[Federal Register Volume 89, Number 131 (Tuesday, July 9, 2024)]
[Notices]
[Pages 56387-56390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15009]



[[Page 56387]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0447]


Addressing Misinformation About Medical Devices and Prescription 
Drugs: Questions and Answers; Draft Guidance for Industry; 
Availability; Agency Information Collection Activities; Proposed 
Collection; 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the availability of a revised draft guidance for industry entitled 
``Addressing Misinformation About Medical Devices and Prescription 
Drugs: Questions and Answers.'' This revised draft guidance, when 
finalized, will describe FDA's current thinking on common questions 
firms may have when voluntarily addressing misinformation about or 
related to their approved/cleared medical products. This guidance 
revises and replaces the draft guidance for industry entitled 
``Internet/Social Media Platforms: Correcting Independent Third-Party 
Misinformation About Prescription Drugs and Medical Devices'' issued in 
June 2014. This revised draft guidance is not final nor is it in effect 
at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by September 9, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit electronic or written comments on the 
proposed collection of information in the draft guidance by September 
9, 2024.

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-2014-D-0447 for ``Addressing Misinformation About Medical Devices 
and Prescription Drugs: 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 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; 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 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 request or include a Fax 
number to which the draft guidance may be sent. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the draft 
guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
Samantha Bryant, 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,

[[Page 56388]]

10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-
0002, 301-837-7151; Kathryn Dennehy, Center for Veterinary Medicine 
(HFV-245), Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-402-7082, [email protected]; 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.
    With regard to the proposed collection of information: 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, PRAS[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Addressing Misinformation About Medical Devices and 
Prescription Drugs: Questions and Answers.'' In addition to describing 
already existing avenues for communications by firms, the guidance sets 
out an enforcement policy for certain kinds of internet-based 
communications that firms might choose to use to address internet-based 
misinformation about or related to the firm's approved/cleared medical 
product when that misinformation is created or disseminated by an 
independent third party. This guidance is not intended to address a 
firm's correction of its own false or misleading representations about 
its medical products. For the purposes of this guidance, the term firms 
refers to the persons or entities legally responsible for the labeling 
of approved/cleared medical products, which includes applicants, 
sponsors, manufacturers, packers, distributors, and any persons 
communicating on behalf of these entities. The term medical product 
refers to a medical device for human use (including one that is a 
biological product), a prescription human drug (including one that is a 
biological product), or a prescription animal drug. The term approved/
cleared medical product refers to medical products (as that term is 
defined in this guidance) that may be introduced into interstate 
commerce for at least one use under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), the Public Health Service Act, and their 
implementing regulations (collectively, the FDA Authorities) as a 
result of having satisfied applicable premarket requirements. For ease 
of reference, when approval and clearance (and similar terms) are used 
in discussing devices, the terms refer to FDA permitting the marketing 
of a device via the premarket approval, premarket notification under 
section 510(k) of the FD&C Act (21 U.S.C. 360(k)), De Novo 
classification, or Humanitarian Device Exemption pathways and to 
devices that are exempt from premarket notification.
    For the purposes of this guidance and as further described in 
