[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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