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 Guidance for Industry
Consumer-Directed Broadcast
Advertisements
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
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 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
products 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 products 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 major
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 Agencys 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. statement, together with adequate provision for dissemination of the products 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 products most important risk
information in consumer-friendly language.
 
! Communicate all information relevant to the products 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 products 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 products 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 to
2 consumers 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 products 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 the
3 components 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 advertisements 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.
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