Guidance for Industry

Consumer-Directed Broadcast

Advertisements

Questions and Answers

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
These questions and answers on the Consumer-Directed Broadcast Advertisements guidance have been prepared by the 1

Intra-Agency Group on Advertising and Promotion at the Food and Drug Administration. They represent 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. 

They do not create or confer any rights for or on any person and do 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.

Consumer-Directed Broadcast Advertisements Guidance

Questions and Answers1

Q: What are the differences, if any, between the draft guidance and the final guidance

concerning consumer-directed (direct-to-consumer or DTC) broadcast advertisements?

A: The final guidance does not differ substantially from the draft guidance. Minor revisions

include: (1) reformatting the assumptions underlying what constitutes a compliant

broadcast advertisement in general; (2) deleting the option under the toll-free telephone

component of the adequate provision approach to offer to fax product labeling to

consumers; (3) emphasizing the need for the print advertisement component of the

adequate provision approach to be broadly disseminated; (4) acknowledging that the print

brochures alternative component of the adequate provision approach was likely to be

feasible only when broadcasting was fairly limited in scope; (5) acknowledging explicitly

that healthcare providers other than physicians and pharmacists can be sources of

additional human drug product information; and (6) adding a discussion to clarify the

differences in satisfactory adequate provision approaches for telephone advertisements,

compared with television or radio advertisements.

Q: In the draft guidance, FDA described four components of its suggested multifaceted

approach to complying with the adequate provision requirement. What is FDA’s position in

the final guidance about whether all the different sources from which consumers can get the
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product labeling need to be included to ensure an acceptable adequate provision approach?

A: The approach to adequate provision discussed in the draft guidance included disclosure of

four sources of product labeling information: (1) a toll-free telephone number; (2) referral

to a print advertisement in a concurrently running print publication, or provision of enough

brochures, with required product information, in various convenient outlets; (3) referral to

a healthcare provider (physician, pharmacist, veterinarian); and (4) an Internet web page

address. Some comments on the draft guidance expressed the general concern that there

was insufficient flexibility in the proposed approach, and felt that product sponsors should

be allowed to determine on a product by product basis the components of adequate

provision to include in a broadcast advertisement. For the following reasons, FDA

continues to believe that a multifaceted approach is the best approach and that, ordinarily,

all four sources should be used.

The approach proposed in the draft guidance was one that the Agency believed could help

ensure adequate access to the advertised product’s labeling by most of a diverse audience

with different information-seeking styles. Targeted audiences are likely to consist of

individuals with different degrees of technological sophistication or access to

technologically sophisticated information sources (like the Internet), with different

information-seeking styles, and with different levels of concern about privacy and how

they receive potentially sensitive information. Adequate provision requires that this broad

audience be able to receive the detailed information.

When FDA issued the draft guidance, it also requested information from manufacturers

and other interested parties concerning consumer use of the four sources of additional

information. No evidence was submitted by manufacturers supporting contentions that

any of the four information sources were underutilized, or that there was significant

overlap in usage. In fact, the results of recent consumer survey research conducted by

both Prevention magazine and TIME Inc. supports FDA’s belief that different sources
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would be used by different individuals in seeking out additional product information on

seeing a broadcast advertisement. The most commonly used source of additional

information about the product appears to be the consumer’s healthcare provider. The

other information sources were used by lower, although approximately equal, percentages

of consumers. The only significant overlap appears to occur when patients consult with a

health professional and also use one of the other three information sources.

The research also suggests, however, that although the toll-free number and referral to a

health professional are being communicated effectively, the web page address, and, to an

even greater degree the print reference, are not. Relatively low percentages of consumers

in the Prevention survey who had seen prescription drug broadcast advertisements said

that they remembered a print or Internet address reference. In contrast, a clear majority

of respondents reported recalling the reference to a healthcare professional and a toll-free

number. The most likely explanation is that the advertisements themselves are

inadequately presenting the web page address and reference to print sources. Even a

cursory examination of existing broadcast advertisements shows that the toll-free

telephone number is on screen for far longer than either the print or web page disclosures. 

FDA continues to believe that a multifaceted approach will best ensure adequate

dissemination of product labeling. Moreover, sponsors of broadcast advertisements for

prescription products should present references to the different information sources in a

more balanced fashion.

