Notice2023-18241
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Alternative Form of Hearing
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
August 24, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces an alternative form of hearing regarding the Center for Drug Evaluation and Research's (CDER's) proposal to refuse to approve ITCA 650 (exenatide in DUROS device), a drug-device combination product that is the subject of a new drug application (NDA) submitted by Intarcia Therapeutics, Inc. (Intarcia). CDER is holding a public hearing before an advisory committee under FDA regulations as an alternative form of hearing.
Full Text
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<title>Federal Register, Volume 88 Issue 163 (Thursday, August 24, 2023)</title>
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[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Pages 57958-57959]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18241]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3499]
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Alternative Form of Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of alternative form of hearing.
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SUMMARY: The Food and Drug Administration (FDA) announces an
alternative form of hearing regarding the Center for Drug Evaluation
and Research's (CDER's) proposal to refuse to approve ITCA 650
(exenatide in DUROS device), a drug-device combination product that is
the subject of a new drug application (NDA) submitted by Intarcia
Therapeutics, Inc. (Intarcia). CDER is holding a public hearing before
an advisory committee under FDA regulations as an alternative form of
hearing.
DATES: The meeting will be held virtually on September 21, 2023, from 9
a.m. to 5:30 p.m. Eastern Time.
ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. Answers to
commonly asked questions including information regarding special
accommodations due to a disability may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2855, email: <a href="/cdn-cgi/l/email-protection#27626a63666467414346094f4f5409404851"><span class="__cf_email__" data-cfemail="ade8e0e9eceeedcbc9cc83c5c5de83cac2db">[email protected]</span></a>; or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area).
SUPPLEMENTARY INFORMATION:
Background: This advisory committee meeting is being held pursuant
to a March 24, 2023, letter from the Chief Scientist of FDA, Dr.
Namandj[eacute] N. Bumpus, wherein she granted Intarcia's request under
Sec. 12.32(b)(3)(ii) (21 CFR 12.32(b)(3)(ii)) for a public hearing
before an advisory committee in lieu of a formal evidentiary public
hearing under part 12 (21 CFR part 12).
Intarcia submitted NDA 209053 for ITCA 650 (exenatide in DUROS
device), a novel drug-device combination product on November 21, 2016,
under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(b)(1)). On September 21, 2017, CDER issued a
complete response (CR) letter to Intarcia under Sec. 314.110(a) (21
CFR 314.110(a)) stating that NDA 209053 could not be approved in its
present form, describing the specific deficiencies and, where possible,
recommending ways that Intarcia might remedy these deficiencies. On
September 9, 2019, Intarcia resubmitted the NDA under section 505(b)(1)
of the FD&C Act. On March 9, 2020, CDER issued a second CR letter
stating that NDA 209053 could not be approved in its present form,
describing the specific deficiencies and, where possible, recommending
ways that Intarcia might remedy these deficiencies. The CR letters
stated that Intarcia is required either to resubmit the application,
fully addressing all deficiencies listed in the letter, or take other
actions available under Sec. 314.110 (i.e., resubmit the application,
withdraw the application, or request an opportunity for a hearing).
Applicable regulations, including 21 CFR 10.75, also provide a
mechanism for applicants to obtain formal review of one or more
decisions reflected in a CR letter.
On March 16, 2021, Intarcia submitted a request under Sec.
314.110(b)(3) for an opportunity for a hearing on whether there are
grounds under section 505(d) of the FD&C Act for denying approval of
NDA 209053. In the Federal Register of September 2, 2021, FDA published
a notice of opportunity for a hearing (NOOH) regarding CDER's proposal
to refuse to approve NDA 209053 submitted by Intarcia for ITCA 650 (86
FR 49334). The NOOH gave Intarcia an opportunity to request a hearing
before the Commissioner of Food and Drugs on CDER's proposal to refuse
to approve NDA 209053. On September 13, 2021, Intarcia submitted a
notice of participation and request for a hearing. Intarcia submitted
data, information, and analyses in support of its hearing request on
November 1, 2021, and February 15, 2022.
On July 29, 2022, CDER issued, via email to Intarcia, a proposed
order proposing to refuse to approve NDA 209053 in its present form
(see Docket No. FDA-2021-N-0874). Intarcia responded to CDER's proposed
order on October 10, 2022.
On February 7, 2023, the Chief Scientist of FDA issued a letter to
Intarcia and CDER that stated, in part: ``Under 21 CFR 12.32(a), a
person seeking a hearing under 21 CFR part 12 may request an
alternative form of hearing, such as a hearing before a public advisory
committee under 21 CFR part 14.'' Dr. Bumpus stated that she would
grant a request from Intarcia for an alternative form of hearing under
part 14 (21 CFR part 14) in lieu of a formal evidentiary hearing under
part 12. On February 20, 2023, Intarcia submitted a request in the form
of a citizen petition under 21 CFR 10.30, requesting a public hearing
before an advisory committee under part 14 in lieu of Intarcia's
pending request for a formal evidentiary hearing under part 12. On
March 24, 2023, Dr. Bumpus issued a letter granting Intarcia's request
for an alternative form of hearing.
Accordingly, CDER is holding this meeting pursuant to the March 24,
2023, letter from Dr. Bumpus, wherein she granted Intarcia's request
under Sec. 12.32(b)(3)(ii) for a public hearing before an advisory
committee in lieu of a formal evidentiary hearing. This document serves
as the notice of an alternative form of hearing as required under Sec.
12.32(e).
Subject of Alternative Form of Hearing: CDER's proposed order to
refuse to approve ITCA 650 (exenatide in DUROS device) is the subject
of the alternative form of hearing before the Endocrinologic and
Metabolic Drugs Advisory Committee (see Docket No. FDA-2021-N-0874).
Parties to the Alternative Form of Hearing: Intarcia Therapeutics,
Inc. and the Center for Drug Evaluation and Research are the parties to
the alternative form of hearing before the Endocrinologic and Metabolic
Drugs Advisory Committee.
Issues To Be Discussed: The issues presented at the hearing will be
those related to the safety and efficacy of ITCA 650, a drug-device
combination product that is the subject of an NDA submitted by Intarcia
(NDA 209053), for the proposed indication, as an adjunct to diet and
exercise, to improve glycemic control in adults with type 2 diabetes
mellitus.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by
[[Page 57959]]
this waiver, and that the ends of justice will be served by allowing
for this modification to FDA's advisory committee meeting procedures.
Dated: August 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18241 Filed 8-23-23; 8:45 am]
BILLING CODE 4164-01-P
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