Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer Print Advertisements for Prescription Drugs; Correction, 80821-80823 [2010-32278]
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mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: New collection (Request for a
new OMB Control Number); Title of
Information Collection: Medicaid State
Plan Preprint for Use by States When
Implementing Section 6505 of the
[Patient Protection and] Affordable Care
Act; Use: [The] CMS has developed a
Medicaid State Plan Preprint for use by
States and specific to support the
January 1, 2011, mandate of the
prohibition on payments outside of the
United States. The Preprint follows the
format and requested information from
prior preprints provided to the States by
CMS and provides a placeholder and
assurance of compliance with section
1902(a) of the Social Security Act; Form
Number: CMS–10367 (OMB#: 0938–
NEW); Frequency: Occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 56; Total
Annual Hours: 5. (For policy questions
regarding this collection contact Carla
Ausby at 410–786–2153. For all other
issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by February 22, 2011:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
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Jkt 223001
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: December 17, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–32197 Filed 12–22–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0266]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Study of Clinical
Efficacy Information in Professional
Labeling and Direct-to-Consumer Print
Advertisements for Prescription
Drugs; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of December 3, 2010 (75 FR
75477). The document announced a
proposed collection of information that
has been submitted to the Office of
Management and Budget (OMB) for
review and clearance under the
Paperwork Reduction Act of 1995 (the
PRA). The document was published
with an error. FDA, upon further
review, realized that 3 comments had
been submitted in response to the 60day notice and the responses to those
comments are included in this notice.
This document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUMMARY:
In FR Doc.
2010–30385, appearing on page 75480,
in the Federal Register of Friday,
SUPPLEMENTARY INFORMATION:
PO 00000
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80821
December 3, 2010, the following
correction is made:
On page 75480, in the third column,
the last sentence in the sixth complete
paragraph states that no comments were
received on the paperwork burden for
the 60-day notice that published in the
Federal Register of June 16, 2010 (75 FR
34142). FDA is correcting that statement
to read: Three comments were received
that expressed support for the research
and recommended minor improvements
to the study. The responses to those
comments are included in the following
paragraphs.
(Comment 1) Several of this
comment’s suggestions have already
been incorporated into our study design.
Specifically, we agree that the study
design should include the variables of
age, education, ethnicity, race, health
literacy, and whether the respondent is
currently being treated with a
prescription drug, and have included
them in the questionnaire. Also, we
have contracted with an organization
that produces realistic ads and stimuli
to ensure that we will show respondents
realistic materials.
Another question from this comment
was the presentation of our
manipulations. To clarify, the specific
format of the presentation will be text
only. We are investigating the use of
charts and other visuals in another
study (FDA–2009–N–0263 (January 5,
2010), ‘‘Presentation of Quantitative
Effectiveness and Risk Information to
Consumers in Direct-to-Consumer (DTC)
Broadcast and Print Advertisements for
Prescription Drugs,’’ OMB control
number 0910–0663.) Because all of the
respondents in the current study will
see the information in the same format,
this will not compromise our ability to
answer the current research questions.
The comment also recommends
expanding the physician study to
include all health care professionals
who have the ability to prescribe (i.e.,
nurse practitioners and physician
assistants). This is a good idea, but it
changes our research question from how
physicians use labels to how prescribers
use labels. These groups vary in
education and may vary in experience
and training in how to interpret and use
clinical trial data. Because we do not
have a sample size that is large enough
to analyze differences between these
groups, we will limit the sample to
physicians in this study.
Finally, the comment recommends
that FDA publish findings from the
preliminary study related to the current
project, ‘‘Mental Models Study of Health
Care Providers’ Understanding of
Prescription Drug Effectiveness’’ (FDA–
2008–N–0589; April 3, 2009). We agree
E:\FR\FM\23DEN1.SGM
23DEN1
mstockstill on DSKH9S0YB1PROD with NOTICES
80822
Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices
and have taken steps to publish this
report on FDA’s Division of Drug
Marketing, Advertising, and
Communications Web site: https://
www.fda.gov/AboutFDA/CentersOffices/
CDER/ucm090276.htm.
