Guidance
for Industry
Consumer-Directed Broadcast Advertisements
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 Veterinary Medicine (CVM)
August 1999
DDMAC
Acrobat version of this document
Questions and Answers
Additional copies of this Guidance are
available from:
Office of Training and Communications
Division of Communications Management
Drug Information Branch, HFD-210
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
(Phone 301-827-4573)
Internet: 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
Internet: http://www.fda.gov/cber/guidelines.htm
Fax: 1-888-CBERFAX or 301-827-3844
Mail: the Voice Information System at 800-835-4709 or 301-827-1800
or
Communications Staff (HFV-12)
Center for Veterinary Medicine (CVM)
7500 Standish Place, Rockville, MD 20855 (Tel) 301-594-1755
http://www.fda.gov/cvm
GUIDANCE FOR INDUSTRY1
Consumer-Directed Broadcast
Advertisements
I. INTRODUCTION
This guidance is intended to assist sponsors who are
interested in advertising their prescription human and animal drugs, including biological
products for humans, directly to consumers through broadcast media, such as television,
radio, or telephone communications systems.2
II. BACKGROUND
The Federal Food, Drug, and Cosmetic Act (the Act)
requires that manufacturers, packers, and distributors (sponsors) who advertise
prescription human and animal drugs, including biological products for humans, disclose in
advertisements certain information about the advertised product's uses and risks. For
prescription drugs and biologics, the Act requires advertisements to contain
"information in brief summary relating to side effects, contraindications, and
effectiveness" (21 U.S.C. 352(n)). The resulting information disclosure is commonly
called the brief summary.
The prescription drug advertising regulations (21 CFR
202.1) distinguish between print and broadcast advertisements. Print advertisements must
include the brief summary, which generally contains each of the risk concepts from the
product's approved package labeling. Advertisements broadcast through media such as
television, radio, or telephone communications systems must disclose the product's major
risks in either the audio or audio and visual parts of the presentation; this is sometimes
called the major statement. This guidance does not address the major statement
requirement.
Sponsors of broadcast advertisements are also required to
present a brief summary or, alternatively, may make "adequate provision ... for
dissemination of the approved or permitted package labeling in connection with the
broadcast presentation" (21 CFR 202.1(e)(1)). This is referred to as the adequate
provision requirement. The regulations thus specify that the majorstatement, together
with adequate provision for dissemination of the product's approved labeling, can provide
the information disclosure required for broadcast advertisements.
The purpose of this guidance is to describe an approach
that FDA believes can fulfill the requirement for adequate provision in connection
with consumer-directed broadcast advertisements for prescription drug and biological
products. The approach presumes that such advertisements:
· Are not false or misleading in any respect. For a
prescription drug, this would include communicating that the advertised product is
available only by prescription and that only a prescribing healthcare professional can
decide whether the product is appropriate for a patient.
· Present a fair balance between information about
effectiveness and information about risk.
· Include a thorough major statement conveying all
of the product's most important risk information in consumer-friendly language.
· Communicate all information relevant to the product's
indication (including limitations to use) in consumer-friendly language.
III. FULFILLING THE ADEQUATE PROVISION
REQUIREMENT
A sponsor wishing to use consumer-directed broadcast
advertisements may meet the adequate provision requirement through an approach that will
allow most of a potentially diverse audience to have reasonably convenient access to the
advertised product's approved labeling. This audience will include many persons with
limited access to technologically sophisticated outlets (e.g., the Internet) and persons
who are uncomfortable actively requesting additional product information or are concerned
about being personally identified in their search for product information. One acceptable
approach to disseminating the product's approved labeling is described below. This
approach includes the following components.
A. Disclosure in the advertisement of an operating
toll-free telephone number for consumers to call for the approved package labeling. Upon
calling, consumers should be given the choice of:
· Having the labeling mailed to them in a timely manner
(e.g., within 2 business days for receipt generally within 4-6 days); or
· Having the labeling read to them over the phone (e.g.,
by offering consumers a selection of prerecorded labeling topics).
