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Guidance for Industry

“Help-Seeking” and Other Disease

Awareness Communications by or on

Behalf of Drug and Device Firms

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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) Kristin Davis at 301-827-2828,

(CBER) Glenn Byrd at 301-827-3028, or (CDRH) Deborah Wolf at 301-594-4595.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Center for Devices and Radiological Health (CDRH)

January 2004

DDMAC
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Guidance for Industry

“Help-Seeking” and Other Disease

Awareness Communications by or on

Behalf of Drug and Device Firms

Additional copies are available from:

Office of Training and Communication

Division of Drug Information, HFD-240

Center for Drug Evaluation and Research, FDA

5600 Fishers Lane

Rockville, MD 20857

(Tel) 301-827-4573

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

and

 Office of Communication, Training and 

Manufacturers Assistance, HFM-40 

Center for Biologics Evaluation and Research, FDA

1401 Rockville Pike, Rockville, MD 20852-1448 

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

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

and

Office of Health and Industry Programs

Division of Small Manufacturers Assistance (HFZ-220)

Center for Devices and Radiological Health, FDA

1350 Piccard Drive

Rockville, MD 20850-4307 U.S.A.

http://www.fda.gov/cdrh/ggpmain.html

Email: dsma@cdrh.fda.gov

Fax: 301-443-8818

(Tel) Manufacturers Assistance: 800-638-2041 or 301-443-6597

(Tel) International Staff Phone: 301-827-3993

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Center for Devices and Radiological Health (CDRH)

January 2004

DDMAC
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TABLE OF CONTENTS

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

II. FDA AUTHORITY OVER DRUG/DEVICE LABELING AND ADVERTISING........ 2

III. DISEASE AWARENESS COMMUNICATIONS BY OR ON BEHALF OF DRUG

AND DEVICE FIRMS ................................................................................................................. 3

A. Characteristics of Disease Awareness Communications ............................................................3

B. Disease Awareness Communications Directed at Health Care Practitioners ..........................4

C. FDA Recommendations for the Content of Disease Awareness Communications ..................4

IV. COMBINING DISEASE AWARENESS COMMUNICATIONS WITH REMINDER

OR PRODUCT CLAIM PROMOTION .................................................................................... 5
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1 Guidance for Industry

2 “Help-Seeking” and Other Disease Awareness Communications 

3 by or on Behalf of Drug and Device Firms

4

5

6

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

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

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

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

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

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

13

14

15

16

17 I. INTRODUCTION

18

19 The purpose of this document is to provide guidance to industry regarding so-called “help20 seeking” and other disease awareness communications, including a description of the specific

21 characteristics of communications that fall into this category. Disease awareness

22 communications are communications disseminated to consumers or health care practitioners that

23 discuss a particular disease or health condition, but do not mention any specific drug or device or

24 make any representation or suggestion concerning a particular drug or device. Help-seeking

25 communications are disease awareness communications directed at consumers. FDA believes

26 that disease awareness communications can provide important health information to consumers

27 and health care practitioners, and can encourage consumers to seek, and health care practitioners

28 to provide, appropriate treatment. This is particularly important for under-diagnosed, under29 treated health conditions, such as depression, hyperlipidemia, hypertension, osteoporosis, and

30 diabetes. 

31

32 Unlike drug and device promotional labeling and prescription drug and restricted device

33 advertising, disease awareness communications are not subject to the requirements of the Federal

34 Food, Drug, and Cosmetic Act (the act) and FDA regulations. FDA recognizes the importance of

35 distinguishing between communications that are under FDA jurisdiction and those that are not. 

36

37 FDA’s guidance documents, including this guidance, do not establish legally enforceable

38 responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should

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

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

41 recommended, but not required. 
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42 II. FDA AUTHORITY OVER DRUG/DEVICE LABELING AND ADVERTISING

43

44 FDA regulates the manufacture, sale, and distribution of drugs and devices in the United States

45 under the authority of the act. This authority includes oversight of promotional labeling for all

46 drugs and devices and advertising for prescription drugs and restricted devices. (21 U.S.C.