(Comment 2) This comment had
several suggestions regarding the
physician study. First, it recommended
that we show physicians the Prescribing
Information (PI) in a manner consistent
with how physicians usually view
sections of it, particularly since how
each physician views the PI may be
highly individualized. We agree.
Because there is likely much variability
in the way physicians view prescription
drug information, we have designed this
part of the study to examine specifically
those habits. To do so, we will show
physicians a highlights section that is
hyperlinked to the more complete
sections of the PI. We will record the
order in which physicians access each
section and how much time they spend
there. This will provide us with
information to gauge how physicians
view the information in the PI,
something that we currently have no
data on.
Second, this comment recommends
that we show physicians final magazine
ads rather than conceptual ads. We
agree and, as discussed in the response
to the previous comment, we have
contracted with an organization that
produces professional-quality ads.
Third, this comment recommends
increasing the sample size from 500 to
800 individuals. We agree that a larger
sample would be desirable, however,
given resource constraints we are not
able to increase the sample size.
Moreover, we have conducted a power
analysis and have determined that our
current sample size is adequate to
answer our research questions.
Fourth, the comment recommends the
removal of statements in the
questionnaire that the drug is fictitious
and instead label it a ‘‘potentially new
drug.’’ FDA had many internal
discussions regarding this issue and
decided that because of the particular
sample, it is necessary to be upfront
with them about the nature of the drug.
Physicians will be more savvy about the
particulars of the chemical entities and
the realism of the clinical benefits and
we do not wish to make them skeptical
of our purposes. We agree that this
approach is preferable for consumers
and so we will inform them that this is
a potentially new drug in that part of the
study.
Fifth, we agree that the characteristics
of participants who are at risk and those
who are or are not treating with a
prescription drug may differ and we
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18:06 Dec 22, 2010
Jkt 223001
will include these variables in our
analyses.
Sixth, the comment recommends
altering question 17 of the questionnaire
to reflect the physicians’ use of the DTC
ad versus their guess as to the
understandability of the ad for patients.
We agree that we are asking physicians
to estimate the level of understanding
their patients have. These perceptions
are of specific interest to us as they
relate to physicians’ perceptions of DTC
advertising and of the presentation of
information in the ads. Physicians who
have been in practice for any length of
time may have a sense of how their
patients will understand materials. This
is a question that we will also
investigate in relation to the number of
years physicians have been in practice.
Seventh, the comment recommends
that question 30 be split into two
questions to separately assess the effect
of DTC advertising on patients and the
effect of DTC advertising on their
practice. We agree and will make that
change.
This comment also had two
suggestions for the consumer part of the
study. First, the comment recommended
against delivering this study on a
handheld device, as the viewing of the
ad may render the concept unclear. We
agree and have struggled with this issue,
but due to the constraints of the internet
panel, we cannot specify the type of
device on which participants must take
the survey. We have included a question
to assess this variable, and we will
analyze it to determine if there are
sizable differences based on viewing
medium.
Second, the comment recommends
that the questionnaire avoid medical
terminology and reference to the
‘‘prescribing information.’’ We have
attempted to make the questionnaire
clear for consumers and do not see the
word ‘‘prescribing information’’ in the
questionnaire. The questionnaire
provided for comment includes
programming notes that the respondent
will not see.
(Comment 3) First, this comment
recommends evaluating the benefits and
risks together and in a similar format so
as not to bias the results. We agree that
the benefits and risks should be
evaluated together and have several
measures to investigate both. We are
keeping the risk information constant
across all of our conditions specifically
so as not to bias the results. Our
research questions involve the
conveyance of information about
benefits. Because of the complexity of
DTC ads, we cannot manipulate both
benefits and risks at the same time. We
are conducting other studies examining
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
the presentation of risk information (For
example, FDA–2010–N–0417 (August
26, 2010), ‘‘Experimental Study of
Format Variations in the Brief Summary
of Direct-to-Consumer Print
Advertisements’’) and collectively, this
body of research will answer questions
of benefit and risk presentation. To
clarify, risk information will be
presented similarly to how it is
currently presented in DTC print ads.
Second, the comment recommends
the introduction of a control arm that is
similar to what is currently being used
in the marketplace. Our design includes
control conditions that do not present
placebo information. These ads will
look identical to the ads for products
that are currently on the market.
