The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products; Public Hearing; Request for Comments, 12966-12969 [2019-06438]
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Federal Register / Vol. 84, No. 64 / Wednesday, April 3, 2019 / Proposed Rules
acquired as a result of full or partial
liquidation of a loan, through
foreclosure, deed in lieu of foreclosure,
or other legal means.
■ 8. Revise § 621.9 to read as follows:
khammond on DSKBBV9HB2PROD with PROPOSALS
§ 621.9
Reinstatement to accrual status.
(a) Before being reinstated to accrual
status, a loan must be current on
contractual payments and the borrower
offered servicing in accordance with the
institution’s policies maintained under
either § 614.4170 or part 617 of this
chapter, whichever is applicable.
Additional reinstatement eligibility
requirements are dependent upon
certain characteristics of the loan under
review.
(1) Loans that were current when
placed in nonaccrual status may be
reinstated to accrual status if the loans
did not become past due while in
nonaccrual status and known risks to
the continued collection of principal or
interest have been addressed through
servicing efforts. If the loan became past
due while in nonaccrual status, it may
only be reinstated under paragraphs
(a)(2) and either (a)(3) or (a)(4) of this
section, as applicable.
(2) Loans past due when placed in
nonaccrual status, or becoming past due
while in nonaccrual status, must have
prior charge offs recovered prior to
reinstatement to accrual status. Charge
offs resulting from formal restructuring
of the loan under part 617 of this
chapter or a TDR are exempt from
recovery under this provision.
(3) Loans that are not adequately
secured and were past due when placed
in nonaccrual status, or became past due
while in nonaccrual status, must remain
current on contractual payments for a
period of sustained performance before
they may be reinstated.
(4) Loans that are adequately secured
but were past due when placed in
nonaccrual status, or became past due
while in nonaccrual status, must have a
recent repayment pattern demonstrating
future repayment capacity to make ontime payments before the loans may be
reinstated. The repayment pattern is
established in one of two ways:
(i) Sustained performance in making
on-time contractual payments, or
(ii) A recent history of making on-time
partial payments in amounts the same
or greater than newly restructured
payment amounts.
(b) Nothing in this section prevents a
current loan from being reinstated to
accrual status in response to a Credit
Review Committee decision issued
under section 4.14D(d) of the Farm
Credit Act of 1971, as amended, when
that decision was made in compliance
with applicable laws, regulations, and
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in accordance with generally accepted
accounting principles.
Dated: March 26, 2019.
Dale Aultman,
Secretary, Farm Credit Administration Board.
[FR Doc. 2019–06216 Filed 4–2–19; 8:45 am]
BILLING CODE 6705–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2019–N–1132]
The Future of Insulin Biosimilars:
Increasing Access and Facilitating the
Efficient Development of Biosimilar
and Interchangeable Insulin Products;
Public Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing a public hearing to discuss
access to affordable insulin products
and issues related to the development
and approval of biosimilar and
interchangeable insulin products.
DATES: The public hearing will be held
on May 13, 2019, from 9 a.m. to 5 p.m.
The public hearing may be extended or
may end early depending on the level of
public participation. Persons seeking to
present at the public hearing must
register by April 29, 2019. Persons
seeking to speak at the public hearing
must register by May 9, 2019. Persons
seeking to attend, but not present at, the
public hearing must register by May 9,
2019. Section III provides attendance
and registration information. Electronic
or written comments will be accepted
after the public hearing until May 31,
2019.
SUMMARY:
The public hearing will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503B), Silver Spring, MD 20993–0002.
Entrance for public hearing participants
(non-FDA employees) is through
Building 1, where routine security
check procedures will be performed. For
parking and security information, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
ADDRESSES:
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filed comments will not be considered.