502(a), (n), (q), (r).)1 47

48

49 The act defines “label” to mean “a display of written, printed, or graphic matter upon the

50 immediate container of any article . . . .” (21 U.S.C. 321(k).) “Labeling” means “all labels and

51 other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers,

52 or (2) accompanying such article.” (21 U.S.C. 321(m).) According to Kordel v. United States,

53 335 U.S. 345 (1948), the language “accompanying such article” in the “labeling” definition

54 includes what supplements or explains an article, “in the manner that a committee report of the

55 Congress accompanies a bill. No physical attachment one to the other is necessary. It is the

56 textual relationship that is significant . . . .” FDA regulations thus define as “labeling” a wide

57 variety of written, printed, or graphic matter that bears a textual relationship with a drug or

58 device. (See 21 CFR 202.1(l)(2).)

59

60 FDA generally recognizes two types of labeling for drugs and devices: FDA-approved labeling

61 and promotional labeling. FDA-approved labeling is prepared in the first instance by the sponsor

62 and then reviewed by the agency as part of the new drug application (NDA), biologics license

63 application (BLA) or premarket approval application (PMA) review. (21 CFR 314.50(c)(2),

64 601.2(a), and 814.20(b)(10).) For prescription products, the FDA-approved labeling must be

65 included in or within the package from which the drug or device is to be dispensed, or else the

66 product is deemed misbranded on the ground that it lacks adequate directions for use. (21 U.S.C.

67 352(f)(1); 21 CFR 201.100(c)(1) and 801.109(c).) Promotional labeling is generally any labeling

68 other than the FDA-approved labeling. For a prescription drug or device to comply with the act’s

69 requirement of adequate directions for use (21 U.S.C. 352(f)(1)), its labeling must contain,

70 among other information, information addressing product hazards and other risk information, as

71 specified in FDA regulations. (21 CFR 201.100(d)(1) & (3) and 801.109(d).) 

72

Advertising2 73 for prescription drugs and restricted devices is also subject to requirements under

74 the act for the disclosure of risk and other information. Advertisements for prescription drugs

75 must include, among other things, “information in brief summary relating to side effects,

76 contraindications, and effectiveness,” as specified in FDA regulations. (21 U.S.C. 352(n); see

77 also 21 CFR 202.1.) Advertisements for restricted devices must include “a brief statement of the

78 intended uses of the device and relevant warnings, precautions, side effects, and

 

1 FDA has authority over promotional labeling and advertising for prescription drugs intended for human use. (21

U.S.C. 352(a) and (n).) FDA also has authority over promotional labeling for all devices. (21 U.S.C. 352(a).) The

agency’s authority over device advertising only extends to restricted devices. (21 U.S.C. 352(q) and (r).) Other

device advertising is regulated by the Federal Trade Commission (FTC). (15 U.S.C. 52.) See also 36 FR 18539;

Sept. 16, 1971.

2 The act does not specifically define “advertising” or “advertisement.” According to FDA regulations (21 CFR

202.1(l)(1)), "Advertisements subject to section 502(n) of the act include advertisements in published journals,

magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television,

and telephone communication systems." 
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79 contraindications . . . .” (21 U.S.C. 352(r).) Both prescription drug and restricted device

80 advertisements also must not be false or misleading. (21 U.S.C. 352(q)(1) & 321(n); 21 CFR

81 202.1(e)(5).)

82

In contrast to product advertisements and promotional labeling pieces, “reminder” promotion3 83 is

84 exempted by regulation from the requirements under the act for the disclosure of risk

85 information. (21 CFR 200.200, 201.100(f), 202.1(e)(2)(i), 801.109(d).) Similarly, an FDA

86 regulation restricting promotion of investigational new drugs provides that a manufacturer may

87 “disseminat[e] . . . scientific findings in scientific or lay media” without engaging in promotional

88 activity, but promotional claims of safety or effectiveness for a use for which the product is

89 under investigation are subject to FDA regulation as advertising or labeling. (21 CFR 312.7(a).) 

