Brief Summary and Adequate Directions 

for Use:  Disclosing Risk Information in 

Consumer-Directed Print Advertisements 

and Promotional Labeling for 

Prescription Drugs 

 
Guidance for Industry 

 
 
 
REVISED DRAFT GUIDANCE
 
 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 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 Communications, Outreach and Development, at 800-835-4709 or 240-402-
7800; or (CVM) Thomas Moskal at 240-402-6251.   
 
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) 

 
August 2015 
Advertising  
Revision 2 
   
Brief Summary and Adequate Directions for 

Use:  Disclosing Risk Information in Consumer-

Directed Print Advertisements and Promotional 

Labeling for Prescription Drugs 

 
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., 4th Floor 

Silver Spring, MD 20993-0002 
  
Phone: 855-543-3784 or 301-796-3400;  Fax: 301-431-6353 

 druginfo@fda.hhs.gov  

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm  
and/or 

 Office of Communication, Outreach and Development  

Center for Biologics Evaluation and Research 
 
 Food and Drug  Administration 
 
10903 New Hampshire Ave., Bldg. 71, rm. 3128, 

Silver Spring, MD 20993-0002 

 Phone: 800-835-4709 or 240-402-7800 

ocod@fda.hhs.gov 
 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm    
and/or 
 
Policy and Regulations  Staff 

 Center for Veterinary Medicine 
 
Food and  Drug Administration 
 
7519 Standish Pl., Rockville, MD 20855 

Phone: (240) 402-7075 

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) 

 
August 2015 

Advertising 
 
Revision 2
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
TABLE OF CONTENTS  
 
 
I.   INTRODUCTION............................................................................................................. 1
  
II.   BACKGROUND ............................................................................................................... 2
  
A.   Legal Overview .............................................................................................................................. 2
  
B.   Policy Overview.............................................................................................................................. 4
  
III. 	  OPTIONS FOR DISCLOSING RISK INFORMATION IN CONSUMER-
DIRECTED PRESCRIPTION DRUG PRINT ADVERTISEMENTS AND 

PROMOTIONAL LABELING  ....................................................................................... 5 
 
A.   Language and Readability ............................................................................................................ 6
  
B.   Content............................................................................................................................................ 6
  
C.   Format........................................................................................................................................... 10 
 
1.  Prescription Drug Facts Box ......................................................................................................... 10 
 
2.  Question and Answer ..................................................................................................................... 10 
 
REFERENCES............................................................................................................................ 12 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Brief Summary and Adequate Directions for Use:  Disclosing Risk 
1 
Information in Consumer-Directed Print Advertisements and 
2 
Promotional Labeling for Prescription Drugs  
3 
 
4 
1 
Guidance for Industry  
5 
6   
7   
8  This revised draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9  Administration (FDA or Agency) on this topic.  It does not create any rights for any person and is not  
10  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
11  applicable statutes and regulations. To  discuss an alternative approach, contact the FDA staff responsible 
12  for this guidance as listed on the title page.  
13   
14   
15   
16  I.  INTRODUCTION  
17   
18  This revised draft guidance provides recommendations on the disclosure of risk information in 
19  prescription drug product advertisements and promotional labeling in print media directed 
20  toward consumers with respect to the brief  summary requirement and the requirement that 
21  adequate directions for use be included with promotional labeling.2  The recommendations 
22  describe an alternative disclosure approach that FDA refers to as a consumer brief summary.   
23  This revised draft guidance does not focus on the presentation of risk information in the main 
24  body of promotional labeling or advertisements and does not apply to promotional materials 
25  directed toward health care professionals.  
26   
27  This revised draft guidance responds to stakeholder requests for specific guidance on the 
28  disclosure of risk information to consumers and incorporates recent social science research 
29  results (Aikin, ODonoghue, et al. 2011). This revised draft guidance revises the draft guidance 
30  entitled Brief Summary:  Disclosing Risk Information in Consumer-Directed Print 
31  Advertisements (issued January 2004).  Additionally, this revised draft guidance (Revision 2) has 
32  been reissued to incorporate animal prescription drugs; there are no other revisions to the revised 
33  draft guidance for industry issued February 9, 2015 (80 FR 6998).   
                                                 
