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Guidance for Industry

Brief Summary: Disclosing Risk

Information in Consumer-Directed

Print Advertisements

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft guidance.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 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) Lesley R. Frank at 301-827-2831 or

(CBER) Glenn Byrd at 301-827-3028.

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)

January 2004

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Guidance for Industry

Brief Summary: Disclosing Risk

Information in Consumer-Directed

Print Advertisements

Additional copies are available from:

Division of Drug Information, HFD-240

Center for Drug Evaluation and Research

Food and Drug Administration

5600 Fishers Lane,

Rockville, MD 20857

(Tel) 301-827-4573

http://www.fda.gov/cder/guidance/index.htm

Or

Office of Communication, Training, and 

Manufacturers Assistance, HFM-40

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike

Rockville, MD 20852-1448

(Tel) Voice Information System at 800-835-4709 or 301-827-1800

http://www.fda.gov/cber/guidelines.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)

January 2004

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TABLE OF CONTENTS

I. INTRODUCTION................................................................................................................. 1

II. BACKGROUND ................................................................................................................... 2

III. OPTIONS FOR DISCLOSING RISK INFORMATION IN CONSUMER-DIRECTED

PRINT ADVERTISEMENTS...................................................................................................... 3

A. FDA-Approved Patient Labeling..................................................................................................4

B. Highlights........................................................................................................................................5

IV. REQUEST FOR THE VIEWS OF INTERESTED PARTIES......................................... 7
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Guidance for Industry1 1

2

3 Brief Summary: Disclosing Risk Information in

4 Consumer-Directed Print Advertisements

5

6

7

8 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current

9 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to

10 bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the

11 applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff

12 responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the

13 appropriate number listed on the title page of this guidance.

14

15

16

17 I. INTRODUCTION

18

19 This guidance provides recommendations on the disclosure of risk information in prescription

20 drug product advertisements directed toward consumers in print media. This draft guidance

21 supersedes the draft guidance on Using FDA-Approved Patient Labeling in Consumer-Directed

22 Print Advertisements, which was issued in April 2001. This guidance does not focus on the

23 presentation of risk information in the main body of the advertisement.

24

25 FDA's guidance documents, including this guidance, do not establish legally enforceable

26 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should

27 be viewed only as recommendations, unless specific regulatory or statutory requirements are

28 cited. The use of the word should in Agency guidances means that something is suggested or

29 recommended, but not required. Thus, FDA does not intend to object to a consumer-directed

30 print advertisement on the ground that it does not fulfill the brief summary requirement solely

31 because it does not comply with the recommendations set forth in this guidance document.

32 Although FDA cannot object to a consumer-directed print advertisement for a prescription drug

33 solely on the basis that the risk information is not presented in consumer-friendly language, the

34 Agency strongly encourages the use of consumer-friendly language in all consumer-directed

35 materials, for the reasons discussed in section III of this document. 

36

37

 

1 This guidance has been prepared by the Division of Drug Marketing, Advertising, and Communications in the

Center for Drug Evaluation and Research (CDER) in coordination with the Center for Biologics Evaluation and

Research (CBER) at the Food and Drug Administration.
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38 II. BACKGROUND

39

40 Under the Federal Food, Drug, and Cosmetic Act (the Act), FDA is responsible for regulating the

41 advertising of prescription drugs. Under Section 502(n) of the Act (21 U.S.C. 352(n)), an

42 advertisement for a prescription drug must contain, in addition to the product's established name

43 and quantitative composition, a "true statement" including "information in brief summary

44 relating to side effects, contraindications, and effectiveness as shall be required in regulations . . . .”

45 This requirement is further defined in the prescription drug advertising regulation at 21 CFR

46 202.1(e)(1), which requires that an advertisement contain a “true statement of information in

47 brief summary relating to side effects, contraindications . . . and effectiveness.” Under 21 CFR

48 202.1(e)(3)(iii)): “The information relating to side effects and contraindications shall disclose

49 each specific side effect and contraindication (which include side effects, warnings, precautions,

50 and contraindications and include any such information under such headings as cautions, special

51 considerations, important notes, etc. . . .) contained in required, approved, or permitted labeling

52 for the advertised drug dosage form(s)" (emphasis added). For purposes of this guidance, the

53 requirement under these provisions that an advertisement for a prescription drug disclose each

54 side effect, warning, precaution, and contraindication from the required, approved, or permitted

55 labeling is the brief summary requirement. 