Third, the comment questions the use
of comparative benefit and comparative
safety questions. We are using these
measures for reliability as another way
to assess consumers’ perceived risk and
benefits. As recommended in the
comment, we are using them for
informational purposes only and not as
a specific, separate measure of
comparative advertising.
Fourth, the comment recognizes the
complexity of the data that are available
to be conveyed in DTC ads. We agree
that there are a number of questions to
be answered that cannot be addressed in
the current study: E.g., variations in
clinical study designs, instruments
used, populations studied, and varying
degrees of severity of illness. We cannot
address all questions in one study and
have chosen to focus on the issues of
placebo and framing in a treatment and
prevention approach. We hope that the
results of this study will spur additional
follow on studies conducted by FDA
and others. Although the issue of
different therapeutic areas is also
relevant, and a study looking at the two
ends of the disease-seriousness
spectrum would be a great follow on,
the basic concepts of information
processing should not differ depending
on drug class. Although we agree that
replication is valuable and necessary,
we do not believe that limiting the study
to two therapeutic areas impugns the
internal validity of the study.
Fifth, the comment recommends
wording changes to the question about
taking the drug if the doctor prescribed
it. Although we understand the
rationale for changing this question, it is
a measure of behavioral intention and as
such, we wanted to have a more blunt
measure of intention. It will not be used
to assess doctor-patient interaction
issues.
Sixth, the comment questions the
inclusion of physicians in the study,
citing concerns that consumer responses
E:\FR\FM\23DEN1.SGM
23DEN1
Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices
cannot be compared to physician
responses and that this comparison is
not relevant to the regulation of DTC
advertisements. Indeed, the primary
reason for conducting the study with
physicians is to explore their processing
of the prescribing information (PI),
wholly separate from the consumer
study. Nevertheless, since we have the
two samples, we are conducting some
exploratory analyses to compare the
responses of consumers to information
about a drug to the physicians’
understanding of the drug. While this
does have relevance to the regulation of
DTC advertising (e.g., a DTC ad that
features a presentation of information
that brings consumers closer to the
assessment of the physician will be
preferred over that same ad with a
presentation of information that moves
them farther away), we are approaching
this comparison as a first, exploratory
attempt at this type of analysis.
Dated: December 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
In the
Federal Register of May 7, 2010 (75 FR
25267), 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, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0650. The
approval expires on December 31, 2012.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: December 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–32277 Filed 12–22–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–32278 Filed 12–22–10; 8:45 am]
Food and Drug Administration
BILLING CODE 4160–01–P
[Docket No. FDA–2010–N–0631]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0074]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794, e-mail:
Jonnalynn.Capezzuto@fda.hhs.gov.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
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18:06 Dec 22, 2010
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Agency Information Collection
Activities: Proposed Collection;
Comment Request; Guidance for
Industry on Updating Labeling for
Susceptibility Test Information in
Systemic Antibacterial Drug Products
and Antimicrobial Susceptibility
Testing Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
FDA’s ‘‘Guidance for Industry on
Updating Labeling for Susceptibility
Test Information in Systemic
Antibacterial Drug Products and
Antimicrobial Susceptibility Testing
Devices.’’ The guidance describes
procedures and responsibilities for
updating information on susceptibility
test interpretive criteria, susceptibility
test methods, and quality control
SUMMARY:
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parameters in the labeling for systemic
antibacterial drug products for human
use, and also describes procedures for
making corresponding changes to
susceptibility test interpretive criteria
for antimicrobial susceptibility testing
(AST) devices.
DATES: Submit either electronic or
written comments on the collection of
information by February 22, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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 below in this
document.
With respect to 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)
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80821-80823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32278]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0266]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Study of Clinical
Efficacy Information in Professional Labeling and Direct-to-Consumer
Print Advertisements for Prescription Drugs; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of December 3, 2010 (75 FR
75477). The document announced a proposed collection of information
that has been submitted to the Office of Management and Budget (OMB)
for review and clearance under the Paperwork Reduction Act of 1995 (the
PRA). The document was published with an error. FDA, upon further
review, realized that 3 comments had been submitted in response to the
60-day notice and the responses to those comments are included in this
notice. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc. 2010-30385, appearing on page
75480, in the Federal Register of Friday, December 3, 2010, the
following correction is made:
On page 75480, in the third column, the last sentence in the sixth
complete paragraph states that no comments were received on the
paperwork burden for the 60-day notice that published in the Federal
Register of June 16, 2010 (75 FR 34142). FDA is correcting that
statement to read: Three comments were received that expressed support
for the research and recommended minor improvements to the study. The
responses to those comments are included in the following paragraphs.
