Guidance for Industry 
Fulfilling Regulatory Requirements 
for Postmarketing Submissions of 
Interactive Promotional Media for 
Prescription Human and Animal 
Drugs and Biologics  
 
 
 
DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) Barbara Chong at (301) 796-1200; 
(CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301-827-
1800; or (CVM) Dorothy McAdams at (240) 276-9300.
 
     
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) 
 
January 2014 
Advertising 
 
 
   
Guidance for Industry 
Fulfilling Regulatory Requirements for 
Postmarketing Submissions of Interactive 
Promotional Media for Prescription 
Human and Animal Drugs and Biologics 
  
Additional copies are available from: 
 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 51, rm. 2201 
Silver Spring, MD 20993-0002 
Tel: 301-796-3400; Fax: 301-847-8714; E-mail: druginfo@fda.hhs.gov 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
Office of Communication, Outreach and Development (HFM-40) 
Center for Biologics Evaluation and Research 
Food and Drug Administration 
1401 Rockville Pike, Suite 200N 
Rockville, MD 20852-1448 
Tel: 800-835-4709 or 301-827-1800; E-mail: ocod@fda.hhs.gov 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm 
 
Communications Staff (CVM) 
Center for Veterinary Medicine 
Food and Drug Administration 
7519 Standish Place, HFV-12 
Rockville, MD 20855 
Tel: 240-276-9300; E-mail: AskCVM@fda.hhs.gov 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/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) 
 
January 2014 
Advertising 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
TABLE OF CONTENTS 
 
I.  INTRODUCTION.......................................................................................................................... 1 
II.  BACKGROUND ............................................................................................................................ 2 
III.   LEGAL OVERVIEW OF STATUTORY AND REGULATORY REQUIREMENTS FOR 
LABELING AND ADVERTISING .............................................................................................. 2 
IV.  FACTORS CONSIDERED IN DETERMINING POSTMARKETING SUBMISSION 
REQUIREMENTS FOR INTERACTIVE PROMOTIONAL MEDIA ................................... 3 
V.  RECOMMENDATIONS FOR SUBMITTING INTERACTIVE PROMOTIONAL         
MEDIA ............................................................................................................................................ 5 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Fulfilling Regulatory Requirements for Postmarketing Submissions of 
1 
Interactive Promotional Media for Prescription Human and Animal 
2 
Drugs and Biologics  
3 
 
4 
5   
6   
7  This draft guidance, when finalized, will represent the Food and Drug Administrations (FDAs or 
8  Agencys) current thinking on this topic.  It does not create or confer any rights for or on any person and 
9  does not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies 
10  the requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
11  approach, contact the FDA staff responsible for implementing this guidance.  If you cannot identify the 
12  appropriate FDA staff, call the appropriate number listed on the title page of this guidance.  
13   
14   
15   
16  I.  INTRODUCTION  
17   
18  This draft guidance is intended to describe FDAs current thinking about how manufacturers, packers, 
19  and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of 
20  prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements 
21  for postmarketing submissions1 of interactive promotional media for their FDA-approved products.2,3  
22  For the purposes of this guidance, the phrase interactive promotional media includes modern tools and 
23  technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, 
24  social networking sites, online communities, and live podcasts) that firms use to promote their drugs.  
25  Although some interactive promotional media are substantially similar in presentation and content to 
26  certain traditional promotional media, such as print media, FDA recognizes that in other cases they 
27  possess certain unique technological features and offer novel presentation and content features.  This draft 
28  guidance describes FDAs current thinking on what the Agency considers to be interactive promotional 
29  media and outlines the considerations taken into account in determining if product communications using 
30  interactive technologies are subject to FDAs postmarketing submission requirements.  Furthermore, this 
31  draft guidance provides FDAs recommendations for how firms can fulfill the regulatory requirement to 
32  submit postmarketing promotional materials to the FDA in a practical manner to address the potential 
                                                      