1  This 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)  at the Food and Drug Administration.  
2 The recommendations of this revised 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 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, 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 in  this guidance therefore also include biological products  for use in  
humans that fall within the definition, as well as both human and animal prescription drugs.   
  1
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
34  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
35  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
36  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
37  the word should in Agency guidances means that something is suggested or recommended, but 
38  not required. 
39   
40  II.  BACKGROUND 
41   
42  A.   Legal Overview 
43   
44  Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Agency has responsibility for 
45  regulating the manufacture, sale, and distribution of drugs in the United States.  This authority 
46  includes oversight of the labeling of drugs (21 U.S.C. 352(a)) and the advertising of prescription 
47  drugs (21 U.S.C. 352(n)). 
48   
49  A print advertisement3 for a prescription drug must contain a true statement of the products 
50  established name; quantitative composition; information in brief summary relating to side 
51  effects, contraindications, and effectiveness; and, for published direct-to-consumer 
52  advertisements, a statement encouraging consumers to report negative side effects to FDA (21 
53  U.S.C. 352(n)).  FDA implementing regulations provide further clarification on the information 
54  to include in brief summary:  a true statement of information in brief summary relating to side 
55  effects, contraindications ([to] . . . include side effects, warnings, precautions, and 
56  contraindications and include any such information under such headings as cautions, special 
57  considerations, important notes, etc.) and effectiveness (21 CFR 202.1(e)(1)).  This information 
58  shall disclose each specific side effect and contraindication . . . contained in required, approved, 
59  or permitted labeling for the advertised drug dosage form(s) . . . (21 CFR 202.1(e)(3)(iii)).  For 
60  purposes of this guidance, the requirement under these provisions that an advertisement for a 
61  prescription drug disclose each side effect, warning, precaution, and contraindication from the 
62  labeling will be referred to as the brief summary requirement. 
63   
64  FDA also has responsibility for regulating labeling for prescription drugs, including promotional 
65  labeling. Section 201(m) of the FD&C Act defines labeling as all labels and other written, 
66  printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) 
67  accompanying such article (21 U.S.C. 321(m)).4  The U.S. Supreme Court has explained that 
68  the language accompanying such article in the labeling definition is interpreted broadly, to 
69  include materials that supplement or explain an article.  No physical attachment between the 
70  materials and the article is necessary; rather, it is the textual relationship between the items that 
71  is significant (Kordel v. United States, 335 U.S. 345, 350 (1948)). FDA generally recognizes 
                                                 
3  The FD&C Act does not  define  what constitutes an advertisement, but FDA regulations provide several 
examples, including advertisements in  published journals, magazines, other periodicals, and newspapers, and  
advertisements broadcast through media such as radio, television, and telephone communication systems (21 CFR  
202.1(l)(1)).  Broadcast advertisements, such  as radio and television advertisements, are not the subject of this 
guidance. 
4 See also  21 CFR 1.3(a). 
  2
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
72  two types of labeling for drugs:  (1) FDA-required labeling5 and (2) promotional labeling.  
73  Promotional labeling is generally any labeling, other than the FDA-required labeling, that is 
74  devised for promotion of the product.  Examples of materials that may be considered 
75  promotional labeling pieces for prescription drugs are described in 21 CFR 202.1(l)(2).   
76   
77  While drug labeling generally must bear adequate directions for use (21 U.S.C. 352(f)(1), 
78  prescription drugs are exempt from this requirement if certain conditions are met.  These 
79  conditions include, among others, that any labeling (as defined in section 201(m)  of the FD&C 
80  Act) that is distributed by or on behalf of the manufacturer, packer, or distributor of the drug, 
81  that furnishes or purports to furnish information for use or which prescribes, recommends, or 
82  suggests a dosage for the use of the drug contains adequate information for such use (21 CFR 
83  201.100(d) and 21 CFR 201.105(d)). Adequate information for such use includes, among 
84  other things, relevant warnings, hazards, contraindications, side effects, and precautions, under 
85  which practitioners licensed by law to administer the drug can use the drug safely and for the 
86  purposes for which it is intended, including all conditions for which it is advertised or 
87  represented . . . (21 CFR 201.100(d)(1); see also 21 CFR 201.105(d)(1)).6  The regulations also 
88  require that if the article is subject to section 505, 512, or 572 of the FD&C Act, the parts of the 
89  labeling providing such information for use are the same in language and emphasis as labeling 
90  approved or permitted under the provisions of sections 505, 512, or 572.  (Id.) 
91   
92  In addition, in order to be exempt from the adequate directions for use requirement in 21 
93  U.S.C. 352(f), any labeling for human prescription drugs described in 21 CFR 201.100(d) must 
94  contain the information required, and in the same format specified by 21 CFR 201.56, 201.57, 
95  and 201.80 (21 CFR 201.100(d)(3)). Generally, the requirements in 21 CFR 201.100(d) have 
96  been fulfilled by including the full FDA-approved package insert (PI) with promotional labeling 
97  materials.  For purposes of this guidance, the requirement under these provisions that a 
98  prescription drug promotional labeling piece include the information set forth in 21 CFR 
99  201.100(d) for prescription human drugs and 21 CFR 201.105(d) for prescription animal drugs, 
100  which is generally fulfilled by inclusion of the full PI, will be referred to as the adequate 
101  directions for use requirement. 
102    
103  To fulfill the brief summary requirement, consumer-directed print advertisements for 
104  prescription drugs frequently include the complete risk-related sections of the PI (also known as 
105  the traditional approach or traditional format).  To fulfill the adequate directions for use 
106  requirement for promotional labeling pieces, the full PI has generally been used.  As discussed 
107  more fully in section II.B, FDA believes these approaches are not optimal for consumer-directed 
108  prescription drug print advertisements and promotional labeling pieces because many consumers 
                                                 
