**Guidance for Industry**

**"Help-Seeking" and Other Disease Awareness Communications by or on
Behalf of Drug and Device Firms**

#########  {#section .TOC-9}

***DRAFT GUIDANCE***

**This guidance document is being distributed for comment purposes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notice announcing the availability of the draft guidance.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**

**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**

**TABLE OF CONTENTS**

# I. INTRODUCTION [1](#i.-introduction) {#i.-introduction-1 .TOC-1}

# II. FDA AUTHORITY OVER DRUG/DEVICE LABELING AND ADVERTISING [2](#ii.-fda-authority-over-drugdevice-labeling-and-advertising) {#ii.-fda-authority-over-drugdevice-labeling-and-advertising-2 .TOC-1}

# III. DISEASE AWARENESS COMMUNICATIONS BY OR ON BEHALF OF DRUG AND DEVICE FIRMS [3](#iii.-disease-awareness-communications-by-or-on-behalf-of-drug-and-device-firms) {#iii.-disease-awareness-communications-by-or-on-behalf-of-drug-and-device-firms-3 .TOC-1}

## A. Characteristics of Disease Awareness Communications [3](#a.-characteristics-of-disease-awareness-communications) {#a.-characteristics-of-disease-awareness-communications-3 .TOC-2}

## B. Disease Awareness Communications Directed at Health Care Practitioners [4](#b.-disease-awareness-communications-directed-at-health-care-practitioners) {#b.-disease-awareness-communications-directed-at-health-care-practitioners-4 .TOC-2}

## C. FDA Recommendations for the Content of Disease Awareness Communications [4](#c.-fda-recommendations-for-the-content-of-disease-awareness-communications) {#c.-fda-recommendations-for-the-content-of-disease-awareness-communications-4 .TOC-2}

# IV. COMBINING DISEASE AWARENESS COMMUNICATIONS WITH REMINDER OR PRODUCT CLAIM PROMOTION [5](#iv.-combining-disease-awareness-communications-with-reminder-or-product-claim-promotion) {#iv.-combining-disease-awareness-communications-with-reminder-or-product-claim-promotion-5 .TOC-1}

**Guidance for Industry**

**"Help-Seeking" and Other Disease Awareness Communications**

**by or on Behalf of Drug and Device Firms**

This draft guidance, when finalized, will represent the Food and Drug
Administration's (FDA's) current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the
approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the
FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the appropriate number listed
on the title page of this guidance.

# I. INTRODUCTION

The purpose of this document is to provide guidance to industry
regarding so-called "help-seeking" and other disease awareness
communications, including a description of the specific characteristics
of communications that fall into this category. Disease awareness
communications are communications disseminated to consumers or health
care practitioners that discuss a particular disease or health
condition, but do not mention any specific drug or device or make any
representation or suggestion concerning a particular drug or device.
Help-seeking communications are disease awareness communications
directed at consumers. FDA believes that disease awareness
communications can provide important health information to consumers and
health care practitioners, and can encourage consumers to seek, and
health care practitioners to provide, appropriate treatment. This is
particularly important for under-diagnosed, under-treated health
conditions, such as depression, hyperlipidemia, hypertension,
osteoporosis, and diabetes.

Unlike drug and device promotional labeling and prescription drug and
restricted device advertising, disease awareness communications are not
subject to the requirements of the Federal Food, Drug, and Cosmetic Act
(the act) and FDA regulations. FDA recognizes the importance of
distinguishing between communications that are under FDA jurisdiction
and those that are not.

FDA's guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word *should* in agency guidances means that
something is suggested or recommended, but not required.

