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

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DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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

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

Contains Nonbinding Recommendations

Draft — Not for Implementation

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 Industry

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

I. INTRODUCTION 16

This guidance responds to common questions firms

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.

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.

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

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.

Terms that appear in bold at first mention are further explained in section II.

This guidance is not intended to address a firm’s correction of its own false or misleading representations about its

medical products.

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

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

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).

This guidance reflects the 50

Agency’s consideration of feedback from interested parties, including comments received on the 51

2014 draft guidance. 52

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

Authorities

(general medical product communications) that firms might also choose to use to 58

address misinformation. More specifically, these subsections describe the following: 59

• 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.

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

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

In this guidance, the FD&C Act, the Public Health Service Act, and their implementing regulations are collectively

referred to as the FDA Authorities.

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”

: 71

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

1. Applicable requirements, if any, related to promotional labeling and advertising

(collectively, promotional communications) 79

2. Applicable requirements, if any, related to postmarketing submission of 81

promotional communications

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.

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).

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.

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).

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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• 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.

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

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 use

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.

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

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.

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,

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.

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.

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.

In August 2022, FDA launched the 219

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.

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

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

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.

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.

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-ev

ents/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-ev

ents/speeches-fda-officials/remarks-fda-commissioner-robert-califf-2022-rx-and-illicit-

drug-summit-04202022.

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Rumor Control web page,

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 efforts

and provided “toolkits” to 222

interested parties.

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.

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

Office of the Commissioner. (2023). Rumor Control. U.S. Food and Drug Administration.

https://www.fda.gov/news-events/rumor-control

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.

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

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).

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

See footnote 8.

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The following examples

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

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.

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

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).

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.

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

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.

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.

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

Disclosure clarity and prominence are assessed case by case.

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Draft — Not for Implementation

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.

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.

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

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.

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)

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

See footnote 11.

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

When final, this guidance will represent FDA’s current thinking on this topic.

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FDA has also issued guidance that provides recommendations for firms that are interested in 758

communicating unapproved use information with payors and similar entities

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.

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.

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.

776

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).

See the guidance for industry Industry-Supported Scientific and Educational Activities (December 1997).

See footnote 34.

These help-seeking or institutional communications are generally not subject to the FDA Authorities.