section II of the guidance, the term misinformation refers to implicit 
or explicit false, inaccurate, or misleading representations of fact 
about or related to the firm's approved/cleared medical product.
    Misinformation about a firm's approved/cleared medical product can 
cause harm to both individuals and the public health in general. Basing 
medical decisions on misinformation can lead patients and healthcare 
providers to choose treatments that are not safe and effective, or 
forgo treatments that are, which can have adverse consequences. While 
misinformation can appear in many forms of communication and be shared 
in many different ways, internet-based forms of communication have 
enabled misinformation to travel quickly and reach more people who 
otherwise might not be exposed to that misinformation. Additionally, 
misinformation about or related to medical products that treat or 
prevent serious or life-threatening diseases is especially concerning 
and represents a significant public health concern.
    This guidance revises and replaces the draft guidance for industry 
entitled ``Internet/Social Media Platforms: Correcting Independent 
Third-Party Misinformation About Prescription Drugs and Medical 
Devices,'' issued in June 2014 (2014 draft guidance). The revised draft 
guidance reflects the Agency's consideration of feedback from 
interested parties, including comments received on the 2014 draft 
guidance. Changes include a revised title, a question-and-answer 
format, and certain changes in scope. For example, the enforcement 
policy now extends to a firm's voluntary ``tailored responsive 
communications'' that address misinformation that suggests that the 
firm's cleared/approved medical product be used for an unapproved use. 
Additionally, new content has been added to reflect changes in 
technology and functionality of internet-based platforms, as well as 
changes in the way information is shared online to help a firm to have 
greater flexibility and control over the timing of the firm's 
communication when the firm chooses to address certain internet-based 
third-party misinformation with ``tailored responsive communications.'' 
This guidance also now includes a subsection on ``general medical 
product communications'' that describes many existing avenues available 
to firms for communicating information about or related to their 
approved/cleared medical products. New examples were also added to 
illustrate the new considerations and recommendations outlined in the 
guidance and to provide additional clarity to firms.
    This revised draft guidance, when finalized, is intended to advance 
FDA's mission to help members of the public get the accurate, up-to-
date, science-based information they need to inform their decisions 
about medical products to maintain and improve their health. More 
specifically, the guidance describes two categories of communications 
firms might choose to use to address misinformation: tailored 
responsive communications and general medical product communications.
    As described in the guidance, a ``tailored responsive 
communication'' is a firm's voluntary, internet-based communication 
that identifies and addresses internet-based misinformation about or 
related to the firm's approved/cleared medical product when that 
misinformation is created or disseminated by an independent third 
party.
    For the purposes of this guidance, communications through existing 
avenues are collectively referred to as ``general medical product 
communications.'' Unlike the tailored responsive communications 
described in the guidance, general medical product communications are 
not necessarily internet-based or prompted by or tailored to address 
specific identified internet-based misinformation. General medical 
product communications can include, among other things, content and 
messaging that address misinformation about a firm's approved/cleared 
medical product. Inclusion in a general medical product communication 
of content that addresses misinformation creates no special 
considerations regarding the application of the FDA Authorities or 
other FDA enforcement policies.
    FDA recognizes that misinformation about or related to medical 
products authorized for emergency use is a public health concern. The 
Agency continues to evaluate the unique considerations that can apply 
to communications by firms addressing misinformation about or related 
to such products. As such, this revised draft guidance does not apply 
to communications by firms that address misinformation about or related