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),  and 601.2(a)).   For  a prescription drug 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), and 201.105(c)(1)). 
6 Adequate information for use under  21 CFR 201.100(d)(1) and 201.105(d)(1) also includes indications, effects, 
dosages, routes, methods,  and frequency  and duration of administration.  
  3
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
109  lack the technical background to understand some of the information as described in the PI.  
110  Additionally, information that may be of limited use to consumers (e.g., clinical pharmacology) 
111  is included. For these reasons, if manufacturers, packers, and distributors, or anyone acting on 
112  their behalf (firms) include the appropriate information discussed in this guidance, FDA does not 
113  intend to object for failure to include each side  effect from the PI in the brief summary in 
114  consumer-directed print advertisements.  Furthermore, if firms include the appropriate 
115  information discussed in this guidance, FDA does not intend to object for failure to include the 
116  entire PI to fulfill the requirements of 201.100(d) or 201.105(d) for consumer-directed  
117  promotional labeling pieces.  
118   
119  In other words, this revised draft guidance recommends alternative approaches firms may use to 
120  develop content that can be used to fulfill both the brief summary requirement for consumer-
121  directed prescription drug print advertisements and the requirements in 201.100(d) or 201.105(d) 
122  for consumer-directed prescription drug print promotional labeling pieces. Suggested research-
123  tested formats for this information are also provided in this revised draft guidance.  The 
124  examples included throughout are intended to provide guidance and illustrate possible 
125  approaches; firms may use alternative approaches if these approaches satisfy the requirements of 
126  the statute and regulations. 
127   
128  B.   Policy Overview 
129   
130  To provide better and more actionable information for consumers, FDA believes that the brief 
131  summary should focus on the most important risk information rather than an exhaustive list of 
132  risks and that the information should be presented in a way most likely to be understood by 
133  consumers.  Thus, FDA strongly recommends against the use of the traditional approach to fulfill 
134  the brief summary requirement in consumer-directed advertisements, an approach in which risk-
135  related sections of the PI are presented verbatim, often in small font.  Because the target audience 
136  of the PI is health care providers, it is written in highly technical medical terminology, which is 
137  potentially of limited value to consumers who may not have the medical or scientific background 
138  to understand this information.  In an FDA survey, few respondents reported reading half or 
139  more of the brief summary presented in the traditional format.  Of those who read at least some  
140  of the brief summary, 55 percent described it as hard to read.  Over 40 percent of respondents in 
141  the survey reported they do not usually read any of the brief summary in direct-to-consumer 
142  prescription drug print advertisements (Aikin, Swasy, et al. 2004).   
143   
144  Furthermore, the risk information in the PI sometimes includes lengthy lists of all possible 
145  adverse events. In general, FDA believes that exhaustive lists that include even minor risks 
146  detract from, and make it difficult for, consumers to comprehend and retain information about 
147  the more important risks.  While remaining an important source of information for consumers, 
148  even the volume of material in excerpted sections of the PI, along with the format (i.e., a smaller 
149  font with limited white space) and the technical language, may serve to detract from consumers 
150  comprehension of the information or from the likelihood of consumers reading the material in its 
151  entirety. Research has demonstrated that people process only a limited amount of information at 
152  one time both in general communications (Lavie 2001; Miller 1994; Shapiro 2001) and in direct-
153  to-consumer prescription drug advertising specifically (Stotka, Rotelli, et al. 2007).  Past 
154  research has shown that alternative formats for the brief summary outperform the traditional, 
  4
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
155  non-consumer-friendly brief summary on measures of consumer risk comprehension (Riggs, 
156  Holdsworth, et al. 2004; Schwartz, Woloshin, et al. 2009; Stotka, Rotelli, et al. 2007; Thumma  
157  1997). 
158   
159  Occasionally, sections taken from the PI to fulfill the brief summary requirement are rewritten in 
160  a manner that is meant to be more understandable to consumers.  However, this approach does 
161  not necessarily solve the problems with the traditional approach.  In research conducted by FDA, 
162  participants who viewed the brief summary information in a format similar to the over-the-
163  counter (OTC) Drug Facts box had better risk recall than those who viewed a traditional, but 
164  consumer-friendly, version of the brief summary.  Two additional alternative formats (a Question 
165  and Answer (Q&A) format and a Highlights version from the content and format rule of 20067) 
166  did not differ from the consumer-friendly traditional format on risk recall or confidence (Aikin, 
167  ODonoghue, et al. 2011).8  
168   
169  For similar reasons that are further exacerbated by  the length and complexity of the full approved 
170  professional labeling, FDA also strongly recommends against providing the full PI to satisfy the 
171  adequate directions for use requirement for consumer-directed print promotional labeling pieces 
172  for prescription drugs. While the Agency recognizes that 21 CFR 201.100(d) and 21 CFR 
173  201.105(d) identify the PI as a source for furnishing adequate directions for use, FDA believes 
174  that following the content and format recommendations in this guidance will better communicate 
175  information and help consumers make informed decisions about the medication being promoted.  
176  By adopting the content and format recommendations in this guidance, firms can also provide 
177  consumers with the same information in both advertising and promotional labeling pieces.   
178   
179  III.   OPTIONS FOR DISCLOSING RISK INFORMATION IN CONSUMER-
180  DIRECTED PRESCRIPTION DRUG PRINT ADVERTISEMENTS AND 
181  PROMOTIONAL LABELING  
182   
183  FDA does not intend to object if a firm does not include each specific side effect and 
184  contraindication from the PI in the brief summary in consumer-directed print advertisements 
185  (21 CFR 202.1(e)(3)(iii)), or does not supply the entire PI to fulfill the requirements in 21 CFR 
186  201.100(d) or 21 CFR 201.105(d) for consumer-directed print promotional labeling pieces, so 
187  long as the firm follows the recommendations and examples in this guidance.  These alternate 
188  approaches will not become a part of FDA-approved labeling.   
189   
190  For purposes of this guidance, in the text and examples below, the consumer-directed 
191  document recommended by FDA as an alternative to the full PI or the risk portions of the 
192  PI in consumer-directed prescription drug print promotional labeling pieces and the brief 
                                                 