56

57 Frequently, to fulfill the brief summary requirement, consumer-directed print advertisements for

58 prescription drugs include the complete risk-related sections of the FDA-approved professional

59 labeling. This information is presented verbatim, in small type. Because this labeling is written

60 for an audience of health care practitioners, it uses highly technical medical terminology. In

addition, although the Agency has drafted guidance discouraging this practice,2 61 FDA-approved

62 professional labeling has often included all possible adverse events, including those that are

63 unlikely to be drug related.

64

65 Although this approach complies with the brief summary requirement, FDA believes it is less

66 than optimal for consumer-directed print advertisements because many consumers do not have

67 the technical background to understand this information. Moreover, the volume of the material,

68 coupled with the format in which it is presented (i.e., very small print and sophisticated medical

69 terminology) discourages its use and makes the information less comprehensible to consumers.

70 In general, FDA believes that exhaustive lists of minor risks distract from and make it difficult to

71 comprehend and retain information on the more important risks. FDA also believes that

72 information intended for a consumer should optimally be communicated in language fully

73 understandable by a lay reader and presented in an easily readable format.

74

75 In 2000, FDA proposed amending its regulations on the format and content of FDA-approved

professional labeling for human prescription drug and biological products (proposed rule).3 76

77 Under the proposed rule, FDA-approved professional labeling would contain a new introduction

 

2 See Guidance for Industry, Content and Format of the Adverse Reactions Section of Labeling for Human

Prescription Drugs and Biologics (DRAFT) (May 2000).

3 Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirement for

Prescription Drug Product Labels (65 FR 81082, December 22, 2000).
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78 section called Highlights of Prescribing Information (Highlights). Highlights would set forth in a

79 concise manner the information that is most important to safe and effective use, including

80 information on the most common and the most serious risks associated with the product.

81

82 If the proposed rule were to become effective, then the FDA-approved professional labeling for

83 new and recently approved drugs and labeling approved by FDA according to supplemental

84 premarket approval applications would include Highlights that FDA believes would be

85 appropriate for manufacturers to use when presenting risk information in consumer-directed print

86 advertisements for prescription drugs. Ideally, the Highlights would be translated from language

87 appropriate for a professional audience into language easily understood by the average

88 consumer. This option is discussed in greater detail in section III.B of this guidance document.

89 Alternatively, a manufacturer could present risk information in its consumer-directed print

90 advertisements by: (1) presenting all risk information from the FDA-approved professional

91 labeling; or (2) reproducing FDA-approved patient labeling, either in its entirety or as modified

92 to omit less important risk information (see section III.A). 

93

94 Unless and until the proposed rule goes into effect, a manufacturer can (1) present all risk

95 information from the FDA-approved professional labeling; (2) reproduce FDA-approved patient

96 labeling, either in its entirety or as modified to omit less important risk information (see section

97 III.A); or (3) provide the risk information that would be appropriate for FDA-approved

98 Highlights (see section III.B).

99

100 On April 23, 2001, FDA announced in the Federal Register (66 FR 20468) the availability of a

101 draft guidance for industry entitled Using FDA-Approved Patient Labeling in Consumer102 Directed Print Advertisements. The draft guidance described how certain FDA-approved patient

103 labeling could be used to disclose risk information in consumer-directed print advertisements for

104 prescription drugs. This draft guidance differs from the previous draft guidance in that it

105 describes several options for disclosing risk information in consumer-directed print

106 advertisements. And, as noted above, this draft guidance supersedes the earlier one.

107

108

109 III. OPTIONS FOR DISCLOSING RISK INFORMATION IN CONSUMER110 DIRECTED PRINT ADVERTISEMENTS

111

112 In the circumstances described below, FDA does not intend to object to a consumer-directed

113 print advertisement for a prescription drug on the ground that it does not present risk information

114 in compliance with the brief summary requirement. Each of the following approaches would

115 provide information on the most serious and the most common risks associated with the product,

116 and would omit less important information. 

117

118 FDA recommends that any advertisement disseminated as described below include a statement

119 reminding consumers that the information presented is not comprehensive and providing a toll120 free telephone number or Web site address (URL) where consumers can obtain additional

121 information if they wish.
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122

123 A. FDA-Approved Patient Labeling

124

125 A prescription drug may have, in addition to FDA-approved professional labeling,

126 FDA-approved patient labeling. This labeling can include Information for the Patient, a

127 Medication Guide, Patient Information, or a Patient Package Insert. Although less extensive than

128 the FDA-approved professional labeling, FDA-approved patient labeling provides risk and

129 benefit information that is material to the decision by the patient (with the involvement of a

130 health care practitioner) whether to use a prescription drug and material to safe and effective use

131 of the drug.

132

133 Generally, FDA-approved patient labeling does not address each specific risk included in the

134 FDA-approved professional labeling. Instead, FDA-approved patient labeling communicates the

135 most important information patients need to use the product appropriately, and it focuses on the

136 product’s most serious risks and its less serious, but most frequently occurring, adverse reactions.

