Document ID: FDA-2020-N-1729-0004
Agency: fda
Document Type: Notice
Title: Revocation of Emergency Use of a Drug During the COVID–19 Pandemic; Availability
Posted Date: 2022-07-26T04:00Z

[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Pages 44407-44409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15956]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1729]

Revocation of Emergency Use of a Drug During the COVID-19 
Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorization (EUA) (the Authorization) 
issued to Gilead Sciences, Inc. (Gilead) for VEKLURY (remdesivir). FDA 
revoked the Authorization on April 25, 2022, under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) given the approval of a supplemental 
new drug application (NDA) for VEKLURY, which expanded the approved 
indication to cover the authorized population. The revocation, which 
includes an explanation of the reasons for the revocation, is reprinted 
in this document.

DATES: The Authorization is revoked as of April 25, 2022.

ADDRESSES: Submit written requests for single copies of the 
Authorization and/or revocation 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. 4340, 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) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
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. On May 1, 2020, FDA issued an 
Authorization (EUA 046) to Gilead for remdesivir, subject to the terms 
of the Authorization. Notice of the issuance of the Authorization was 
published in the Federal Register on September 11, 2020 (85 FR 56231), 
as required by section 564(h)(1) of the FD&C Act. Subsequent amendments 
to the Authorization on August 28, 2020, October 1, 2020, October 16, 
2020, October 22, 2020, and January 21, 2022, were made available on 
FDA's website.

II. 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 April 25, 2022, FDA revoked the EUA for VEKLURY because 
the criteria for issuance were no longer met. Under section 564(c)(3) 
of the FD&C Act, an EUA may be issued only if FDA concludes there is no 
adequate, approved,\1\ and available alternative to the product for 
diagnosing, preventing, or treating the disease or condition. On April 
25, 2022, FDA approved a supplemental NDA to NDA 214787 for VEKLURY, 
which expanded the approved indication to the following:
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    \1\ In the context of section 564, the term ``approved'' refers 
to a product that is approved, licensed, or cleared under section 
505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), or 
360(e)) or section 351 of the Public Health Service Act (42 U.S.C. 
262). See section 564(a)(2) of the FD&C Act.

    Veklury is a severe acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated 
for the treatment of coronavirus disease 2019 (COVID-19) in adults 
and pediatric patients (28 days of age and older and weighing at 
least 3 kg) with positive results of direct SARS-CoV-2 viral 
testing, who are:
     Hospitalized, or
     Not Hospitalized and have mild-to-moderate COVID-19 and 
are at high risk for progression to severe COVID-19, including 
hospitalization or death.

    FDA has concluded that VEKLURY approved under NDA 214787 is an 
adequate, approved, and available alternative to the VEKLURY available 
for emergency use for the treatment of COVID-19 for purposes of section 
564(c)(3) of the FD&C Act. Accordingly, FDA revoked EUA 046 for 
emergency use of VEKLURY, pursuant to section 564(g)(2) of the FD&C 
Act.

III. Electronic Access

[[Page 44408]]

    An electronic version of this document and the full text of the 
Authorization and revocation are available on the internet from https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization and https://www.regulations.gov/.

IV. 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 Gilead's VEKLURY (remdesivir). The revocation in 
its entirety follows and provides an explanation of the reasons for 
revocation, as required by section 564(h)(1) of the FD&C Act.
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[GRAPHIC] [TIFF OMITTED] TN26JY22.159

    Dated: July 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15956 Filed 7-25-22; 8:45 am]
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