1 21 CFR 314.81(b)(3)(i); 21 CFR 601.12(f)(4); and 21 CFR 514.80(b)(5)(ii).  See Section III for a detailed 
description of these postmarketing submission requirements. 
2 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) and the Center for Veterinary Medicine (CVM). 
3 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 
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)).  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. 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
33  volume of real-time information that is continuously posted and shared through various interactive 
34  promotional media platforms. 
35   
36  The organization of the draft guidance is as follows: after some background information regarding 
37  postmarketing submission requirements (Section II), a brief legal overview of statutory and regulatory 
38  requirements for labeling and advertising is presented, including postmarketing submission requirements 
39  (III).  Then, considerations related to submission of interactive promotional media are discussed with 
40  some illustrative examples (IV), and, finally, FDAs recommendations for submitting such promotional 
41  materials are provided (V).   
42   
43  FDAs guidance documents, including this draft guidance, do not establish legally enforceable rights or 
44  responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should be 
45  viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use 
46  of the word should in Agency guidances means that something is suggested or recommended, but not 
47  required.  
48   
49  II.  BACKGROUND   
50   
51  FDAs regulation of prescription drug product promotion extends both to promotional activities that are 
52  carried out by the firm itself, and to promotion conducted on the firms behalf.  In determining whether 
53  the firm is accountable for a communication about its product(s), the Agency considers whether the firm 
54  or anyone acting on its behalf is influencing or controlling the product promotional activity or 
55  communication in whole or part.  Firms may have a variety of options for how much control they exert 
56  over activities that utilize interactive promotional media, regardless of whether the promotional activity 
57  occurs on firm-sponsored or third-party venues.  For example, a firm may promote its products through 
58  product websites, discussion boards, chat rooms, or other public electronic forums that it maintains and 
59  over which it has full control.  In addition, third-party sites (i.e., websites and other venues that are either 
60  entirely independent of a firms control and influence, or not fully controlled by a firm) may promote a 
61  firms products.   
62   
63  As part of the postmarketing reporting requirements under the Federal Food, Drug, and Cosmetic Act 
64  (FD&C Act), application holders are required to submit all promotional labeling and advertising pieces at 
65  the time of initial dissemination of the labeling and at the time of initial publication of the advertisement 
66  for a drug.  However, for some interactive promotional media, submission at the time of initial 
67  dissemination may pose a challenge for firms, particularly when these media communicate information 
68  that is displayed in real time.  While at the time of initial dissemination does not refer to submissions on 
69  a weekly, monthly, or other routine schedule, FDA intends to exercise its enforcement discretion under 
70  certain circumstances due to the high volume of information that may be posted within short periods of 
71  time using interactive promotional media that allow for real-time communications.  If a firm submits 
72  interactive promotional media in the manner described in this draft guidance, FDA intends to exercise 
73  enforcement discretion regarding the regulatory requirements for postmarketing submissions related to 
74  promotional labeling and advertising. 
75   
76  III.   LEGAL OVERVIEW OF STATUTORY AND REGULATORY REQUIREMENTS FOR 
77  LABELING AND ADVERTISING 
