Guidance for Industry 
 
Internet/Social Media Platforms: 
Correcting Independent Third-Party 
Misinformation About Prescription 
Drugs and Medical Devices 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 90 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to http://www.regulations.gov.  Submit written 
comments to the Division of Dockets Management (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) Julie Chronis at 301-796-1200; 
(CBER) Office of Communication, Outreach and Development at 800-835-4709 or 240-402-
7800; (CVM) Thomas Moskal at 240-276-9300; or (CDRH) Deborah Wolf at 301-796-5732. 
 
 
 
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 Veterinary Medicine (CVM) 
Center for Devices and Radiological Health (CDRH) 
 
June 2014 
Advertising 
 
 
 
  Guidance for Industry 
Internet/Social Media Platforms: Correcting 
Independent Third-Party Misinformation 
About Prescription Drugs and Medical 
Devices 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug  Communications Staff (CVM) 
Information  Center for Veterinary Medicine 
Center for Drug Evaluation and Research  Food and Drug Administration 
Food and Drug Administration  7519 Standish Place, HFV-12 
10903 New Hampshire Ave., Bldg. 51, rm. 2201  Rockville, MD 20855 
Silver Spring, MD 20993-0002  Tel: 240-276-9300; 
Tel: 301-796-3400; Fax: 301-847-8714;  E-mail: AskCVM@fda.hhs.gov 
E-mail: druginfo@fda.hhs.gov  http://www.fda.gov/AnimalVeterinary/GuidanceComplian
http://www.fda.gov/Drugs/GuidanceComplianceRegula ceEnforcement/GuidanceforIndustry/default.htm 
toryInformation/Guidances/default.htm   
   
Office of Communication, Outreach and Development   Office of the Center Director 
Center for Biologics Evaluation and Research  Guidance and Policy Development 
Food and Drug Administration  Center for Devices and Radiological Health 
10903 New Hampshire Ave., WO71, Room 3128  Food and Drug Administration 
Silver Spring, MD 20993  10903 New Hampshire Ave., Bldg. 66, rm. 5431 
 Silver Spring, MD 20993-0002 
Tel: 800-835-4709 or 240-402-7800;  
Tel:  301-796-5900; 
E-mail: ocod@fda.hhs.gov 
E-mail: CDRH-Guidance@fda.hhs.gov 
http://www.fda.gov/BiologicsBloodVaccines/Guidance
http://www.fda.gov/MedicalDevices/DeviceRegulationand
ComplianceRegulatoryInformation/default.htm 
Guidance/GuidanceDocuments/default.htm   
 
 
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 Veterinary Medicine (CVM) 
Center for Devices and Radiological Health (CDRH) 
 
June 2014 
Advertising
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION.......................................................................................................................... 1 
II.  BACKGROUND ............................................................................................................................ 2 
III.  DETERMINING WHETHER THIS DRAFT GUIDANCE APPLIES .................................... 3 
IV.  RECOMMENDATIONS FOR THE CORRECTION OF MISINFORMATION ABOUT 
PRESCRIPTION DRUGS AND MEDICAL DEVICES ............................................................ 5 
A.  Appropriate Corrective Information ................................................................................... 5 
B.  Correcting a Clearly Defined Portion of a Forum .............................................................. 6 
C.  Approaches to Correcting Misinformation ......................................................................... 7 
D.  Communications That Fall Outside the Scope of This Guidance ....................................... 8 
E.  The Consequences of Correcting Misinformation .............................................................. 9 
 
