[Federal Register Volume 70, Number 240 (Thursday, December 15, 2005)]
[Notices]
[Pages 74321-74324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0016]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
17, 2006.

ADDRESSES:  OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 it's 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 http://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 is a function of whether they have an 
interest in the 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 OTC medications, to form a 
benefit-risk judgment, to make brand comparison, 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 balanced assessment of possible changes in the 
format and content of the brief summary is necessary. FDA's objectives 
for communicating important information

[[Page 74322]]

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, this 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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    This study will be the first in a series of studies examining the 
format and content of the brief summary in DTC print advertisements. 
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.
    This study will employ a between-subjects crossed factorial design 
using a mall-intercept protocol. The factors will be medical condition 
(high cholesterol versus obesity versus asthma versus allergies) and 
riskiness (high versus low) of the drug. Consumers will be screened to 
be either currently diagnosed with one of the previously mentioned 
conditions or currently giving care to someone who has been diagnosed. 
Participants will be shown one ad. For example, 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 to verify the 
generalizability of the sample. Participants will be offered a $5 
incentive for their time. A total of 420 participants will be involved. 
This will be a one time (rather than annual) collection of information.
    In the Federal Register of February 8, 2005 (70 FR 6691), FDA 
announced the availability of the draft guidance and requested comments 
for 60 days on the information collection. Two comments were received. 
Both comments included statements of support for the research itself.

A. Comments To Be Adopted

    In the original proposal, our stimulus ad displayed a prescription 
drug that was available in a new patch form. We proposed this 
administration mechanism because we required a legitimate advertising 
draw that was not safety or efficacy based and thought a new 
administration form would solve these issues. Comment 1 expressed 
concern that because the patch is a less common mode of administration 
than the typical pill, such a novel product might alter individuals' 
normal search behavior and skew our results. The comment suggested that 
we present a drug with the standard administration form, a pill. With 
consideration, we have decided to drop the patch delivery mechanism and 
instead feature a ``once-weekly'' dosing regimen as a differentiation 
point in the advertisement. We feel this dosing claim will be 
realistic, interesting, not confounded with safety or efficacy, and 
should avoid potential problems related to less common administration 
mechanisms.
    In the notice, we had proposed examining education level by 
blocking respondents by those who have attended some college or less 
and those who have attended some college or more. Comment 2 suggested 
that we segment education level further than proposed, and that we 
specifically add more ``high school or less'' individuals. We agree 
that education is an important variable that may influence key 
responses, and will measure finer segments of education. Additionally, 
we will ensure that a minimum of 30 percent of our sample has a high 
school degree or lower.
    Comment 2 also noted that to reflect reality we should ensure a mix 
of respondents within the diagnosed population who are currently being 
treated and those who have yet to be treated. Although we do not have 
the resources to screen and solicit subjects and control on this 
variable, we plan to inquire as to participants' prescription and 
nonprescription drug usage and aim for a blend of individuals currently 
being treated and those yet to be treated.
    We concur with the comment's concern that participants be recruited 
in a manner that does not bias their responses. We plan to use blinded 
recruitment so that respondents do not know exactly why they were 
chosen for the study, the nature of the interview, or the purpose of 
the research, as suggested by comment 2.
    Comment 1 suggested that the main body of our stimulus ad fulfill 
all of the regulatory requirements for a truthful, fair, and balanced 
ad. The final stimulus ad has been evaluated by reviewers in the 
Division of Drug Marketing, Advertising and Communications for 
compliance with all applicable regulations.

B. Comments To Be Adopted With Modifications

    The proposed mock brief summary contained a wide variety of topics 
culled from a review of existing brief summaries and from the input of 
focus groups. Comment 1 suggested that we remove all sections in our 
mock brief summary not currently required by regulation. We considered 
this suggestion and agree that some sections may be removed at this 
stage in the research. For example, a section on ``Lab Test 
Abnormalities'' may not be useful to consumers during initial exposure 
to a brand in a magazine read-through, as simulated in our study. 
However, the main purpose of our first study is to determine how people 
use the brief summary and what sections people find more or less 
useful. In order to fully assess this question, we feel that we must 
include sections that are not currently required.
    It is reasonable to assume that people use the brief summary to 
decide whether to talk to their doctor about the advertised drug. This 
may be a reasonable assumption; however, people may also use the brief 
summary to verify claims on the main page, to compare the advertised 
drug to another, or to keep on hand as a reference. Until we know how 
people use the brief summary, we cannot assume that certain sections 
are irrelevant. Moreover, without testing this assumption, we cannot 
assume that the sections currently required by regulation are the only 
valuable sections. Those sections currently required by law (e.g., 
warnings, precautions, contraindications, adverse events) are also 
those that consumers are likely to find most useful, and will always be 
placed in the first column in our mock brief summaries. Nevertheless, 
we find it impossible to fully address our research question without 
including other sections.
    In balancing the tradeoff between the realism of the magazine-
reading situation and the need for experimenter control, our original 
proposal had left the issue of mode of presentation open. Both comments 
suggested that it would be valuable to measure the amount of time each 
participant spends reading