7  See 21  CFR 201.56,  201.57, 201.58, and 201.80.  
8  Participants who viewed the brief summary information in  a format similar to the OTC Drug Facts box  had better 
risk  recall, greater confidence in their ability to  perform  tasks related to the brief summary, more positive attitudes 
toward the ad, and greater preference for the format than did those who viewed a traditional, but consumer-friendly, 
version of the brief summary.  Participants had more positive attitudes toward the Q&A format and the Highlights 
format than toward the traditional format, and  participants who  viewed the Q&A format had more positive attitudes 
toward the ad than those who viewed the traditional format.  
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193  summary requirement in consumer-directed prescription drug advertisements will be 
194  referred to as the consumer brief summary. 
195   
196  A.  Language and Readability 
197   
198  FDA strongly encourages the use of consumer-friendly language in all consumer-directed 
199  materials.  The consumer brief summary should be written in language designed for 
200  understanding by a broad target audience with various levels of literacy skills.  Technical 
201  language, scientific terms, and medical jargon should be avoided.  A conversational tone or 
202  language designed to engage the reader may be useful, such as in the following examples. 
203   
204     do not use if you have . . . or who should not use . . . rather than 
205  contraindications 
206     what is [drug name] rather than indication  
207     drowsiness not somnolence  
208     fainting not syncope 
209   
210  The information in the consumer brief summary must be presented in a readable format (21 
211  U.S.C. 352(c); 21 CFR 202.1(e)(7)(viii)).  Different techniques can be used to assist consumers 
212  with comprehension of information.  For example, signals,9 such as headlines and subheadings, 
213  help communicate important information (Loman and Mayer 1983; Meyer 2003; Spyridakis and 
214  Standal 1987). Consumers are influenced by the layout of print information in their ability to 
215  pay attention to and process specific features of a document (Adams and Edworthy 1995; 
216  Brundage, Feldman-Stewart, et al. 2005; Frantz 1993; Morrow, Leirer, et al. 1995; Niemela and 
217  Saariluoma 2003; Wogalter and Vigilante 2003).  Font size and type style can affect the 
218  readability of information (Adams and Edworthy 1995; Arditi and Cho 2005; Baker 2006; 
219  Sheedy, Subbaram, et al. 2005; Tantillo and Mathisen 1995; Wogalter and Vigilante 2003). 
220   
221  Therefore, the consumer brief summary should be presented visually in a manner designed for 
222  ease of use by consumers.  Carrying over elements of the main body of the ad (such as logos and 
223  branded colors) may help the reader understand the connection between the consumer brief 
224  summary and the promotional piece.  Font size and style should be selected or designed for 
225  readability. Using double spacing between paragraphs and indentations, as opposed to plain 
226  block paragraphs, helps maximize background space (also called white space) and improves 
227  readability. Arranging information in text boxes (i.e., paragraphs of information on a similar 
228  topic surrounded by borders) with headings (Hyona and Lorch 2004) and other attention-drawing 
229  symbols (e.g., bullets, capitalization of select words or phrases) may also be useful to consumers. 
230   
231  B.  Content 
232   
233  FDAs current thinking is that the consumer brief summary should provide clinically significant 
234  information on the most serious and the most common risks associated with the product and omit 
                                                 
