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Guidance for Industry
Brief Summary: Disclosing Risk Information in Consumer-Directed
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DRAFT GUIDANCE
(PDF
version of this document)
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the availability of the draft guidance.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
DDMAC
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
DDMAC
TABLE OF CONTENTS
I. INTRODUCTION
II. BACKGROUND
III. OPTIONS FOR
DISCLOSING RISK INFORMATION IN CONSUMER-DIRECTED PRINT
ADVERTISEMENTS
IV. REQUEST
FOR THE VIEWS OF INTERESTED PARTIES
Guidance for
Industry1
Brief Summary: Disclosing Risk Information in
Consumer-Directed Print Advertisements
This draft
guidance, when finalized, will represent the Food and Drug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 it 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
This guidance provides
recommendations on the disclosure of risk information in
prescription drug product advertisements directed toward consumers
in print media. This draft guidance supersedes the draft guidance on
Using FDA-Approved Patient Labeling in Consumer-Directed Print
Advertisements, which was issued in April 2001. This guidance
does not focus on the presentation of risk information in the main
body of the advertisement.
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. Thus, FDA
does not intend to object to a consumer-directed print advertisement
on the ground that it does not fulfill the brief summary requirement
solely because it does not comply with the recommendations set forth
in this guidance document. Although FDA cannot object to a
consumer-directed print advertisement for a prescription drug solely
on the basis that the risk information is not presented in
consumer-friendly language, the Agency strongly encourages the use
of consumer-friendly language in all consumer-directed materials,
for the reasons discussed in section III of this document.
II.
BACKGROUND
Under the Federal Food, Drug, and
Cosmetic Act (the Act), FDA is responsible for regulating the
advertising of prescription drugs. Under Section 502(n) of the Act
(21 U.S.C. 352(n)), an advertisement for a prescription drug must
contain, in addition to the product's established name and
quantitative composition, a "true statement" including "information
in brief summary relating to side effects, contraindications, and
effectiveness as shall be required in regulations . . . ." This
requirement is further defined in the prescription drug advertising
regulation at 21 CFR 202.1(e)(1), which requires that an
advertisement contain a "true statement of information in brief
summary relating to side effects, contraindications . . . and
effectiveness." Under 21 CFR 202.1(e)(3)(iii)): "The information
relating to side effects and contraindications shall disclose
each specific side effect and contraindication (which include
side effects, warnings, precautions, and contraindications and
include any such information under such headings as cautions,
special considerations, important notes, etc. . . .) contained in
required, approved, or permitted labeling for the advertised drug
dosage form(s)" (emphasis added). For purposes of this guidance, the
requirement under these provisions that an advertisement for a
prescription drug disclose each side effect, warning, precaution,
and contraindication from the required, approved, or permitted
labeling is the brief summary requirement.
Frequently, to fulfill the brief
summary requirement, consumer-directed print advertisements for
prescription drugs include the complete risk-related sections of the
FDA-approved professional labeling. This information is presented
verbatim, in small type. Because this labeling is written 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
FDA-approved professional labeling has often included all possible
adverse events, including those that are unlikely to be drug
related.
Although this approach complies with
the brief summary requirement, FDA believes it is less than optimal
for consumer-directed print advertisements because many consumers do
not have the technical background to understand this information.
Moreover, the volume of the material, coupled with the format in
which it is presented (i.e., very small print and sophisticated
medical terminology) discourages its use and makes the information
less comprehensible to consumers. In general, FDA believes that
exhaustive lists of minor risks distract from and make it difficult
to comprehend and retain information on the more important risks.
FDA also believes that information intended for a consumer should
optimally be communicated in language fully understandable by a lay
reader and presented in an easily readable format.
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 Under the proposed
rule, FDA-approved professional labeling would contain a new
introduction section called Highlights of Prescribing Information
(Highlights). Highlights would set forth in a concise manner the
information that is most important to safe and effective use,
including information on the most common and the most serious risks
associated with the product.
If the proposed rule were to become
effective, then the FDA-approved professional labeling for new and
recently approved drugs and labeling approved by FDA according to
supplemental premarket approval applications would include
Highlights that FDA believes would be appropriate for manufacturers
to use when presenting risk information in consumer-directed print
advertisements for prescription drugs. Ideally, the Highlights would
be translated from language appropriate for a professional audience
into language easily understood by the average consumer. This option
is discussed in greater detail in section III.B of this guidance
document. Alternatively, a manufacturer could present risk
information in its consumer-directed print advertisements by: (1)
presenting all risk information from the FDA-approved professional
labeling; or (2) reproducing FDA-approved patient labeling, either
in its entirety or as modified to omit less important risk
information (see section III.A).
Unless and until the proposed rule
goes into effect, a manufacturer can (1) present all risk
information from the FDA-approved professional labeling; (2)
reproduce FDA-approved patient labeling, either in its entirety or
as modified to omit less important risk information (see section
III.A); or (3) provide the risk information that would be
appropriate for FDA-approved Highlights (see section III.B).