[[Page 74323]]

the main page and the brief summary page of the display ads. After much 
discussion we have decided to initially present the stimulus ad on a 
computer screen. Participants will be presented with a page or two of 
instructions and their reading speed will be tracked when they click 
the option to move to the next page. Then they will be presented with 
the test ad as well as two other filler ads, at least one of which will 
have two pages; a ``front'' and a ``back.'' These ads will enable us to 
determine basic reading speeds as well as comparative speeds between 
the main page and brief summary page and between the test ad and other 
ads. Given the importance of the reading time variable, we have chosen 
to exercise more experimental control to assess reading times and page-
switching (via computer-based recording of times and switching) rather 
than present the test ad in a magazine mock-up which would not permit a 
reliable assessment of these reading behaviors.
    Another comment discussed sample size issues, limited resources, 
and tradeoffs. Comment 2 suggested that we have a minimum of 75 
respondents per cell, rather than 30 per cell. Comment 1 described a 
plan that would have doubled our sample size from approximately 400 to 
approximately 800, but expressed understanding that resource 
limitations may prohibit this approach. Therefore, this comment 
suggested reducing the number of medical conditions studied from four 
to two, maintaining asthma and high cholesterol. Additionally, the 
comment suggested that disease severity within the condition may be an 
important variable that affects consumer use of the brief summary.
    Our modifications have taken these related comments into account. 
Our original plan was a 4 x 2 design, with four medical conditions 
(asthma, high cholesterol, allergies, and obesity) and two levels of 
drug risk severity (high and low) included. We proposed this design for 
several reasons. First, to ensure generalizability, we suggested four 
medical conditions that would vary in symptom presentation, severity, 
and chronicity. Second, we manipulated drug risk severity to address 
the idea that information-search of the brief summary page might differ 
given the risk information included on the main page.
    On the basis of all comments, we have revised this design. We now 
propose a 3 x 2 design, with three medical conditions (asthma, high 
cholesterol, and obesity) and two levels of disease severity (high and 
low). Dropping the allergy category, which already includes a number of 
OTC options, still leaves us with a range of conditions. We will 
maintain the obesity category due to its public health implications and 
current public interest. We were persuaded by the argument that 
severity within a disease may be an important driver of information-
search and will include this variable as a covariate.

C. Comments Considered and Not Adopted

    Comment 2 suggested that we conduct qualitative research before 
embarking on a quantitative project. Specifically, it was suggested 
that qualitative one-on-one interviews may better address the questions 
we plan to ask. We have already conducted focus groups on this question 
that have guided the development of the questions we plan to ask in the 
three quantitative studies and provided initial ideas about how people 
use the brief summary and what they prefer in terms of content and 
format.
    Comment 2 also requested that we ask more qualitative questions at 
the beginning of the study before delving into quantitative questions. 
We are, however, limited to approximately 20 minutes with each 
respondent, and can therefore ask only a limited number of questions. 
Recognizing this, we have included as many open-ended questions as we 
can, but at this time we feel we cannot add substantially more 
questions to the interview.
    Comment 2 also suggested that we use an existing, known 
prescription product in our stimulus materials instead of a new-to-
market, novel one. Given the research goal, we feel it is essential to 
control for likely confounds that might arise from prior experience 
with existing, known product. Therefore, we will continue to use a new-
to-market drug as a stimulus.
    Comment 1 recommended that we avoid randomly selecting people face-
to-face inside a mall, but instead use a random-digit dialing procedure 
to recruit participants. We discussed with the contractor using a 
prescreened panel. However, given resource constraints, the contractor 
felt that recruitment would be more effective if the traditional mall-
intercept procedure was employed. As noted earlier, prior to the study 
these respondents will not be sensitized to the specific task or the 
purpose of the research; participants will be informed of these issues 
at the end of the study.
    We will not be using a mock-up of a magazine, as suggested by 
comment 1, for reasons discussed earlier in this document. Our main 
interest is in participants' viewing of the brief summary when they 
have viewed it, rather than whether it is compelling enough to stop to 
look at. We instead plan to use computer technology to measure the 
amount of time spent reading the main page and the brief summary page. 
Based in part on comment 1's suggestions, we will include at least two 
other advertisements, to obtain comparative reading times, and to 
diffuse the pressure on the reading of the stimulus ad.
    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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Total                                                                                                        153
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 74324]]

    Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-24040 Filed 12-14-05; 8:45 am]
BILLING CODE 4160-01-S