Electronic comments must be submitted
on or before May 31, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 31, 2019. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–1132 for ‘‘The Future of Insulin
Biosimilars: Increasing Access and
Facilitating the Efficient Development of
Insulin Biosimilar and Interchangeable
Products; Public Hearing; Request for
Comments.’’ Received comments, those
filed in a timely manner (see
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ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3138, Silver Spring,
MD 20993, 301–796–9203,
OMPTFeedback@fda.hhs.gov (please
use ‘‘Insulin Biosimilars part 15’’ as
subject line).
SUPPLEMENTARY INFORMATION:
I. Background
The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act)
requires that on March 23, 2020, an
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approved marketing application for a
biological product under section 505 of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355) will be
deemed to be a license for the biological
product under section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C.
262) and regulated under the PHS Act.
The transition of biological products
currently approved under the FD&C Act
to the PHS Act will open the pathway
to market for new products that are
biosimilar to, or interchangeable with,
these transitioned products. The
biological products affected by this
transition include insulin products,
insulin mix products, and insulin
analog products (collectively described
in this notification as ‘‘insulin
products’’), which historically have
been approved under the FD&C Act.
Insulin is a lifesaving drug that many
Americans depend on to treat their
diabetes. In recent years, however,
increases in the prices of insulin
products have raised serious concerns
about the ability for many patients to
access the insulin needed to survive.
FDA is holding this public hearing to
receive input from stakeholders as the
Agency prepares for the submission and
review of applications for biosimilar
and interchangeable insulin products.
FDA anticipates that these products,
once they are approved, will bring new
competition to the insulin market and
help provide affordable treatment
options to patients with diabetes
without compromising safety and
effectiveness.
The BPCI Act amended the PHS Act
and other statutes to create an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. This abbreviated pathway
allows an applicant to rely on certain
existing knowledge about the safety and
effectiveness of a biological reference
product to support approval, provided
the sponsor can demonstrate that its
product meets the applicable statutory
standards, including biosimilarity.
Thus, the sponsor may be able to
develop the biosimilar at a lower cost,
relative to the development of a novel
biological product submitted in a standalone marketing application. The PHS
Act defines biosimilarity to mean ‘‘that
the biological product is highly similar
to the reference product
notwithstanding minor differences in
clinically inactive components’’ and
that ‘‘there are no clinically meaningful
differences between the biological
product and the reference product in
terms of the safety, purity, and potency
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of the product’’ (section 351(i)(2) of the
PHS Act).
An interchangeable biosimilar may be
substituted for the reference product
without the intervention of the
prescribing healthcare provider (see
section 351(i)(3) of the PHS Act). To
meet the standard of
‘‘interchangeability,’’ an applicant must
provide sufficient information to
demonstrate: (1) Biosimilarity; (2) that
the biological product can be expected
to produce the same clinical result as
the reference product in any given
patient; and (3) for products
administered more than once to an
individual, that the risk in terms of
safety or diminished efficacy of
alternating or switching between the use
of the biological product and the
reference product is not greater than the
risk of using the reference product
without such alternation or switch
(section 351(k)(4) of the PHS Act).
After the March 23, 2020, transition,
insulin products that will be deemed to
be licensed under the PHS Act will be
able to act as reference products for
proposed biosimilar or interchangeable
insulin products. There are currently no
approved prescription insulin products
that can be substituted at the pharmacy
level. An interchangeable insulin
product can be substituted for the
reference insulin product at the
pharmacy, potentially leading to
increased access and lower costs for
patients.
This public hearing is a component of
FDA’s broader effort to facilitate the
growth of a competitive market for
biologics. In July 2018, FDA issued its
Biosimilars Action Plan, which focuses
on four areas of FDA activities: (1)
Improving the efficiency of the
biosimilar and interchangeable product
development and approval process; (2)
maximizing scientific and regulatory
clarity for the biosimilar product
development community; (3)
developing effective communications to
improve understanding of biosimilars
among patients, clinicians, and payors;
and (4) supporting market competition
by reducing gaming of FDA
requirements or other attempts to
unfairly delay competition. On
September 4, 2018, FDA held a public
meeting entitled ‘‘Facilitating
Competition and Innovation in the
Biological Products Marketplace’’ (see
83 FR 35154, July 25, 2018) and
received submissions to an associated
docket (Docket No. FDA–2018–N–2689).