(Comment 1) Several of this comment's suggestions have already been
incorporated into our study design. Specifically, we agree that the
study design should include the variables of age, education, ethnicity,
race, health literacy, and whether the respondent is currently being
treated with a prescription drug, and have included them in the
questionnaire. Also, we have contracted with an organization that
produces realistic ads and stimuli to ensure that we will show
respondents realistic materials.
Another question from this comment was the presentation of our
manipulations. To clarify, the specific format of the presentation will
be text only. We are investigating the use of charts and other visuals
in another study (FDA-2009-N-0263 (January 5, 2010), ``Presentation of
Quantitative Effectiveness and Risk Information to Consumers in Direct-
to-Consumer (DTC) Broadcast and Print Advertisements for Prescription
Drugs,'' OMB control number 0910-0663.) Because all of the respondents
in the current study will see the information in the same format, this
will not compromise our ability to answer the current research
questions.
The comment also recommends expanding the physician study to
include all health care professionals who have the ability to prescribe
(i.e., nurse practitioners and physician assistants). This is a good
idea, but it changes our research question from how physicians use
labels to how prescribers use labels. These groups vary in education
and may vary in experience and training in how to interpret and use
clinical trial data. Because we do not have a sample size that is large
enough to analyze differences between these groups, we will limit the
sample to physicians in this study.
Finally, the comment recommends that FDA publish findings from the
preliminary study related to the current project, ``Mental Models Study
of Health Care Providers' Understanding of Prescription Drug
Effectiveness'' (FDA-2008-N-0589; April 3, 2009). We agree
[[Page 80822]]
and have taken steps to publish this report on FDA's Division of Drug
Marketing, Advertising, and Communications Web site: https://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090276.htm.
(Comment 2) This comment had several suggestions regarding the
physician study. First, it recommended that we show physicians the
Prescribing Information (PI) in a manner consistent with how physicians
usually view sections of it, particularly since how each physician
views the PI may be highly individualized. We agree. Because there is
likely much variability in the way physicians view prescription drug
information, we have designed this part of the study to examine
specifically those habits. To do so, we will show physicians a
highlights section that is hyperlinked to the more complete sections of
the PI. We will record the order in which physicians access each
section and how much time they spend there. This will provide us with
information to gauge how physicians view the information in the PI,
something that we currently have no data on.
Second, this comment recommends that we show physicians final
magazine ads rather than conceptual ads. We agree and, as discussed in
the response to the previous comment, we have contracted with an
organization that produces professional-quality ads.
Third, this comment recommends increasing the sample size from 500
to 800 individuals. We agree that a larger sample would be desirable,
however, given resource constraints we are not able to increase the
sample size. Moreover, we have conducted a power analysis and have
determined that our current sample size is adequate to answer our
research questions.
Fourth, the comment recommends the removal of statements in the
questionnaire that the drug is fictitious and instead label it a
``potentially new drug.'' FDA had many internal discussions regarding
this issue and decided that because of the particular sample, it is
necessary to be upfront with them about the nature of the drug.
Physicians will be more savvy about the particulars of the chemical
entities and the realism of the clinical benefits and we do not wish to
make them skeptical of our purposes. We agree that this approach is
preferable for consumers and so we will inform them that this is a
potentially new drug in that part of the study.
Fifth, we agree that the characteristics of participants who are at
risk and those who are or are not treating with a prescription drug may
differ and we will include these variables in our analyses.
Sixth, the comment recommends altering question 17 of the
questionnaire to reflect the physicians' use of the DTC ad versus their
guess as to the understandability of the ad for patients. We agree that
we are asking physicians to estimate the level of understanding their
patients have. These perceptions are of specific interest to us as they
relate to physicians' perceptions of DTC advertising and of the
presentation of information in the ads. Physicians who have been in
practice for any length of time may have a sense of how their patients
will understand materials. This is a question that we will also
investigate in relation to the number of years physicians have been in
practice.