9  Signaling has been defined  as the use of writing devices designed to  emphasize aspects of a texts structure or  
content without altering the information in  the text (Lorch, Lorch, et al. 1993).  
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235  less pertinent information.  FDA recommends that firms look to available standards to determine 
236  which risks should be included. For example, FDA-approved patient labeling and Medication 
237  Guides, or, for animal drugs, a client information sheet, if available for the drug at issue, may be 
238  an appropriate starting point to determine which risks should be included in the consumer brief 
239  summary and, in fact, may contain the same risk information that should appear in the consumer 
240  brief summary.  However, some information in patient labelingsuch as information found in 
241  the Directions for Use section (for human prescription drugs) or the client information sheet (for 
242  animal drugs)is not necessary to include in the consumer brief summary.  Additionally, 
243  information not contained in patient labeling, such as information about certain relevant drug 
244  risks, might need to be added to the consumer brief summary. 
245   
246  Under the final rule for Requirements on the Content and Format of Labeling for Human 
247  Prescription Drug and Biological Products (the Physician Labeling Rule or PLR),10 the 
248  labeling of new and recently approved products11 must include Highlights of Prescribing 
249  Information (Highlights).  FDA believes the criteria used for selecting risk information for the 
250  Highlights section are an appropriate reference for firms to use when determining which risk 
251  information topics to address in the consumer brief summary.  See 21 CFR 201.57(a). In 
252  addition, information in the consumer brief summary should be placed in an order similar to 
253  information in the Highlights section (Boxed Warning followed by Contraindications, Warnings 
254  and Precautions, etc.).  However, since information in the Highlights section is intended for use 
255  in conjunction with information in the full PI and the full PI is not being provided, generally the 
256  information in the consumer brief summary should be more detailed and provide more material 
257  information than what is contained in the Highlights.  For drugs for which the PLR is not 
258  applicable (i.e., new animal drugs and some human drugs), similar information can be taken 
259  from the analogous sections of each drugs PI.  
260   
261  For each of the formats discussed below, or for alternative formats, information addressing the 
262  following should be included: 
263   
264     Boxed Warning12  
265     All Contraindications 
266     Certain information regarding Warnings and Precautions:  
267  o   the most clinically significant information from the Warnings and Precautions 
268  section(s) of the PI; 
269  o   information that would affect a decision to prescribe or take a drug;  
270  o   monitoring or laboratory tests that may be needed;  
271  o   special precautions not set forth in other parts of the PI; and 
272  o   measures that can be taken to prevent or mitigate harm.   
273   
                                                 