90

91

92 III. DISEASE AWARENESS COMMUNICATIONS BY OR ON BEHALF OF DRUG

93 AND DEVICE FIRMS

94

95 A. Characteristics of Disease Awareness Communications

96

97 FDA will treat as a disease awareness communications any communications by or on behalf of a

98 manufacturer, distributor, or retailer of a drug or device that:

99

100 • discuss a disease or health condition;

101 • if consumer-directed, advise the audience to “see your doctor” for possible diagnosis

102 and/or treatment;

103 • if aimed at health care practitioners, encourage awareness of signs of the particular

104 disease or health condition, or otherwise provide information to assist in the diagnosis of

105 the particular disease or health condition;

106 • do not mention a particular drug or device; and

107 • do not include any representation or suggestion relating to a particular drug or device.

108

109 This kind of communication constitutes neither labeling nor advertising and is, therefore, not

110 subject to the requirements for the disclosure of risk information and other requirements under

111 the act. As discussed in greater detail below in section IV, however, there are circumstances in

112 which FDA will treat as labeling or advertising a supposed disease awareness communication

113 that is combined with reminder advertising or labeling. In this situation, or in other situations

114 where a supposed disease awareness communication is determined to, by implication, identify a

115 particular drug or device, the communication can be considered labeling or advertising and can

116 therefore be subject to regulation by FDA.

117

 

3 According to FDA regulations (21 CFR 200.200(a)(1) and 801.109(d)), reminder labeling is labeling that calls

attention to the name of a drug or device but does not, among other things, include indications, dosage

recommendations, or other representations or suggestions concerning safety of effectiveness. Similarly, “Reminder

advertisements are those which call attention to the name of the drug product but do not include indications or

dosage recommendations for use of the drug product.” (21 CFR 202.1(e)(2)(i).)
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118 Where a company is the only manufacturer of a commercially available medical product for a

119 particular disease or health condition or where a company only manufactures one product, that

120 company is not automatically disqualified from disseminating communications that discuss a

121 disease or health condition relating to that product. If, however, FDA determines that a supposed

122 disease awareness communication impliedly identifies a particular drug or device, which may be

123 the case when a communication relates to a drug or device that is the only drug or device in its

diagnostic or therapeutic class or the only product manufactured by a company,4 124 then the agency

125 may treat the communication as labeling or advertising under the act.

126

127 B. Disease Awareness Communications Directed at Health Care Practitioners

128

129 As noted above in section III.A, disease awareness communications can be directed at either

130 consumers or health care practitioners. In this section, FDA is providing examples of materials

131 that drug and device firms might disseminate to health care practitioners as disease awareness

132 communications to help clarify when those communications would not be considered advertising

133 or labeling subject to the requirements of the act and of FDA regulations.

134

135 1. Recommendations for screening and treatment of a disease or health condition in

136 primary care settings (e.g., National Institute of Mental Health screening and

137 treatment recommendations for depression in men in primary care settings)

138

139 2. Counseling recommendations for health care practitioners with respect to a

140 particular disease or health condition (e.g., Alliance for Cervical Cancer

141 Prevention cervical cancer prevention "fact sheet") 

142

143 Although the examples above involve materials prepared and disseminated by or on behalf of a

144 government agency and an educational organization, respectively, FDA believes the same types

145 of communications may be prepared and/or disseminated by or on behalf of drug and device

146 firms. 

147

148 If communications such as those described above as examples are not disseminated by or on

149 behalf of a drug or device firm, they would be outside of FDA’s labeling and advertising

150 jurisdiction, whether or not they meet the criteria for disease awareness communications set forth

151 in section III.A of this guidance document. 