On April 23, 2001, FDA announced in
the Federal Register (66 FR 20468) the availability of a
draft guidance for industry entitled Using FDA-Approved Patient
Labeling in Consumer-Directed Print Advertisements. The draft
guidance described how certain FDA-approved patient labeling could
be used to disclose risk information in consumer-directed print
advertisements for prescription drugs. This draft guidance differs
from the previous draft guidance in that it describes several
options for disclosing risk information in consumer-directed print
advertisements. And, as noted above, this draft guidance supersedes
the earlier one.
III. OPTIONS
FOR DISCLOSING RISK INFORMATION IN CONSUMER-DIRECTED PRINT
ADVERTISEMENTS
In the circumstances described
below, FDA does not intend to object to a consumer-directed print
advertisement for a prescription drug on the ground that it does not
present risk information in compliance with the brief summary
requirement. Each of the following approaches would provide
information on the most serious and the most common risks associated
with the product, and would omit less important information.
FDA recommends that any
advertisement disseminated as described below include a statement
reminding consumers that the information presented is not
comprehensive and providing a toll-free telephone number or Web site
address (URL) where consumers can obtain additional information if
they wish.
A prescription drug may have, in
addition to FDA-approved professional labeling, FDA-approved
patient labeling. This labeling can include Information for the
Patient, a Medication Guide, Patient Information, or a Patient
Package Insert. Although less extensive than the FDA-approved
professional labeling, FDA-approved patient labeling provides risk
and benefit information that is material to the decision by the
patient (with the involvement of a health care practitioner) whether
to use a prescription drug and material to safe and effective use of
the drug.
Generally, FDA-approved patient
labeling does not address each specific risk included
in the FDA-approved professional labeling. Instead, FDA-approved
patient labeling communicates the most important information
patients need to use the product appropriately, and it focuses on
the product's most serious risks and its less serious, but most
frequently occurring, adverse reactions. We believe that omitting
less serious, infrequent risks from patient labeling may actually
increase the usefulness of this labeling for its audience by making
the more important risks stand out more clearly. For these reasons,
FDA believes that FDA-approved patient labeling is a better vehicle
for communicating risk information to consumers than lengthy,
technical FDA-approved professional labeling.
Not all FDA-approved patient
labeling describes a product's most serious risks and its less
serious, but most frequently occurring, adverse reactions. Some
FDA-approved patient labeling primarily gives instructions for use
(e.g., directions on how to use medications delivered through
inhalation, a patch, or injection). Other FDA-approved patient
labeling focuses primarily on a single important warning. Where
FDA-approved patient labeling has a narrow focus and does not
provide information on the product's most serious risks and its less
serious, but most frequently occurring, adverse reactions, FDA
believes this labeling would not be suitable for conveying risk
information in a consumer-directed print advertisement.
The Agency recognizes that some
FDA-approved patient labeling includes information in addition to
risk information (e.g., directions for use or a discussion of the
disease state being treated). Deletion of this information from the
labeling when using it to present risk information in a
consumer-directed print advertisement is likely to help the consumer
focus on the most important risk information for the drug.
The following describes the Agency's
thinking on the use of FDA-approved patient labeling to present risk
information in consumer-directed print advertisements for
prescription drugs instead of presenting verbatim the risk-related
sections of FDA-approved professional labeling.
- Contraindications: all;
- Warnings: all;
- Precautions: the major
precautions, including any that describe serious
adverse drug experiences
(as defined in 21 CFR 312.32(a) & 314.80(a)) or steps to be
taken to avoid such experiences; and
- Adverse Reactions: the 3-5
most common nonserious adverse reactions most likely to
affect the patient's quality of life or compliance with drug
therapy.
Infrequently, risk information
included in the Precautions or Adverse Reactions section of
FDA-approved professional labeling would, under current
practice, appear in the Warnings section. In such a case, that
risk information should be deemed to appear in the Warnings
section for purposes of this guidance document.
2. Reprinted Risk Information
Only
FDA does not intend to object to
a consumer-directed print advertisement for a prescription drug
on the ground that it does not present risk information in
compliance with the brief summary requirement if it includes the
FDA-approved patient labeling for the drug and if that labeling:
(1) has been modified to include only risk information (e.g., by
deleting instructions for use); and (2) includes information
from the advertised product's FDA-approved professional labeling
addressing the following risks:
- Contraindications: all;
- Warnings: all;
- Precautions: the major
precautions, including any that describe serious
adverse drug experiences
(as defined in 21 CFR 312.32(a) & 314.80(a)) or steps to be
taken to avoid such experiences; and
- Adverse Reactions: the 3-5
most common nonserious adverse reactions most likely to
affect the patient's quality of life or compliance with drug
therapy.
Infrequently, risk information
included in the Precautions or Adverse Reactions section of
FDA-approved professional labeling would, under current
practice, appear in the Warnings section. In such a case, that
risk information should be deemed to appear in the Warnings
section for purposes of this guidance document.
B.