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

FDA regulates the manufacture, sale, and distribution of drugs and
devices in the United States under the authority of the act. This
authority includes oversight of promotional labeling for all drugs and
devices and advertising for prescription drugs and restricted devices.
(21 U.S.C. 502(a), (n), (q), (r).)[^1]

The act defines "label" to mean "a display of written, printed, or
graphic matter upon the immediate container of any article . . . ." (21
U.S.C. 321(k).) "Labeling" means "all labels and other written, printed,
or graphic matter (1) upon any article or any of its containers or
wrappers, or (2) accompanying such article." (21 U.S.C. 321(m).)
According to *Kordel* *v.* *United States*, 335 U.S. 345 (1948), the
language "accompanying such article" in the "labeling" definition
includes what supplements or explains an article, "in the manner that a
committee report of the Congress accompanies a bill. No physical
attachment one to the other is necessary. It is the textual relationship
that is significant . . . ." FDA regulations thus define as "labeling" a
wide variety of written, printed, or graphic matter that bears a textual
relationship with a drug or device. (See 21 CFR 202.1(l)(2).)

FDA generally recognizes two types of labeling for drugs and devices:
FDA-approved labeling and promotional labeling. FDA-approved labeling is
prepared in the first instance by the sponsor and then reviewed by the
agency as part of the new drug application (NDA), biologics license
application (BLA) or premarket approval application (PMA) review. (21
CFR 314.50(c)(2), 601.2(a), and 814.20(b)(10).) For prescription
products, the FDA-approved labeling must be included in or within the
package from which the drug or device is to be dispensed, or else the
product is deemed misbranded on the ground that it lacks adequate
directions for use. (21 U.S.C. 352(f)(1); 21 CFR 201.100(c)(1) and
801.109(c).) Promotional labeling is generally any labeling other than
the FDA-approved labeling. For a prescription drug or device to comply
with the act's requirement of adequate directions for use (21 U.S.C.
352(f)(1)), its 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
801.109(d).)

Advertising[^2] for prescription drugs and restricted devices is also
subject to requirements under the act for the disclosure of risk and
other information. Advertisements for prescription drugs must include,
among other things, "information in brief summary relating to side
effects, contraindications, and effectiveness," as specified in FDA
regulations. (21 U.S.C. 352(n); see also 21 CFR 202.1.) Advertisements
for restricted devices must include "a brief statement of the intended
uses of the device and relevant warnings, precautions, side effects, and
contraindications . . . ." (21 U.S.C. 352(r).) Both prescription drug
and restricted device advertisements also must not be false or
misleading. (21 U.S.C. 352(q)(1) & 321(n); 21 CFR 202.1(e)(5).)

In contrast to product advertisements and promotional labeling pieces,
"reminder" promotion[^3] is exempted by regulation from the requirements
under the act for the disclosure of risk information. (21 CFR 200.200,
201.100(f), 202.1(e)(2)(i), 801.109(d).) Similarly, an FDA regulation
restricting promotion of investigational new drugs provides that a
manufacturer may "disseminat\[e\] . . . scientific findings in
scientific or lay media" without engaging in promotional activity, but
promotional claims of safety or effectiveness for a use for which the
product is under investigation are subject to FDA regulation as
advertising or labeling. (21 CFR 312.7(a).)

# III. DISEASE AWARENESS COMMUNICATIONS BY OR ON BEHALF OF DRUG AND DEVICE FIRMS

## A. Characteristics of Disease Awareness Communications

FDA will treat as a disease awareness communications any communications
by or on behalf of a manufacturer, distributor, or retailer of a drug or
device that:

-   discuss a disease or health condition;

-   if consumer-directed, advise the audience to "see your doctor" for
    possible diagnosis and/or treatment;

-   if aimed at health care practitioners, encourage awareness of signs
    of the particular disease or health condition, or otherwise provide
    information to assist in the diagnosis of the particular disease or
    health condition;

-   do not mention a particular drug or device; and

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

This kind of communication constitutes neither labeling nor advertising
and is, therefore, not subject to the requirements for the disclosure of
risk information and other requirements under the act. As discussed in
greater detail below in section IV, however, there are circumstances in
which FDA will treat as labeling or advertising a supposed disease
awareness communication that is combined with reminder advertising or
labeling. In this situation, or in other situations where a supposed
disease awareness communication is determined to, by implication,
identify a particular drug or device, the communication can be
considered labeling or advertising and can therefore be subject to
regulation by FDA.

