Notice2022-15956
Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 26, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 142 (Tuesday, July 26, 2022)</title>
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[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Pages 44407-44409]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Hospitalized, or
<bullet> 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 <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a> and <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
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.
BILLING CODE 4164-01-P
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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]
BILLING CODE 4164-01-C
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