B. Reference in the advertisement to a mechanism to
provide package labeling toconsumers with restricted access to sophisticated technology,
such as the Internet, and those who are uncomfortable actively requesting additional
product information or are concerned about being personally identified in their search for
product information. One acceptable mechanism would be to provide the additional product
information in the form of print advertisements appearing concurrently in publications
that reach the exposed audience. The location of at least one of these advertisements
would be referenced in the broadcast advertisement. If a print advertisement is part of an
adequate provision procedure, it should supply a toll-free telephone number and an address
for further consumer access to full package labeling. This mechanism of providing access
to product labeling has the advantage of also providing considerable information in the
form of the required brief summary and in the advertising text itself.
When a broadcast advertisement is broadly disseminated,
FDA believes that ensuring that passive and privacy-sensitive information seekers have
adequate access to detailed product information is critical to complying with the adequate
provision regulatory requirement. Thus, print advertisements associated with broadly
disseminated broadcast advertisements should be comparably broadly disseminated in terms
of the targeted audiences.
An alternative mechanism for providing private access to
product information would be to ensure the availability of sufficient numbers of brochures
containing package labeling in a variety of publicly accessible sites (e.g., pharmacies,
doctors' offices, grocery stores, public libraries). Brochures should be available at
enough sites so that most consumers exposed to the broadcast advertisement can obtain the
labeling without traveling beyond their normal range of activities. This alternative
mechanism is likely to be logistically feasible only when the associated broadcast
advertising campaign is relatively limited in audience reach.
C. Disclosure in the advertisement of an Internet web page
(URL) address that provides access to the package labeling.
D. Disclosure in the advertisement that pharmacists,
physicians (or other healthcare providers), or veterinarians (in the case of animal drugs)
may provide additional product information to consumers. This statement should communicate
clearly that the referenced professional is a source of additional product information.
Telephone advertisements that make a product claim (not
reminder advertisements) occur when there is a telephone communication between an
individual and a product's sponsor where both a product name and a representation or
suggestion relating to a product (e.g., its indication) are disclosed by the sponsor.
Under these circumstances, such advertisements are subject to the disclosure requirements
of the Act and the regulations. However, telephone advertisements are different from
advertisements broadcast through television and radio. By participating in the telephone
communication, the consumer has already indicated his or her willingness to discuss the
topic or receive additional information. Consequently, adequate provision for
disseminating product labeling in connection with telephone advertisements may be achieved
with fewer of thecomponents listed above. For such advertisements, adequate provision
could consist of the availability of the option of having product labeling mailed to the
caller in a timely manner (e.g., within 2 business days for receipt generally within 4-6
days), or having the labeling read to them over the phone (e.g., by allowing consumers to
select from prerecorded labeling topics), as well as disclosing that healthcare providers
are a source of additional product information.
When a broadcast advertisement is presented in a foreign
language, the information sources that are part of the advertisement's "adequate
provision" mechanism (i.e., print advertisements or brochures, web sites, toll-free
telephone number recorded messages or operators) should be in the language of the
broadcast ad. Regardless of the language used for the advertisement, current broadcast
advertising regulations require the dissemination of approved product labeling, which, in
most cases, must be in English, and is generally written in language directed to
healthcare professionals. The Agency strongly encourages sponsors to consider the benefits
of also providing consumers with nonpromotional, consumer-friendly product
information in the language of the broadcast ad (e.g., FDA-approved patient labeling or
accurate, consumer-friendly translations of product labeling information).
The FDA encourages sponsors who use this adequate
provision mechanism to collect relevant data on consumer use and make their findings
publicly known. FDA also encourages sponsors and other interested parties to make known
their research relating to the overall effects of DTC promotion on the public health.
1 This guidance has
been prepared by the Intra-Agency Group on Advertising and Promotion at the Food and Drug
Administration. This guidance represents the Agency's current thinking on procedures to
fulfill the requirements for disclosure of product information in connection with
consumer-directed broadcast advertisements for prescription human and animal drugs, and
human biological products. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statute, regulations, or both.
2 This guidance is not intended to
cover the advertising of restricted medical devices, which are subject to the requirements
of section 502(r) of the Federal Food, Drug, and Cosmetic Act.
FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: CDER/OCD
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