Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

10305995dftrv1.docx
Addressing Misinformation
About Medical Devices and
Prescription Drugs
Questions and Answers
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to https://www.regulations.gov. Submit written
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the
docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact (CDER) Samantha Bryant, 301-796-1200;
(CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010;
(CDRH) Stephanie Philbin, 301-837-7151; (CVM) Office of Surveillance and Compliance, 240-
402-7082; or (OC) Julie Finegan, 301-827-4830.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Veterinary Medicine (CVM)
Office of the Commissioner (OC)
July 2024
Procedural
Revision 1

Addressing Misinformation About Medical Devices and
Prescription Drugs
Questions and Answers
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4 th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
and/or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: ocod@fda.hhs.gov
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
and/or
Office of Policy
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Room 5431
Silver Spring, MD 20993-0002
Email: CDRH-Guidance@fda.hhs.gov
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-
and-radiation-emitting-products
and/or
Policy and Regulations Staff
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, Rockville, MD 20855
and/or
Office of Policy
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 32, Room 4252
Silver Spring, MD 20993-0002
Phone: 301-827-4830
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Veterinary Medicine (CVM)
Office of the Commissioner (OC)
July 2024
Procedural
Revision 1

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TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	SCOPE ............................................................................................................................... 4
III. 	BACKGROUND ............................................................................................................... 6
IV. 	QUESTIONS AND ANSWERS ....................................................................................... 8
A. 	Tailored Responsive Communications..................................................................................... 8
B. 	General Medical Product Communications .......................................................................... 18

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Addressing Misinformation About Medical Devices and	1
Prescription Drugs	2
Questions and Answers	3
Guidance for Industry1
4
5
6
This draft guidance, when finalized, will represent the current thinking of the Food and Drug	7
Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not	8
binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the	9
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible	10
for this guidance as listed on the title page.	11
12
13
14
15
I. 	INTRODUCTION	16
17
This guidance responds to common questions firms2 may have when voluntarily addressing	18
misinformation about or related to their approved/cleared medical products. In addition to	19
describing already existing avenues for communications by firms, this guidance sets out an	20
enforcement policy for certain kinds of internet-based communications that firms might choose	21
to use to address internet-based misinformation about or related to the firm’s approved/cleared	22
medical product when that misinformation is created or disseminated by an independent third	23
party.3 The recommendations and illustrative examples in this guidance are intended to help	24
support firms that choose to address misinformation about or related to their approved/cleared	25
medical products.4	
26
27
For the purposes of this guidance and as further described in section II, the term misinformation	28
refers to implicit or explicit false, inaccurate, or misleading representations of fact about or	29
related to a firm’s approved/cleared medical product. Misinformation about or related to a firm’s	30
1 This guidance has been prepared by the Office of Prescription Drug Promotion in the Office of Medical Policy in
the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research,
the Center for Devices and Radiological Health, the Center for Veterinary Medicine, and the Office of the
Commissioner at the Food and Drug Administration.
2 Terms that appear in bold at first mention are further explained in section II.
3 This guidance is not intended to address a firm’s correction of its own false or misleading representations about its
medical products.
4 This revised draft guidance does not apply to communications by firms that address misinformation about or
related to an emergency use authorized for the firm’s medical product under section 564 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), whether the use that is subject to emergency use authorization
is an “unapproved use of an approved product” or is a use of an “unapproved product” as those terms are used in
section 564(a). See sections 564(a)(2) and (a)(4) of the FD&C Act.

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approved/cleared medical product can cause harm to both individuals and the public health in	31
general. Basing medical decisions on misinformation can lead patients and health care providers	32
(HCPs) to choose treatments that are not safe and effective, or to forgo treatments that are, which	33
can have adverse consequences. While misinformation can appear in many forms of	34
communication and be shared in many different ways, internet-based forms of communication	35
have enabled misinformation to travel quickly and reach more people who otherwise might not	36
be exposed to that misinformation. The spread of misinformation on the internet can be	37
particularly rapid and harmful when the misinformation is shared by an internet user who has a	38
large follower base or holds a position of trust, since those users may have a wider range or	39
higher degree of influence. Additionally, misinformation about or related to medical products	40
that treat or prevent serious or life-threatening diseases is especially concerning and represents a	41
significant public health concern.	42
43
This guidance, when finalized, is intended to advance FDA’s mission to help members of the	44
public get the accurate, up-to-date, science-based information they need to inform their decisions	45
about medical products to maintain and improve their health.	46
47
This guidance revises and replaces the draft guidance for industry Internet/Social Media	48
Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and	49
Medical Devices issued in June 2014 (2014 draft guidance).5 This guidance reflects the	50
Agency’s consideration of feedback from interested parties, including comments received on the	51
2014 draft guidance.	52
53
This guidance includes two subsections within section IV. Subsection IV.A sets out	54
recommendations for certain kinds of internet-based communications (tailored responsive	55
communications) that firms might choose to use to address internet-based misinformation.	56
Subsection IV.B describes already existing avenues for communications by firms under the FDA	57
Authorities6 (general medical product communications) that firms might also choose to use to	58
address misinformation. More specifically, these subsections describe the following:	59
60
• 	Subsection A. Tailored Responsive Communications: Subsection IV.A outlines	61
recommendations for firms’ tailored responsive communications. A tailored responsive	62
communication is a firm’s voluntary, internet-based communication that identifies and	63
addresses internet-based misinformation about or related to the firm’s approved/cleared	64
medical product when that misinformation is created or disseminated by an independent	65
third party.7	
66
67
This guidance outlines an enforcement policy for tailored responsive communications,	68
based on recommendations in subsection IV.A. For the purposes of this guidance, we	69
5 We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
6 In this guidance, the FD&C Act, the Public Health Service Act, and their implementing regulations are collectively
referred to as the FDA Authorities.
7 This type of misinformation is further described in Q1.