 
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1   
1
2  Guidance for Industry  
3   
4  Internet/Social Media Platforms: Correcting Independent  
5  Third-Party Misinformation About  
6  Prescription Drugs and Medical Devices  
7   
8   
9  This draft guidance, when finalized, will represent the Food and Drug Administrations (FDAs 
10  or Agencys) current thinking on this topic.  It does not create or confer any rights for or on any 
11  person and does not operate to bind FDA or the public.  You can use an alternative approach if 
12  the approach satisfies the requirements of the applicable statutes and regulations.  If you want to 
13  discuss an alternative approach, contact the FDA staff responsible for implementing this 
14  guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number listed on 
15  the title page of this guidance.  
16   
17  I.  INTRODUCTION 
18   
19  This draft guidance is intended to describe FDAs current thinking about how manufacturers, 
20  packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical 
21  devices for human use (devices)2 should respond, if they choose to respond, to misinformation 
22  related to a firms own FDA-approved or -cleared products when that information is created or 
23  disseminated by independent third parties on the Internet or through social media or other 
24  technological venues (Internet/social media), regardless of whether that misinformation appears 
25  on a firms own forum or an independent third-party forum or website. This draft guidance 
26  responds to (among other things) stakeholder requests for specific guidance regarding a firms 
27  voluntary correction of misinformation when that misinformation is created or disseminated by 
28  an independent third party. 
29   
                                                 
1 This draft guidance has been prepared by the Office of Prescription Drug Promotion (OPDP) in the Center for 
Drug Evaluation and Research (CDER) in consultation with the Center for Biologics Evaluation and Research 
(CBER), the Center for Veterinary Medicine (CVM), and the Center for Devices and Radiological Health (CDRH). 
2 The recommendations in this draft guidance also apply to biological products that are approved for marketing 
under section 351 of the Public Health Service Act (PHS Act).  Because each biological product also meets the 
definition of drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), it is also subject to 
regulation under provisions of the FD&C Act applicable to drugs or devices, as well as the regulations implementing 
these provisions, except that a biological product licensed under section 351 of the PHS Act is not required to have 
an approved new drug application under section 505 of the FD&C Act (21 U.S.C. 355).  See PHS Act section 351(j) 
(42 U.S.C. 262(j)).  References to drugs and devices in this guidance therefore also include biological products 
that fall within each of those definitions.  The recommendations in this draft guidance do not apply to veterinary 
biological products regulated under the Virus-Serum-Toxin Act (21 U.S.C. 151, et seq.) by the U.S. Department of 
Agriculture.  This draft guidance does not address devices solely intended for use in animals. 
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30  FDAs guidance documents, including this draft guidance, do not establish legally enforceable 
31  rights or responsibilities.  Instead, guidances describe the Agencys current thinking on a topic 
32  and should be viewed only as recommendations, unless specific regulatory or statutory 
33  requirements are cited.  The use of the word should in Agency guidances means that something 
34  is suggested or recommended, but not required. 
35   
36  II.  BACKGROUND 
37   
38  Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Agency has responsibility for 
39  regulating the manufacture, sale, and distribution of drugs and medical devices in the United 
40  States.  This authority includes oversight of the labeling of drugs and medical devices (21 U.S.C. 
41  352(a)) and the advertising of prescription drugs and restricted medical devices (21 U.S.C. 
42  352(n), (q), and (r)). 3 
43   
44  Section 201(m) of the FD&C Act defines labeling as all labels and other written, printed, or 
45  graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying 
46  such article (21 U.S.C. 321(m)).4  The U.S. Supreme Court has explained that the language 
47  accompanying such article in the labeling definition is interpreted broadly, to include 
48  materials that supplement or explain an article.  No physical attachment between the materials 
49  and the article is necessary; rather, it is the textual relationship between the items that is 
50  significant (Kordel v. United States, 335 U.S. 345, 350 (1948)).  FDA generally recognizes two 
51  types of labeling:  (1) FDA-required labeling5 and (2) promotional labeling.  Promotional 
52  labeling is generally any labeling, other than the FDA-required labeling, that is devised for 
53  promotion of the product.  Examples of materials that may be considered promotional labeling 
54  pieces for prescription drugs are described in 21 CFR 202.1(l)(2).  The scope of labeling 
55  requirements for prescription medical devices is described in 21 CFR 801.109. 
56   
57  The FD&C Act does not define what constitutes an advertisement, but FDA regulations 
58  provide several examples, including advertisements in published journals, magazines, other 
                                                 
