Guidance for Industry
"Help-Seeking" and Other Disease Awareness Communications by or on
Behalf of Drug and Device Firms
(PDF version of this document)
DRAFT
GUIDANCE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distributed for comment purposes only.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the availability of the draft guidance.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
II.
FDA AUTHORITY OVER DRUG/DEVICE LABELING AND ADVERTISING
III.
DISEASE AWARENESS COMMUNICATIONS BY OR ON BEHALF OF DRUG AND DEVICE
FIRMS
IV.
COMBINING DISEASE AWARENESS COMMUNICATIONS WITH REMINDER OR PRODUCT
CLAIM PROMOTION
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).)
Advertising2
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" promotion3
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
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 93see your doctor94 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.
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.
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, 93There is help for a particular medical condition; see
your doctor.94 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, 93This specific product is available;
see your doctor.94 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 93labeling94 or
93advertising94 mandated by the act and regulations. With regard to
the second factor, FDA recognizes that 93close physical or temporal
proximity94 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 93close temporal proximity94 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
93proximity94 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), New York: Academic
Press (hereinafter 93Fiske & Neuberg94); 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 93Higgins & Bargh94); 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;
Back
to Top
Back to Guidance Page
PDF requires the free Adobe
Acrobat Reader
Date created: December 20, 2005 |