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refer to this policy for firms’ tailored responsive communications as “the enforcement	70
policy outlined in this guidance”8:	71
72
First, if a firm chooses to share a tailored responsive communication to address	73
misinformation consistent with the recommendations in subsection IV.A, Q1 and Q3	74
through Q5, FDA does not intend to enforce (with respect to that tailored responsive	75
communication):	76
77
1. 	Applicable requirements, if any, related to promotional labeling and advertising9	
78
(collectively, promotional communications)	79
80
2. 	Applicable requirements, if any, related to postmarketing submission of	81
promotional communications10	
82
83
Second, where the tailored responsive communication addresses misinformation that	84
suggests that the firm’s approved/cleared medical product should be used for an	85
unapproved use and the tailored responsive communication is consistent with the	86
recommendations in subsection IV.A, Q1 and Q3 through Q5, FDA does not intend to	87
use such communication standing alone as evidence of a new intended use.11	
88
8 Note that the enforcement policy outlined in this guidance for firms’ tailored responsive communications does not
include television (TV) and radio advertisements, even when disseminated by firms via the internet (such as during
streamed TV shows). However, although TV and radio advertisements disseminated by firms are not within the
scope of the enforcement policy outlined in this guidance for firms’ tailored responsive communications, firms can
share general medical product communications, including TV and radio advertisements, to support diverse strategies
for addressing misinformation. Firms can also consider using general medical product communications in a variety
of settings, internet-based or not, to address misinformation that is disseminated in a non-internet-based
communication (see Q8).
9 See, e.g., sections 201(n) and 502(a) and (n) of the FD&C Act (21 U.S.C. 321(n) and 352(a) and (n)); 21 CFR
1.21(a) and 202.1(e); and sections 502(q) and (r) of the FD&C Act (21 U.S.C. 352(q) and (r)). For example, if a
tailored responsive communication does not contain a comprehensive presentation of a prescription drug’s side
effects and contraindications, FDA does not intend to take enforcement action so long as the tailored responsive
communication discloses any risks that are material to its specific content (see Q4) and otherwise follows the
recommendations of this guidance.
10 See, e.g., 21 CFR 314.81(b)(3)(i) and 601.12(f)(4) (regarding postmarketing submissions of promotional
communications for drugs and biologics for human use using Form FDA 2253); section 506(c)(2)(A)(ii) of the
FD&C Act (21 U.S.C. 356(c)(2)(A)(ii)); 21 CFR 314.550 and 21 CFR 601.45 (regarding submissions of
promotional communications for accelerated approval products); section 506(h)(3)(B) of the FD&C Act (21 U.S.C.
356(h)(3)(B)) (regarding submissions of promotional communications for Limited Population Antibacterial and
Antifungal Drugs); 21 CFR 314.640 (subpart I) and 601.94 (subpart H) (regarding submission of promotional
communications for products where human efficacy studies are not ethical or feasible); and 21 CFR 514.80(b)(5)(ii)
(regarding submission of promotional communications for animal drugs).
11 The concept of intended use is fundamental to the regulatory approach for medical products embodied in the FDA
Authorities. Intended use is an element in the definitions of drug and device, helping to define the scope of FDA’s
authority over medical products and subjecting the medical products to the drug or device provisions of the FDA
Authorities, as applicable. In addition, intended use may affect the appropriate premarket review pathway for a
medical product and is a separate element in establishing certain violations under the FDA Authorities. See,
generally, the notice of proposed rulemaking “Regulations Regarding ‘Intended Uses’” (85 FR 59718 at 59724,

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89
• 	Subsection B. General Medical Product Communications: Subsection IV.B describes	90
many existing avenues available to firms for communicating information about or related	91
to their approved/cleared medical products (e.g., sales aids, TV and radio advertisements,	92
help-seeking and institutional communications). For the purposes of this guidance,	93
communications through existing avenues are collectively referred to as general medical	94
product communications. Unlike the tailored responsive communications described in	95
subsection IV.A, general medical product communications are not necessarily internet-	96
based or prompted by or tailored to address specific identified internet-based	97
misinformation. General medical product communications can include, among other	98
things, content and messaging that address misinformation about a firm’s	99
approved/cleared medical product. Inclusion in a general medical product	100
communication of content that addresses misinformation creates no special	101
considerations regarding the application of the FDA Authorities or other FDA	102
enforcement policies. General medical product communications are expected to comply	103
with all applicable requirements of the FDA Authorities, unless the communication is the	104
subject of another enforcement policy. For further description of other enforcement	105
policies and general medical product communications, see Q8.	106
107
This guidance includes examples intended to illustrate some of the recommendations and general	108
considerations outlined in the guidance. The examples in this guidance contain hypothetical	109
scenarios for illustrative purposes only.	110
111
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.	112
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only	113
as recommendations, unless specific regulatory or statutory requirements are cited. The use of	114
the word should in Agency guidances means that something is suggested or recommended, but	115
not required.	116
117
118
II. 	SCOPE	119
120
For the purposes of this guidance, the scope of the terms in bold is further explained as follows:	121
122
• 	Misinformation refers to implicit or explicit false, inaccurate, or misleading	123
representations of fact about or related to the firm’s approved/cleared medical product.	124
This includes false, inaccurate, or misleading:	125
126
− 	Representations of fact about or related to approved or unapproved uses of the firm’s	127
approved/cleared medical product	128
129
September 23, 2020) and the final rule “Regulations Regarding ‘Intended Uses’” (86 FR 41383 at 41385, August 2,
2021). FDA acknowledges that a tailored responsive communication addressing misinformation about or related to
an unapproved use might not always be persuasive evidence of a new intended use, but this guidance nevertheless
offers the assurance that FDA does not intend to rely on a tailored responsive communication that follows the
recommendations of this guidance, standing alone, as evidence of a new intended use.

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− 	Representations of fact about or related to instructions/directions for use from the	130
FDA-required labeling of the firm’s approved/cleared medical product	131
132
− 	Representations of fact about or related to an attribute of the firm’s approved/cleared	133
medical product that is independent of any particular use (e.g., statements about	134
where the medical product is made or about the components of the medical product)	135
136
− 	Representations of scientific information about or related to the firm’s	137
approved/cleared medical product (e.g., scientific information about a medical	138
product’s risk, effectiveness, or mechanism of action; representations about the type,	139
characteristics, or extent of scientific information about the approved/cleared medical	140
product)	141
142
− 	Representations that omit a fact or facts that are material in light of the	143
representations made or implied about or related to the firm’s approved/cleared	144
medical product	145
146
• 	Firms refers to the persons or entities legally responsible for the labeling of	147
approved/cleared medical products, which includes applicants, sponsors, manufacturers,	148
packers, distributors, and any persons communicating on behalf of these entities.	149
150
• 	Medical product refers to a medical device for human use (including one that is a	151
biological product), a prescription human drug (including one that is a biological	152
product), or a prescription animal drug.	153
154
• 	Approved/cleared medical product refers to medical products (as that term is defined in	155
this guidance) that may be introduced into interstate commerce for at least one use under	156
the FDA Authorities as a result of having satisfied applicable premarket requirements.	157
For ease of reference, when approval and clearance (and similar terms) are used in	158
discussing devices, the terms refer to FDA permitting the marketing of a device via the	159
premarket approval (PMA), premarket notification under section 510(k) of the FD&C	160
Act (510(k)), De Novo classification, or Humanitarian Device Exemption (HDE)	161
pathways and to devices that are exempt from premarket notification.	162
163
• 	FDA-required labeling refers to the labeling reviewed and approved by FDA as part of	164
the medical product premarket review process.12 For medical devices for human use, this	165
includes the labeling approved during the review of a PMA application, HDE application,	166
or De Novo classification request. For medical devices for human use not subject to	167
PMA but instead subject to 510(k) requirements or exempt from premarket review, the	168
term FDA-required labeling includes the labeling that provides indications for use and	169
12 Such labeling may include, for example, the FDA-approved Prescribing Information for a human drug (including
a drug that is licensed as a biological product), carton labeling, container labels, and FDA-approved patient labeling,
if any, that, under 21 CFR 201.100(d), must accompany any labeling distributed by or on behalf of the manufacturer,
packer, or distributor of the drug; the FDA-approved Prescribing Information for a prescription animal drug; or the
labeling approved during the premarket approval process for a device.

