[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1146-1150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31539]
[[Page 1146]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0053]
Communications From Firms to Health Care Providers Regarding
Scientific Information on Unapproved Uses of Approved/Cleared Medical
Products: Questions and Answers; Guidance for Industry; Availability;
Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request
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 final guidance for industry entitled
``Communications From Firms to Health Care Providers Regarding
Scientific Information on Unapproved Uses of Approved/Cleared Medical
Products: Questions and Answers.'' This guidance describes FDA's
enforcement policy regarding certain firm-initiated communications of
scientific information on unapproved use(s) of the firm's approved/
cleared medical products to health care providers (HCPs) engaged in
prescribing or administering medical products to individual patients.
This guidance finalizes the revised draft guidance of the same title
issued in October 2023. The October 2023 revised draft guidance revised
and replaced the draft guidance entitled ``Distributing Scientific and
Medical Publications on Unapproved New Uses--Recommended Practices,''
issued in March 2014, which itself revised the final guidance entitled
``Good Reprint Practices for the Distribution of Medical Journal
Articles and Medical or Scientific Reference Publications on Unapproved
New Uses of Approved Drugs and Approved or Cleared Medical Devices,''
issued in January 2009. This guidance is not for current
implementation, pending the Office of Management and Budget's (OMB's)
decision on the collection of information.
DATES: The announcement of the guidance is published in the Federal
Register on January 7, 2025. Submit written comments on the collection
of information by February 21, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find the particular information
collections by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control numbers
that FDA is seeking to revise are 0910-0686 and 0910-0485. Also include
the FDA docket number found in brackets in the heading of this
document. You may submit either electronic or written comments on
Agency guidances 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-2008-D-0053 for ``Communications From Firms to Health Care
Providers Regarding Scientific Information on Unapproved Uses of
Approved/Cleared Medical Products: Questions and Answers.'' 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, 240-402-7500.
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.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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this 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; the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; the
Office of Policy, Center for Devices
[[Page 1147]]
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or
the Policy and Regulations Staff, Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Kathleen David, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Room 3203, Silver Spring, MD 20993-0002, 301-796-1200; James
Myers, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002, 240-402-7911; Stephanie Philbin, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002,
301-837-7151; Kathryn Dennehy, Office of Surveillance and Compliance,
Center for Veterinary Medicine, Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-7002; or Julie Finegan,
Office of Policy, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver
Spring, MD 20993-0002, 301-827-4830.
Regarding the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Communications From Firms to Health Care Providers Regarding
Scientific Information on Unapproved Uses of Approved/Cleared Medical
Products: Questions and Answers.'' This guidance describes FDA's
enforcement policy regarding certain firm-initiated communications of
scientific information on unapproved use(s) of the firm's approved/
cleared medical products to HCPs engaged in prescribing or
administering medical products to individual patients. FDA is issuing
this guidance to provide reassurance to firms that, if they choose to
provide communications consistent with the recommendations in this
guidance, FDA does not intend to use the firm's dissemination of such
communication standing alone as evidence of a new intended use.
Additionally, FDA does not expect a firm to submit such a communication
to the Agency at the time the communication is initially shared with
HCPs. We acknowledge that firms communicate in other ways and with
other audiences, and this guidance neither speaks to nor intends to
convey any views on communications that are not within the scope of the
enforcement policy outlined in this guidance.
The fact that a communication by a firm does not share all the
characteristics of communications that are within the scope of this
enforcement policy does not alone mean that FDA intends to rely on it
to establish a new intended use. A key tenet underlying this
enforcement approach is that, to promote the public health, any
individual firm-initiated communication of scientific information about
unapproved use(s) of that firm's approved/cleared medical product(s)
should be truthful and non-misleading, and provide and appropriately
present all information necessary for HCPs to understand and evaluate
the strengths and weaknesses, validity, and clinical utility of the
scientific information on unapproved use(s) in that specific
communication. Accordingly, the guidance provides recommendations
consistent with those principles. The guidance also describes the
characteristics of the specific source publications contained in firm-
initiated communications that fall within the enforcement policy
outlined in this guidance.
Specifically, this guidance provides recommendations for firms
initiating the sharing with HCPs of:
Source publications that are:
--Published scientific or medical journal articles (reprints)
--Published clinical reference resources, as follows:
[ssquf] Clinical practice guidelines (CPGs)
[ssquf] Scientific or medical reference texts (reference texts)
[ssquf] Materials from digital clinical practice resources
Firm-generated presentations of scientific information on
unapproved use(s) provided with a source publication
For the purposes of this guidance, these specific types of firm-
initiated communications to HCPs, in combination with the disclosures
recommended in this guidance, are referred to as scientific information
on unapproved use(s) of approved/cleared medical product communications
(hereafter referred to as ``SIUU communications'').