3 Devices may become restricted by regulation issued under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)), by 
performance standard issued pursuant to section 514(a)(2)(B)(v) (21 U.S.C. 360d(a)(2)(B)(v)), or by order 
approving an application for premarket approval (i.e., a PMA) pursuant to section 515(d)(1)(B)(ii) (21 U.S.C. 
360e(d)(1)(B)(ii)). 
4 See also 21 CFR 1.3(a). 
5 Much FDA-required labeling is subject to FDA review and approval.  For example, after drafting by the 
manufacturer, labeling is reviewed and approved by FDA as part of the new drug application (NDA), new animal 
drug application (NADA), biologics license application (BLA) or premarket approval application (PMA) review 
(see 21 CFR 314.50(c)(2), 514.1(b)(3), 601.2(a), 814.20(b)(10), and 814.44(d)).  For devices that are subject to 
premarket notification (510(k)) requirements, the 510(k) must contain the proposed labeling sufficient to describe 
the device, its intended use, and the directions for its use (21 CFR 807.87(e)).  All devices, including those exempt 
from premarket review, are subject to the requirements of applicable labeling regulations, including requirements for 
adequate directions for use (see 21 CFR Part 801).  For a prescription drug or prescription device to be exempted 
from the FD&C Acts requirement of adequate directions for use (21 U.S.C. 352(f)(1)), its FDA-required labeling 
must contain, among other information, information addressing product hazards and other risk information, as 
specified in FDA regulations (21 CFR 201.100(d)(1), (3), 201.105(c)(1), and 801.109). 
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59  periodicals, and newspapers, and advertisements broadcast through media such as radio, 
60  television, and telephone communication systems (21 CFR 202.1(l)(1)). 
61   
62  The Internet and Internet-based technologies have made it easier for third parties who are 
63  independent of firms to disseminate information about drugs and devices.  Information created 
64  by third parties (which for purposes of this guidance is user-generated content (UGC)) might 
65  appear on an interactive portion of a firm-controlled website or other interactive Internet/social 
66  media platform, or information might appear on a website or other Internet/social media platform 
67  that is independent of, or not under the control or influence of, a firm.  Many Internet/social 
68  media platforms allow for real-time and continuous communications and interactions (e.g., 
69  blogs, microblogs, social networks, online communities, and live podcasts) while other platforms 
70  do not provide a means for interactive content to be posted.  Whether a forum is interactive may 
71  affect the means by which a firm is able to respond to information.  
72   
73  Although the Internet has facilitated the transmission of information, allowing patients and other 
74  interested parties the opportunity to share experiences as well as to communicate with others 
75  about drugs and devices, UGC might not always be accurate and may be dangerous or harmful to 
76  the public health.  For the purposes of this draft guidance, misinformation is defined as positive 
77  or negative incorrect representations or implications about a firms product created or 
78  disseminated by independent third parties who are not under the firms control or influence and 
79  that is not produced by, or on behalf of, or prompted by the firm in any particular.  FDA has 
80  determined it may benefit the public health for firms to correct misinformation about their 
81  products (including, for example, situations in which a firm is aware of misinformation that may 
82  be dangerous or harmful to the public health).   
83   
84  If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as 
85  described in this draft guidance, FDA does not intend to object if the corrective information 
86  voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements 
87  regarding labeling or advertising, if any.  If a firm chooses to respond to misinformation about its 
88  products using non-truthful or misleading information or in a manner other than that 
89  recommended in this draft guidance, however, FDA may object if the information provided by 
90  the firm does not comply with applicable regulatory requirements related to labeling or 
91  advertising, if any.   
92   
93  III.  DETERMINING WHETHER THIS DRAFT GUIDANCE APPLIES  
94   
95  This draft guidance does not apply when a firm is responsible for the product communication 
96  that contains misinformation.  A firm is responsible for communications that are owned, 
97  controlled, created, or influenced, or affirmatively adopted or endorsed, by, or on behalf of, the 
98  firm.  A firm is thus responsible for communications on the Internet and Internet-based 
99  platforms, such as social media, made by its employees or any agents acting on behalf of the firm 
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100  to promote the firms product, and these communications must comply with any applicable 
101  regulatory requirements.6  Firms should not use this guidance in these situations.   
102   
103  Example 1: As part of a marketing campaign, a member of a firms marketing 
104  department posts incorrect statements about a products safety or efficacy compared to 
105  the efficacy of a competitors product on a discussion board hosted by an independent 
106  third party.  The firm is responsible for the content of the communication because the 
107  member of the firms marketing department is acting on behalf of the firm.  Thus, this 
108  draft guidance would not apply. 
109   
110  Additionally, if a firm writes, collaborates on, or exerts control or influence on product-specific 
111  content provided by a third party, to the extent that responsibility for the development of the 
112  content is imputable to the firm, the recommendations set forth in this guidance do not apply.  
113  Accordingly, as a general matter, the firm must comply with all applicable regulatory 
114  requirements related to labeling or advertising for that content. 
115   
116  Example 2: A firm hosts a discussion group on its own website, monitors the discussion 
117  for content that does not speak positively about its product, then removes or edits 
118  postings that portray its product in a negative light, and adds positive postings about the 
119  product.  This firm is exerting control over the UGC and is responsible for the resulting 
120  content.  Thus, the firms actions would not fall under the scope of this guidance. 
121   
122  In contrast, this draft guidance applies when a firm is not responsible for a product-related 
123  communication that appears on the firms own forum, an independent third-party website, or 
124  through social media, and the firm chooses to correct misinformation about its own product 
125  contained in that communication.  In such cases, we recommend that the firm do so as described 
126  in this draft guidance. 
127   
128  Firms are generally not responsible for third-party UGC about their products when the UGC is 
129  truly independent of the firm (e.g., is not produced by, or on behalf of, or prompted by the firm 
130  in any particular) regardless of whether the firm owns or operates the platform on which the 
131  communication appears.7  If the firm owns or operates the platform or created or initiated the 
                                                 