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adequate directions for use and other information required to appear on the label or in	170
labeling.	171
172
• 	Approved use13 refers to a use that is lawfully included as an indication or use in the	173
FDA-required labeling of an approved/cleared medical product (as the terms FDA-	174
required labeling and approved/cleared medical product are defined in this guidance).	175
176
• 	Unapproved use refers to a use that is not lawfully included as an indication or use in the	177
FDA-required labeling of an approved/cleared medical product (as the terms FDA-	178
required labeling and approved/cleared medical product are defined in this guidance).	179
180
• 	Internet-based refers to information available through the internet (regardless of whether	181
the information originated on the internet). This includes, for example, information	182
available via social media, podcasts, email (e.g., listserv), group messaging, and	183
discussion forums.	184
185
• 	Setting refers to the location where content appears. Internet-based settings include	186
websites, internet-connected applications, platforms, or other internet-based media.	187
188
• 	Independent third party refers to a person or entity that, in communicating about a	189
firm’s approved/cleared medical product, is not acting on behalf of that firm.	190
191
192
III. 	BACKGROUND	193
194
Misinformation in the health information environment is a longstanding and increasingly	195
widespread public health concern. FDA has long been involved in addressing the public health	196
concerns stemming from misinformation. For example, in the 1980s during the early years of	197
the AIDS crisis, when researchers were struggling to identify the virus that was causing the	198
rapidly expanding epidemic, audiences were inundated with false, misleading, and inaccurate	199
information about the causes of and treatments for the disease. During this period, FDA took	200
action against numerous fraudulent cures that claimed therapeutic benefits in treating or	201
preventing HIV/AIDS.14	
202
203
In the modern American health care system, many individuals want to take an active role in their	204
health care decision-making, and they often seek out relevant information to inform their	205
choices. The internet is now the leading source used by consumers to obtain health	206
13 The term approved use is chosen for ease of reference within this guidance. We note that for certain categories of
medical products, the FDA Authorities use terms other than approved to describe satisfaction of applicable
premarket requirements.
14 Office of the Commissioner. (2019). The History of FDA’s Role in Preventing the Spread of HIV/AIDS. U.S.
Food and Drug Administration. https://www.fda.gov/about-fda/fda-history-exhibits/history-fdas-role-preventing-
spread-hivaids.

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information,15 and HCPs also frequently seek the latest medical information on the internet.16,17	
207
However, not all information about medical products found on the internet is reliable; there are	208
many false, inaccurate, or misleading statements shared on the internet. The structure and	209
popularity of social media platforms have meant that false, inaccurate, and misleading	210
information about medical products can spread rapidly to a broad audience.18	
211
212
FDA continues to proactively engage in addressing misinformation through a number of efforts.	213
FDA has enhanced and expanded its social media presence and communications on the internet	214
to inform public understanding and help improve understanding of the uses, benefits, and risks of	215
FDA-regulated medical products as well as to foster better understanding of the role FDA plays	216
in the regulation of medical products.19 FDA has also used speaking engagements to draw	217
attention to the dangers of misinformation and to provide factual and accurate information about	218
FDA-regulated medical products and public health issues.20 In August 2022, FDA launched the	219
15 See, e.g., Aikin KJ, Sullivan HW, Berktold J, Stein KL, and Hoverman VJ. (2021). Consumers’ Experience With
and Attitudes Toward Direct-to-Consumer Prescription Drug Promotion: A Nationally Representative Survey.
Health Marketing Quarterly, DOI: 10.1080/07359683.2021.1947067.
16 See, e.g., Van der Keylen P, Tomandl J, Wollmann K, Möhler R, Sofroniou M, Maun A, Voigt-Radloff S, and
Frank L. (2020). The Online Health Information Needs of Family Physicians: Systematic Review of Qualitative and
Quantitative Studies. J Med Internet Res, 22(12):e18816. https://doi.org/10.2196/18816.
17 See, e.g., Clarke MA, Belden JL, Koopman RJ, Steege LM, Moore JL, Canfield SM, and Kim MS. (2013).
Information Needs and Information‐Seeking Behaviour Analysis of Primary Care Physicians and Nurses: A
Literature Review. Health Information and Libraries Journal, 30(3), 178–190. https://doi.org/10.1111/hir.12036.
18 See, e.g., Suarez-Lledo V, Alvarez-Galvez J. (2021). Prevalence of Health Misinformation on Social Media:
Systematic Review. J Med Internet Res, 23(1):e17187, DOI: 10.2196/17187; Health Misinformation — Current
Priorities of the U.S. Surgeon General. (2021). https://www.hhs.gov/surgeongeneral/priorities/health-
misinformation/index.html.
19 See, e.g., Center for Drug Evaluation and Research. (2023). Overview of Our Role Regulating and Approving
Drugs | Video series. U.S. Food and Drug Administration. https://www.fda.gov/drugs/information-consumers-and-
patients-drugs/overview-our-role-regulating-and-approving-drugs-video-series.
20 Speeches by FDA Officials, for example: Califf, R. (2023, May 25). Remarks by Dr. Califf to the 2023 FDLI
Conference. U.S. Food and Drug Administration. https://www.fda.gov/news-events/speeches-fda-officials/remarks-
commissioner-robert-califf-2023-food-and-drug-law-institute-fdli-annual-conference-05172023; Califf, R. (2023a,
May 8). Patient Empowerment in the Digital Health Era. U.S. Food and Drug Administration.
https://www.fda.gov/news-events/speeches-fda-officials/speech-robert-m-califf-md-national-health-councils-2023-
science-patient-engagement-symposium-patient; Califf, R. (2023a, April 28). Food is Medicine National Summit:
“Transforming Health Care.” U.S. Food and Drug Administration. https://www.fda.gov/news-events/speeches-fda-
officials/remarks-commissioner-robert-m-califf-food-medicine-national-summit-transforming-health-care-
04262023; Califf, R. (2022, October 1). Remarks by FDA Commissioner Robert Califf to Health Connect South.
U.S. Food and Drug Administration. https://www.fda.gov/news-events/speeches-fda-officials/remarks-fda-
commissioner-robert-califf-health-connect-south-09222022; Califf, R. (2022a, April 20). Remarks by FDA
Commissioner Robert Califf to the 2022 RX and Illicit Drug Summit. U.S. Food and Drug Administration.
https://www.fda.gov/news-events/speeches-fda-officials/remarks-fda-commissioner-robert-califf-2022-rx-and-illicit-
drug-summit-04202022.