137 We believe that omitting less serious, infrequent risks from patient labeling may actually

138 increase the usefulness of this labeling for its audience by making the more important risks stand

139 out more clearly. For these reasons, FDA believes that FDA-approved patient labeling is a better

140 vehicle for communicating risk information to consumers than lengthy, technical FDA-approved

141 professional labeling. 

142

143 Not all FDA-approved patient labeling describes a product’s most serious risks and its less

144 serious, but most frequently occurring, adverse reactions. Some FDA-approved patient labeling

145 primarily gives instructions for use (e.g., directions on how to use medications delivered through

146 inhalation, a patch, or injection). Other FDA-approved patient labeling focuses primarily on a

147 single important warning. Where FDA-approved patient labeling has a narrow focus and does

148 not provide information on the product’s most serious risks and its less serious, but most

149 frequently occurring, adverse reactions, FDA believes this labeling would not be suitable for

150 conveying risk information in a consumer-directed print advertisement.

151

152 The Agency recognizes that some FDA-approved patient labeling includes information in

153 addition to risk information (e.g., directions for use or a discussion of the disease state being

154 treated). Deletion of this information from the labeling when using it to present risk information

155 in a consumer-directed print advertisement is likely to help the consumer focus on the most

156 important risk information for the drug.

157

158 The following describes the Agency's thinking on the use of FDA-approved patient labeling to

159 present risk information in consumer-directed print advertisements for prescription drugs instead

160 of presenting verbatim the risk-related sections of FDA-approved professional labeling.

161

162 1. Reprinted as Approved

163

164 FDA does not intend to object to a consumer-directed print advertisement for a

165 prescription drug on the ground that it does not present risk information in compliance

166 with the brief summary requirement if it includes the FDA-approved patient labeling for
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167 the drug and if that labeling: (1) is reprinted in full in the advertisement; and (2) includes

168 information from the advertised product’s FDA-approved professional labeling

169 addressing the following risks:

170

171 • Contraindications: all;

172 • Warnings: all;

173 • Precautions: the major precautions, including any that describe serious adverse

174 drug experiences (as defined in 21 CFR 312.32(a) & 314.80(a)) or steps to be

175 taken to avoid such experiences; and

176 • Adverse Reactions: the 3-5 most common nonserious adverse reactions most

177 likely to affect the patient's quality of life or compliance with drug therapy.

178

179 Infrequently, risk information included in the Precautions or Adverse Reactions section

180 of FDA-approved professional labeling would, under current practice, appear in the

181 Warnings section. In such a case, that risk information should be deemed to appear in the

182 Warnings section for purposes of this guidance document. 

183

184 2. Reprinted Risk Information Only

185

186 FDA does not intend to object to a consumer-directed print advertisement for a

187 prescription drug on the ground that it does not present risk information in compliance

188 with the brief summary requirement if it includes the FDA-approved patient labeling for

189 the drug and if that labeling: (1) has been modified to include only risk information (e.g.,

190 by deleting instructions for use); and (2) includes information from the advertised

191 product’s FDA-approved professional labeling addressing the following risks:

192

193 • Contraindications: all;

194 • Warnings: all;

195 • Precautions: the major precautions, including any that describe serious adverse

196 drug experiences (as defined in 21 CFR 312.32(a) & 314.80(a)) or steps to be

197 taken to avoid such experiences; and

198 • Adverse Reactions: the 3-5 most common nonserious adverse reactions most

199 likely to affect the patient's quality of life or compliance with drug therapy.

200

201 Infrequently, risk information included in the Precautions or Adverse Reactions section

202 of FDA-approved professional labeling would, under current practice, appear in the

203 Warnings section. In such a case, that risk information should be deemed to appear in the

204 Warnings section for purposes of this guidance document. 

205

206 B. Highlights

207

208 1. Before the Proposed Rule Becomes Effective

209

210 Unless and until the proposed rule becomes effective, FDA does not intend to object to a

211 consumer-directed print advertisement for a prescription drug on the ground that it does
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212 not present risk information in compliance with the brief summary requirement if it

213 includes the risk information that would appear in the Highlights section of FDA214 approved labeling for the product, including information addressing the following risks:

215

216 • Contraindications: all;

217 • Warnings: all;

218 • Precautions: the major precautions, including any that describe serious adverse

219 drug experiences (as defined in 21 CFR 312.32(a) & 314.80(a)) or steps to be

220 taken to avoid such experiences; and

221 • Adverse Reactions: the 3-5 most common nonserious adverse reactions most

222 likely to affect the patient's quality of life or compliance with drug therapy.