10 Requirements on the Content  and Format of Labeling for Human Prescription Drug and Biological Products (71 
 
FR 3922, Jan  24, 2006). 

11 The PLR applies to  human prescription  drugs that were approved after,  on, or  5 years prior to the effective date of  

the rule, and to older drugs for which certain supplements are submitted (21 CFR 201.56(b)). 

12 Certain  recommendations will not apply to all drugs.  For example, not all drugs have a Boxed  Warning.  If a 

recommendation is not applicable, the information should  be  omitted. 
 
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274  FDA also recommends that the most frequently13 occurring Adverse Reactions be included in the 
275  consumer brief summary.14  If a product has more than one indication, the most common 
276  Adverse Reactions for each indication being promoted should be included, if included in the PI, 
277  rather than pooled results for all indications (which could include indications that are not being 
278  promoted).  Adverse Reactions should be listed in the same order as in the PI. 
279   
280  Other important Adverse Reactions, such as those that are serious15 or those that lead to 
281  discontinuation of the drug or dosage adjustment, should be included unless they are repeated 
282  elsewhere in the PI (e.g., risks included in Warnings and Precautions).   
283   
284  Material information regarding any of these risks may also include the severity of the risks, such  
285  as whether they are debilitating, life-threatening, irreversible, or whether stopping the medication 
286  will alleviate or mitigate the risks.  If early warning signs of risks are known, consumers should 
287  be given information about these signs and the importance of informing their health care 
288  provider about the signs. Firms may also include information regarding the need for monitoring 
289  or testing during treatment.  Other material information may be relevant depending on the drug 
290  and its risk profile. 
291   
292  FDA also believes that the consumer brief summary should include the indication for the use 
293  being promoted, any clinically significant drug interactions,16 and information regarding topics 
294  or issues consumers should discuss with their health care providers (e.g., other drugs they are 
295  taking or pre-existing conditions).  Other types of information may be included if relevant to the 
296  drug or specific indication referred to in the promotion (e.g., that a drug is not indicated for use 
297  for more than 4 weeks for the indication being advertised even if a different indication allows for 
298  a longer use). Information relating to special populations (e.g., children or young animals, the 
299  elderly or geriatric animals, pregnant or nursing women or animals, people or animals with liver 
300  or renal impairment, food-producing animals) should be included if they are of particular 
                                                 