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Rumor Control web page,21 which is focused on public health priorities and describes what	220
information is accurate and what is a rumor and how interested parties can help stop the spread	221
of misinformation. FDA has also undertaken educational efforts22 and provided “toolkits” to	222
interested parties.23 These toolkits include materials and messages from FDA about public	223
health issues and FDA-regulated medical products that can empower interested parties by	224
providing them with resources that better enable them to address false, misleading, and	225
inaccurate information with facts. FDA also routinely creates and shares webinars, email alerts,	226
videos, podcasts, and medical product safety communications in order to provide factual and	227
accurate information to the public.24	
228
229
In addition to FDA’s actions to support its commitment to addressing misinformation, other	230
interested parties can also help the public get truthful, accurate, and scientifically sound	231
information. We are therefore issuing this revised draft guidance to describe avenues available	232
to firms interested in addressing misinformation and to provide recommendations for firms that	233
choose to voluntarily address internet-based misinformation about or related to their own	234
approved/cleared medical products.	235
236
237
IV. 	QUESTIONS AND ANSWERS	238
239
A. 	Tailored Responsive Communications	240
241
Q1. 	Within the enforcement policy outlined in this guidance, what types of	242
misinformation might a firm choose to address with a tailored responsive	243
communication?	244
245
The enforcement policy outlined in this guidance applies when a firm voluntarily shares an	246
internet-based communication that identifies and addresses misinformation that is:	247
248
• 	about or related to the firm’s approved/cleared medical product;	249
250
• 	in an internet-based communication; and	251
21 Office of the Commissioner. (2023). Rumor Control. U.S. Food and Drug Administration.
https://www.fda.gov/news-events/rumor-control.
22 As an example, these efforts include a variety of multimedia resources, online outreach, and other educational
tools to inform patients and HCPs about the benefits and safety of biosimilars while dispelling misinformation; see
https://www.fda.gov/drugs/our-perspective/education-efforts-help-increase-biosimilar-understanding-and-
acceptance.
23 FDA toolkits include, for example: FDA Office of Women’s Health. (2023). Mammograms Matter: 5 Things to
Know About Mammograms. U.S. Food and Drug Administration.
https://www.fda.gov/media/172601/download?attachment.
24 For information about recent public meetings, workshops, and conferences held by FDA, see
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops. To learn about ways to stay informed
and connected with FDA through video, social media, email alerts, and podcasts, see https://www.fda.gov/news-
events/interactive-and-social-media.

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252
• 	created or disseminated by an independent third party.	253
254
Firms remain free to use other communications (see subsection IV.B. General Medical Product	255
Communications) to address statements that are not covered by the enforcement policy outlined	256
in this guidance.	257
258
Note that the enforcement policy outlined in this guidance is not limited to situations in which	259
the firm’s approved/cleared medical product is explicitly named in the identified misinformation.	260
For example, the identified misinformation may include false information about an entire class of	261
drugs or category of devices that includes a firm’s approved/cleared medical product (e.g.,	262
“statins cause earlobe enlargement”). In that case, a firm could choose to use a tailored	263
responsive communication if one of the firm’s approved/cleared medical products is included in	264
the referenced class of medical products.	265
266
We note there are some important limitations on the enforcement policy outlined in this	267
guidance. Because, under this policy, FDA does not intend to enforce certain requirements that	268
help ensure that the information firms disseminate about their medical products is truthful, non-	269
misleading, and consistent with the FDA-required labeling, it is important that this policy be	270
drawn sufficiently narrowly so that it helps support firms’ voluntary efforts to address	271
misinformation but does not undermine the purposes of those requirements. The limitations on	272
the enforcement policy are as follows:	273
274
As previously noted in section I, TV and radio advertisements are not within the scope of the	275
enforcement policy outlined in this guidance for firms’ tailored responsive communications,	276
even when disseminated by firms via the internet (such as advertisements during streamed TV	277
shows).25 Additionally, in the case of misinformation about or related to unapproved uses of	278
approved/cleared medical products, the enforcement policy outlined in this guidance is limited to	279
a firm’s response to misinformation created or disseminated by an independent third party that	280
suggests that the firm’s approved/cleared medical product should be used for an unapproved use.	281
Further, the enforcement policy outlined in this guidance does not extend to a firm’s responses to	282
statements describing opinions or value statements about a firm’s approved/cleared medical	283
product. It also does not extend to a firm’s responses to representations about an individual	284
patient’s experience using a firm’s approved/cleared medical product (whether made by that	285
patient or others). Notwithstanding these limits, the enforcement policy outlined in this guidance	286
provides an additional communication avenue for firms beyond preexisting channels for	287
communication and thus expands, rather than restricts, firms’ options for communications.	288
Firms also remain free to use general medical product communications (see subsection IV.B) to	289
address communications about or related to their medical products, including independent third-	290
party communications that fall outside the enforcement policy for tailored responsive	291
communications outlined in this guidance.	292
293
25 See footnote 8.

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The following examples26 illustrate communications that include opinions, value statements, or	294
representations about an individual patient’s experience such that the firm’s responses to them	295
would not fall within the enforcement policy outlined in this guidance (but these	296
communications could be addressed with general medical product communications):	297
298
Example 1: An influencer, who is an independent third party, posts a video on his social	299
media account telling his followers that he does not like Drug X, a prescription drug	300
indicated to treat acne vulgaris, because it didn’t work for his acne vulgaris. He	301
recommends his followers consider a different treatment.	302
303
The influencer’s statements describe his own experience, opinion, and value judgments.	304
305
Example 2: A celebrity, who is an independent third party, posts on their social media	306
account regarding their cousin’s reported negative personal experience after using Drug	307
X, a prescription drug approved for chronic weight management in patients with obesity.	308
The celebrity opines that they believe Drug X made their cousin gain weight rather than	309
lose weight.	310
311
The celebrity’s statements describe an individual’s experience and opinion.	312
313
Example 3: A celebrity and well-known animal lover, who is an independent third party,	314
makes a statement on her social media accounts saying that she has stopped giving her	315
dogs Drug A, an animal drug indicated for the treatment and prevention of flea	316
infestation in dogs, and switched to Drug B, another animal drug indicated for the	317
treatment and prevention of flea infestation in dogs. She states that Drug B is working	318
much better for her dogs.	319
320
The celebrity’s statement describes her personal experience.	321
322
However, in cases where an opinion, value statement, or representation about an individual	323
patient’s experience references, either implicitly or explicitly, a basis that falls within the	324
definition of misinformation in section II, a firm’s use of a tailored responsive communication to	325
address the underlying misinformation would be consistent with the enforcement policy outlined	326
in this guidance if the tailored responsive communication follows other recommendations in Q3	327
through Q5. This distinction is illustrated in some of the examples provided in Q2.	328
329
26 Each of the examples in this guidance is intended to stand on its own, and the use of “Drug X” or similar terms
represents a different fictitious medical product in each example.