II. Purpose and Scope of the Public
Hearing
FDA is holding this public hearing to
receive input from patients, families,
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healthcare providers, and other
stakeholders who live with diabetes or
care for someone with diabetes about
the challenges and opportunities FDA
should consider as we prepare for the
submission and review of applications
for biosimilar and interchangeable
insulin products. We also want to hear
from manufacturers and other
stakeholders about the development
process for biosimilar and
interchangeable insulin products. FDA
has determined that a public hearing is
the most appropriate way to ensure
public engagement on these topics.
Questions for Commenters to Address:
FDA is soliciting input on steps the
Agency can take to facilitate increased
access to insulin products, including
biosimilar and interchangeable insulin
products. FDA is interested in how we
can encourage the development of
biosimilar and interchangeable insulin
products, while achieving the balance
between competition and innovation
intended by Congress in the BPCI Act.
Although FDA welcomes all feedback
on any public health, scientific,
regulatory, or legal considerations
relating to this topic, we particularly
encourage commenters to consider the
following topics and questions as they
prepare their comments or statements.
1. Scientific standards for evaluating
the biosimilarity and interchangeability
of an insulin product.
a. What considerations should FDA
take into account when evaluating data
and other information submitted by an
applicant, including from analytical and
clinical studies, to determine whether
an insulin product is biosimilar to a
reference product?
b. What considerations should FDA
take into account when evaluating data
and other information submitted by an
applicant, to determine whether an
insulin product is interchangeable with
a reference product?
2. Other regulatory considerations: Do
certain insulin products, for example,
those that include use in insulin pumps
for continuous subcutaneous infusion
among the approved uses or those
approved with over-the-counter
marketing status, raise unique scientific
considerations? What factors should
FDA consider when evaluating a
proposed biosimilar or interchangeable
insulin product if the reference product
raises such considerations? Are there
additional factors FDA should evaluate
for interchangeable insulin products,
which may be substituted at the
pharmacy for the reference product
without the involvement of the
prescriber?
3. Patient experience: What aspects of
the patient experience with insulin
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products should FDA consider when
evaluating a proposed biosimilar or
interchangeable insulin product?
4. Information resources for patients,
clinicians, pharmacists, and other
stakeholders: What information is
needed to develop effective
communications to improve
understanding and promote awareness
among patients, clinicians, pharmacists,
and other stakeholders about biosimilar
and interchangeable insulin products?
III. Participating in the Public Hearing
The FDA Conference Center at the
White Oak location is a Federal facility
with security procedures and limited
seating. Attendance will be free and on
a first-come, first-served basis. An
agenda for the hearing and any other
background materials will be made
available 5 days before the hearing at
https://www.fda.gov/FDAgov/
NewsEvents/MeetingsConferences
Workshops/ucm632081.htm. If you need
special accommodations because of a
disability, please contact Allison
Hoffman (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
hearing.
Registration and Requests for Formal
Oral Presentations: For those interested
in presenting at the meeting with a
formal oral presentation, please register
at https://www.eventbrite.com/e/insulinbiosimilar-part-15-tickets-56571622245
as ‘‘In-person presenter’’. Presenter
registrations are due April 29, 2019.
FDA will try to accommodate all
persons who wish to make a formal oral
presentation. Formal oral presenters
may use an accompanying slide deck.
Individuals wishing to present should
identify their name, affiliation (if
appropriate), and the number of the
specific question, or questions, they
wish to address. This will help FDA
organize the presentations. Individuals
and organizations with common
interests should consider consolidating
or coordinating their presentations and
request time for a joint presentation.