78   
79  Under the FD&C Act, the Agency has responsibility for regulating the manufacture, sale, and distribution 
80  of drugs in the United States.  This authority includes oversight of the labeling and advertising of 
81  prescription drugs and biologics (21 U.S.C. 352 (a) & (n)). 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
82     
83  Section 201(m) of the FD&C Act defines labeling as all labels and other written, printed, or graphic 
84  matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article (21 
85  U.S.C. 321(m)).4  The U.S. Supreme Court has explained that the language accompanying such article 
86  in the labeling definition is interpreted broadly, to include materials that supplement or explain an 
87  article.  No physical attachment between the materials and the article is necessary; rather, it is the textual 
88  relationship between the items that is significant.  Kordel v. United States, 335 U.S. 345, 350 (1948).  
89  FDA generally recognizes two types of labeling for drugs: FDA-required labeling and promotional 
90  labeling.  Promotional labeling is generally any labeling, other than the FDA-required labeling, that is 
91  devised for promotion of the product.  Examples of promotional labeling pieces are described at 21 CFR 
92  202.1(l)(2).     
93   
94  Also, under the FD&C Act and FDA's implementing regulations, the applicant shall submit specimens of 
95  mailing pieces and any other labeling or advertising devised for promotion of the drug product at the time 
96  of initial dissemination of the labeling and at the time of initial publication of the advertisement for a 
97  prescription drug product.  Each submission is required to be accompanied by a completed Form FDA 
98  2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) (21 CFR 
99  314.81(b)(3)(i) and 21 CFR 601.12(f)(4)). 
100   
101  For prescription and over-the-counter new animal drugs, the applicant must submit at the time of initial 
102  dissemination one set of specimens of mailing pieces and other labeling.  For prescription new animal 
103  drugs, the applicant must also submit one set of specimens of any advertisement at the time of initial 
104  publication or broadcast.  Each submission of promotional labeling or advertisements must be 
105  accompanied by a completed Form FDA 2301 (21 CFR 514.80(b)(5)(ii)). 
106   
107  IV.  FACTORS CONSIDERED IN DETERMINING POSTMARKETING SUBMISSION 
108  REQUIREMENTS FOR INTERACTIVE PROMOTIONAL MEDIA 
109   
110  FDA considers the following in determining a firms responsibility for submitting interactive promotional 
111  media to FDA as required by postmarketing submission requirements: 
112   
113  1.  A firm is responsible for product promotional communications on sites that are owned, controlled, 
114  created, influenced, or operated by, or on behalf of, the firm. 
115   
116  Such product promotional communications may include firm-sponsored microblogs (e.g., Twitter), social 
117  networking sites (e.g., Facebook), firm blogs, and other sites that are under the control or influence of the 
118  firm.  In determining whether a firm must submit promotional material about its product(s) to FDA, the 
119  Agency considers whether the firm, or anyone acting on its behalf, is influencing or controlling the 
120  promotional activity or communication in whole or part.  Thus, a firm is responsible if it exerts influence 
121  over a site in any particular, even if the influence is limited in scope.  For example, if the firm 
122  collaborates on or has editorial, preview, or review privilege over the content provided, then it is 
123  responsible for that content. 
124   
125  Example 1:  A firm provides on its product website an online forum that gives users the opportunity to 
126  post comments about the use of its product.  In this case, the firm is responsible for submitting to FDA the 
127  product website to meet the postmarketing submission requirements because the firm created, owns, or 
                                                      
