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, 74321-74324 [05-24040]
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74321
Federal Register / Vol. 70, No. 240 / Thursday, December 15, 2005 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Number of respondents
Number of responses/respondent
Average burden/response
(in hours)
Questionnaire for conference registrants/attendees ........................................
Focus groups ...................................................................................................
Web-based .......................................................................................................
Other customer surveys ..................................................................................
1,000
80
1,000
400
1
1
1
1
15/60
1
20/60
15/60
250
80
333
100
Total ..........................................................................................................
........................
........................
........................
763
Type of survey
Dated: December 8, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E5–7382 Filed 12–14–05; 8:45 am]
BILLING CODE 4163–18–P
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.
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
VerDate Aug<31>2005
17:24 Dec 14, 2005
Jkt 208001
has submitted the following proposed
collection of information to OMB for
review and clearance.
Evaluation of Consumer-Friendly
Formats for Brief Summary in Directto-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 (§ 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
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Total burden
hours
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 https://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
§ 202.1(e)(3)(iii). Frequently, sponsors
print in small type, verbatim, the riskrelated 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
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Federal Register / Vol. 70, No. 240 / Thursday, December 15, 2005 / Notices
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.
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 betweensubjects 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
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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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 ‘‘onceweekly’’ 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
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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
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Federal Register / Vol. 70, No. 240 / Thursday, December 15, 2005 / Notices
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-onone 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
74323
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-toface 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 BURDEN1
Annual Frequency
per Response
No. of Respondents
Total Annual
Responses
Hours per
Response
Total Hours
800 (screener)
1
800
.017
14
420 (survey)
1
420
.33
139
Total
1 There
153
are no capital costs or operating and maintenance costs associated with this collection of information.
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74324
Federal Register / Vol. 70, No. 240 / Thursday, December 15, 2005 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0389]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reprocessed
Single-Use Device Labeling
AGENCY:
Reprocessed Single-Use Device
Labeling (21 U.S.C. 352(u))
Food and Drug Administration,
HHS.
ACTION:
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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.
Notice.
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 comments be
faxed to the Office of Information and
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
352), among other things, establishes
requirements that the label or labeling of
a medical device must meet so that it is
not misbranded and subject to
regulatory action. The Medical Device
User Fee and Modernization Act of 2002
(MDUFMA) (Public Law 107–250)
amended section 502 of the act to add
section 502(u) to require devices (both
new and reprocessed) to bear
prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
Section 2(c) of The Medical Device User
Fee Stabilization Act of 2005 (MDUFSA)
(Public Law 109–43) amends section
502(u) of the act by limiting the
provision to reprocessed single-use
devices (SUDs) and the manufacturers
who reprocess them. Under the
amended provision, if the original SUD
or an attachment to it prominently and
conspicuously bears the name of the
manufacturer, then the reprocessor of
the SUD is required to identify itself by
name, abbreviation, or symbol, in a
prominent and conspicuous manner on
the device or attachment to the device.
If the original SUD does not
prominently and conspicuously bear the
name of the manufacturer, the
manufacturer who reprocesses the SUD
for reuse may identify itself using a
detachable label that is intended to be
affixed to the patient record. MDUFSA
was enacted on August 1, 2005, and
becomes self-implementing on August
1, 2006.
The requirements of section 502(u) of
the act impose a minimal burden on
industry. This section of the act only
requires the manufacturer, packer, or
distributor of a device to include their
name and address on the labeling of a
device. This information is readily
available to the establishment and easily
supplied. From its registration and
premarket submission database, FDA
estimates that there are 3 establishments
that distribute approximately 300
reprocessed SUDs. Each response is
anticipated to take 0.1 hours resulting in
a total burden to industry of 30 hours.
In the Federal Register of September
29, 2005 (70 FR 56910), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of the Act
No. of
Respondents
502(u)
1 There
Annual Responses
per Respondent
3
Total Annual
Responses
100
Hours per
Response
300
Total Hours
0.1
30
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–24041 Filed 12–14–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
[Docket No. 2004N–0442]
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Food and Drug Administration Recall
Regulations (Guidelines)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
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that a collection of information entitled
‘‘FDA Recall Regulations (Guidelines)’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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 the
Federal Register of August 24, 2005 (70
FR 49654), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
E:\FR\FM\15DEN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 240 (Thursday, December 15, 2005)]
[Notices]
[Pages 74321-74324]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24040]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
800 (screener) 1 800 .017 14
---------------------------------------------------------
---------------------------------------------------------
Total 153
----------------------------------------------------------------------------------------------------------------
\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
