved
product, but it does not require manufacturers or providers
to actually participate in such use.
FDA is required to take various actions to support the
development and review of MCMs, including participation
in meetings with applicants and issuance of guidance.
Pursuant to P.L. 115-92, upon request from the Secretary of
Defense, FDA must take specified actions to expedite the
development and review of certain medical products if there
is an actual or significant potential for a military emergency
and if that medical product would be reasonably likely to
diagnose, prevent, treat, or mitigate such life-threatening
risk. FDA also must meet with DOD and other development
partners to discuss the development status of projects that
are the highest priorities to DOD (e.g., freeze-dried plasma
products and platelet alternatives).
Emergency Use without an EUA
PAHPRA established new FFDCA §564A, which allows
the HHS Secretary (FDA by delegation of authority) to
facilitate certain emergency activities involving eligible
products, also referred to in FDA guidance as eligible
medical countermeasures (MCMs). An eligible product or
MCM is an FDA-approved medical product intended to
prevent, diagnose, or treat a disease or condition involving
one or more CBRN agents, or a serious or life-threatening
disease caused by such product, and that is intended for use
when (1) a determination of an actual or significant
potential for an emergency has been made by the Secretary
of DHS, DOD, or HHS, or (2) a material threat has been
identified by the Secretary of DHS. This authority is
independent of the EUA authority under FFDCA §564.
Prior to PAHPRA, FDA would often issue an EUA for use
of an approved product even if it was intended to be used
Medical Product Development
FDA also is required to award a priority review voucher to
the sponsor of an approved material threat MCM
application that is intended to (1) prevent, or treat harm
from a CBRN agent identified as a material threat, or (2)
“mitigate, prevent, or treat harm from a condition that may
result in adverse health consequences or death and may be
caused by administering a drug, or biological product
against such agent.” The voucher can be used for the
priority review of another application.
Agata Dabrowska, Analyst in Health Policy
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IF10745
Emergency Use Authorization and FDA’s Related Authorities
Disclaimer
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https://crsreports.congress.gov | IF10745 · VERSION 4 · UPDATED