Notice2025-22466
Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information
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
December 11, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a request for information from interested parties and the public to share their perspectives with FDA on testosterone replacement therapy for men. The Agency intends to use the information submitted to help inform considerations related to testosterone therapy for men.
Full Text
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<title>Federal Register, Volume 90 Issue 236 (Thursday, December 11, 2025)</title>
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[Federal Register Volume 90, Number 236 (Thursday, December 11, 2025)]
[Notices]
[Pages 57474-57476]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22466]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6743]
Food and Drug Administration Expert Panel on Testosterone
Replacement Therapy for Men; Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a request for information from interested parties and the
public to share their perspectives with FDA on testosterone replacement
therapy for men. The Agency intends to use the information submitted to
help inform considerations related to testosterone therapy for men.
DATES: Either electronic or written comments on the notice must be
submitted by February 9, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 9, 2026. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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
[[Page 57475]]
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> 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.
<bullet> 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-2025-N-6743 for ``Food and Drug Administration Expert Panel on
Testosterone Replacement Therapy for Men; Request for Information.''
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Renu Lal, Division of Drug
Information, Center for Drug Evaluation and Research, Food and Drug
Administration, 240-753-3395, <a href="/cdn-cgi/l/email-protection#6a0e181f0d03040c052a0c0e0b44020219440d051c"><span class="__cf_email__" data-cfemail="781c0a0d1f11161e17381e1c195610100b561f170e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA plans to hold an Expert Panel on December 10, 2025, on
Testosterone Replacement Therapy (TRT) for Men (the panel). The purpose
of the panel is to allow individual panel members to share their
perspectives on TRT.
During the meeting, FDA anticipates that the panel members may
discuss a range of topics related to the risks and benefits of male
hormone therapy. The panel may include discussion of myths surrounding
testosterone, and its perception as a lifestyle medication. FDA
anticipates that panel members may review data regarding trends in
average testosterone levels in men over recent decades, the potential
causes, preventive strategies, and a variety of other related issues.
Patient safety remains FDA's top priority, and any potential new
indications will be based on rigorous scientific evidence and
comprehensive risk-benefit analysis. The panel members may discuss
safety concerns including, but not limited to, cardiovascular risks,
prostate health, fertility impairment, and potential for abuse.
This multi-stakeholder panel will include healthcare professionals,
researchers, industry representatives, and military health experts to
ensure comprehensive perspectives. FDA recognizes the unique needs of
different populations, including military personnel facing specific
occupational health challenges. Evidence-based protocols that
healthcare providers can confidently implement were discussed by the
panel. Any potential updates to testosterone labeling, including
revisions to approved indications, will undergo the FDA's standard
rigorous review process. FDA will continue robust oversight of both
prescription testosterone therapies and over-the-counter supplements.
II. Purpose of Request for Information
This request for information provides an opportunity for interested
parties and the public--including commercial drug developers, health
care providers, consumers, and other relevant groups--to share their
perspectives with FDA on the indications, dosing, route of
administration, duration of treatment, and goals of treatment.
Specifically, FDA is interested in perspectives on the scientific,
regulatory, and practical considerations that shape testosterone use.
III. Questions for Consideration
We seek input on the questions presented below. While the questions
are aimed at gathering information most pertinent to the administration
of TRT for men, we welcome any additional data and information
regarding the real-world prescribing patterns and clinical uses for TRT
that may improve our understanding and advance our public health
mission. To help FDA review comments efficiently, please identify the
question to which you are responding by its associated category and
number. If you are responding to more than one question, please
identify each question to which you are responding, and categorize each
response by question.
A. General
1. What are the potential impacts of TRT on: cardiovascular and
thromboembolic disease, genitourinary systems, musculoskeletal health,
frailty, and depression?
2. How do the risks and benefits of TRT differ based on timing of
hormone initiation, age of initiation of treatment, duration of use,
formulation (type of testosterone replacement used), dose, and route of
administration?
3. What are the biggest opportunities to improve education of
providers and patients concerning the prescription of TRT?
4. How could interested parties--including, but not limited to,
drug developers, health care providers, patients, consumers, and
retailers--work together to further identify therapeutic uses of TRT
and generate evidence supporting the safety and efficacy of these uses?
B. Scientific Considerations
1. FDA seeks input on definitions and diagnostic thresholds for
age-related androgen deficiency.
2. FDA seeks input on research priorities that could enhance the
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scientific understanding of TRT for men, including areas where
additional evidence or data generation may be most valuable.
3. What scientific barriers might limit progress in increasing the
availability of TRT?
4. What additional scientific tools, technologies, or data sources
could support the availability of TRT?
5. Are there specific diseases or conditions that have not,
traditionally, been treated with TRT for which testosterone could be
safely and effectively used and which are currently not indicated in
FDA-approved product labeling? If so, please provide the data or
evidence supporting these potential uses.
(Authority: 21 U.S.C. 355.)
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22466 Filed 12-10-25; 8:45 am]
BILLING CODE 4164-01-P
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