Where a company is the only manufacturer of a commercially available
medical product for a particular disease or health condition or where a
company only manufactures one product, that company is not automatically
disqualified from disseminating communications that discuss a disease or
health condition relating to that product. If, however, FDA determines
that a supposed disease awareness communication impliedly identifies a
particular drug or device, which may be 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] then the agency may treat the communication as labeling or
advertising under the act.

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

## 

As noted above in section III.A, disease awareness communications can be
directed at either consumers or health care practitioners. In this
section, FDA is providing examples of materials that drug and device
firms might disseminate to health care practitioners as disease
awareness communications to help clarify when those communications would
not be considered advertising or labeling subject to the requirements of
the act and of FDA regulations.

1.  Recommendations for screening and treatment of a disease or health
    condition in primary care settings (e.g., National Institute of
    Mental Health screening and treatment recommendations for depression
    in men in primary care settings)

2.  Counseling recommendations for health care practitioners with
    respect to a particular disease or health condition (e.g., Alliance
    for Cervical Cancer Prevention cervical cancer prevention \"fact
    sheet\")

Although the examples above involve materials prepared and disseminated
by or on behalf of a government agency and an educational organization,
respectively, FDA believes the same types of communications may be
prepared and/or disseminated by or on behalf of drug and device firms.

If communications such as those described above as examples are not
disseminated by or on behalf of a drug or device firm, they would be
outside of FDA's labeling and advertising jurisdiction, whether or not
they meet the criteria for disease awareness communications set forth in
section III.A of this guidance document.

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

FDA encourages drug and device manufacturers to develop disease
awareness communications, particularly for diseases and health
conditions of particular public health importance. FDA particularly
encourages the development of disease awareness communications for
serious or life-threatening diseases or health conditions that are
under-diagnosed or under-treated.

FDA believes that disease awareness communications should be designed
with certain principles in mind.[^5] In general, disease awareness
communications should:

-   be disease- or health condition-specific;

-   enhance consumer or health care practitioner education;

-   be clear and accurate;

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

-   contain a responsible public health message (i.e., information on
    the prevention, diagnosis or treatment of a disease or condition).

In addition, disease awareness communications aimed at consumers should

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

-   avoid encouraging self-diagnosis and self-treatment.

# IV. COMBINING DISEASE AWARENESS COMMUNICATIONS WITH REMINDER OR PRODUCT CLAIM PROMOTION

As discussed above, a supposed disease awareness communication
disseminated by or on behalf of a drug or device manufacturer, packer,
or distributor can be subject to regulation by FDA as promotional
labeling or advertising if it mentions a specific drug or device or
contains a representation or suggestion concerning a specific drug or
device. This section focuses on one specific situation in which a
supposed disease awareness communication may be treated by FDA as
labeling or advertising: when the communication is presented in
combination with reminder promotion or product claim promotion in a way
that causes the audience to perceive the two pieces as one advertisement
or promotional labeling piece.

For example, some drug firms have broadcast help-seeking advertisements
in combination with perceptually similar reminder advertisements,
separated only by a brief period containing unrelated intervening
matter. When considered in isolation, the help-seeking advertisement
conveys the message, "There is help for a particular medical condition;
see your doctor." As discussed above, this advertisement would be
neither labeling nor advertising and thus would not be subject to the
requirements under the act for the disclosure of risk and other
information. The perceptually similar reminder advertisement, by itself,
conveys the message, "This specific product is available; see your
doctor." As discussed above, this advertisement would be exempted by
regulation from the requirements for disclosure of risk or other
information.

Together, however, these two advertisements communicate information
about a treatable disease or health condition and the name of a product
approved for treatment of a disease or health condition, and effectively
constitute an advertisement that communicates a product's indication and
efficacy for a certain medical condition without providing risk and
other information. If a disease awareness or help-seeking piece and a
reminder advertisement are presented in a manner that causes their
messages to be linked together by the audience, the failure of the
combined communication to include the risk and other information
required under the act and FDA regulations would cause the advertised
product to be misbranded.