Seventh, the comment recommends that question 30 be split into two
questions to separately assess the effect of DTC advertising on
patients and the effect of DTC advertising on their practice. We agree
and will make that change.
This comment also had two suggestions for the consumer part of the
study. First, the comment recommended against delivering this study on
a handheld device, as the viewing of the ad may render the concept
unclear. We agree and have struggled with this issue, but due to the
constraints of the internet panel, we cannot specify the type of device
on which participants must take the survey. We have included a question
to assess this variable, and we will analyze it to determine if there
are sizable differences based on viewing medium.
Second, the comment recommends that the questionnaire avoid medical
terminology and reference to the ``prescribing information.'' We have
attempted to make the questionnaire clear for consumers and do not see
the word ``prescribing information'' in the questionnaire. The
questionnaire provided for comment includes programming notes that the
respondent will not see.
(Comment 3) First, this comment recommends evaluating the benefits
and risks together and in a similar format so as not to bias the
results. We agree that the benefits and risks should be evaluated
together and have several measures to investigate both. We are keeping
the risk information constant across all of our conditions specifically
so as not to bias the results. Our research questions involve the
conveyance of information about benefits. Because of the complexity of
DTC ads, we cannot manipulate both benefits and risks at the same time.
We are conducting other studies examining the presentation of risk
information (For example, FDA-2010-N-0417 (August 26, 2010),
``Experimental Study of Format Variations in the Brief Summary of
Direct-to-Consumer Print Advertisements'') and collectively, this body
of research will answer questions of benefit and risk presentation. To
clarify, risk information will be presented similarly to how it is
currently presented in DTC print ads.
Second, the comment recommends the introduction of a control arm
that is similar to what is currently being used in the marketplace. Our
design includes control conditions that do not present placebo
information. These ads will look identical to the ads for products that
are currently on the market.
Third, the comment questions the use of comparative benefit and
comparative safety questions. We are using these measures for
reliability as another way to assess consumers' perceived risk and
benefits. As recommended in the comment, we are using them for
informational purposes only and not as a specific, separate measure of
comparative advertising.
Fourth, the comment recognizes the complexity of the data that are
available to be conveyed in DTC ads. We agree that there are a number
of questions to be answered that cannot be addressed in the current
study: E.g., variations in clinical study designs, instruments used,
populations studied, and varying degrees of severity of illness. We
cannot address all questions in one study and have chosen to focus on
the issues of placebo and framing in a treatment and prevention
approach. We hope that the results of this study will spur additional
follow on studies conducted by FDA and others. Although the issue of
different therapeutic areas is also relevant, and a study looking at
the two ends of the disease-seriousness spectrum would be a great
follow on, the basic concepts of information processing should not
differ depending on drug class. Although we agree that replication is
valuable and necessary, we do not believe that limiting the study to
two therapeutic areas impugns the internal validity of the study.
Fifth, the comment recommends wording changes to the question about
taking the drug if the doctor prescribed it. Although we understand the
rationale for changing this question, it is a measure of behavioral
intention and as such, we wanted to have a more blunt measure of
intention. It will not be used to assess doctor-patient interaction
issues.
Sixth, the comment questions the inclusion of physicians in the
study, citing concerns that consumer responses
[[Page 80823]]
cannot be compared to physician responses and that this comparison is
not relevant to the regulation of DTC advertisements. Indeed, the
primary reason for conducting the study with physicians is to explore
their processing of the prescribing information (PI), wholly separate
from the consumer study. Nevertheless, since we have the two samples,
we are conducting some exploratory analyses to compare the responses of
consumers to information about a drug to the physicians' understanding
of the drug. While this does have relevance to the regulation of DTC
advertising (e.g., a DTC ad that features a presentation of information
that brings consumers closer to the assessment of the physician will be
preferred over that same ad with a presentation of information that
moves them farther away), we are approaching this comparison as a
first, exploratory attempt at this type of analysis.
Dated: December 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32278 Filed 12-22-10; 8:45 am]
BILLING CODE 4160-01-P