152

153 C. FDA Recommendations for the Content of Disease Awareness

154 Communications

155

 

4 In either of these situations, the mere appearance of the company’s name in conjunction with a disease reference

could trigger the act's advertising or labeling requirements, depending on the overall meaning and context of the

communication. Similarly, depending on meaning and context, FDA might have jurisdiction over statements

regarding the benefits of a product class to which a company's drug or device belonged, even if the communication

in which the statements occurred did not mention any specific product. Where FDA does not have jurisdiction, the

agency may nevertheless take appropriate action (e.g., issuing a public statement or referring the matter to the FTC)

where we believe a communication is false or misleading, or includes an unbalanced presentation of the benefits and

risks of a particular product class.
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156 FDA encourages drug and device manufacturers to develop disease awareness communications,

157 particularly for diseases and health conditions of particular public health importance. FDA

158 particularly encourages the development of disease awareness communications for serious or

159 life-threatening diseases or health conditions that are under-diagnosed or under-treated.

160

161 FDA believes that disease awareness communications should be designed with certain principles

in mind.5 162 In general, disease awareness communications should:

163

164 • be disease- or health condition-specific; 

165 • enhance consumer or health care practitioner education; 

166 • be clear and accurate; 

167 • identify the population at risk or affected by the disease or health condition; and

168 • contain a responsible public health message (i.e., information on the prevention,

169 diagnosis or treatment of a disease or condition).

170

171 In addition, disease awareness communications aimed at consumers should 

172

173 • refer consumers to a qualified health care practitioner for more information; and

174 • avoid encouraging self-diagnosis and self-treatment.

175

176

177 IV. COMBINING DISEASE AWARENESS COMMUNICATIONS WITH

178 REMINDER OR PRODUCT CLAIM PROMOTION

179

180 As discussed above, a supposed disease awareness communication disseminated by or on behalf

181 of a drug or device manufacturer, packer, or distributor can be subject to regulation by FDA as

182 promotional labeling or advertising if it mentions a specific drug or device or contains a

183 representation or suggestion concerning a specific drug or device. This section focuses on one

184 specific situation in which a supposed disease awareness communication may be treated by FDA

185 as labeling or advertising: when the communication is presented in combination with reminder

186 promotion or product claim promotion in a way that causes the audience to perceive the two

187 pieces as one advertisement or promotional labeling piece.

188

189 For example, some drug firms have broadcast help-seeking advertisements in combination with

190 perceptually similar reminder advertisements, separated only by a brief period containing

191 unrelated intervening matter. When considered in isolation, the help-seeking advertisement

192 conveys the message, “There is help for a particular medical condition; see your doctor.” As

193 discussed above, this advertisement would be neither labeling nor advertising and thus would not

194 be subject to the requirements under the act for the disclosure of risk and other information. The

195 perceptually similar reminder advertisement, by itself, conveys the message, “This specific

196 product is available; see your doctor.” As discussed above, this advertisement would be

197 exempted by regulation from the requirements for disclosure of risk or other information. 

198

 

5 These principles are taken from the American Medical Association policy on Direct-to-Consumer Advertising

(DTCA) of Prescription Drugs (H-105.988).
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199 Together, however, these two advertisements communicate information about a treatable disease

200 or health condition and the name of a product approved for treatment of a disease or health

201 condition, and effectively constitute an advertisement that communicates a product’s indication

202 and efficacy for a certain medical condition without providing risk and other information. If a

203 disease awareness or help-seeking piece and a reminder advertisement are presented in a manner

204 that causes their messages to be linked together by the audience, the failure of the combined

205 communication to include the risk and other information required under the act and FDA

206 regulations would cause the advertised product to be misbranded. 

207

208 Similarly, a supposed disease awareness communication could be properly treated as advertising

209 or promotional labeling if presented in combination with a product claim advertisement or

210 promotional labeling piece in a manner that causes the pieces’ messages to be linked together by

211 the audience. In such a case, the combined communication would also communicate a particular

212 product’s indication and efficacy for a certain medical condition. If the combined

213 communication does not comply with the act and FDA’s advertising or labeling regulations, the

214 communication would cause the promoted product to be misbranded.