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Q2. 	Within the enforcement policy outlined in this guidance, what are some examples of	330
internet-based, independent third-party communications that include	331
misinformation that a firm might choose to address with a tailored responsive	332
communication?	333
334
The following are examples of some general scenarios involving internet-based, independent	335
third-party communications that include misinformation that a firm might choose to address with	336
a tailored responsive communication within the enforcement policy outlined in this guidance.	337
338
Example 4: An HCP, who is an independent third party, posts on her own social media	339
account a statement that Drug Class A (a class of drugs approved to lower low-density	340
lipoprotein (LDL) cholesterol, as an adjunct to diet, in certain patients) has been shown to	341
cause Alzheimer’s disease and therefore should not be used by patients to lower LDL.	342
343
There is no evidence that drugs in Drug Class A cause Alzheimer’s disease. The HCP’s	344
statement is false, inaccurate, and/or misleading.	345
346
Example 5: A celebrity, who is an independent third party, posts on her social media	347
account that she recommends using Drug X because it works great to prevent pregnancy,	348
and you can even take it after sex to prevent pregnancy.	349
350
Drug X is only indicated for the prevention of pregnancy when used prior to sexual	351
intercourse. There is no evidence that Drug X is effective in preventing pregnancy when	352
used after sex, as the celebrity describes. The celebrity’s statement that Drug X works	353
great to prevent pregnancy is a statement that reflects an individual patient’s opinion, so a	354
firm’s response to this part of her communication would not be within the enforcement	355
policy outlined in this guidance. However, the celebrity’s statement about when to take	356
Drug X is false, inaccurate, and/or misleading. A firm’s response to this statement about	357
when to take Drug X could fall within the enforcement policy outlined in this guidance if	358
the recommendations of the guidance are followed.	359
360
Example 6: A sports celebrity, who is an independent third party, posts on his blog about	361
Device Y, a 510(k) cleared water-circulating cold therapy device, intended for the	362
temporary relief of localized pain. He tells his blog readers that Device Y was cleared by	363
FDA for use to accelerate healing and that anyone with an injury should use the device	364
and keep the wrap directly on their skin, rather than putting any towels or barriers	365
between the wrap and their skin. He also advises blog readers to keep the device on and	366
running all the time for the best pain relief and to accelerate healing.	367
368
Device Y, the water-circulating cold therapy device referenced by the sports celebrity,	369
includes directions to limit use to a specific number of minutes in each therapy session	370
and to always keep barriers between the wrap and a patient’s skin to prevent potentially	371
serious reactions and injuries. The device is intended for pain relief, and there is no	372
evidence that it has an effect on healing time. The sports celebrity’s statements about	373
how to use Device Y and about what Device Y is FDA-cleared to treat are false,	374
inaccurate, and/or misleading.	375

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376
Example 7: A well-known blogger, who is an independent third party, is writing a post	377
on the opioid epidemic. He notes that there is a prescription drug, Drug X, that is a	378
reversal agent that you can use to rescue patients suffering from an overdose. He tells	379
people not to administer Drug X to someone who has overdosed on opioids because you	380
will overdose on opioids yourself by administering Drug X. He tells people to instead	381
dial 9-1-1 and wait for help to arrive.	382
383
The Prescribing Information for Drug X includes instructions for how to administer Drug	384
X in a manner that is safe for both the patient and the individual administering Drug X.	385
For Drug X to be effective, it is critical to administer it as soon as possible in a person	386
with a known or suspected opioid overdose. The blogger’s statement that administration	387
of the reversal agent will result in overdose for the person administering the drug is false,	388
inaccurate, and/or misleading.	389
390
Example 8: A nurse, who is an independent third party, posts on his online blog that a	391
new prescription drug, Drug X, has been approved to treat non-small cell lung cancer.	392
393
According to the Prescribing Information for Drug X, it is a second-line treatment	394
approved for certain patients with non-small cell lung cancer who have tried a	395
chemotherapy regimen containing platinum, but that chemotherapy regimen did not work	396
or is no longer working. The nurse’s post is false, inaccurate, and/or misleading because	397
the nurse omits material facts regarding the full indication for Drug X.	398
399
Example 9: An influencer, who is an independent third party, posts on his social media	400
account that he is supportive of his 25-year-old wife taking Drug X, a medical product	401
approved to treat acne vulgaris, since she is happy with the results and there are no	402
known side effects of the drug.	403
404
The Prescribing Information for Drug X includes a boxed warning about embryo-fetal	405
toxicity and a contraindication (Drug X is contraindicated during pregnancy) because	406
there is an extremely high risk of severe birth defects if pregnancy occurs while taking	407
Drug X in any amount, even for short periods of time. The influencer’s statement that his	408
wife is happy with the results of Drug X reflects an individual patient’s experience and	409
opinion, so a firm’s response to this part of his communication would not be within the	410
enforcement policy outlined in this guidance. However, the influencer’s statement that	411
he is supportive of his wife taking Drug X because there are no known side effects rests	412
on a basis that falls within the definition of misinformation because the statement that	413
there are no known side effects of the drug is false. Therefore, a firm’s response to this	414
statement could fall within the enforcement policy outlined in this guidance if the	415
recommendations of the guidance are followed.	416
417
Example 10: A medical doctor with a large social media following, who is an	418
independent third party, posts a statement that published studies show that Device Y	419
increases the risk of severe, life-threatening vascular injuries tenfold over other	420
comparable devices.	421