[[Page 56389]]

to an emergency use authorized for the firm's medical product under 
section 564 of the FD&C Act (21 U.S.C. 360bbb-3), whether that be an 
emergency use authorized for an ``unapproved use of an approved 
product'', or an emergency use authorized for an ``unapproved 
product'', as those terms are used in section 564(a) of the FD&C Act. 
See section 564 of the FD&C Act for more information on the authorities 
for emergency use authorizations.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised draft 
guidance, when finalized, will represent the current thinking of FDA on 
``Addressing Misinformation About Medical Devices and Prescription 
Drugs: 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

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Disclosures for Tailored Responsive Communications Addressing 
Misinformation About Medical Devices and Prescription Drugs

OMB Control Number 0910-NEW

    The revised draft guidance document, ``Addressing Misinformation 
About Medical Devices and Prescription Drugs: Questions and Answers,'' 
describes two categories of communications firms might choose to use to 
address misinformation: tailored responsive communications and general 
medical product communications. As explained in the guidance, general 
medical product communications are already existing avenues for 
communication and are subject to approved information collections, 
summarized below. The revised draft guidance recommends that a firm's 
tailored responsive communication clearly identify both the specific 
misinformation that the firm is addressing and a specific internet-
based, independent third-party communication in which that 
misinformation appears. Additionally, the revised draft guidance 
discusses disclosures that we recommend firms include when choosing to 
share tailored responsive communications.
    Specifically, the guidance recommends that firms include (1) a 
mechanism for obtaining a copy of the current FDA-required labeling 
(including FDA-approved patient labeling, if any), (2) the date the 
firm's tailored responsive communication is posted (if a date is not 
automatically generated), and (3) a disclosure that the tailored 
responsive communication is being shared by the medical product firm or 
that the person addressing the misinformation is affiliated with the 
firm and is authorized to provide information on behalf of the firm 
about the medical product. The guidance also provides recommendations 
for firms that wish to use a tailored responsive communication to 
address misinformation about or related to an unapproved use of the 
firm's approved/cleared medical product. Specifically, the guidance 
recommends including an additional disclosure identifying the 
unapproved use and noting that the unapproved use of the medical 
product has not been approved by FDA and that the safety and 
effectiveness of the medical product for the unapproved use has not 
been established.
    We estimate the burden of the information collection as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                   Number of
    Recommended disclosure         Number of      disclosures    Total annual      Average burden per     Total
  activity; guidance section      respondents         per         disclosures          disclosure         hours
                                                  respondent
----------------------------------------------------------------------------------------------------------------
Clearly identify both the                  958              50          47,900  0.4 (24 minutes).......   19,160
 specific misinformation that
 the firm is addressing and a
 specific internet-based,
 independent third-party
 communication in which that
 misinformation appears;
 Section IV.A. Q3.
A mechanism for obtaining a                958              50          47,900  0.1 (6 minutes)........    4,790
 copy of the current FDA-
 required labeling (including
 FDA-approved patient
 labeling, if any); Section
 IV.A. Q5.
The date the firm's tailored               958              50          47,900  0.05 (3 minutes).......    2,395
 responsive communication is
 posted (if a date is not
 automatically generated);
 Section IV.A. Q5.
A disclosure that the tailored             958              50          47,900  0.1 (6 minutes)........    4,790
 responsive communication is
 being shared by the medical
 product firm or that the
 person addressing the
 misinformation is affiliated
 with the firm and is
 authorized to provide
 information on behalf of the
 firm about the medical
 product; Section IV.A. Q5.
In the case of a tailored                  958               5           4,790  0.1 (6 minutes)........      479
 responsive communication that
 addresses misinformation
 about an unapproved use of
 the firm's approved/cleared
 medical product, a disclosure
 identifying the unapproved
 use and noting that the
 unapproved use of the medical
 product has not been approved
 by FDA and that the safety
 and effectiveness of the
 medical product for the
 unapproved use has not been
 established; Section IV.A. Q5.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............         196,390  .......................   31,614
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 56390]]

    Based on data currently available to FDA on the number of firms 
disseminating promotional communications about prescription drugs (697) 
combined with an estimated number of device firms marketing products 
(261), we assume that approximately 958 firms (``number of 
respondents'' in table 1) might each choose to disseminate 50 tailored 
responsive communications annually. Our estimate of the burden per 
disclosure reflects what we believe is the average burden based on the 
number and content and complexity of disclosures as recommended in the 
guidance.
    This draft guidance also refers to previously approved FDA 
collections of information. The collections of information in 21 CFR 
part 314 are approved under OMB control number 0910-0001. The 
collections of information in 21 CFR part 201 regarding content and 
format of labeling for human drug and biological products are approved 
under OMB control number 0910-0572. The collections of information in 
21 CFR part 801 are approved under OMB control number 0910-0485. The 
collections of information in 21 CFR 202.1 regarding prescription drug 
advertising are approved under OMB control number 0910-0686. The 
collections of information in 21 CFR part 601 regarding marketing 
approval of biological products are approved under OMB control number 
0910-0338; and the collections of information regarding marketing 
approval of animal drug products in 21 CFR part 514 are approved under 
OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the draft 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.

    Dated: July 3, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15009 Filed 7-8-24; 8:45 am]
BILLING CODE 4164-01-P