4 See also 21 CFR 1.3(a). 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
128  operates the website.  (See the discussion regarding user generated content (UGC) on firm-owned or firm-
129  controlled venues at the end of this section.) 
130   
131  2.  Under certain circumstances, a firm is responsible for promotion on third-party sites.   
132   
133  A firm is responsible for promotion on a third-party site if the firm has any control or influence on the 
134  third-party site, even if that influence is limited in scope.  For example, if a firm collaborates, or has 
135  editorial, preview, or review privilege, then it is responsible for its promotion on the site and, as such, that 
136  site is subject to submission to FDA to meet postmarketing submission requirements.  However, if a firm 
137  provides only financial support (e.g., through an unrestricted educational grant) and has no other control 
138  or influence on that site, then the firm is not responsible for information on a third-party site, and has no 
139  obligation to submit the content to FDA.  Furthermore, if a firm is merely providing promotional 
140  materials to a third-party site but does not direct the placement of the promotion within the site and has no 
141  other control or influence on that site, the firm is responsible only for the content it places there and, thus, 
142  is responsible only for submitting to FDA promotional content that was disseminated on that site. 
143   
144  Example 2:  A firm does not have any control of, or influence on, information on an independent third-
145  party site but chooses to promote its product on this site (e.g., by providing specific promotional content 
146  such as firm-initiated UGC).  In this situation, to meet postmarketing submission requirements, the firm is 
147  responsible for submitting to FDA the promotional content it provided to the site.  (See Section V for 
148  FDAs recommendations for how to submit.)  
149   
150  Example 3:  A firm makes suggestions on the placement of its promotional messages on an independent 
151  third-party site.  Because the firm influenced the placement of its promotion within the third-party site, 
152  the firm is responsible for submitting to FDA the promotion, along with the surrounding pages, to 
153  adequately provide context to facilitate the review of the third-party site, in order to fulfill the 
154  postmarketing submission requirements.   
155   
156  In summary, regardless of financial support, if a firm has any control of, or influence on, the third-party 
157  site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing 
158  submission requirements. 
159   
160  3.  A firm is responsible for the content generated by an employee or agent who is acting on behalf of 
161  the firm to promote the firms product. 
162   
163  FDAs regulation of prescription drug product promotion extends both to promotional activities that are 
164  carried out by the firm itself, and to promotion conducted on the firms behalf.  Therefore, a firm is 
165  responsible for the content generated by its employees or any agents acting on behalf of the firm who 
166  promote the firms product.  For example, if an employee or agent of a firm, such as a medical science 
167  liaison or paid speaker (e.g., a key opinion leader) acting on the firms behalf, comments on a third-party 
168  site about the firms product, the firm is responsible for the content its employee or agent provides.  A 
169  firm is also responsible for the content on a bloggers site if the blogger is acting on behalf of the firm.  
170  Therefore, a firm is responsible for UGC and communications of its employees or anyone acting on 
171  behalf of the firm and, as such, those materials are subject to submission to FDA to meet the 
172  postmarketing submission requirements. 
173   
174  All UGC meeting these parameters for interactive promotional media should be submitted to the FDA as 
175  recommended below in Section V. 
176   
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
177  Example 4:  A sales representative acting on behalf of a firm posts comments about the innovative release 
178  mechanism of the firms product on an independent third-party site.  Because the sales representative is 
179  acting on behalf of the firm, the firm is responsible for submitting the comments to FDA to meet the 
180  postmarketing submission requirements. 
181   
182  Example 5:  A representative of a firm, such as a blogger paid by the firm, maintains a blog about the 
183  firms product.  The firm is responsible for submitting the blog to FDA to meet the postmarketing 
184  submission requirements. 
185   
186  FDA recommends that a firm be transparent in disclosing its involvement on a site by clearly identifying 
187  the UGC and communications of its employees or third parties acting on behalf of the firm.  This could be 
188  achieved by inclusion of the firm's identifier (e.g., name or logo) as part of the communication.  However, 
189  a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, 
190  or on behalf of, or prompted by the firm in any particular).5  FDA will not ordinarily view UGC on firm-
191  owned or firm-controlled venues such as blogs, message boards, and chat rooms as promotional content 
192  on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on 
193  the UGC. 
194   
195  FDA recommends that a firm submit to the Agency on Form FDA 2253 or Form FDA 2301 specimens of 
196  the interactive promotional media being used on the firm-owned or firm-controlled venue (e.g., blog, 
197  message board, or chat room), as described below in Section V.  FDA recognizes that firms may be 
198  submitting both firm-generated and independent UGC on Form FDA 2253 or Form FDA 2301 as both 
199  firm-generated and independent UGC may be dispersed throughout the interactive promotional venue.    
200   
201  V.  RECOMMENDATIONS FOR SUBMITTING INTERACTIVE PROMOTIONAL MEDIA 
202   
203  FDA recognizes the challenges of submitting promotional materials that display real-time information 
204  and, in this section, recommendations for submitting interactive promotional media are provided.  If a 
205  firm submits interactive promotional media in the manner described in this draft guidance, FDA intends 
206  to exercise enforcement discretion regarding the regulatory requirements for postmarketing submissions 
207  related to promotional labeling and advertising.  However, the Agencys expectations for submitting static 
208  promotional materials (e.g., sites that do not allow real-time communications and emails with 
209  predetermined content) that are substantially similar to traditional promotional materials in presentation 
210  and content remain unchanged.6 
211   
212  Unless otherwise specified in this guidance, the principles set forth below apply to the submission of 
213  interactive promotional media that display real-time communications, regardless of the target audience.  
                                                      
