Notice2021-13183
Authorization and Revocation of Emergency Use of Drugs 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
June 23, 2021
Effective
March 12, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for a drug for use during the COVID-19 pandemic. FDA issued the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by B. Braun Melsungen AG. The Authorization contains, among other things, conditions on the emergency use of the authorized drug. The Authorization follows 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 United States 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 revocation of the Authorization issued to Eli Lilly and Company for bamlanivimab alone. FDA revoked this authorization on April 16, 2021. Reprinted in this document is the issuance of the Authorization and the revocation, which include an explanation of the reasons for issuance or revocation.
Full Text
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<title>Federal Register, Volume 86 Issue 118 (Wednesday, June 23, 2021)</title>
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[Federal Register Volume 86, Number 118 (Wednesday, June 23, 2021)]
[Notices]
[Pages 32938-32950]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13183]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1729]
Authorization and Revocation of Emergency Use of Drugs 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
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for a drug for use during the COVID-19 pandemic. FDA issued the
Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C
Act), as requested by B. Braun Melsungen AG. The Authorization
contains, among other things, conditions on the emergency use of the
authorized drug. The Authorization follows 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 United States 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 revocation of the
Authorization issued to Eli Lilly and Company for bamlanivimab alone.
FDA revoked this authorization on April 16, 2021. Reprinted in this
document is the issuance of the Authorization and the revocation, which
include an explanation of the reasons for issuance or revocation.
DATES: The Authorization for B. Braun Melsungen AG was effective as of
March 12, 2021 and the revocation for Eli Lilly and Company was
effective as of April 16, 2021.
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. 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.
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 United States (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
[[Page 32939]]
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 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 Authorization
The Authorization follows 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 United States 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 authorized the emergency use of a drug during the COVID-19
pandemic. On March 12, 2021, FDA issued an EUA to B. Braun Melsungen AG
for Propofol-Lipuro 1% injectable emulsion, subject to the terms of the
Authorization. The Authorization in its entirety (not including the
authorized version of the fact sheets and other written materials)
follows, below in section VI Electronic Access, and provides 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
On November 9, 2020, FDA issued an Authorization to Eli Lilly and
Company for bamlanivimab alone and reissued the Authorization on
February 9, 2021 and March 2, 2021. Notice of the issuance of the
Authorization was published in the Federal Register on February 19,
2021 (86 FR 10290), as required by section 564(h)(1) of the FD&C Act.
FDA authorized bamlanivimab alone for emergency use for the treatment
of mild to moderate COVID-19 in adults and pediatric patients (12 years
of age and older weighing at least 40 kg) with positive results of
direct SARS-CoV-2 viral testing, and who are at high risk for
progressing to severe Coronavirus Disease 2019 (COVID-19) and/or
hospitalization. Subsequent to the issuance of the Authorization, as
described in the revocation letter reprinted in this notice, FDA
considered new data and new information that became available. 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 16, 2021, FDA revoked the EUA for Eli Lilly and Company
for bamlanivimab alone because the criteria for issuance were no longer
met. Based on a review of the new data and new information, FDA
concluded it is no longer reasonable to believe that the known and
potential benefits of bamlanivimab alone outweigh the known and
potential risks for the product. A summary of these new data and new
information includes the following:
<bullet> Vesicular stomatitis virus-based pseudovirus expressing
spike protein with variant substitutions, specifically E484K and L452R,
exhibit large reductions (>1,000 fold) in susceptibility to
bamlanivimab alone in neutralization assays.
<bullet> The Centers for Disease Control and Prevention (CDC)
national genomic surveillance program has reported an increasing
frequency of SARS-CoV-2 variants that are expected to be resistant to
bamlanivimab alone.
<bullet> Testing technologies that enable health care providers to
test individual patients for SARS-CoV-2 viral variants prior to
initiation of treatment with monoclonal antibodies are not available
and frequencies are changing rapidly. Therefore, empiric treatment with
monoclonal antibody therapies that are expected to retain activity
broadly across the U.S. is needed to reduce the likelihood of treatment
failure.
<bullet> On April 8, 2021, the National Institutes of Health
updated its treatment guidelines for COVID-19 recommending against the
use of bamlanivimab alone.
Accordingly, FDA revoked the EUA for emergency use of bamlanivimab
alone 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 Eli Lilly and Company for bamlanivimab alone.
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The revocation in its entirety follows, below in 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
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>.
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Dated: June 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13183 Filed 6-22-21; 8:45 am]
BILLING CODE 4164-01-C
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</html>Indexed from Federal Register on June 23, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.