6 For example, with respect to prescription drugs and biologics, firms should consult the draft guidance for industry 
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for 
Prescription Human and Animal Drugs and Biologics for recommendations regarding how firms can fulfill 
regulatory requirements for postmarketing submissions of interactive promotional media (e.g., blog, message board, 
or chat room) for their FDA-approved products.  When final, this guidance will represent the FDAs current thinking 
on this topic.  For the most recent version of a guidance, check the FDA Drugs guidance webpage at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
7 Cf. 47 U.S.C. 230(c)(1) (no provider or user of an interactive computer service shall be treated as the publisher or 
speaker of any information provided by another information content provider).  The Communications Decency Act 
further defines information content provider as someone responsible, in whole or in part, for the creation or 
development of information provided through the Internet or any other interactive computer service (47 U.S.C. 
230(f)(3)). 
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132  forum on which such UGC appears, the firm should include an overarching clear and 
133  conspicuous statement that the firm did not create or control the UGC. 
134   
135  Example 3: A firm becomes aware of a blogger who is posting inaccurate information 
136  about the firms product.  The blogger does not have a relationship with the firm and the 
137  firm does not compensate the blogger for the blog or for any other activity.  The firm is 
138  not responsible for the content of the blog.  The firm may decide to attempt to correct the 
139  misinformation, but it is not obligated to attempt to correct it.  
140   
141  Example 4: A firm hosts a discussion forum about its drugs or devices FDA-approved 
142  use on its corporate website and does not participate in the discussion, but it does monitor 
143  the forum for profanity and obscenity.  The forum includes an overarching clear and 
144  conspicuous statement that the firm did not create the content of the forum.  The firm is 
145  not responsible for the information that is posted by independent third parties and can, if 
146  it so chooses, correct misinformation according to this guidance. 
147   
148  However, a firms control over, involvement with, or influence over a product-related 
149  communication, even when generated by a third party, may result in the firm being responsible 
150  for the information as a promotional communication.  Thus, firms might be responsible for UGC 
151  that they solicit or influence, regardless of the forum. 
152   
153  IV.  RECOMMENDATIONS FOR THE CORRECTION OF MISINFORMATION 
154  ABOUT PRESCRIPTION DRUGS AND MEDICAL DEVICES 
155   
156  A.  Appropriate Corrective Information 
157   
158  This draft guidance sets forth approaches a firm may use once it decides to voluntarily correct 
159  misinformation about its own product that is created or disseminated by an independent third 
160  party who is not under the firms control or influence.  In accordance with the approaches 
161  discussed below, a firm may choose to provide appropriate truthful and non-misleading 
162  corrective information or, alternatively, it may provide a reputable source from which to obtain 
163  the correct information, such as the firms contact information.8  For purposes of this draft 
164  guidance, to be considered appropriate corrective information, a firms communication should:  
165   
166    Be relevant and responsive to the misinformation; 
167    
168    Be limited and tailored to the misinformation; 
169   
170    Be non-promotional in nature, tone, and presentation; 
171   
172    Be accurate; 
173   
                                                 