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422
There are no published studies that support the assertion that Device Y increases the risk	423
of severe, life-threatening vascular injuries, and Device Y’s prescribing information also	424
does not include any warnings about vascular injuries. The statement by the medical	425
doctor is false, inaccurate, and/or misleading.	426
427
Example 11: A content creator on a social media platform, who is an independent third	428
party, posts a video on the social media platform where they make claims that a study has	429
just been found that shows that a prescription drug manufacturer has known for years that	430
its medical product, Drug X, is lethal to humans. The content creator includes a link in	431
their video to a published study that was conducted prior to the drug’s approval.	432
433
The study described in the publication that is the basis for the content creator’s claims	434
was a safety pharmacology study designed specifically to assess the effects of Drug X on	435
the central nervous system in rats at a range of doses, some that were 40 to 50 times the	436
maximum recommended dose for humans. Central nervous system toxicity leading to	437
mortality was only seen in rats given greater than 40 times the maximum dose	438
recommended for humans in the Prescribing Information for Drug X. The study and the	439
findings do not support the content creator’s statement that the drug is lethal to humans.	440
The content creator’s statements are false, inaccurate, and/or misleading.	441
442
Example 12: A veterinary technician and well-known podcaster, who is an independent	443
third party, uploads a new episode of her podcast to the host platform she uses for her	444
podcast series on animal health issues. In the new episode, the veterinary technician	445
discusses the use of animal Drug X, a newly approved drug for the control of pruritus	446
associated with allergic dermatitis in dogs. The veterinary technician discusses how hard	447
it is for pets to struggle with allergies and states that animal Drug X is an option for all	448
pet owners who have pets with any kind of allergy, since studies have shown it works for	449
every kind of allergic reaction.	450
451
Animal Drug X is only indicated for use in dogs and only for the control of pruritus	452
(severe skin itching) associated with allergic dermatitis, and there are no studies that have	453
shown it works for every kind of allergic reaction. The veterinary technician’s statements	454
that indicate that studies support the conclusion that animal Drug X is an option for all	455
pets and works for every kind of allergic reaction are false, inaccurate, and/or misleading.	456
457
Example 13: An individual, who is an independent third party, posts on his social media	458
account that his dad is taking a new prescription drug, Drug X, in the form of an injection	459
to treat his lung cancer. The individual states that Drug X is a terrible choice for his dad	460
because it is made using tissue from cadavers.	461
462
While the individual’s statement that Drug X is a terrible choice is a value statement, that	463
statement rests on a basis that falls within the definition of misinformation because the	464
statement that Drug X is made using tissue from cadavers is false. Therefore, a firm’s	465
response to this statement could fall within the enforcement policy outlined in this	466
guidance if the recommendations of the guidance are followed.	467

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468
Q3. 	For the purposes of the enforcement policy outlined in this guidance, should a	469
tailored responsive communication identify a specific communication being	470
addressed, as well as the specific misinformation in that communication? If so,	471
how?	472
473
Yes, a firm’s tailored responsive communication should clearly identify both the specific	474
misinformation that the firm is addressing and a specific internet-based, independent third-party	475
communication in which that misinformation appears.27	
476
477
There are a number of mechanisms through which firms might identify a specific internet-based,	478
independent third-party communication. For example, a firm might share a tailored responsive	479
communication in conjunction with a specific internet-based, independent third-party	480
communication or capture and embed an internet-based, independent third-party communication	481
(or a portion of it) in a tailored responsive communication. When a firm identifies	482
misinformation that is widespread, the firm should, at a minimum, clearly identify at least one	483
internet-based, independent third-party communication that contains the misinformation the firm	484
is addressing. A firm might do this by, for example, noting the date and specific location within	485
the internet-based setting where the independent third-party communication was posted. A firm	486
can also note that the identified misinformation appears on other social media platforms.	487
488
In addition to identifying a specific internet-based, independent third-party communication, a	489
firm’s tailored responsive communication should clearly identify what specific misinformation	490
within an internet-based, independent third-party communication the firm is addressing. Note, if	491
a firm indicates that their tailored responsive communication is, for example, addressing just one	492
sentence of content posted by an independent third party in a specific location within an internet-	493
based setting, the firm should address each piece of misinformation in that sentence.	494
495
Example 14: A firm decides to voluntarily address misinformation about its	496
approved/cleared medical product that appeared in an internet-based short form video	497
posted by an independent third party on a social media platform. The firm posts a	498
tailored responsive communication in the form of a short-form video on their medical	499
product’s page, on the same social media platform. To identify the specific	500
misinformation the firm is addressing, the firm incorporates a segment of the original	501
video containing the misinformation into its response video, and the firm’s	502
communication clearly identifies the specific false, inaccurate, or misleading content it is	503
addressing within the video segment. The firm also describes the specific location within	504
the internet-based setting as well as the date of the independent third party’s social media	505
post that contained the misinformation.	506
507
27 Because addressing misinformation is voluntary, firms are under no obligation to continue to monitor or address
responses to the firm’s tailored responsive communication.

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Q4. 	For the purposes of the enforcement policy outlined in this guidance, what should a	508
firm consider when determining what information to include in their tailored	509
responsive communication?	510
511
For the purposes of the enforcement policy outlined in this guidance, a firm should ensure that	512
the information in their tailored responsive communication is:	513
514
• 	Truthful and accurate.	515
516
• 	Scientifically sound.	517
518
− To be scientifically sound, any study or analysis that informs a firm’s tailored	519
responsive communication, at a minimum, should meet generally accepted design and	520
other methodological standards for the particular type of study or analysis performed	521
(e.g., provide a clear description of the hypothesis stated and tested, acknowledge and	522
account for potential bias, and otherwise meet generally accepted scientific standards	523
for the type of study or analysis performed), taking into account established scientific	524
principles. Statistical rigor and validity are generally necessary, but not sufficient, for	525
a study or analysis to be scientifically sound.	526
527
• 	Directly relevant and responsive to the identified misinformation.	528
529
• 	Limited to the information necessary to address the identified misinformation as well as	530
any recommended disclosures (see Q5).28 Note, this does not mean a firm can omit	531
information that is material to the specific content of the tailored responsive	532
communication.	533
534
Example 15: A firm identifies an internet-based, independent third-party communication	535
that includes a false statement alleging that the firm is aware of and has failed to disclose	536
that there have been multiple fatalities associated with a specific adverse reaction for the	537
firm’s prescription human drug, Drug X. The firm has received no reports of fatalities	538
associated with the specific adverse event for Drug X. 29 However, the Prescribing	539
Information for Drug X includes a warning for the adverse reaction. If the firm chooses	540
to address the false statement and notes that no reports have been made to the firm	541
regarding patient fatalities due to this adverse reaction, the warning from the Prescribing	542
Information about the adverse reaction is material to the information in the firm’s	543
response.	544
545
28 If a firm chooses to also include a statement in its tailored responsive communication to contact the firm’s medical
or scientific affairs staff for more information, that also would be consistent with the recommendations in this
guidance.
29 If the firm obtained or received adverse drug experience information, that information would be subject to the
reporting requirements under 21 CFR 314.80 and 314.98.