FDA believes that it is critical to have additional product information available in print,

especially for audience members who are particularly sensitive to privacy issues in seeking

out additional information. Supportive data from the TIME, Inc. survey indicated that

about half of consumers say it is either extremely or very important for DTC advertising to

be able to be reviewed privately to avoid embarrassment. Given this, it is important that

these sources of information be prominent and widely available. A display ad with

graphics is more likely to be easily found than straight text when presented in a magazine
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or newspaper format. FDA therefore recommends that sponsors consider the enhanced

value for consumers of including more than just a brief summary and a 1-800 number in

print advertisements that are part of adequate provision.

Q: What does the final guidance say about the alternative to the print advertisement

component of adequate provision of making brochures available in many different convenient

locations?

A: The draft guidance offered an alternative to referencing a print advertisement as part of

adequate provision. The alternative was to provide brochures with full product

information in a variety of convenient, publicly accessible sites, such as pharmacies,

doctors’ offices, grocery stores, and public libraries. A concern with this method

expressed by some comments was that it would be difficult to ensure the availability of

enough of the brochures in sites outside the control of the advertised product’s sponsor. 

Another comment was that such brochures should only be made available at doctors’

offices and pharmacies. The Agency agrees that the provision of sufficient brochures for a

national broadcast audience might be difficult, but decided to retain the alternative because

it could be a useful option in some cases (e.g., under certain relatively limited broadcasting

circumstances). FDA believes, however, that limiting distribution to doctors’ offices and

pharmacies would defeat the purpose of this component, which is to help ensure

widespread access to product information for people who may be uncomfortable with

being personally identifiable, including those uncomfortable having their initial information

searches take place in medical care arenas.

Q: I’ve seen references in prescription drug broadcast advertisements to print ads for the

product in very targeted, relatively limited availability magazines. How well does this practice

fulfill the adequate provision requirement?

A: In monitoring various broadcast advertisements since the draft guidance was issued for
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comment in August 1997, FDA has noted wide variability in the print publications used to

fulfill this component of adequate provision. FDA has also received data indicating wide

variability in the likelihood of exposure of consumers to associated print advertisements. 

Some sponsors’ approaches to this component of adequate provision have included

publication in, and reference in their broadcast advertisements to, magazines with

relatively wide circulation and availability. For some products advertised on TV and

radio, print advertisements have appeared in multiple magazines, increasing the likelihood

that passive information seekers will be exposed to additional product information. Other

sponsors, in contrast, have published advertisements solely in infrequently published or

limited distribution magazines that are unlikely to be available in places such as newsstands

and grocery stores for more than a week during the period of a month or two that the

broadcast advertisement is airing. This practice greatly decreases the likelihood that

passive information seekers will be exposed to product information and that information

seekers concerned about their privacy will be able to find such information. 

FDA generally believes that a sponsor has not provided adequate access to the product’s

package labeling when the print component of their adequate provision approach is highly

targeted or made only narrowly available and the product is broadly advertised in

broadcast media. FDA intends to monitor the availability of print advertisements to

passive and privacy-sensitive information seekers, when such advertisements are part of an

adequate provision approach. In doing so, FDA may request that sponsors provide

information on the availability of this component. Such requests could include information

about reach, frequency, and total number of exposures of both the broadcast and

associated print advertisements.

Q: At meetings, I’ve heard about data that suggest that not many broadcast ad viewers ask

to have product labeling sent to them by facsimile. Given this, why does FDA include faxing

the labeling as part of its adequate provision approach?
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A: Specific comments made concerning the draft guidance pointed to the logistically

cumbersome nature of ensuring the delivery of faxes resulting from calls made to the tollfree telephone number. In addition, FDA notes that data from more than one product

manufacturer indicate that only a small percentage of callers request that product labeling

be faxed to them. FDA also believes that individuals who own a fax machine are likely to

have convenient access to the Internet. Given that the Agency has no wish to burden

sponsors unnecessarily by encouraging overlapping availability of labeling through

different technologically sophisticated means, the Agency has reconsidered its position

with regard to faxes and revised the guidance to delete the suggestion that consumers

calling the toll-free telephone number be offered the option of having product labeling

faxed to them.

Q: The draft guidance included the mechanism of having package insert information

read to consumers through the toll-free telephone number. Do consumers use this and is it

really necessary?

A: Limited data from at least one manufacturer, as well as additional anecdotal reports,

suggest that a significant percentage of callers ask to have product information read to

them. Therefore, FDA kept this option in the final guidance. Once consumers gain

experience with the mechanism, it is conceivable that such requests to have PI information

read will decrease significantly. If it appears that people are not using this mechanism, we

are prepared to revise the guidance. 

