[Federal Register Volume 85, Number 177 (Friday, September 11, 2020)]
[Notices]
[Pages 56231-56264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20041]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1729]
Authorizations and Revocation of Emergency Use of Drugs During
the COVID-19 Pandemic; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of four Emergency Use Authorizations (EUAs) (the
Authorizations) for drugs for use during the COVID-19 pandemic. FDA
issued four Authorizations under the Federal Food, Drug, and Cosmetic
Act (FD&C Act), as requested by the Department of Health and Human
Services (HHS) Biomedical Advanced Research and Development Authority
(BARDA), Fresenius Medical Care, Gilead Sciences, Inc., and Fresenius
Kabi USA, LLC. The Authorizations contain, among other things,
conditions on the emergency use of the authorized drugs. The
Authorizations follow the February 4, 2020, determination by the
Secretary of HHS that there is a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves a novel (new)
coronavirus. The virus is now named SARS-CoV-2, which causes the
illness COVID-19. On the basis of such determination, the Secretary of
HHS declared on March 27, 2020, that circumstances exist justifying the
authorization of emergency use of drugs and biological products during
the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms
of any authorization issued under that section. FDA is also announcing
the subsequent revocation of the Authorization issued to BARDA for oral
formulations of chloroquine phosphate and hydroxychloroquine sulfate.
FDA revoked this authorization on June 15, 2020. The Authorizations,
and the revocation, which include an explanation of the reasons for
issuance or revocation, are reprinted in this document.
DATES: The Authorization for BARDA was effective as of March 28, 2020,
and the revocation of this Authorization is effective as of June 15,
2020; the Authorization for Fresenius Medical Care is effective as of
April 30, 2020; the Authorization for Gilead Sciences, Inc. is
effective as of May 1, 2020; the Authorization for Fresenius Kabi USA,
LLC is effective as of May 8, 2020.
ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.
FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. With this EUA authority, FDA can help ensure that medical
countermeasures may be used in emergencies to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives.
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50, United States Code, of attack with
(i) a biological, chemical, radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
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\1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of
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a drug, device, or biological product intended for use when the
Secretary of HHS has declared that circumstances exist justifying the
authorization of emergency use. Products appropriate for emergency use
may include products and uses that are not approved, cleared, or
licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21
U.S.C. 355, 360(k), 360b, and 360e) or section 351 of the PHS Act (42
U.S.C. 262), or conditionally approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after
consultation with the HHS Assistant Secretary for Preparedness and
Response, the Director of the National Institutes of Health, and the
Director of the Centers for Disease Control and Prevention (to the
extent feasible and appropriate given the applicable circumstances),
FDA \2\ concludes: (1) That an agent referred to in a declaration of
emergency or threat can cause a serious or life-threatening disease or
condition; (2) that, based on the totality of scientific evidence
available to FDA, including data from adequate and well-controlled
clinical trials, if available, it is reasonable to believe that: (A)
The product may be effective in diagnosing, treating, or preventing (i)
such disease or condition; or (ii) a serious or life-threatening
disease or condition caused by a product authorized under section 564,
approved or cleared under the FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating, or preventing such a disease
or condition caused by such an agent; and (B) the known and potential
benefits of the product, when used to diagnose, prevent, or treat such
disease or condition, outweigh the known and potential risks of the
product, taking into consideration the material threat posed by the
agent or agents identified in a declaration under section 564(b)(1)(D)
of the FD&C Act, if applicable; (3) that there is no adequate,
approved, and available alternative to the product for diagnosing,
preventing, or treating such disease or condition; (4) in the case of a
determination described in section 564(b)(1)(B)(ii), that the request
for emergency use is made by the Secretary of Defense; and (5) that
such other criteria as may be prescribed by regulation are satisfied.
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\2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.
III. The Authorizations
The Authorizations follow the February 4, 2020, determination by
the Secretary of HHS that there is a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves a novel (new)
coronavirus. The virus is now named SARS-CoV-2, which causes the
illness COVID-19. Notice of the Secretary's determination was provided
in the Federal Register on February 7, 2020 (85 FR 7316). On the basis
of such determination, the Secretary of HHS declared on March 27, 2020,
that circumstances exist justifying the authorization of emergency use
of drugs and biological products during the COVID-19 pandemic, pursuant
to section 564 of the FD&C Act, subject to the terms of any
authorization issued under that section. Notice of the Secretary's
declaration was provided in the Federal Register on April 1, 2020 (85
FR 18250). Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
issued four authorizations for the emergency use of drugs during the
COVID-19 pandemic. On March 28, 2020, FDA issued an EUA to BARDA for
oral formulations of chloroquine phosphate and hydroxychloroquine
sulfate, subject to the terms of the Authorization. On April 30, 2020,
FDA issued an EUA to Fresenius Medical Care for multiFiltrate PRO
System and multiBic/multiPlus Solutions, subject to the terms of the
Authorization. On May 1, 2020, FDA issued an EUA to Gilead Sciences,
Inc. for remdesivir, subject to the terms of the Authorization. On May
8, 2020, FDA issued an EUA to Fresenius Kabi USA, LLC for Fresenius
Propoven 2% Emulsion, subject to the terms of the Authorization. The
Authorizations in their entirety (not including the authorized versions
of the fact sheets and other written materials) follow, below section
VI Electronic Access, and provide an explanation of the reasons for
issuance, as required by section 564(h)(1) of the FD&C Act.
IV. EUA Criteria for Issuance No Longer Met
Under section 564(g)(2) of the FD&C Act, the Secretary of HHS may
revoke an EUA if, among other things, the criteria for issuance are no
longer met. On June 15, 2020, FDA revoked the EUA for BARDA for oral
formulations of chloroquine phosphate and hydroxychloroquine sulfate
because the criteria for issuance were no longer met. Under section
564(c)(2) of the FD&C Act, an EUA may be issued only if FDA concludes
that, based on the totality of scientific evidence available to the
Secretary, including data from adequate and well-controlled clinical
trials, if available, it is reasonable to believe that: (1) The product
may be effective in diagnosing, treating, or preventing such disease or
condition and (2) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product. Based on a review of new
information and a reevaluation of information available at the time the
EUA was issued, FDA now concludes it is no longer reasonable to believe
that (1) oral formulations of chloroquine phosphate and
hydroxychloroquine sulfate may be effective in treating COVID-19 for
the uses authorized in the EUA, or (2) the known and potential benefits
of these products outweigh their known and potential risks for those
uses. Accordingly, FDA revokes the EUA for emergency use of chloroquine
phosphate and hydroxychloroquine sulfate to treat COVID-19, pursuant to
section 564(g)(2) of the FD&C Act.
V. The Revocation
Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for BARDA's oral formulations of chloroquine phosphate
and hydroxychloroquine sulfate. The revocation in its entirety follows,
below section VI. Electronic Access, and provides an explanation of the
reasons for revocation, as required by section 564(h)(1) of the FD&C
Act.
VI. Electronic Access
An electronic version of this document and the full text of the
Authorizations and revocation are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
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Dated: September 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20041 Filed 9-10-20; 8:45 am]
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