[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Pages 13903-13905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04877]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-6084]
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for
Improving Glycemic Control; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Type 2
Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving
Glycemic Control.'' This draft guidance replaces the guidance for
industry entitled ``Diabetes Mellitus--Evaluating Cardiovascular Risk
in New Antidiabetic Therapies to Treat Type 2 Diabetes'' and the draft
guidance for industry ``Diabetes Mellitus: Developing Drugs and
Therapeutic Biologics for Treatment and Prevention,'' both of which are
being withdrawn. This draft guidance outlines the Agency's current
recommendations on the evaluation of safety for new drugs and biologics
to improve glycemic control in patients with type 2 diabetes.
Publication of this guidance is intended to provide clarity on the
expectations for the development of drugs and biologics to improve
glycemic control and to serve as a focus for commentary and feedback.
DATES: Submit either electronic or written comments on the draft
guidance by June 8, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-6084 for ``Type 2 Diabetes Mellitus: Evaluating the Safety
of New Drugs for Improving Glycemic Control.'' Received comments 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
[[Page 13904]]
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.govinfo.gov/content/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Silvana Borges, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3200, Silver Spring, MD 20993-0002, 301-
796-0963.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs
for Improving Glycemic Control.'' This draft guidance replaces the
guidance for industry entitled ``Diabetes Mellitus--Evaluating
Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2
Diabetes,'' published in December 2008, and the draft guidance for
industry ``Diabetes Mellitus: Developing Drugs and Therapeutic
Biologics for Treatment and Prevention,'' published in February 2008,
both of which are being withdrawn.
In response to questions and concerns about increased
cardiovascular risk with certain antidiabetic therapies, FDA convened
an advisory committee meeting in July 2008 to discuss the role of
cardiovascular risk assessments for the safety evaluation of drugs and
biologics developed for the treatment of type 2 diabetes. Based, in
part, on comments expressed at that meeting, the Agency issued a
guidance for industry in December 2008 outlining recommendations on the
evaluation of cardiovascular risk for new antidiabetic therapies. That
guidance stated that developers should demonstrate that new
antidiabetic drugs and biologics would not result in an unacceptable
increase in cardiovascular risk.
Since that time, FDA has reviewed the results of several
cardiovascular outcome trials (CVOTs) conducted to meet the December
2008 guidance recommendations. None of the CVOTs to date have
identified an increased risk of ischemic cardiovascular events; some of
the CVOTs have instead demonstrated a reduced risk for cardiovascular
events. In light of the CVOT results, FDA is revisiting the
recommendations of the December 2008 guidance and is now proposing an
updated approach to evaluating the safety of new drugs and biologics to
improve glycemic control. In addition, FDA is withdrawing the February
2008 guidance because its recommendations for safety assessment have
become outdated.
FDA is establishing this docket to solicit input from stakeholders
on all aspects of these issues, including comments on specific
questions posed in section II, Additional Issues for Consideration.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Type 2
Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving
Glycemic Control.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
II. Additional Issues for Consideration
FDA is soliciting comments from stakeholders regarding the issues
described in this notice and the draft guidance. In addition to any
other aspects of the guidance that stakeholders may care to comment
upon, FDA is interested in answers to the following questions/topics in
particular:
A. Size of Population and Exposure to the Investigational Drug/Biologic
1. Is it more important to emphasize the number of patients exposed
or the amount of exposure (i.e., number of patient-years)? Or should
there be expectations set for both parameters?
2. What would constitute a minimally acceptable database (either in
number of patients, number of patient-years, or both) in terms of
exposure to investigational drug/biologic at time of filing of the
marketing application?
B. Demographic Characteristics of the Population
1. What are the important comorbid conditions to include?
2. What would be a minimally acceptable number of patients or
number of patient-years to include for each important comorbid
condition?
C. Necessary Safety Evaluations
1. Are there specific safety concerns for patients with type 2
diabetes that should be rigorously evaluated?
2. If there are specific safety concerns that should be rigorously
evaluated, how should that assessment be conducted?
3. Is the adjudication of adverse events related to a specific
safety concern a necessary part of the safety assessment? If so, should
it be conducted by an independent, blinded adjudication committee or
would other means of adjudication be adequate?
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved FDA collections
of information. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collection of
information in 21 CFR part 312 has been approved under OMB control
number 0910-0014; the collection of information in 21 CFR part 314 has
been approved under OMB control number 0910-0001; and the collection of
information for clinical trial data monitoring committees has been
approved under OMB control number 0910-0581.
IV. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
[[Page 13905]]
Dated: March 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04877 Filed 3-9-20; 8:45 am]
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