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Q5. 	For the purposes of the enforcement policy outlined in this guidance, what	546
additional disclosures should a firm include in a tailored responsive	547
communication?	548
549
FDA recommends that firms include certain disclosures in their tailored responsive	550
communication to help ensure that audiences have the appropriate context to understand the	551
communication, as follows:	552
553
• 	A mechanism for obtaining a copy of the current FDA-required labeling (including FDA-	554
approved patient labeling, if any). This is particularly important because under the	555
enforcement policy outlined in this guidance, depending on the nature of the identified	556
misinformation, risk information and other key information about the approved/cleared	557
medical product (e.g., the medical product’s full indication) might not be included in the	558
firm’s tailored responsive communication if that information is not directly relevant and	559
responsive to the identified misinformation or material to the information in the tailored	560
responsive communication (see Q4).	561
562
• 	The date the firm’s tailored responsive communication is posted (if a date is not	563
automatically generated).	564
565
• 	A disclosure that the tailored responsive communication is being shared by the medical	566
product firm or that the person addressing the misinformation is providing information	567
about the medical product on behalf of the firm. For example:	568
569
− 	“This information is being shared by [Firm X], the maker of [Medical Product Y].”	570
571
− 	“This information is being shared on behalf of [Firm X], the maker of [Medical	572
Product Y].”	573
574
Additionally, if a firm wishes to use a tailored responsive communication to address	575
misinformation that suggests that the firm’s approved/cleared medical product should be used for	576
an unapproved use, FDA recommends that it include:	577
578
• 	A statement identifying the unapproved use or uses and noting that the unapproved use or	579
uses of the medical product have not been approved by FDA and that the safety and	580
effectiveness of the medical product for the unapproved use or uses has not been	581
established. For example, the following statement would be consistent with this	582
recommendation:	583
584
− 	“[Medical Product X] has not been approved by FDA for use in [Condition Y], and	585
the safety and effectiveness of [Medical Product X] for [Condition Y] has not been	586
established.”	587
588
Tailored responsive communications should clearly and prominently present all recommended	589
disclosures. Factors to be considered when determining whether information is clearly and	590
prominently presented include, but are not limited to, type size, style of font, layout, contrast,	591

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graphic design, headlines, spacing, volume, articulation, pace, and any other techniques to	592
achieve emphasis or notice.30 For tailored responsive communications that have both audio and	593
visual components, FDA recommends that disclosures be presented in both the audio and in the	594
text at the same time using the same words (key terms and phrases or a full transcript).	595
596
Q6. 	Is the enforcement policy outlined in this guidance limited to tailored responsive	597
communications that are shared by firms only in the same internet-based setting or	598
settings where the identified misinformation appears or appeared?	599
600
No. The enforcement policy outlined in this guidance is not limited to cases in which firms share	601
their tailored responsive communication in the same internet-based setting or settings where the	602
identified misinformation appears or appeared. If firms choose to share their tailored responsive	603
communication in different or additional internet-based settings, that tailored responsive	604
communication would still fall within the enforcement policy outlined in this guidance.	605
606
Example 16: A firm decides to voluntarily address misinformation about its	607
approved/cleared medical product that was shared through an internet-based blog by an	608
independent third party. The firm posts a tailored responsive communication to address	609
this specific misinformation on several social media platforms where the firm has	610
accounts for its medical product. In the firm’s social media post, the firm clearly	611
identifies the specific misinformation to which it is responding and also includes a	612
description of the specific location within the internet-based setting as well as the date of	613
the independent third party’s blog post that contained the misinformation.	614
615
Q7. 	Are there other operational and presentational considerations that FDA	616
recommends a firm take into account when addressing misinformation with a	617
tailored responsive communication?	618
619
Yes, there are a number of operational and presentational considerations that FDA recommends a	620
firm take into account, as follows:	621
622
• 	FDA recommends that when firms choose to voluntarily address misinformation, they	623
prioritize (1) misinformation that has current relevance (e.g., misinformation that is	624
trending or actively spreading on internet-based platforms) and (2) misinformation that is	625
being spread by independent third parties that have large follower bases or hold positions	626
of trust because those users may have a wider range or a higher degree of influence. For	627
example, a post by a social media personality with a large follower count will generally	628
reach a broader group of users compared to a user with a small follower count.	629
630
• 	If the setting where a firm chooses to post its tailored responsive communication has	631
functionality that allows communications to be shared to other settings by a user who is	632
an independent third party, the firm should consider whether the shared version of its	633
tailored responsive communication would include the entirety of the original post. Some	634
settings may not allow the entirety of the tailored responsive communication, including	635
30 Disclosure clarity and prominence are assessed case by case.

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all disclosures recommended in this guidance, to be transferred when a firm has enabled	636
sharing of its post to other settings.	637
638
Example 17: A firm posts a tailored responsive communication on platform A and	639
includes the recommended disclosures in a caption within the firm’s post. The firm	640
specifically enables sharing of its post to platform B because the post will display on that	641
platform in its entirety when shared. The firm does not enable sharing to platform C	642
because the caption containing the disclosures will not be displayed in that platform.	643
644
• 	Firms should consider the layout and format of platform controls (e.g., engagement	645
buttons) to help ensure that the firm’s tailored responsive communication, including all	646
disclosures recommended in this guidance, are not obscured in the setting where the	647
tailored responsive communication is being posted. A firm should also consider how the	648
location of platform controls in other settings would impact how its tailored responsive	649
communication would appear in that setting if the firm enabled sharing of its response to	650
that setting.	651
652
• 	When firms enable sharing to other settings, firms should consider how the limitations of	653
these other settings may impact their tailored responsive communication. For example,	654
the inclusion of platform-specific branding or watermarks applied from the use of a	655
specific platform’s built-in video creation tool can limit the distribution of the tailored	656
responsive communication to other settings.	657
658
The following example includes layout, format, and portability considerations for a firm’s	659
tailored responsive communication.	660
661
Example 18: A firm decides to voluntarily address misinformation about its	662
approved/cleared medical product on a social media platform and posts a response video	663
on the firm’s own social media account within the same social media platform where the	664
misinformation was identified. The firm enables sharing of its post. The firm clearly	665
identifies an internet-based, independent third-party communication and the specific	666
misinformation within that communication that it is addressing. The firm includes the	667
disclosures recommended in Q5 of this guidance in the audio as well as in on-screen text	668
within the video component of the post instead of captions below the video because	669
captions may not transfer with the post if the post is shared to other settings.	670
Additionally, the firm ensures that no platform controls (e.g., engagement buttons)	671
obscure the disclosures in the tailored responsive communication by including the on-	672
screen text for those disclosures in the middle third of the video and considers how its	673
post will display if shared by users to other settings.	674
675
B. 	General Medical Product Communications	676
677
Q8. 	Can a firm address misinformation about or related to its approved/cleared medical	678
product through existing avenues other than tailored responsive communications?	679
680