13 The list of Adverse Reactions identified as most frequently occurring or most common is usually generated  from a 
table of Adverse Reactions from clinical trials in the approved labeling.   Rates of most common Adverse Reactions  
vary, but should  be appropriate to the nature of a drugs Adverse Reactions profile and the size and composition  of  
the safety database.  See the guidance for industry entitled  Labeling for Human Prescription Drug and  Biological  
ProductsImplementing the PLR Content and Format Requirements (Feb 2013), available on the Internet at 
http://www.fda.gov/Drugs/default.htm under Guidances (Drugs).   
14 This recommendation comports with the information required in the Highlights section (21 CFR  201.57(a)(11)),  
and is also applicable to  drugs to  which the PLR does not apply.  
15  Serious Adverse Reaction  refers to any reaction occurring at any dose that results in any of the following 
outcomes:  death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent  or  significant  disability or incapacity, or a congenital anomaly or birth  defect.  Important  
medical events that may not result in death,  be life-threatening, or  require  hospitalization may be considered serious  
Adverse Reactions when, based upon appropriate medical judgment, they  may jeopardize the patient  or subject, and 
may require medical or surgical intervention to prevent one of the outcomes listed in this definition.  See the 
guidance for industry entitled  Adverse Reactions Section of  Labeling for Human Prescription Drug and  Biological  
ProductsContent and Format  (Jan  2006).  For animal drugs, the term  serious adverse drug experience is defined 
as an adverse event that is fatal, or life-threatening,  or requires professional intervention, or causes an abortion, or  
stillbirth, or infertility, or congenital anomaly, or prolonged or permanent disability, or disfigurement (21 CFR 
514.3). 
16 For example, for a drug with PLR labeling, typically the most clinically significant drug  interactions appear in the 
Contraindications or Warnings and Precautions sections. 
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301  concern based on the drugs known or potential safety profile (e.g., not recommended for use in 
302  children based on adverse events; not for use in nursing women due to the potential for harm to 
303  the infant; drug withdrawal periods in different animal populations). 
304   
305  In general, certain information found in the PI or in FDA-approved patient labeling can be 
306  excluded from the consumer brief summary.  This information might include dosage and 
307  administration, how the drug is supplied, clinical pharmacology, specific directions regarding use 
308  of the drug (such as how to perform an injection or how to use a patch), or how long the drug 
309  takes to work. However, excluding certain information from the consumer brief summary does 
310  not mean that the same information can be omitted from other parts of the promotional piece 
311  (e.g., information that a drug is administered via an injection versus orally might be material 
312  information that is required in the main body of the promotional piece, while detailed 
313  instructions for use may be omitted from the consumer brief summary).   
314   
315  FDA also recommends that, because the risk information in the consumer brief summary is not 
316  comprehensive, the consumer brief summary should include a statement (1) reminding 
317  consumers that the information presented is not comprehensive; (2) suggesting that consumers 
318  speak to their health care provider, veterinarian, or pharmacist; and (3) containing a toll-free 
319  telephone number or website address (uniform resource locator or URL) where consumers can 
320  obtain the FDA-approved product labeling.17  For example: 
321   
322     The risk information provided here is not comprehensive. To learn more, talk 
323  about [drug name] with your health care provider or pharmacist [veterinarian].  
324  The FDA-approved product labeling can be found at www.drugnamePI.com or 1-
325  800-555-DRUG.  
326   
327     This information is not comprehensive. 
328     How to get more information:   
329    Talk to your health care provider or pharmacist [veterinarian]  
330    Visit www.drugnamePI.com to obtain the FDA-approved product labeling 
331    Call 1-800-555-DRUG 
332   
333  The consumer brief summary may also contain a title such as Important Facts or Summary of 
334  Information about . . . along with the drugs name.18  
335   
336  When the PI is revised, the consumer brief summary for the drug must be reviewed and revised 
337  promptly if pertinent information has been changed  (21 CFR 314.70(a)(4), 514.8(c)(2), and 
338  601.12(a)(4)). 
339   
                                                 
17 This  recommendation is distinct and separate from the adequate  provision requirement for broadcast  
advertisements found at  21 CFR 202.1(e)(1).  This  guidance only covers print advertisements and print  promotional  
labeling and does not  apply  to broadcast  advertisements.  
18  See the revised  draft guidance for industry entitled  Product  Name Placement, Size, and Prominence in Advertising  
and Promotional  Labeling (Nov  2013).  When final, this guidance will represent the FDAs current thinking on this 
topic.  
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340  C.  Format 
341   
342  Various formats may be used when conveying information in the consumer brief summary.  
343  Although other formats may be acceptable, the following two sections describe recommended 
344  formats that have been tested in research.  
345   
346  1.   Prescription Drug Facts Box 
347   
348  Ever since the labeling rule for OTC human drugs was finalized more than a decade ago,19 OTC 
349  products have contained a Drug Facts box on each product.  For the consumer brief summary, a 
350  layout similar to the OTC Drug Facts box may be familiar to consumers and may offer 
351  advantages over other formats.  In a study testing various brief summary formats, the Drug Facts 
352  box format resulted in better recall of the risk information when compared to the traditional 
353  format (which was written in consumer-friendly language).  Consumers in the same study who 
354  saw the Drug Facts box also reported that they felt more confident in their ability to use the 
355  information when compared to consumers who saw the traditional format.  In addition, 
356  consumers had more positive attitudes toward the Drug Facts box format than toward two other 
357  formats:  the traditional format and a format that is structured like the Highlights section of the 
358  PI (Aikin, ODonoghue, et al. 2011). 
359   
360  Under a prescription Drug Facts box format, information could appear within a box similar to the 
361  OTC Drug Facts box. Standardized headings may assist consumers in locating and 
362  comprehending important drug information.  For example:  
363   
364     Uses 
365     Do not use if you 
366     Warnings 
367     Ask a health care provider before use if 
368     When using this product you may have 
369   
370  The recommended content for this format is set forth in section III.B above, and the 
371  recommendation to use consumer-friendly language also applies.  
372   
373  2.  Question and Answer 
374   
375  A Question and Answer (Q&A) format simulates a dialogue using personal pronouns, thus 
376  increasing consumer interest in, and comprehension of, the information.  The study testing brief 
377  summary formats found that consumers had more positive attitudes toward a Q&A format than 
378  the traditional brief summary (which was written in consumer-friendly language).  However, this  
379  study did not find a difference in risk recall or confidence between the Q&A format and the 
380  traditional format.  Because consumers preferred the Q&A format and the format did not 
                                                 