Q: What about DTC prescription drug advertising in general? Aren’t there a lot of

negative effects associated with it? Isn’t FDA interested in these?

A: A number of comments asserted that the draft guidance was inappropriate because of

postulated negative effects associated with consumer-directed prescription drug

advertisements in general. These comments generally asserted that FDA was shirking its
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responsibility to the public health by allowing any DTC advertising, and was exacerbating

the ill effects of prior actions concerning DTC promotion by inappropriately loosening

restrictions on broadcast advertisements. 

FDA is unaware of any data supporting the assertion that the public health or animal

health is being harmed, or is likely to be harmed, by the Agency’s actions in facilitating

consumer-directed broadcast advertising. FDA has repeatedly requested empirical data

that would document the hypothesized effects — negative and positive — of DTC

promotion on several factors related to public health. Despite years of print DTC

advertising, no rigorous evidence has been presented to demonstrate that DTC advertising

has had any of the hypothesized ill effects. In the absence of such data, FDA believed that

the advantages of having a broadcast environment that would encourage communication

of both the benefits and the risks of advertised products outweighed the postulated, but

never demonstrated, disadvantages. In issuing the draft guidance, FDA again asked that

research be conducted to document the effects of DTC promotion on the public health and

animal health and specified that it would conduct an evaluation of such effects within 2

years of finalizing the guidance.

FDA does not agree that it has loosened restrictions on broadcast advertisements,

although we have taken steps to make them more feasible. Since being promulgated in the

1960s, the regulations have provided for alternative requirements for broadcast, as

compared with print, advertisements. Although product sponsors theoretically had the

option of using the adequate provision alternative instead of presenting a brief summary in

connection with broadcast advertisements, the absence of formal guidance created

uncertainty about how the Agency would treat any particular approach. The result was a

broadcast environment confusing to consumers and less than optimal for effectively

communicating product information. Given that there are no legal impediments to such

consumer-directed broadcast advertising, the Agency was obliged to provide appropriate

guidance.
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Q: The draft guidance emphasized the underlying regulatory assumption about broadcast

advertisements that they must contain disclosure of all of the most important risks associated

with the product. Can this really be done in consumer-directed broadcast advertisements?

A: A basic regulatory requirement for any broadcast advertisement is that it include a

thorough major statement conveying all of the product’s most important risk information. 

Some comments asserted that the limited duration of a broadcast advertisement would not

permit adequate presentation of potential risks or an adequate risk/benefit discussion. 

FDA believes that risk information can be adequately communicated in a broadcast

advertisement. Since the draft guidance was issued for comment in August 1997, many

product sponsors have produced broadcast advertisements that FDA believes satisfactorily

disclose the most important risk information about the advertised products. In some

cases, FDA has objected to the initial content or presentation of risk disclosure, but in

virtually all of these cases, the sponsor was able to revise the advertisements to address

FDA’s concerns. Success in presenting risk information may reflect the choice of

products for broadcast DTC promotion; many have been drugs without major risks. It

may be that sponsors are reluctant to promote products with serious risks to consumers in

a broadcast format.

Some comments asserted that there should be no risks or only general risks disclosed in

broadcast advertisements. The regulations, however, provide only limited flexibility for

risk disclosure in broadcast advertisements. The regulations specify that such ads must

include information relating to the product’s major risks (“major side effects and

contraindications”) in addition to providing either a brief summary or adequate provision

for disseminating full product labeling. More significantly, the Federal Food, Drug, and

Cosmetic Act (the act) specifies clearly that advertisements must contain “information in

brief summary relating to side effects, contraindications, and effectiveness” of the

advertised drug (21 U.S.C. 352(n)). FDA believes that the clarity of the statute on this

matter precludes permitting such advertisements to omit product risks completely. In
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addition, FDA believes that the benefits and risks of drugs are specific, not general, and

that even though the prescribing decision ultimately will be made by the patient’s

healthcare provider, a patient’s decision to discuss with his or her provider the possibility

of getting a prescription for the advertised product should be shaped by at least a general

understanding of the product’s benefit(s) and risk(s). This also helps assure that these

risks will be part of the discussion. The Agency notes that DTC broadcast promotion

cannot possibly contain information sufficient for even a medically trained person to make

an informed decision about use of the product, much less a person without such training. 