8 For example, a firm may choose to provide contact information for the firms Medical Affairs Department. 
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174    Be consistent with the FDA-required labeling for the product;  
175   
176    Be supported by sufficient evidence, including substantial evidence, when appropriate, 
177  for prescription drugs;  
178   
179    Either be posted in conjunction with the misinformation in the same area or forum (if 
180  posted directly to the forum by the firm), or should reference the misinformation and be 
181  intended to be posted in conjunction with the misinformation (if provided to the forum 
182  operator or author) (see section IV.B); and 
183   
184    Disclose that the person providing the corrective information is affiliated with the firm 
185  that manufactures, packs, or distributes the product. 
186   
187  Because risk and other information about the product are not necessarily part of corrective 
188  information, the FDA-required labeling should be included or provided in a readily accessible 
189  format.  As two examples, a firm may provide a link that goes directly to the FDA-required 
190  labeling or may provide a link that opens a new window to a portable document format (PDF) 
191  file.  The information should not be provided by including a link to a promotional website even if 
192  the information is available on the promotional website.  Please note that if the uniform resource 
193  locator (URL), web address, or link where viewers are directed to obtain the respective FDA-
194  required labeling is promotional in content or tone, FDA would not consider the corrective 
195  information to fall within the scope of this draft guidance. 
196   
197  Example 5: A firm discovers a chat room where participants are discussing the firms 
198  product for one of its approved indicationsdiabetes.  The firm finds misinformation 
199  posted by an independent third party about the diabetes indication that the firm would 
200  like to correct according to this draft guidance.  Although the product has multiple 
201  approved indications, the firm should limit its corrective information to the relevant 
202  diabetes indication being discussed. 
203   
204  Example 6: An independent third party writes an online post stating that one reason he 
205  likes taking a prescription drug (or using a device) is that it has no food restrictions, 
206  which is inconsistent with information from the required labeling regarding the need to 
207  avoid taking the drug with fatty foods (or to avoid using the device in a certain way).  
208  The firm decides to correct the misinformation according to this draft guidance.  The 
209  firms representative identifies herself as being affiliated with the firm and posts the 
210  corrective information from the required labeling.  She also includes a direct link to the 
211  FDA-required labeling.  
212   
213  B.  Correcting a Clearly Defined Portion of a Forum 
214   
215  FDA recognizes that the Internet, social media, and other technological venues contain a vast 
216  amount of information and even one particular forum might have a large quantity of information.  
217  It may be difficult for a firm to correct all misinformation about its products in one forum 
218  depending on the nature of the forum, the quantity of information, and the length of time the 
219  forum encompasses.  Furthermore, technologies or platforms that may be used to view the forum 
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220  affect what information will simultaneously be displayed to users.  In light of these 
221  considerations, if a firm corrects one or more occurrences of misinformation, it is not expected to 
222  correct each piece of misinformation in an entire forum.  However, a firm should clearly identify 
223  the misinformation it is correcting, define the portion of the forum it is correcting, and should 
224  correct all the misinformation that appears in that clearly defined portion.  A firm should 
225  describe the location or the nature of the misinformation that was corrected and should provide a 
226  date the correction is made to ensure that parties reading the information do not assume the firm 
227  has responded to the entire forum.  
228   
229  Example 7: A firm decides to correct misinformation posted by an independent third 