19 See Food and Drug Administration, Final  Rule; Over-The-Counter  Human Drugs, Labeling Requirements (64 
FR 13254, Mar 17, 1999).  
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381  decrease risk recall (Aikin, ODonoghue, et al. 2011), this format is recommended over the 

382  traditional brief summary. 

383 
  
384  Under the Q&A format, information in the consumer brief summary could appear in columns or 

385  a similar layout.  Headings would be framed in the form of questions, for example: 

386 
  
387     What is [drug] used for? 

388     When should I not take [drug]? 

389     What Warnings should I know about [drug]?
  
390     What should I tell my health care provider?
   
391     What are the side effects of [drug]? 

392     What other medications might interact with [drug]?  

393 
  
394  The recommended content for this format is set forth in section III.B above, and the 

395  recommendation to use consumer-friendly language also applies. 
 
396 

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397  REFERENCES  
398   
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402   
403  Aikin, KJ, AC ODonoghue, J Swasy, and HW  Sullivan, 2011, A Randomized Trial of Risk 
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406   
407  Aikin, K, J Swasy, and A Braman, 2004, Patient and Physician Attitudes and Behaviors 
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420   
421  FDA guidance for industry, 2013, Product Name Placement, Size, and Prominence in  
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425  Frantz, JP, 1993, Effect of Location and Presentation Format on Attention to and Compliance 
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427   
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440   
441  Meyer, BJF, 2003, Text Coherence and Readability, Topics in Language Disorders, 23:204-224. 
442   
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443  Miller, GA, 1994, The Magical Number Seven, Plus or Minus Two: Some Limits on Our 
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447   
448  Morrow, D, V Leirer, and P Altieri, 1995, List Formats Improve Medication Instructions for 
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451  Niemela, M, and P Saariluoma, 2003, Layout Attributes and Recall, Behaviour and Information 
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453   
454  Riggs, DL, SM Holdsworth, and DR McAvoy, 2004, Direct-to-Consumer Advertising: 
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458  Schwartz, LM, S Woloshin, and HG Welch, 2009, Communicating Drug Benefits and Harms 
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460   
461  Shapiro, K, ed., 2001, The Limits of Attention:  Temporal Constraints in Human Information 
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463   
464  Sheedy, JE, MV Subbaram, AB Zimmerman, and JR Hayes, 2005, Text Legibility and the Letter 
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466   
467  Spyridakis, JH, and TC Standal, 1987, Signals in Expository Prose:  Effects on Reading 
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469   
470  Stotka, JL, MD Rotelli, SA Dowsett, MW Elsner, SM Holdsworth, PJ Pitts, and DR McAvoy, 
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473   
474  Tantillo, J, J Di Lorenzo-Aiss, and RE Mathisen, 1995, Quantifying Perceived Differences in 
475  Type Styles: An Exploratory Study, Psychology and Marketing, 12:447-457.  
476   
477  Thumma, C, May 1997, Consumer Engagement with Health Information, Paper Presented at the 
478  Meeting of the Marketing and Public Policy Conference, Washington, DC. 
479   
480  Wogalter, MS, and WJ Vigilante, 2003, Effects of Label Format on Knowledge Acquisition and 
481  Perceived Readability by Younger and Older Adults, Ergonomics, 46:327-344. 
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