Individual organizations are limited to a
single presentation slot. FDA will notify
registered presenters of their scheduled
presentation times. The time allotted for
each presentation will depend on the
number of individuals who wish to
speak. Registered presenters making a
formal oral presentation are encouraged
to submit an electronic copy of their
presentation (PowerPoint or PDF) to
OMPTFeedback@fda.hhs.gov with the
subject line ‘‘Insulin Biosimilars part 15
Presentation’’ on or before May 6, 2019.
Persons registered to present are
encouraged to arrive at the hearing room
early and check in at the onsite
registration table to confirm their
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designated presentation time. Actual
presentation times, however, may vary
based on how the meeting progresses in
real time.
Registration and Requests for Open
Public Hearing Speaker slots: For those
interested in participating as an Open
Public Hearing speaker, please register
at https://www.eventbrite.com/e/insulinbiosimilar-part-15-tickets-56571622245
as ‘‘In-person Open Public Hearing
presenter’’. Open Public Hearing
registrations are due May 9, 2019;
however, you may sign up as an Open
Public Hearing speaker the day of the
meeting. Time and space are limited
and available on a first-come, firstserved basis. Open Public Hearing
speakers have less allotted time than
formal oral presenters and will deliver
oral testimony only (no accompanying
slide deck).
Persons registered to participate
during the Open Public Hearing are
encouraged to arrive at the hearing room
early and check in at the onsite
registration table to confirm their Open
Public Hearing participation.
Those without internet or email
access can request to participate as a
formal presenter or an open public
hearing speaker by contacting Allison
Hoffman by the above dates (see FOR
FURTHER INFORMATION CONTACT).
In-person attendance: For those who
would like to attend in-person, but who
are not making a formal presentation or
participating in the Open Public
Hearing, please register at https://
www.eventbrite.com/e/insulinbiosimilar-part-15-tickets-56571622245
as ‘‘In-person attendee—no
participation’’. You may choose not to
register; however, seating is limited, and
space will be available on a first-come,
first-served basis.
Streaming Webcast of the Public
Hearing: For those unable to attend in
person, FDA will provide a live webcast
of the hearing. To join the hearing via
the webcast, please go to https://
collaboration.fda.gov/insulin051319.
Please register at https://
www.eventbrite.com/e/insulinbiosimilar-part-15-tickets-56571622245
as ‘‘online (webcast only)’’.
Media: Please register at https://
www.eventbrite.com/e/insulinbiosimilar-part-15-tickets-56571622245
as ‘‘Media’’ by May 9, 2019.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://www.fda.gov/
FDAgov/NewsEvents/
MeetingsConferencesWorkshops/
ucm632081.htm and https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES).
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IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). The hearing will be
conducted by a presiding officer, who
will be accompanied by FDA senior
management from the Office of the
Commissioner, the Center for Devices
and Radiological Health, the Center for
Drug Evaluation and Research, and the
Office of the Chief Counsel. Under
§ 15.30(f) (21 CFR 15.30(f)), the hearing
is informal, and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Public hearings under part 15 are
subject to FDA’s policy and procedures
for electronic media coverage of FDA’s
public administrative proceedings (21
CFR part 10, subpart C). Under 21 CFR
10.205, representatives of the media
may be permitted, subject to certain
limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. Persons
attending FDA’s hearings are advised
that the Agency is not responsible for
providing access to electrical outlets.
The hearing will be transcribed as
stipulated in § 15.30(b) (see
Transcripts). To the extent that the
conditions for the hearing, as described
in this notification, conflict with any
provisions set out in part 15, this
notification acts as a waiver of those
provisions as specified in § 15.30(h).
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06438 Filed 4–2–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2019–N–1482]
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Scientific Data and Information About
Products Containing Cannabis or
Cannabis-Derived Compounds; Public
Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public hearing to
obtain scientific data and information
SUMMARY:
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about the safety, manufacturing, product
quality, marketing, labeling, and sale of
products containing cannabis or
cannabis-derived compounds.
DATES: The public hearing will be held
on May 31, 2019, from 8 a.m. to 6 p.m.