230  party on one page of an interactive website.  The misinformation consists of three 
231  consecutive sentences about the firms product.  The firm should correct all three 
232  sentences.  It should provide a statement that the firm is responding only to the specified 
233  information on that one page and provide the date the change was made.  The firm is not 
234  expected to correct misinformation that appears on other webpages of the website.  
235   
236  Example 8: A firm decides to correct misinformation posted by an independent third 
237  party who has commented on a blog that allows comments.  The firm should correct each 
238  piece of misinformation in the particular comment to which it is responding.  The firm 
239  should provide a statement that it is responding only to one particular comment along 
240  with the date the correction is provided.  The firm is not expected to correct 
241  misinformation that appears in other comments.  
242   
243  A firm should correct all misinformation in the clearly defined portion of the forum it identifies.  
244  For example, if a firm chooses to correct only misinformation that portrays its product in a 
245  negative light in a third-party communication but does not address misinformation that overstates 
246  the benefits of its product in that same clearly defined portion of the communication, the firms 
247  actions do not meet the recommendations in this draft guidance.  Additionally, if a firm chooses 
248  to correct more than one piece of misinformation in a forum, the portion of the forum that the 
249  firm is expected to correct may be defined, in part, by the locations of the pieces of 
250  misinformation the firm corrects and the location of additional pieces of misinformation. 
251   
252  Example 9: A firm decides to correct misinformation posted on a blog that allows 
253  comments.  The firm corrects misinformation in several blog postings that provide 
254  incorrect risk information associated with the product and makes clear it is only 
255  correcting those pieces of misinformation, but the firm does not address exaggerated 
256  efficacy claims in favor of the firms product in other postings that appear to readers 
257  between the postings it is correcting.  Even if the firm corrects the misinformation in the 
258  limited posts it chose, the firms actions are not in accord with this guidance because it 
259  has intentionally selected only negative information about its product to correct while 
260  readily accessible and visible positive misinformation was not corrected. 
261   
262  C.  Approaches to Correcting Misinformation  
263   
264  If a firm chooses to correct misinformation, it may do so by correcting misinformation directly 
265  on the forum.  Alternatively, the firm may provide the corrective information to the independent 
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266  author for the author to incorporate; the firm may request that the author remove the 
267  misinformation or allow comments to be posted; or the firm may request that the site 
268  administrator remove the misinformation or allow comments to be posted.  The following are 
269  examples of approaches that FDA considers to be within the scope of this draft guidance and that 
270  firms may take to correct misinformation.  
271   
272  Example 10: A firm encounters misinformation posted by an independent third party 
273  about its product on a website sponsored by a patient group.  The website allows 
274  comments to be posted by viewers.  The firm may post corrective information directly on 
275  the website. 
276   
277  Example 11: A firm finds a webpage about its product that was written by an 
278  independent third party on an Internet-based, interactive, collaboratively edited 
279  encyclopedia.  The firm may choose to contact the author of the webpage and provide 
280  corrective information to the author. 
281   
282  Example 12: An independent third party posts a video on a video hosting website about a 
283  firms product.  It is not possible for viewers, such as a firm, to post comments about the 
284  video.  The firm may contact the entity that administers the website and ask that entity to 
285  allow comments about the video to be posted so that the firm may post corrective 
286  information. 
287   
288  FDA recognizes that a firm cannot control whether an independent third party refuses to correct 