223

224 Infrequently, risk information included in the Precautions or Adverse Reactions section

225 of FDA-approved professional labeling would, under current practice, appear in the

226 Warnings section. In such a case, that risk information should be deemed to appear in the

227 Warnings section for purposes of this guidance document. 

228

229 2. If the Proposed Rule Were to Become Effective

230

231 If the proposed rule were to go into effect, FDA would not intend to object to a

232 consumer-directed print advertisement for a prescription drug on the ground that it does

233 not present risk information in compliance with the brief summary requirement if the

234 advertisement reproduces the parts of the Highlights of FDA-approved professional

235 labeling that set forth risk information (e.g., Boxed Warning, Contraindications,

236 Warnings/Precautions, Most Common Adverse Reactions).

237

238 To illustrate, we are providing as separate documents (1) an example of a fictional

239 prescription drug product Highlights and (2) an example of the fictional Highlights in

240 consumer-friendly format and language illustrating an appropriate way to convey risk

241 information under this option. The example omits some non-risk information, such as

242 How Supplied and Dosage and Administration information.

243

244 3. FDA Recommendations On Use Of Consumer-Friendly Language

245

246 For consumers to realize full benefit from the more streamlined presentation of risk

247 information described in section IV.B.1 and 2, Highlights ideally should be written in

248 language fully understandable by a lay reader and should not contain technical, scientific

249 terms or jargon. Thus, FDA encourages Highlights intended for use in consumer-directed

250 print advertisements to be written in language that is easy to understand, use, or deal with

251 by ordinary individuals under normal conditions. For example, a consumer may not

252 understand the term “Contraindications” but is more likely to understand the phrase “You

253 should not take drug X if . . . .” 

254
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255

256 IV. REQUEST FOR THE VIEWS OF INTERESTED PARTIES

257

258 In this draft guidance, FDA describes several options for presenting the risk information in

259 consumer-directed print advertisements. In crafting these options, FDA evaluated several

260 approaches for communicating complex information in various labeling formats. Examples of

261 the agency’s past experience in this area include both the redesign of food labeling under the

Nutritional Labeling and Education Act of 19904 262 and the standardization of the format and

content for the labeling of over-the-counter drug products.5 263

264

265 The promotion of prescription drugs differs from the promotion of many other products. While

266 prescription drugs offer medical benefits, these products may also pose significant risks to

267 patients. Based on available data and information, and on the results of FDA's own research, the

268 agency believes consumer-directed promotion of prescription drugs can convey useful health

269 information to patients. But for such promotion to have this beneficial effect, it must be truthful,

270 non-misleading, and scientifically substantiated. This means, for example, that prescription drug

271 promotion must include appropriate information on the risks associated with the use of the drug,

272 and that this information must be properly presented.

273

274 FDA recognizes that the language and format chosen to present risk information can affect

275 consumer understanding. We have not evaluated how presenting the information in different

276 formats affects consumer comprehension, and we believe that there is much to be learned before

277 we develop final guidance on how best to inform patients about the drugs being promoted.

278 Therefore, the agency is soliciting comments, suggestions, or results of research in this area from

279 interested parties to help assess what is most useful for consumers to ensure that they are

280 provided with concise, understandable risk information that will help them make well-informed

281 decisions. The agency is also encouraging the development of new approaches to presenting risk

282 information.

283

284 For example, as noted above, risk information in a consumer-directed print advertisement for a

285 prescription drug is set forth in detail in an accompanying "brief summary" and is also

286 incorporated into the text in the body of the advertisement. An alternative to including risk

287 information in the text in the body of the advertisement would be to include risk information as

288 bullet points in a “risk information window” in the body of the advertisement. The window

289 could appear prominently in the advertisement (e.g., in the top half) and could bear a title (e.g.,

290 “Important Safety Information”) calling attention to the information it contains. FDA

291 specifically requests comments on this approach. A specific issue on which FDA requests

292 comment is whether, in some cases, it may be impossible for all of the necessary risk information

293 to be presented in a bullet format in the risk information window. FDA requests comments on

294 whether, in those cases, FDA should recommend that the bulleted information be accompanied

295 by additional risk information in the text in the body of the advertisement.

296

 

4 Pub. L. No. 101-535 (Nov. 8, 1990).

5 See, e.g., 64 FR 13254; March 17, 1999.
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297 Some have suggested that the essence of the risk information could be incorporated into the body

298 of the advertisement, obviating the need for disclosure of risk information in a separate part of

299 the advertisement. FDA requests comments on such an approach, including on whether this

300 approach might be appropriate for only a subset of prescription drugs (e.g., drugs with safety

301 profiles that can be succinctly summarized).