Emergency Use Authorization and FDA’s Related Authorities

Emergency Use Authorization and FDA’s Related Authorities

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Updated August 13, 2018
Emergency Use Authorization and FDA’s Related Authorities
Under most circumstances, drugs, medical devices, and
the emergency use of certain medical products upon one of
biologics may only be introduced into interstate commerce
the following determinations:
if they have been approved, cleared, or licensed by the Food
and Drug Administration (FDA). Under certain
 A determination by the Secretary of the Department of
circumstances, however, FDA may permit a medical
Homeland Security (DHS) that there is an actual or
product to be provided to patients outside the standard
significant potential for a domestic emergency involving
regulatory framework. One of these circumstances is if the
a heightened risk of attack with one or more CBRN
Secretary of Health and Human Services (HHS) declares,
agents;
pursuant to §564 of the Federal Food, Drug, and Cosmetic
Act (FFDCA), that an emergency or threat exists due to a
 A determination by the Secretary of the Department of
chemical, biological, radiologic, or nuclear (CBRN) agent,
Defense (DOD) that there is an actual or significant
in which case the HHS Secretary may temporarily authorize
potential for a military emergency involving a
the emergency use of an unapproved product or the
heightened risk of attack with either with one or more
unapproved use of an approved product. P.L. 115-92,
CBRN agents, or with one or more agents that may
signed into law on December 12, 2017, amended this
cause or are associated with an imminently life-
authority to allow for emergency uses of medical products
threatening and specific risk to United States military
for threats in addition to CBRN agents, to include agents
forces;
that may cause or are associated with an imminently life-
threatening and specific risk to the United States military.
 A determination by the HHS Secretary that there is an
The four-step process required to authorize the emergency
actual or significant potential for a public health
use of a medical product—referred to as Emergency Use
emergency that affects or has significant potential to
Authorization (EUA)—is shown in Figure 1 and described
affect national security or the health and security of
in the following sections.
United States citizens living abroad, and that involves
one or more CBRN agents; or
Figure 1. Steps in Emergency Use Authorization
 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
Source: Developed by CRS based on FFDCA §564.
issuing an EUA, provided that certain criteria are met:

Secretarial Determination and
 the CBRN agent that is the subject of the EUA can
Declaration
cause a serious of life-threatening disease or condition;
FFDCA §564, established by the Project BioShield Act of
2004 (P.L. 108-276) and amended by the Pandemic and
 the product may be effective in diagnosing, treating, or
All-Hazards Preparedness Reauthorization Act of 2013
preventing such disease or condition, based on the
(PAHPRA, P.L. 113-5) and P.L. 115-92, allows the HHS
totality of the available scientific evidence;
Secretary to declare that the circumstances exist justifying
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Emergency Use Authorization and FDA’s Related Authorities
 the known and potential benefits of the product
during an emergency for its approved indication because
outweigh its known and potential risks; and
certain preparedness and response activities (e.g.,
dispensing without a prescription) otherwise could have
 there is no adequate, approved, and available alternative
violated the FFDCA. Section 564A authorizes FDA to:
to the product.
 Extend expiration dating of an eligible product for use in
Conditions of Authorization
a CBRN emergency if the extension is supported by
FFDCA §564 directs FDA to impose certain required
appropriate scientific evaluation;
conditions in an EUA and allows for additional
discretionary conditions where appropriate. The required
 Allow deviations from GMP requirements to
conditions vary depending upon whether the EUA is for an
accommodate emergency response needs;
unapproved product or for an unapproved use of an
approved product. For an unapproved product, the
 Issue emergency use instructions to inform health care
conditions of use must: (1) ensure that health care
providers or individuals to whom the product is being
professionals administering the product receive required
administered about the product’s conditions of use; and
information; (2) ensure that individuals to whom the
product is administered receive required information; (3)
 Waive Risk Evaluation and Mitigation Strategies
provide for the monitoring and reporting of adverse events
(REMS) requirements for an eligible product based on
associated with the product; and (4) provide for
the same emergency conditions that allow an EUA.
recordkeeping and reporting by the manufacturer. For an
unapproved use of an approved product, only the first two
Section 564A also waives the applicability of certain
conditions listed above are required and additional
requirements to allow for emergency dispensing without a
conditions regarding monitoring, reporting, and
prescription, provided that such dispensing occurs as
recordkeeping may be imposed. For both types of EUAs,
permitted by state law in the state in which it is being
FDA may waive or limit Good Manufacturing Practice
dispensed, or it is in accordance with an emergency
(GMP) requirements (e.g., storage and handling) and
dispensing order issued by FDA.
prescription requirements.
Products Held for Emergency Use
In general, an EUA will remain in effect for the duration of
PAHPRA established new FFDCA §564B, which allows
the emergency declaration made by the HHS Secretary,
government entities and their agents to preposition or
unless revoked at an earlier date. In either case, the product
stockpile an unapproved medical product intended for
that was subject to the EUA may continue to be used by a
emergency use, provided the product is held and not used
patient who began treatment before revocation or
until it is approved, cleared, or licensed; authorized for
termination, as deemed necessary by the patient’s attending
investigational use; or authorized for use under an EUA.
physician.
Medical Product Development
The HHS Secretary (FDA by delegation of authority) must
FDA is required to take various actions to support the
promptly publish in the Federal Register a notice of each
development and review of MCMs, including participation
EUA, along with reasons for issuance, a description of
in meetings with applicants and issuance of guidance.
intended use, and any contraindications of the product. The
Pursuant to P.L. 115-92, upon request from the Secretary of
issuance of an EUA authorizes the emergency use of an
Defense, FDA must take specified actions to expedite the
unapproved product or an unapproved use of an approved
development and review of certain medical products if there
product, but it does not require manufacturers or providers
is an actual or significant potential for a military emergency
to actually participate in such use.
and if that medical product would be reasonably likely to
diagnose, prevent, treat, or mitigate such life-threatening
Emergency Use without an EUA
risk. FDA also must meet with DOD and other development
PAHPRA established new FFDCA §564A, which allows
partners to discuss the development status of projects that
the HHS Secretary (FDA by delegation of authority) to
are the highest priorities to DOD (e.g., freeze-dried plasma
facilitate certain emergency activities involving eligible
products and platelet alternatives).
products, also referred to in FDA guidance as eligible
medical countermeasures (MCMs). An eligible product or
FDA also is required to award a priority review voucher to
MCM is an FDA-approved medical product intended to
the sponsor of an approved material threat MCM
prevent, diagnose, or treat a disease or condition involving
application that is intended to (1) prevent, or treat harm
one or more CBRN agents, or a serious or life-threatening
from a CBRN agent identified as a material threat, or (2)
disease caused by such product, and that is intended for use
“mitigate, prevent, or treat harm from a condition that may
when (1) a determination of an actual or significant
result in adverse health consequences or death and may be
potential for an emergency has been made by the Secretary
caused by administering a drug, or biological product
of DHS, DOD, or HHS, or (2) a material threat has been
against such agent.” The voucher can be used for the
identified by the Secretary of DHS. This authority is
priority review of another application.
independent of the EUA authority under FFDCA §564.
Agata Dabrowska, Analyst in Health Policy
Prior to PAHPRA, FDA would often issue an EUA for use
of an approved product even if it was intended to be used
IF10745
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Emergency Use Authorization and FDA’s Related Authorities

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https://crsreports.congress.gov | IF10745 · VERSION 4 · UPDATED