Submit requests to make oral
presentations and comments at the
public hearing by May 10, 2019.
Electronic or written comments will be
accepted until July 2, 2019. See the
SUPPLEMENTARY INFORMATION section for
registration and information.
ADDRESSES: The public hearing will be
held at FDA White Oak Campus,10903
New Hampshire Ave., Building 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public hearing
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
FDA is establishing a docket for
public comment on this hearing. The
docket number is FDA–2019–N–1482.
The docket will close on July 2, 2019.
Submit either electronic or written
comments on this public hearing by July
2, 2019. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before July 2, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 2, 2019. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
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12969
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–1482 for ‘‘Scientific Data and
Information about Products Containing
Cannabis or Cannabis-Derived
Compounds; Public Hearing; Request for
Comments.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
our consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
E:\FR\FM\03APP1.SGM
03APP1
]]>Agencies
[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Proposed Rules]
[Pages 12966-12969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06438]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2019-N-1132]
The Future of Insulin Biosimilars: Increasing Access and
Facilitating the Efficient Development of Biosimilar and
Interchangeable Insulin Products; Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing to discuss access to affordable insulin
products and issues related to the development and approval of
biosimilar and interchangeable insulin products.
DATES: The public hearing will be held on May 13, 2019, from 9 a.m. to
5 p.m. The public hearing may be extended or may end early depending on
the level of public participation. Persons seeking to present at the
public hearing must register by April 29, 2019. Persons seeking to
speak at the public hearing must register by May 9, 2019. Persons
seeking to attend, but not present at, the public hearing must register
by May 9, 2019. Section III provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until May 31, 2019.
ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503B), Silver Spring, MD 20993-0002. Entrance for public hearing
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before May 31, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of May 31, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-1132 for ``The Future of Insulin Biosimilars: Increasing
Access and Facilitating the Efficient Development of Insulin Biosimilar
and Interchangeable Products; Public Hearing; Request for Comments.''
Received comments, those filed in a timely manner (see
[[Page 12967]]
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3138, Silver
Spring, MD 20993, 301-796-9203, [email protected] (please use
``Insulin Biosimilars part 15'' as subject line).
SUPPLEMENTARY INFORMATION:
I. Background
The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) requires that on March 23, 2020, an approved marketing application
for a biological product under section 505 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355) will be deemed to be a
license for the biological product under section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C. 262) and regulated under the
PHS Act. The transition of biological products currently approved under
the FD&C Act to the PHS Act will open the pathway to market for new
products that are biosimilar to, or interchangeable with, these
transitioned products. The biological products affected by this
transition include insulin products, insulin mix products, and insulin
analog products (collectively described in this notification as
``insulin products''), which historically have been approved under the
FD&C Act.
Insulin is a lifesaving drug that many Americans depend on to treat
their diabetes. In recent years, however, increases in the prices of
insulin products have raised serious concerns about the ability for
many patients to access the insulin needed to survive. FDA is holding
this public hearing to receive input from stakeholders as the Agency
prepares for the submission and review of applications for biosimilar
and interchangeable insulin products. FDA anticipates that these
products, once they are approved, will bring new competition to the
insulin market and help provide affordable treatment options to
patients with diabetes without compromising safety and effectiveness.
The BPCI Act amended the PHS Act and other statutes to create an
abbreviated licensure pathway for biological products shown to be
biosimilar to, or interchangeable with, an FDA-licensed biological
reference product. This abbreviated pathway allows an applicant to rely
on certain existing knowledge about the safety and effectiveness of a
biological reference product to support approval, provided the sponsor
can demonstrate that its product meets the applicable statutory
standards, including biosimilarity. Thus, the sponsor may be able to
develop the biosimilar at a lower cost, relative to the development of
a novel biological product submitted in a stand-alone marketing
application. The PHS Act defines biosimilarity to mean ``that the
biological product is highly similar to the reference product
notwithstanding minor differences in clinically inactive components''
and that ``there are no clinically meaningful differences between the
biological product and the reference product in terms of the safety,
purity, and potency of the product'' (section 351(i)(2) of the PHS
Act).