289  the misinformation, or corrects only a portion of the misinformation even though the firm 
290  provided complete corrective information, or declines to include the respective required labeling, 
291  or declines to remove misinformation, or does not correct all the misinformation in one clearly 
292  defined part (if the firm sought to correct more than one piece of misinformation).  Accordingly, 
293  FDA will not hold a firm accountable for an independent third partys subsequent actions or lack 
294  thereof. 
295   
296  Example 13: A firm finds a webpage about its product that was written by an 
297  independent third party on an interactive reference website.  The firm contacts the author 
298  of the webpage and provides corrective information to the author.  The firm is not 
299  accountable for the authors subsequent actions or lack thereof.    
300   
301  D.  Communications That Fall Outside the Scope of This Guidance 
302   
303  Once a firm undertakes the correction of misinformation, FDA does not expect the firm to 
304  continue to monitor the website or communication that previously included UGC containing 
305  misinformation.  However, when a communication by or on behalf of the firm to the UGC 
306  author, site administrator, or the forum goes beyond the correction of misinformation, the 
307  communication falls outside the scope of this draft guidance. 
308   
309  Example 14: A firm decides to correct misinformation found in a blog entry where the 
310  blogger is not affiliated with the firm.  The firm is not obligated to continue to monitor 
311  the blog although it may choose to do so.  The blogger responds to the firms correction, 
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312  disputes the corrective information, and also brings up another facet of the products 
313  adverse event profile.  The firm replies with additional corrective information that is 
314  consistent with the original corrective information and that corrects the new 
315  misinformation about the products adverse event profile.  The blogger replies again and 
316  now disputes the effectiveness of the product.  The firm responds again with slogans and 
317  examples of patient profiles from its marketing campaign.  The slogans and patient 
318  profiles go beyond providing corrective information.  The firms communications now 
319  must comply with any applicable regulatory requirements related to labeling or 
320  advertising. 
321   
322  Example 15: An independent third party downplays a labeled contraindication on an 
323  email distribution list.  A firm provides, to the distribution list recipients, the corrective 
324  information regarding the contraindication, and additionally provides information 
325  unrelated to the contraindication comparing the safety profile of its product to a 
326  competitors product.  The firms communication goes beyond providing corrective 
327  information with respect to the third partys statements about the products 
328  contraindication and, therefore, is not considered to be a correction of misinformation 
329  within the scope of this draft guidance. 
330   
331  E.  The Consequences of Correcting Misinformation 
332   
333  When a firm voluntarily undertakes the correction of misinformation in a truthful and non-
334  misleading manner pursuant to the recommendations in this draft guidance, FDA does not intend 
335  to object if these voluntary corrections do not satisfy otherwise applicable regulatory 
336  requirements, if any.  If a firm chooses to provide information outside the scope of this draft 
337  guidance, the firm should ensure the information it provides complies with any applicable 
338  requirements related to labeling or advertising.  Information considered to be outside the scope 
339  of this guidance includes information that does not meet criteria listed above. 
340    
341  FDA does not expect firms to submit corrections to the Agency when correcting misinformation 
342  pursuant to this draft guidance; however, FDA recommends that firms keep records to assist in 
343  responding to questions that may come from the Agency.  The records should include, for 
344  example, the content of the misinformation, where it appeared, the date it appeared or was 
345  located, the corrective information that was provided, and the date the corrective information 
346  was provided.  
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