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Yes, a firm can use many existing avenues for communicating information about or related to its	681
approved/cleared medical product or products, including information that addresses	682
misinformation. For the purposes of this guidance, communications through existing avenues	683
are collectively referred to as general medical product communications. With the exception of	684
communications that fall within the enforcement policy outlined in this guidance, the inclusion	685
of content aimed at addressing misinformation—whether implicitly or explicitly—creates no	686
special considerations regarding the application of the FDA Authorities or other FDA	687
enforcement policies.	688
689
Promotional communications are one type of general medical product communication that often	690
provide information about an approved/cleared medical product’s safety and effectiveness.31	
691
Using such promotional communications that comply with the FDA Authorities to provide	692
truthful and non-misleading information about the approved uses of a firm’s medical product is	693
one avenue for addressing misinformation. In promotional communications, a firm can choose to	694
address misinformation implicitly, without repeating or redirecting attention to that	695
misinformation, or if preferred, the firm can call out the misinformation expressly, with the	696
degree of specificity that it chooses.32 In promotional communications, a firm can also provide a	697
broad scope of information about its medical product, rather than retaining a narrow focus on	698
communicating the information that is directly relevant and responsive to specific	699
misinformation.	700
701
A firm can also design its promotional communications to be shared in a variety of settings,	702
internet-based or not, which could support diverse strategies for addressing misinformation. For	703
example, if a firm wants to address a misinformation concept about or related to its medical	704
product that has become widespread in both internet-based and non-internet-based settings,	705
choosing communications that comply with applicable FDA labeling/advertising requirements	706
would generally give the firm flexibility to decide how to craft and direct its communications to	707
reach as many people who may have encountered the misinformation as possible. That might	708
include, for example, enlisting the help of HCPs through promotional communications directed	709
to that audience; reaching the general public through a TV advertising campaign; enlisting an	710
influencer to convey the firm’s message in internet-based settings; or any combination of these	711
techniques. If the resulting promotional communication is consistent with applicable FDA	712
labeling/advertising requirements, there are no special considerations created by the fact that the	713
promotional communication addresses misinformation.	714
715
FDA has issued a number of guidance documents with recommendations for firms relevant to the	716
sharing of promotional communications about their approved/cleared medical products. The	717
recommendations in these guidances can also be used by firms that intend to use promotional	718
31 Certain exceptions exist, for example, regarding reminder labeling for prescription devices and prescription drugs
and reminder advertisements for prescription drugs. See, e.g., 21 CFR 801.109(d) for prescription devices and 21
CFR 201.100(f), 201.105(d), and 202.1(e)(2)(i) for prescription drugs.
32 While the enforcement policy outlined in this guidance includes recommendations for identifying the specific
misinformation that a firm’s tailored responsive communication addresses, those recommendations do not restrict a
firm from identifying misinformation with specificity in other types of communications that fall outside the scope of
the enforcement policy outlined in this guidance.

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communications to address misinformation about or related to the approved uses of their medical	719
products. For example, the guidance for industry Medical Product Communications That Are	720
Consistent With the FDA-Required Labeling: Questions and Answers (June 2018) (CFL	721
guidance) provides firms with specific recommendations for communicating data and	722
information in promotional communications that are not contained within the FDA-required	723
labeling but are consistent with the FDA-required labeling for a medical product. The CFL	724
guidance also provides general recommendations for conveying information in a truthful and	725
non-misleading way, with illustrative examples, to aid firms in complying with the FDA	726
Authorities.	727
728
Additionally, the guidance for industry Presenting Quantitative Efficacy and Risk Information in	729
Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (December 2023) (Quant	730
Info guidance) outlines FDA’s recommendations for how firms that include quantitative efficacy	731
or risk information in direct-to-consumer promotional communications for their drugs can make	732
the language and presentation more consumer friendly. The Quant Info guidance covers the	733
following topics: (1) providing quantitative efficacy or risk information for the control group,	734
when applicable; (2) presenting probability information in terms of absolute frequencies,	735
percentages, and relative frequencies; (3) formatting quantitative efficacy or risk information;	736
and (4) using visual aids to illustrate quantitative efficacy or risk information. The	737
recommendations in the Quant Info guidance are aimed at helping firms convey information	738
about a drug’s efficacy and risks so the audience understands the information. Communications	739
that facilitate comprehension of the information they contain can be effective tools in addressing	740
misinformation.	741
742
In addition to the enforcement policy outlined in this guidance as it relates to addressing	743
misinformation about or related to unapproved uses of approved/cleared medical products, FDA	744
has issued other documents that describe other circumstances when a firm’s dissemination of	745
information regarding an unapproved use of its approved/cleared medical product, standing	746
alone, would not be determinative of intended use.33,34 The applicability of these documents is	747
not changed when such a dissemination of information helps address misinformation.	748
749
FDA has also issued the draft guidance for industry Communications From Firms to Health Care	750
Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical	751
Products: Questions and Answers (October 2023) (SIUU guidance)35 that provides answers to	752
common questions regarding certain communications of scientific information on unapproved	753
use(s) of approved/cleared medical products, which may be helpful in addressing	754
misinformation. The recommendations in the SIUU guidance are not changed when the SIUU	755
communication helps address misinformation that may be spreading among the HCP audience.	756
757
33 See footnote 11.
34 See the FDA Memorandum: Public Health Interests and First Amendment Considerations Related to
Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (January
2017, pages 20–21) (available at https://www.regulations.gov/document?D=FDA-2016-N-1149-0040).
35 When final, this guidance will represent FDA’s current thinking on this topic.

Contains Nonbinding Recommendations
Draft — Not for Implementation
21
FDA has also issued guidance that provides recommendations for firms that are interested in	758
communicating unapproved use information with payors and similar entities36 and has provided	759
guidance with recommendations for industry support of scientific or educational activities (such	760
as Continuing Medical Education programs), which can be an important source of information	761
on medical products for HCPs.37 In addition, it has long been FDA policy not to consider a	762
firm’s presentation of truthful and non-misleading scientific information about unapproved uses	763
at the planned sessions and presentations at medical or scientific conferences to be evidence of	764
intended use when the presentation is made in non-promotional settings and is not accompanied	765
by promotional communications.38 All of the communication types discussed in these guidances	766
could be used by firms to address misinformation.	767
768
Finally, communications sometimes characterized as help-seeking or institutional represent	769
another option firms have to address misinformation. These are communications that (1) do not	770
name any specific medical product or make representations or suggestions that are associated	771
with a specific medical product and (2) are separate and distinct from promotional	772
communications about any specific approved/cleared medical product. Such communications	773
are often used to provide information to raise awareness about diseases or general classes of	774
available treatments. This information may be helpful in addressing false, inaccurate, or	775
misleading information on these topics.39	
776
36 See the guidance for industry and review staff Drug and Device Manufacturer Communications With Payors,
Formulary Committees, and Similar Entities: Questions and Answers (June 2018). See also section 502(gg) of the
FD&C Act enacted in December 2022 as part of the Consolidated Appropriations Act, 2023 (Public Law 117-328).
37 See the guidance for industry Industry-Supported Scientific and Educational Activities (December 1997).
38 See footnote 34.
39 These help-seeking or institutional communications are generally not subject to the FDA Authorities.