Similarly, a supposed disease awareness communication could be properly
treated as advertising or promotional labeling if presented in
combination with a product claim advertisement or promotional labeling
piece in a manner that causes the pieces' messages to be linked together
by the audience. In such a case, the combined communication would also
communicate a particular product's indication and efficacy for a certain
medical condition. If the combined communication does not comply with
the act and FDA's advertising or labeling regulations, the communication
would cause the promoted product to be misbranded.

Psychology and marketing research suggests that the greater the
perceptual similarity between disease awareness communications and
reminder or product claim promotions (i.e., similarities in terms of
their themes, such as story lines, or other presentation elements, such
as colors, logos, tag lines, graphics, etc.), and the closer they are
presented physically or in time to one another, the more likely it is
that the separate messages contained in the two pieces will be
remembered together in memory as one entity.[^6] Perceptual similarity
is an important factor because research indicates that pieces are most
likely to be linked together in memory when they have prominent cues in
common, such as distinctive visual elements, a common narrator or
background music, or a common story line.[^7]

Perceptually similar communications or promotional pieces that appear
closely in time or in close physical proximity have a repetitive effect
on each other. Repetition of information helps solidify and reinforce it
in memory;[^8] thus, disseminating pieces with similar presentation
elements will increase the likelihood the messages from each piece will
be remembered and that mental links between the pieces will be formed
and strengthened. For example, a help-seeking communication preceding a
perceptually similar reminder advertisement (or vice-versa) is likely to
reinforce, through repetition, the images and message encoded in
memory.[^9] The practical result of this process is that the audience
will perceive these as components of one complete promotional piece. The
more similar disease awareness communications and reminder promotional
pieces or product claim promotional pieces are in terms of their
presentation elements and the closer to one another they are presented
physically or in time, the more likely it is that the key messages in
the two pieces will be associated in memory.

In determining whether two communications together qualify as
promotional labeling or advertising, and therefore must comply with the
act and FDA regulations relating to advertising or labeling, FDA
considers the following factors:

-   Are the pieces perceptually distinct in use of graphic, visual,
    thematic, or other presentation elements?

-   Are the pieces presented in close physical or temporal proximity?

Of these two factors, FDA considers the determinant issue to be whether
the pieces are perceptually distinct. Thus, FDA recommends that
manufacturers, packers, and distributors ensure that their disease
awareness communications and reminder promotional pieces or product
claim promotional pieces are sufficiently distinctive in terms of their
thematic, graphic, visual and other presentation elements so that they
will not be perceived as a single promotional piece that includes both a
product name and a use, and is thus subject to the requirements for
"labeling" or "advertising" mandated by the act and regulations. With
regard to the second factor, FDA recognizes that "close physical or
temporal proximity" is difficult to define precisely and is unaware of
any data that help establish specific criteria. FDA requests comment on
whether such data do exist or, in the absence of data, whether there
would be utility in trying to develop specific criteria. For example,
the agency could consider two communications that are not perceptually
distinct to be in "close temporal proximity" in a broadcast
advertisement if they were presented within the same 15 minutes of a one
half hour program or the same half hour of a one hour program.
Similarly, the agency requests comment on how "proximity" could be best
considered for two communications that are not perceptually distinct if
they were presented in the same publication (i.e., magazine, newspaper).

[^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.\"

[^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).)

[^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.

[^5]: These principles are taken from the American Medical Association
    policy on Direct-to-Consumer Advertising (DTCA) of Prescription
    Drugs (H-105.988).

[^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)]{.underline}, 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]{.underline}, 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]{.underline}, [10]{.underline}, 179-199.

[^7]: Fiske & Neuberg; Higgins & Bargh.

[^8]: Fiske, S.T. and Taylor, S.E. (1991). [Social
    Cognition]{.underline}. New York: McGraw Hill.

[^9]: Zhao, X. (1997). Clutter and serial order redefined and retested.
    [Journal of Advertising Research]{.underline},
    [September/October]{.underline}, 57-73;