215

216 Psychology and marketing research suggests that the greater the perceptual similarity between

217 disease awareness communications and reminder or product claim promotions (i.e., similarities

218 in terms of their themes, such as story lines, or other presentation elements, such as colors, logos,

219 tag lines, graphics, etc.), and the closer they are presented physically or in time to one another,

220 the more likely it is that the separate messages contained in the two pieces will be remembered

together in memory as one entity.6 221 Perceptual similarity is an important factor because research

222 indicates that pieces are most likely to be linked together in memory when they have prominent

223 cues in common, such as distinctive visual elements, a common narrator or background music, or

a common story line.7 224

225

226 Perceptually similar communications or promotional pieces that appear closely in time or in

227 close physical proximity have a repetitive effect on each other. Repetition of information helps

solidify and reinforce it in memory;8 228 thus, disseminating pieces with similar presentation

229 elements will increase the likelihood the messages from each piece will be remembered and that

230 mental links between the pieces will be formed and strengthened. For example, a help-seeking

231 communication preceding a perceptually similar reminder advertisement (or vice-versa) is likely

to reinforce, through repetition, the images and message encoded in memory.9 232 The practical

 

6 Fiske, S.T. and Neuberg, S.L. (1990). A continuum of impression formation, from category-based to individuating

processes: Influences of information and motivation on attention and interpretation. In M.P. Zanna (Ed.), Advances

in Experimental Social Psychology (Vol. 23), New York: Academic Press (hereinafter “Fiske & Neuberg”);

Higgins, E.T. and Bargh, J.A. (1987). Social cognition and social perception. In M.R. Rosenweig & L.W. Porter

(Eds.), Annual Review of Psychology, 38, 369-425. (hereinafter “Higgins & Bargh”); Baeyens, F., Crombez, G.,

and Eelen, P. (1988). Once in contact, always in contact: Evaluative conditioning is resistant to extinction.

Advanced Behavioral Research and Therapy, 10, 179-199.

7 Fiske & Neuberg; Higgins & Bargh.

8 Fiske, S.T. and Taylor, S.E. (1991). Social Cognition. New York: McGraw Hill.

9 Zhao, X. (1997). Clutter and serial order redefined and retested. Journal of Advertising Research,

September/October, 57-73; 
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233 result of this process is that the audience will perceive these as components of one complete

234 promotional piece. The more similar disease awareness communications and reminder

235 promotional pieces or product claim promotional pieces are in terms of their presentation

236 elements and the closer to one another they are presented physically or in time, the more likely it

237 is that the key messages in the two pieces will be associated in memory. 

238

239 In determining whether two communications together qualify as promotional labeling or

240 advertising, and therefore must comply with the act and FDA regulations relating to advertising

241 or labeling, FDA considers the following factors:

242

243 • Are the pieces perceptually distinct in use of graphic, visual, thematic, or other

244 presentation elements? 

245 • Are the pieces presented in close physical or temporal proximity?

246

247 Of these two factors, FDA considers the determinant issue to be whether the pieces are

248 perceptually distinct. Thus, FDA recommends that manufacturers, packers, and distributors

249 ensure that their disease awareness communications and reminder promotional pieces or product

250 claim promotional pieces are sufficiently distinctive in terms of their thematic, graphic, visual

251 and other presentation elements so that they will not be perceived as a single promotional piece

252 that includes both a product name and a use, and is thus subject to the requirements for

253 “labeling” or “advertising” mandated by the act and regulations. With regard to the second

254 factor, FDA recognizes that “close physical or temporal proximity” is difficult to define precisely

255 and is unaware of any data that help establish specific criteria. FDA requests comment on

256 whether such data do exist or, in the absence of data, whether there would be utility in trying to

257 develop specific criteria. For example, the agency could consider two communications that are

258 not perceptually distinct to be in “close temporal proximity” in a broadcast advertisement if they

259 were presented within the same 15 minutes of a one half hour program or the same half hour of a

260 one hour program. Similarly, the agency requests comment on how “proximity” could be best

261 considered for two communications that are not perceptually distinct if they were presented in

262 the same publication (i.e., magazine, newspaper).