This guidance finalizes the revised draft guidance of the same
title issued in October 2023 (88 FR 73031). FDA considered comments
received on the draft guidance as the guidance was finalized. Changes
from the draft to the final guidance include (1) reorganizing the
guidance to include dedicated glossary and policy sections; (2)
revising the recommendations for source publications to provide
additional specificity and examples to illustrate the recommendations;
(3) refining language around presentational considerations to provide
additional clarity and an additional example; and (4) updating the
section on firm-generated presentations to specify that the
recommendations apply to firm-generated presentations of scientific
information from any of the source publications addressed in the
guidance. In addition, editorial changes were made for clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Communications From Firms to Health Care
Providers Regarding Scientific Information on Unapproved Uses of
Approved/Cleared Medical Products: Questions and Answers.'' 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. Paperwork Reduction Act of 1995
In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information for OMB review and clearance. This
guidance is not for current implementation, pending OMB's decision on
the collection of information.
Manufacturer Communications on Approved and Unapproved Uses of Drugs
OMB Control Number 0910-0686--Revision; and Medical Device Labeling
OMB Control No. 0910-0485--Revision
The guidance document entitled ``Communications From Firms to
Health Care Providers Regarding Scientific Information on Unapproved
Uses of Approved/Cleared Medical Products: Questions and Answers''
discusses third-party disclosure recommendations regarding information
that we recommend firms include in SIUU
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communications if the firms choose to publicly share such
communications.
In the Federal Register of October 24, 2023 (88 FR 73031), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received in response to the
four information collection topics solicited in the notice.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden--OMB Control No. 0910-0686 \1\
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Number of
Information collection activity; guidance Number of disclosures per Total annual Average burden per disclosure Total hours
section respondents respondent disclosures
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A statement that the unapproved use(s) of the 747 30 22,410 0.1 (6 minutes)....................... 2,241
medical product has not been approved by FDA
and that the safety and effectiveness of the
medical product for the unapproved use(s) has
not been established; section V. Q2.
A statement disclosing the FDA-approved use(s) 747 27 20,169 0.1 (6 minutes)....................... 2,016.9
of the medical product, including any
limitations of use specified in the FDA-
required labeling; section V. Q2.
A statement disclosing any limitations, 747 5 3,735 0.2 (12 minutes)...................... 747
restrictions, cautions, warnings, or
precautions described in the FDA-required
labeling about the unapproved use(s); section
V. Q2.
A copy of the most current FDA-required 747 27 20,169 0.1 (6 minutes)....................... 2,016.9
labeling (or a mechanism for obtaining this
labeling, as appropriate); section V. Q2.
A statement describing any contraindication(s) 747 3 2,241 0.1 (6 minutes)....................... 224.1
in the FDA-required labeling for the medical
product; section V. Q2.
A statement describing any serious, life- 747 25 18,675 0.2 (12 minutes)...................... 3,735
threatening, or fatal risks posed by the
medical product that are in the FDA-required
labeling for the medical product or known by
the firm and that are relevant to the
unapproved use(s). If a risk evaluation and
mitigation strategy (REMS) has been
established under 21 U.S.C. 355-1, the
statement should disclose that fact and
should describe the goal(s) of the REMS;
section V. Q2.
A statement identifying any authors, editors, 747 20 14,940 0.2 (12 minutes)...................... 2,988
or other contributors to publication(s)
included in the SIUU communication who were
employees of or consultants to or who
received compensation from the firm at the
time of writing, editing, or contributing to
the publication, to the extent a firm acting
reasonably would know of such relationship;
section V. Q2.
In the case of an SIUU communication that 747 20 14,940 2.75.................................. 41,085
includes one or more source publications
primarily focused on a particular scientific
study or studies, for each such study where
the following information is not included in
the source publication, provide a description
of:.
--All material aspects of study design,
methodology, and results;
--All material limitations related to the
study design, methodology, and results;
--Any conclusions--from other
scientifically sound studies that
evaluated the same or similar hypotheses
or research questions--that are in
conflict with the conclusions from the
studies or analyses described in the
source publication(s). The citations for
any such studies should also be included;
section V. Q2.
The publication date of any referenced or 747 3 2,241 0.1 (6 minutes)....................... 224.1
included source publication (if not specified
in the source publication or citation);
section V. Q2.
When a firm shares an SIUU communication that 747 3 2,241 0.1 (6 minutes)....................... 224.1
does not include a firm-generated
presentation, but does include an unabridged
CPG or reference text in its entirety that
discusses a wide range of medical products
and that discussion is not primarily focused
on one or more of a firm's medical products,
the firm should include, in lieu of some of
the specific disclosures listed above, a more
general statement in the SIUU communication,
such as ``This [CPG/reference text] describes
some uses of medical products that are not
approved by FDA, and the safety and
effectiveness of any unapproved use(s) have
not been established.''; section V. Q4.
When a firm shares an SIUU communication that 747 10 7,470 0.1 (6 minutes)....................... 747
includes a firm-generated presentation of
scientific information on unapproved use(s)
provided with a source publication, that SIUU
communication should clearly disclose what
portions of the SIUU communication are firm-
generated; section V. Q5.