An interchangeable biosimilar may be substituted for the reference
product without the intervention of the prescribing healthcare provider
(see section 351(i)(3) of the PHS Act). To meet the standard of
``interchangeability,'' an applicant must provide sufficient
information to demonstrate: (1) Biosimilarity; (2) that the biological
product can be expected to produce the same clinical result as the
reference product in any given patient; and (3) for products
administered more than once to an individual, that the risk in terms of
safety or diminished efficacy of alternating or switching between the
use of the biological product and the reference product is not greater
than the risk of using the reference product without such alternation
or switch (section 351(k)(4) of the PHS Act).
After the March 23, 2020, transition, insulin products that will be
deemed to be licensed under the PHS Act will be able to act as
reference products for proposed biosimilar or interchangeable insulin
products. There are currently no approved prescription insulin products
that can be substituted at the pharmacy level. An interchangeable
insulin product can be substituted for the reference insulin product at
the pharmacy, potentially leading to increased access and lower costs
for patients.
This public hearing is a component of FDA's broader effort to
facilitate the growth of a competitive market for biologics. In July
2018, FDA issued its Biosimilars Action Plan, which focuses on four
areas of FDA activities: (1) Improving the efficiency of the biosimilar
and interchangeable product development and approval process; (2)
maximizing scientific and regulatory clarity for the biosimilar product
development community; (3) developing effective communications to
improve understanding of biosimilars among patients, clinicians, and
payors; and (4) supporting market competition by reducing gaming of FDA
requirements or other attempts to unfairly delay competition. On
September 4, 2018, FDA held a public meeting entitled ``Facilitating
Competition and Innovation in the Biological Products Marketplace''
(see 83 FR 35154, July 25, 2018) and received submissions to an
associated docket (Docket No. FDA-2018-N-2689).
II. Purpose and Scope of the Public Hearing
FDA is holding this public hearing to receive input from patients,
families,
[[Page 12968]]
healthcare providers, and other stakeholders who live with diabetes or
care for someone with diabetes about the challenges and opportunities
FDA should consider as we prepare for the submission and review of
applications for biosimilar and interchangeable insulin products. We
also want to hear from manufacturers and other stakeholders about the
development process for biosimilar and interchangeable insulin
products. FDA has determined that a public hearing is the most
appropriate way to ensure public engagement on these topics.
Questions for Commenters to Address: FDA is soliciting input on
steps the Agency can take to facilitate increased access to insulin
products, including biosimilar and interchangeable insulin products.
FDA is interested in how we can encourage the development of biosimilar
and interchangeable insulin products, while achieving the balance
between competition and innovation intended by Congress in the BPCI
Act. Although FDA welcomes all feedback on any public health,
scientific, regulatory, or legal considerations relating to this topic,
we particularly encourage commenters to consider the following topics
and questions as they prepare their comments or statements.
1. Scientific standards for evaluating the biosimilarity and
interchangeability of an insulin product.
a. What considerations should FDA take into account when evaluating
data and other information submitted by an applicant, including from
analytical and clinical studies, to determine whether an insulin
product is biosimilar to a reference product?
b. What considerations should FDA take into account when evaluating
data and other information submitted by an applicant, to determine
whether an insulin product is interchangeable with a reference product?
2. Other regulatory considerations: Do certain insulin products,
for example, those that include use in insulin pumps for continuous
subcutaneous infusion among the approved uses or those approved with
over-the-counter marketing status, raise unique scientific
considerations? What factors should FDA consider when evaluating a
proposed biosimilar or interchangeable insulin product if the reference
product raises such considerations? Are there additional factors FDA
should evaluate for interchangeable insulin products, which may be
substituted at the pharmacy for the reference product without the
involvement of the prescriber?
3. Patient experience: What aspects of the patient experience with
insulin products should FDA consider when evaluating a proposed
biosimilar or interchangeable insulin product?
