[Federal Register Volume 70, Number 25 (Tuesday, February 8, 2005)]
[Notices]
[Pages 6691-6693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0016]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Evaluation of Consumer-Friendly Formats for Brief 
Summary in Direct-to-Consumer Print Advertisements for Prescription 
Drugs: Study 1

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on a proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a study of consumer evaluations of various 
consumer-friendly formats for the brief summary in direct-to-consumer 
(DTC) prescription drug print advertisements.

DATES: Submit written or electronic comments on the collection of 
information by April 11, 2005.

ADDRESSES: Submit electric comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information 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 found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to each of the following collection of information, 
FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-
Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 903(b)(2)(c) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to 
conduct research relating to drugs and other FDA regulated products in 
carrying out the provisions of the act. Under the act, a drug is 
misbranded if its labeling or advertising is false or misleading. In 
addition, section 502(n) of the act (21 U.S.C. 352(n)) specifies that 
advertisements for prescription drugs and biological products must 
provide a true statement of information ``***in brief summary***'' 
about the advertised product's ``***side effects, contraindications and 
effectiveness***.'' Generally, the display text of an advertisement 
presents a fair and balanced disclosure of the product's indication and 
benefits and the product's side effects and contraindications. The 
prescription drug advertising regulations (Sec.  202.1(e)(3)(iii) (21 
CFR 202.1(e)(3)(iii))) specify that the information about risks must 
include each specific side effect and contraindication'' from the 
advertised drug's approved labeling. The regulation also specifies that 
the phrase ``side effect and contraindication'' refers to all of the 
categories of risk information required in the approved product 
labeling written for health professionals, including the Warnings, 
Precautions, and Adverse Reactions sections. Thus, every risk in an 
advertised drug's approved labeling must be addressed to meet these 
regulations.
    In recent years, FDA has become concerned about the adequacy of the 
brief summary in DTC print advertisements. Although advertising of 
prescription drugs was once primarily addressed to health 
professionals, consumers increasingly have become a primary target 
audience, and DTC advertising has dramatically increased in the past 
few years. Results of the FDA 2002 survey on DTC advertising (available 
at www.fda.gov/cder/ddmac/researchka.htm) provide some information 
regarding the extent to which consumers read these ads and the brief 
summary that accompanies the main ad--41 percent of respondents in 2002 
reported they do not usually read any of the brief summary. Use of the 
brief summary was a function of whether they have an interest in the

[[Page 6692]]