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Total..................................... .............. ................ 129,231 ...................................... 56,249.1
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a current listing of firms promoting human and animal drug
products in calendar year (CY) 2022, we assume 747 firms (``number of
respondents'' in table 1) may each choose to publicly share 30 SIUU
communications annually. Our estimate of the burden per disclosure (2.5
hours) reflects what we believe is the average burden based on the
number and content and complexity of disclosures as recommended in the
guidance.
[[Page 1149]]
Table 2--Estimated Annual Third-Party Disclosure Burden--OMB Control No. 0910-0485 \1\
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Number of
Information collection activity; guidance Number of disclosures per Total annual Average burden per disclosure Total hours
section respondents respondent disclosures
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A statement that the unapproved use(s) of the 261 30 7,830 0.1 (6 minutes)....................... 783
medical product has not been approved by FDA
and that the safety and effectiveness of the
medical product for the unapproved use(s) has
not been established; section V. Q2.
A statement disclosing the FDA-approved use(s) 261 27 7,047 0.1 (6 minutes)....................... 704.7
of the medical product, including any
limitations of use specified in the FDA-
required labeling; section V. Q2.
A statement disclosing any limitations, 261 5 1,305 0.2 (12 minutes)...................... 261
restrictions, cautions, warnings, or
precautions described in the FDA-required
labeling about the unapproved use(s); section
V. Q2.
A copy of the most current FDA-required 261 27 7,047 0.1 (6 minutes)....................... 704.7
labeling (or a mechanism for obtaining this
labeling, as appropriate); section V. Q2.
A statement describing any contraindication(s) 261 3 783 0.1 (6 minutes)....................... 78.3
in the FDA-required labeling for the medical
product; section V. Q2.
A statement describing any serious, life- 261 25 6,525 0.2 (12 minutes)...................... 1,305
threatening, or fatal risks posed by the
medical product that are in the FDA-required
labeling for the medical product or known by
the firm and that are relevant to the
unapproved use(s). If a risk evaluation and
mitigation strategy (REMS) has been
established under 21 U.S.C. 355-1, the
statement should disclose that fact and
should describe the goal(s) of the REMS;
section V. Q2.
A statement identifying any authors, editors, 261 20 5,220 0.2 (12 minutes)...................... 1,044
or other contributors to publication(s)
included in the SIUU communication who were
employees of or consultants to or who
received compensation from the firm at the
time of writing, editing, or contributing to
the publication, to the extent a firm acting
reasonably would know of such relationship;
section V. Q2.
In the case of an SIUU communication that 261 20 5,220 2.75.................................. 14,355
includes one or more source publications
primarily focused on a particular scientific
study or studies, for each such study where
the following information is not included in
the source publication, provide a description
of:.
--All material aspects of study design,
methodology, and results
--All material limitations related to the
study design, methodology, and results
--Any conclusions--from other
scientifically sound studies that
evaluated the same or similar hypotheses
or research questions--that are in
conflict with the conclusions from the
studies or analyses described in the
source publication(s). The citations for
any such studies should also be included;
section V. Q2
The publication date of any referenced or 261 3 783 0.1 (6 minutes)....................... 78.3
included source publication (if not specified
in the source publication or citation);
section V. Q2.
When a firm shares an SIUU communication that 261 3 783 0.1 (6 minutes)....................... 78.3
does not include a firm-generated
presentation, but does include an unabridged
CPG or reference text in its entirety that
discusses a wide range of medical products
and that discussion is not primarily focused
on one or more of a firm's medical products,
the firm should include, in lieu of some of
the specific disclosures listed above, a more
general statement in the SIUU communication,
such as ``This [CPG/reference text] describes
some uses of medical products that are not
approved by FDA and the safety and
effectiveness of any unapproved use(s) have
not been established.''; section V. Q4.
When a firm shares an SIUU communication that 261 10 2,610 0.1 (6 minutes)....................... 261
includes a firm-generated presentation of
scientific information on unapproved use(s)
provided with a source publication, that SIUU
communication should clearly disclose what
portions of the SIUU communication are firm-
generated; section V. Q5.
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Total..................................... .............. ................ 45,153 ...................................... 19,653.3
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on an estimated number of device firms marketing products in
calendar year (CY) 2022, we assume 261 firms (``number of respondents''
in table 1) may each choose to publicly share 30 SIUU communications
annually. Our estimate of the burden per disclosure (2.5 hours)
reflects what we believe is the average burden based on the number and
content and complexity of disclosures as recommended in the guidance.
FDA is issuing this final guidance subject to OMB approval of the
collection of information. Before implementing the guidance, FDA will
publish a notice in the Federal Register announcing OMB's decision to
approve, modify, or disapprove the collection of information.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
[[Page 1150]]
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31539 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P