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, 6691-6693 [05-2419]
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Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices
* * * (d) if the applicant is not a Tribe
or Alaska Native Village government,
the applicant must submit proof that a
majority of the governing board of
directors is representative of the
community to be served.’’ The reference
to Native non-profit organizations was
inadvertently placed in the text. This
correction will be reflected in all three
FY 05 ANA program announcements.
Technical Correction: Upon general
review of the Notice, Section II.
Evaluation Criteria (a) additional text is
needed to clarify the use of the ANA
Project Abstract form in relation to
Criteria One: Introduction and Project
Summary/Application Format.
Instructional text will be inserted in the
ANA evaluation Criterion One to state
‘‘In addition to using the ANA Project
Abstract form, applicants will submit a
brief narrative summary of the project
that provides more information on the
applicant and proposed project.’’ The
additional text will provide clarity to
the applicant as they respond to the
program announcement.
Dated: January 31, 2005.
Quanah Crossland Stamps,
Commissioner, Administration for Native
Americans.
[FR Doc. 05–2325 Filed 2–7–05; 8:45 am]
BILLING CODE 4184–01–M
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.
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
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18:12 Feb 07, 2005
Jkt 205001
(DTC) prescription drug print
advertisements.
Submit written or electronic
comments on the collection of
information by April 11, 2005.
DATES:
Submit electric comments
on the collection of information to:
https://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.
ADDRESSES:
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.
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.
SUPPLEMENTARY INFORMATION:
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6691
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
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 (§ 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
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08FEN1
6692
Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices
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 other prescription brands or overthe-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.
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
1For 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.
VerDate jul<14>2003
18:12 Feb 07, 2005
Jkt 205001
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.
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
2Slaughter, E., Seventh Annual Survey on
Consumer Reaction to DTC Advertising of
Prescription Medicines. Rodale, Inc., 2004.
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Fmt 4703
Sfmt 4703
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
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08FEN1
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Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices
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 BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
800 (screener)
1
800
.017
14
432 (survey)
1
432
.33
143
Total
1 There
157
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0038]
Reporting of Adverse Events to
Institutional Review Boards; Public
Hearing
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comment.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public hearing to consider the process
by which institutional review boards
(IRBs) obtain and review information on
adverse events that occur during the
conduct of clinical investigations. FDA
is increasingly aware of concerns within
the IRB community that the process is
burdensome, inefficient, and not as
effective as it should be in providing
IRBs the information they need to
ensure that the rights and welfare of
human subjects are protected during the
course of a clinical study. The purpose
of the hearing is to solicit information
and views from interested persons on
issues and concerns regarding the
submission of adverse events to and
their review by IRBs. FDA is seeking
general information about the nature of
the problem and possible solutions,
responses to specific questions (see
section III of this document), and any
other pertinent information stakeholders
would like to share.
Date and Time: The public hearing
will be held on March 21, 2005, from 9
a.m. to 5 p.m. Submit written or
electronic notices of participation by
4:30 p.m. on March 4, 2005. Submit
SUMMARY:
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18:12 Feb 07, 2005
Jkt 205001
written and electronic comments by
April 21, 2005.
Location: The public hearing will be
held at the Advisors and Consultants
Staff Conference Room, 5630 Fishers
Lane, Rockville, MD 20857.
Addresses: Written or electronic
notices of participation should be
submitted to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, e-mail:
FDADockets@oc.fda.gov; or on the
Internet at https://
www.accessdata.fda.gov/scripts/oc/
dockets/meetings/meetingdocket.cfm.
Written or electronic comments should
be submitted to https://
www.accessdata.fda.gov/scripts/oc/
dockets/commentdocket.cfm or to the
Division of Dockets Management (see
Addresses above).
Contacts: Nancy L. Stanisic, Center
for Drug Evaluation and Research (HFD–
1), Food and Drug Administration, 5600
Fishers Lane, rm. 9–64, Rockville, MD
20857, 301–827–1660, FAX: 301–443–
9718, e-mail: stanisicn@cder.fda.gov.
For Registration and/or to participate
in the meeting: Because of limited
seating, we recommend that persons
interested in attending the meeting
register at https://
www.accessdata.fda.gov/scripts/oc/
dockets/meetings/meetingdocket.cfm.
Registration will be accepted on a firstcome, first-served basis.
The procedures governing the hearing
are found in part 15 (21 CFR part 15).
If you wish to make an oral presentation
during the open public comment period
of the hearing, you must state your
intention on your registration form (see
Addresses). To participate, submit your
name, title, business affiliation, address,
telephone, fax number, and e-mail
address. You should also submit a
written statement at the time of
registration for each discussion question
you wish to address, the names and
addresses of all individuals that plan to
participate, and the approximate time
requested to make your presentation.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
Individuals who have registered to make
an oral presentation will be notified of
the scheduled time for their
presentation prior to the hearing.
Depending on the number of
presentations, FDA may need to limit
the time allotted for each presentation.
Presentations will be limited to the
questions and subject matter identified
in section III of this document.
Presenters should submit two copies of
each presentation given. All participants
are encouraged to attend the entire day.
If you need special accommodations
due to a disability, please inform the
registration contact person when you
register.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical investigations regulated by
FDA under sections 505(i) (drugs and
biologics) and 520(g) (medical devices)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i) and 360j(g)) must
be reviewed and approved by an IRB in
a manner consistent with the
requirements of 21 CFR part 50 and part
56 (21 CFR part 56). To approve a
proposed clinical investigation, IRBs
must determine, among other things,
that the risks to subjects are minimized;
the risks are reasonable in relation to
anticipated benefits (if any); the
selection of subjects is equitable; and
the informed consent process is
adequate for the anticipated study
population and appropriately
documented (see § 56.111).
After their initial review and approval
of a clinical study, IRBs are required to
conduct continuing review of the study
at intervals appropriate to the degree of
risk presented by a study (at least
annually) (§ 56.109(f)). IRBs are required
to follow written procedures for
continuing review of research and for
determining which studies require
review more often than annually
(§ 56.108(a)), and must maintain records
of continuing review activities
(§ 56.115(a)(3)).
E:\FR\FM\08FEN1.SGM
08FEN1
]]>Agencies
[Federal Register Volume 70, Number 25 (Tuesday, February 8, 2005)]
[Notices]
[Pages 6691-6693]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2419]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\Slaughter, E., Seventh Annual Survey on Consumer Reaction to
DTC Advertising of Prescription Medicines. Rodale, Inc., 2004.
---------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
800 (screener) 1 800 .017 14
----------------------------------------------------------------------------------------------------------------
432 (survey) 1 432 .33 143
----------------------------------------------------------------------------------------------------------------
Total ................. ................. .................. 157
----------------------------------------------------------------------------------------------------------------
\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