Highlights
1. Before the Proposed Rule
Becomes Effective
Unless and until the proposed
rule becomes effective, FDA does not intend to object to a
consumer-directed print advertisement for a prescription drug on
the ground that it does not present risk information in
compliance with the brief summary requirement if it includes the
risk information that would appear in the Highlights section of
FDA-approved labeling for the product, including information
addressing the following risks:
- Contraindications: all;
- Warnings: all;
- Precautions: the major
precautions, including any that describe serious
adverse drug experiences
(as defined in 21 CFR 312.32(a) & 314.80(a)) or steps to be
taken to avoid such experiences; and
- Adverse Reactions: the 3-5
most common nonserious adverse reactions most likely to
affect the patient's quality of life or compliance with drug
therapy.
Infrequently, risk information
included in the Precautions or Adverse Reactions section of
FDA-approved professional labeling would, under current
practice, appear in the Warnings section. In such a case, that
risk information should be deemed to appear in the Warnings
section for purposes of this guidance document.
2. If the Proposed Rule Were
to Become Effective
If the proposed rule were to go
into effect, FDA would not intend to object to a
consumer-directed print advertisement for a prescription drug on
the ground that it does not present risk information in
compliance with the brief summary requirement if the
advertisement reproduces the parts of the Highlights of
FDA-approved professional labeling that set forth risk
information (e.g., Boxed Warning, Contraindications,
Warnings/Precautions, Most Common Adverse Reactions).
To illustrate, we are providing
as separate documents (1) an example of a fictional prescription
drug product Highlights and (2) an example of the fictional
Highlights in consumer-friendly format and language illustrating
an appropriate way to convey risk information under this option.
The example omits some non-risk information, such as How
Supplied and Dosage and Administration information.
3. FDA Recommendations On Use
Of Consumer-Friendly Language
For consumers to realize full
benefit from the more streamlined presentation of risk
information described in section IV.B.1 and 2, Highlights
ideally should be written in language fully understandable by a
lay reader and should not contain technical, scientific terms or
jargon. Thus, FDA encourages Highlights intended for use in
consumer-directed print advertisements to be written in language
that is easy to understand, use, or deal with by ordinary
individuals under normal conditions. For example, a consumer may
not understand the term "Contraindications" but is more likely
to understand the phrase "You should not take drug X if . . . ."
IV. REQUEST
FOR THE VIEWS OF INTERESTED PARTIES
In this draft guidance, FDA
describes several options for presenting the risk information in
consumer-directed print advertisements. In crafting these options,
FDA evaluated several approaches for communicating complex
information in various labeling formats. Examples of the agency's
past experience in this area include both the redesign of food
labeling under the Nutritional Labeling and Education Act of 19904
and the standardization of the format and content for the labeling
of over-the-counter drug products.5
The promotion of prescription drugs
differs from the promotion of many other products. While
prescription drugs offer medical benefits, these products may also
pose significant risks to patients. Based on available data and
information, and on the results of FDA's own research, the agency
believes consumer-directed promotion of prescription drugs can
convey useful health information to patients. But for such promotion
to have this beneficial effect, it must be truthful, non-misleading,
and scientifically substantiated. This means, for example, that
prescription drug promotion must include appropriate information on
the risks associated with the use of the drug, and that this
information must be properly presented.
FDA recognizes that the language and
format chosen to present risk information can affect consumer
understanding. We have not evaluated how presenting the information
in different formats affects consumer comprehension, and we believe
that there is much to be learned before we develop final guidance on
how best to inform patients about the drugs being promoted.
Therefore, the agency is soliciting comments, suggestions, or
results of research in this area from interested parties to help
assess what is most useful for consumers to ensure that they are
provided with concise, understandable risk information that will
help them make well-informed decisions. The agency is also
encouraging the development of new approaches to presenting risk
information.
For example, as noted above, risk
information in a consumer-directed print advertisement for a
prescription drug is set forth in detail in an accompanying "brief
summary" and is also incorporated into the text in the body of the
advertisement. An alternative to including risk information in the
text in the body of the advertisement would be to include risk
information as bullet points in a "risk information window" in the
body of the advertisement. The window could appear prominently in
the advertisement (e.g., in the top half) and could bear a title
(e.g., "Important Safety Information") calling attention to the
information it contains. FDA specifically requests comments on this
approach. A specific issue on which FDA requests comment is whether,
in some cases, it may be impossible for all of the necessary risk
information to be presented in a bullet format in the risk
information window. FDA requests comments on whether, in those
cases, FDA should recommend that the bulleted information be
accompanied by additional risk information in the text in the body
of the advertisement.
Some have suggested that the essence
of the risk information could be incorporated into the body of the
advertisement, obviating the need for disclosure of risk information
in a separate part of the advertisement. FDA requests comments on
such an approach, including on whether this approach might be
appropriate for only a subset of prescription drugs (e.g., drugs
with safety profiles that can be succinctly summarized).
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.
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).
4 Pub. L. No.
101-535 (Nov. 8, 1990).
5 See, e.g., 64 FR
13254; March 17, 1999.
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Date created: November 22, 2005 |
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