4. Information resources for patients, clinicians, pharmacists, and
other stakeholders: What information is needed to develop effective
communications to improve understanding and promote awareness among
patients, clinicians, pharmacists, and other stakeholders about
biosimilar and interchangeable insulin products?
III. Participating in the Public Hearing
The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance will
be free and on a first-come, first-served basis. An agenda for the
hearing and any other background materials will be made available 5
days before the hearing at https://www.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm632081.htm. If you need special
accommodations because of a disability, please contact Allison Hoffman
(see FOR FURTHER INFORMATION CONTACT) at least 7 days before the
hearing.
Registration and Requests for Formal Oral Presentations: For those
interested in presenting at the meeting with a formal oral
presentation, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person presenter''.
Presenter registrations are due April 29, 2019.
FDA will try to accommodate all persons who wish to make a formal
oral presentation. Formal oral presenters may use an accompanying slide
deck. Individuals wishing to present should identify their name,
affiliation (if appropriate), and the number of the specific question,
or questions, they wish to address. This will help FDA organize the
presentations. Individuals and organizations with common interests
should consider consolidating or coordinating their presentations and
request time for a joint presentation. Individual organizations are
limited to a single presentation slot. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Registered presenters making a formal oral presentation are
encouraged to submit an electronic copy of their presentation
(PowerPoint or PDF) to [email protected] with the subject line
``Insulin Biosimilars part 15 Presentation'' on or before May 6, 2019.
Persons registered to present are encouraged to arrive at the hearing
room early and check in at the onsite registration table to confirm
their designated presentation time. Actual presentation times, however,
may vary based on how the meeting progresses in real time.
Registration and Requests for Open Public Hearing Speaker slots:
For those interested in participating as an Open Public Hearing
speaker, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person Open Public
Hearing presenter''. Open Public Hearing registrations are due May 9,
2019; however, you may sign up as an Open Public Hearing speaker the
day of the meeting. Time and space are limited and available on a
first-come, first-served basis. Open Public Hearing speakers have less
allotted time than formal oral presenters and will deliver oral
testimony only (no accompanying slide deck).
Persons registered to participate during the Open Public Hearing
are encouraged to arrive at the hearing room early and check in at the
onsite registration table to confirm their Open Public Hearing
participation.
Those without internet or email access can request to participate
as a formal presenter or an open public hearing speaker by contacting
Allison Hoffman by the above dates (see FOR FURTHER INFORMATION
CONTACT).
In-person attendance: For those who would like to attend in-person,
but who are not making a formal presentation or participating in the
Open Public Hearing, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person
attendee--no participation''. You may choose not to register; however,
seating is limited, and space will be available on a first-come, first-
served basis.
Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://collaboration.fda.gov/insulin051319. Please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``online (webcast only)''.
Media: Please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``Media'' by May 9, 2019.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm632081.htm and https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES).
[[Page 12969]]
IV. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner, the Center for Devices and Radiological Health, the
Center for Drug Evaluation and Research, and the Office of the Chief
Counsel. Under Sec. 15.30(f) (21 CFR 15.30(f)), the hearing is
informal, and the rules of evidence do not apply. No participant may
interrupt the presentation of another participant. Public hearings
under part 15 are subject to FDA's policy and procedures for electronic
media coverage of FDA's public administrative proceedings (21 CFR part
10, subpart C). Under 21 CFR 10.205, representatives of the media may
be permitted, subject to certain limitations, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. Persons attending FDA's hearings are
advised that the Agency is not responsible for providing access to
electrical outlets. The hearing will be transcribed as stipulated in
Sec. 15.30(b) (see Transcripts). To the extent that the conditions for
the hearing, as described in this notification, conflict with any
provisions set out in part 15, this notification acts as a waiver of
those provisions as specified in Sec. 15.30(h).
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06438 Filed 4-2-19; 8:45 am]
BILLING CODE 4164-01-P