5 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). 
6 Please note that the Agency expects that submissions of static promotional materials should remain unchanged.  
For example, a firm should submit its entire static product website at the time of first use.  If the firm then updates 
one page or section of this static product website, the firm can submit only the updated page or section with a cross-
reference to the original submission of the website noted on Form FDA 2253 or Form FDA 2301, including the date 
of the original submission.  If the website is substantially revised, the firm should submit the revised website in its 
entirety. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
214  The examples and recommendations provided are intended to provide guidance and illustrate possible 
215  approaches.  Firms are free to use alternative approaches if these approaches satisfy the requirements of 
216  the statute and regulations.   
217   
218  1.  At the time of initial display, a firm should submit in its entirety all sites for which it is responsible 
219  on Form FDA 2253 or Form FDA 2301.  For example, the firm should submit the comprehensive 
220  static product website with the addition of the interactive or real-time components.7   
221   
222  The firm should include annotations to describe the parts that are interactive and allow for real-time 
223  communications.  Any subsequent changes should be annotated and resubmitted to the Agency on Form 
224  FDA 2253 or Form FDA 2301 at the time of initial display (i.e., resubmission).  The firm should also 
225  provide a cross-reference by noting the submission date of the most recent version of the site in the 
226  comments section of the form.  However, after the initial submission or resubmission, if the site is 
227  publically accessible without restrictions such as a password or subscription (non-restricted) and  
228  remains unchanged other than displaying real-time information, FDA does not intend to object if the firm 
229  submits to the Agency on Form FDA 2253 or Form FDA 2301 an updated listing of the site that does not 
230  include screenshots or other visual representations of the actual interactive or real-time communication, as 
231  described in number 3 below. If access to the site is restricted (e.g., is password protected or a 
232  subscription is required), see number 4 below. 
233   
234  2.  For third-party sites on which a firms participation is limited to interactive or real-time 
235  communications, a firm should submit the home page of the third-party site, along with the 
236  interactive page within the third-party site and the firms first communication, on Form FDA 2253 or 
237  Form FDA 2301 at the time of initial display.   
238   
239  The firm may include any annotations that describe its communications within the third-party site.  After 
240  the initial submission, if the firm remains an active participant on the third-party site, and that site is non-
241  restricted, FDA does not intend to object if the firm submits to the Agency on Form FDA 2253 or Form 
242  FDA 2301 an updated listing of the site that does not include screenshots or other visual representations 
243  of the actual interactive or real-time communication, as described in number 3 below.  If access to the site 
244  is restricted, see number 4 below. 
245   
246  3.  Once every month, a firm should submit an updated listing of all non-restricted sites for which it is 
247  responsible or in which it remains an active participant and that include interactive or real-time 
248  communications.  Firms need not submit screenshots or other visual representations of the actual 
249  interactive or real-time communications with the monthly updates. 
250   
251  Once every month, the firm should submit a Form FDA 2253 or Form FDA 2301 for the non-restricted 
252  sites for which the firm is responsible or in which it remains an active participant and that include 
253  interactive or real-time communications.  Multiple sites and the corresponding documents can be 
254  submitted with a single Form FDA 2253 or Form FDA 2301.  Firms should include a separate document 
255  for each site which includes the site name, URL, and date range, as well as a cross-reference to the date of 
256  the most recent submission of the site.  Screenshots or other visual representations of the actual 
257  interactive or real-time communications need not be submitted with the monthly updates if the site is non-
                                                      
7 It is preferable for the firm to submit the interactive or real-time communications in an archivable format that 
allows FDA to view and interact with the submission in the same way as the end user (e.g., working links).  
Alternatively, firms should submit screen shots or other visual representations. 
 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
258  restricted.  The appropriate FDA center (CDER, CBER, or CVM) should be informed via general 
259  correspondence on the first day the firm ceases to be active on a site. 
260   
261  4.  However, if a site has restricted access and, as such, FDA may not have access to the site, a firm   
262  should submit all content related to the discussion (e.g., all UGC about the topic), which may or may 
263  not include independent UGC, to adequately provide context to facilitate the review.  Screenshots or 
264  other visual representations of the actual site, including the interactive or real-time communications, 
265  should be submitted monthly on Form FDA 2253 or Form FDA 2301. 
266   
267  5.  When submitting the site, FDA recommends that a firm take formatting factors (e.g., appearance, 
268  layout, visual impression) into consideration to enable the Agency to view the communications as a 
269  whole. 
  7