condition; about 45 percent of those having a particular interest in 
the advertised drug read all or almost all of the brief summary.
    Because the regulations do not specify how to address each risk, 
sponsors can use discretion in fulfilling the brief summary requirement 
under Sec.  202.1(e)(3)(iii). Frequently, sponsors print in small type, 
verbatim, the risk-related sections of the approved product labeling 
(also called the package insert, professional labeling, or prescribing 
information). This labeling is written for health professionals, using 
medical terminology. FDA believes that while this is one reasonable way 
to fulfill the brief summary requirement for print advertisements 
directed toward health professionals, this method may be difficult for 
consumers to understand.
    Consumers may use the brief summary for many purposes, such as to 
learn about new treatments, to compare with other prescription brands 
or over-the-counter (OTC) medications, to form a benefit-risk judgment, 
to generate questions for their healthcare provider, and to verify 
promotional claims. All of these possible uses contribute to achieving 
more informed healthcare decisions.
    These different uses likely involve different mental processing 
strategies, therefore a careful assessment of possible changes in the 
format and content of the brief summary is necessary. FDA's objectives 
for communicating important information and sponsors' discretion in 
choosing what specific information to include requires an understanding 
of the range of consumer uses of the brief summary.\1\ Thus, as a first 
step in assessing content and format options for the brief summary, the 
current research will investigate the nature of consumers' goals when 
they read prescription drug print advertisements, and the relative 
usefulness of the information topics presented.
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    \1\For other FDA research investigating the relationship between 
consumer processing and issues of format and content, see Levy, Fein 
and Schucker ``Performance Characteristics of Seven Nutrition Label 
Formats,'' Journal of Public Policy and Marketing, (Spring) 15(1), 
1-15, 1996.
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    The current study will be the first in a series of studies 
examining the format and content of the brief summary in DTC print 
advertisements. Format and other content issues will be examined in 
following studies. This first study will consider the full context of 
the ``side effect, contraindications, and effectiveness'' information 
presented in prescription drug advertisements, in terms of what 
consumers are trying to learn from the entire ad, including the display 
(or main) page and the brief summary, and what about each is useful. In 
addition, the research will directly consider caregivers, another 
important audience for prescription drug advertising. It is estimated 
that 46 percent of adults help provide healthcare for someone else.\2\ 
Caregivers provide a range of activities, from reminding another person 
to follow a diet to deciding whether the person in their care will use 
a prescription drug at all. About 58 percent of caregivers report 
seeking additional information about the condition they are helping to 
manage.
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    \2\Slaughter, E., Seventh Annual Survey on Consumer Reaction to 
DTC Advertising of Prescription Medicines. Rodale, Inc., 2004.
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    Design Overview: This study will employ a between-subjects crossed 
factorial design using a mall-intercept protocol. Eight print 
advertisements will be created using two levels of drug risk severity 
and four medical conditions. Thus, the factors will be severity of risk 
(high versus low) and medical condition (high cholesterol versus 
obesity versus asthma versus allergies). Other side effect and risk 
information will be constant across conditions. Participants, those 
diagnosed with the condition and those who are caregivers for a person 
with the condition, will be asked to read a single print advertisement 
for a new prescription drug. After reading the advertisement, they will 
be asked questions about their use and evaluation of information topics 
presented in the advertisement.
    Factors:
     Participants. Consumers will be screened and recruited by 
the contractor to be either currently diagnosed with one of the above 
conditions, at risk of developing one of the conditions, or currently 
giving care to someone who has been diagnosed. A caregiver will be 
defined as an adult male or female who has a concern for the well-being 
of another person (parent, child, spouse, close friend, or relative) 
who is currently receiving medication for one of the four medical 
conditions, and who provides a (near daily) support activity for that 
person. The support may range from simply reminding them to take their 
medication to providing direct guidance and physical assistance with 
their treatment regimen. Thus, participants will be nested within 
medical condition and randomly assigned to either high or low level of 
risk. Each condition will be balanced with respect to gender.
    Multiple disease conditions will be incorporated to provide 
generality. The medical conditions chosen represent a variety of 
conditions varying in severity and for which treatments range from 
multiple over-the-counter possibilities (allergies) to those where the 
medications are potentially quite complex and serious (weight loss). 
These conditions are likely to occur in both males and females, may 
involve a caregiver, and have fairly high prevalence rates in the 
general population.
    Participants will be screened to represent a range of education 
levels (some college or less vs. completed college or more). Because 
the task presumes basic reading abilities, all participants will have 
English as their primary language and, as appropriate, be required to 
bring reading glasses with them to the site.
     Severity of Risk. The severity of drug side effects is an 
important attribute in consumers' evaluation of new prescription 
products. For example, it may be an important reference point for 
evaluating benefit claims and for directing further information search. 
Variation in aspects of consumer mental processing of a prescription 
drug advertisement, such as confirmation or clarification of 
promotional claims, may be expected depending on the risk information 
presented in the display (first) page portion of the advertisement for 
a new brand.
    By incorporating variation in brand risk as a design factor in this 
study, we can further our confidence in observing a more representative 
spectrum in how consumers use the brief summary. Risk will be varied to 
create ``high'' and ``low'' levels of perceived product risk as 
follows:
    HIGH: In rare cases, Oncor may cause heart damage. You should 
contact your doctor right away if you get a severe cough or chest pain.
    LOW: In rare cases, Oncor may cause dry mouth. You should contact 
your doctor if your dry mouth lasts for more than 4 days.
    Procedure: Participants will be shown one ad, e.g., an ad for a 
high risk drug for asthma or an ad for a low risk drug for high 
cholesterol. Then a structured interview will be conducted with each 
participant to examine a number of important perceptions about the 
brief summary, including perceived riskiness of the drug, ratings of 
individual sections in the brief summary information, and perceived 
usefulness of brief summary information. Finally, demographic and 
health care utilization information will be collected. Interviews are 
expected to last approximately 20 minutes and participants will be 
offered a $5

[[Page 6693]]

incentive for their time. A total of 432 participants will be involved. 
This will be a one time (rather than annual) collection of information.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                                      Annual Frequency     Total Annual         Hours per
        No. of  Respondents             per Response        Responses           Response          Total Hours
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800 (screener)                                       1                800                .017                 14
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432 (survey)                                         1                432                .33                 143
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Total                                .................  .................  ..................                157
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2419 Filed 2-7-05; 8:45 am]
BILLING CODE 4160-01-S