The decision to use a prescription drug requires a consultation between the patient and a

healthcare provider familiar with the entire product labeling.

Q: What about the requirement for disclosure of product information (e.g., product

labeling, brief summary) that is generally not written for consumers? Can’t it be written so

consumers can understand it?

A: FDA acknowledges that product labeling generally is written for healthcare professionals. 

However, the number of Physicians’ Desk References sold to consumers attests to the

value many consumers place on medical product labeling information. In addition, the

regulations are straightforward in specifying that “approved or permitted” package

labeling be disseminated in connection with broadcast advertisements. However, the

guidance encourages sponsors to consider the benefits of also providing consumers with

nonpromotional, consumer friendly product information. The Agency notes that it is

currently evaluating the regulations as they relate to DTC print promotion and will address

this issue in greater detail at a later date.

In addition, FDA has consistently noted that the brief summary required for prescription

drug advertisements does not need to consist of a reprinting of the risk-related sections of

product labeling, and can be written in light of the target audience, as long as all the risk

concepts are addressed. Finally, the Agency reiterates that if patients do not understand
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all of the information in brief summaries or labeling, their prescriber can answer any

questions they may have. 

Q: I’ve noticed that there are consumer-directed broadcast advertisements that are in

Spanish. What’s the required information in this case and how does the sponsor ensure that

the audience for these ads have access to this information?

A: When an advertisement is clearly directed toward an audience that speaks a foreign

language, it is critical that the information sources that are part of the “adequate

provision” mechanism be understood by the targeted audience. Therefore, the various

sources of product information (i.e., the toll-free telephone number, print advertisement,

web site) should be in the language of the advertisement. This would provide the

necessary link to the required information. The regulations require dissemination of

approved product labeling, which generally must be in English. However, the Agency

strongly encourages sponsors to consider the benefits of also providing foreign language

speaking consumers with nonpromotional, consumer-friendly product information in the

language of the broadcast advertisement.

Q: Can’t healthcare professionals other than physicians write out prescriptions for these

medications? Some broadcast ads seem to suggest that only physicians can prescribe certain

medications.

A: There is a difference between human drugs and animal drugs with respect to prescribing

authority. Only veterinarians can prescribe animal drugs. However, for human drugs,

prescribing authority is determined by state law. In some states, healthcare professionals

other than physicians can prescribe human drugs. FDA notes that the inclusion of

pharmacists as part of the suggested mechanism for achieving adequate provision clearly

indicates that healthcare professionals other than physicians are sources of additional

product information. Because FDA does not wish to undermine the important
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contribution of various healthcare professions, it revised the guidance to suggest that the

term other healthcare providers may be used in the referenced adequate provision

component. FDA also reminds sponsors of prescription drug advertisements to be careful

not to imply that only physicians can prescribe their products.

Q: It seems as though the risk information that’s included in DTC broadcast

advertisements is often being read at the same time that there is information disclosed in the

video part of the advertisement about the components of the adequate provision procedure. Is

this a potential problem for the communication of both types of information?

A: FDA previously solicited research on such questions as how best to integrate risk

messages into broadcast advertisements. This question is of special concern given the

television advertisements that have aired since the draft guidance was issued. Since

August 1997, television advertisements have appeared for over 25 prescription animal or

human drug products. For a number of these advertisements, FDA noted through letters

to various product sponsors that the disclosure of risk information was deficient in one

way or another. Many of these objections were based on the presentation of distracting

visual images in the background during the required audio disclosure of the advertised

product’s major risks. The Agency was concerned that such distractions interfered with

the adequate communication of required risk information. In addition, in at least two

cases, FDA has determined that advertisements were violative because information about

different risks was simultaneously presented in the audio and visual parts of the

presentation, making both topics unlikely to be adequately comprehended or processed. 

To date, FDA has not objected to video presentation of the adequate provision disclosures

simultaneously with the required audio presentation of the risk information (generally by a

voice over). Historically, FDA has believed that the simple processing needed to notice,

read, comprehend, and process adequate provision video disclosures would not interfere

with the processing of risk information presented in the audio. However, given the data

mentioned previously showing low recall of the print and web page disclosures, FDA is
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becoming concerned that this common practice may interfere with the communication of

critical risk information or with the simultaneous disclosure of the adequate provision

components. Consequently, FDA will be examining this question very carefully within the

2-year evaluation period. FDA specifically solicits the submission of empirical data

concerning this question.