Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements, 18407-18410 [2015-07818]
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Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Food and Drug Administration
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
[Docket No. FDA–2014–N–0554]
tkelley on DSK4VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, National
Institute of Dental and Craniofacial
Research.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), title 5 U.S.C., as amended for
the review, discussion, and evaluation
of individual intramural programs and
projects conducted by the National
Institute of Dental & Craniofacial
Research, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, National Institute of Dental and
Craniofacial Research.
Date: May 28–29, 2015.
Time: May 28, 2015, 12:00 p.m. to 5:40
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, Room 117, NIH Campus,
Bethesda, MD 20892.
Time: May 29, 2015, 8:00 a.m. to
Adjournment.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, Room 117, NIH Campus,
Bethesda, MD 20892
Contact Person: Alicia J. Dombroski, Ph.D.,
Director, Division of Extramural Activities,
Natl Inst of Dental and Craniofacial Research,
National Institutes of Health, Bethesda, MD
20892, (301) 594–4805.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcr.nih.gov/about/
CouncilCommittees.asp, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: March 31, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–07738 Filed 4–3–15; 8:45 am]
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Comparative Price
Information in Direct-to-Consumer and
Professional Prescription Drug
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 May 6,
2015.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910-New and
title, ‘‘Comparative Price Information in
Direct-to-Consumer and Professional
Prescription Drug Advertisements.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
SUMMARY:
Comparative Price Information in
Direct-to-Consumer and Professional
Prescription Drug Advertisements—
(0910–NEW)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
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18407
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
By their very nature, medical and
health decisions are comparative (e.g.,
treat versus not treat). For consumers,
these decisions may include the use of
prescription drug products versus over
the counter products versus herbal
supplements, as well as one
prescription brand versus another
prescription brand. Similarly,
advertising is often comparative. In
prescription drug advertising, sponsors
are permitted to include truthful, nonmisleading information about the price
of their products in promotion. This
may extend to price comparison
information, wherein sponsors may
include information about the price of a
competing product in order to make
advantageous claims. Currently, when
price comparisons are made, the
advertisement (ad) should also include
context that the two drugs may not be
comparable in terms of efficacy and
safety and that the acquisition costs
presented do not necessarily reflect the
actual prices paid by consumers,
pharmacies, or third party payers.
Despite the inclusion of this additional
information, there is concern that
adding contextual information about
efficacy or safety is not sufficient to
correct the impression that the products
are interchangeable and that price is the
main factor to consider. The Office of
Prescription Drug Promotion plans to
investigate, through empirical research,
the impact of price comparison
information and additional contextual
information on prescription drug
product perceptions. This will be
investigated in direct-to-consumer
(DTC) and healthcare-directed
professional advertising for prescription
drugs.
Design Overview and Procedure
The design consists of two pretests
and a main study. We will conduct two
sequential pretest waves prior to main
data collection. The purpose the pretests
are to: (1) Ensure the stimuli are
understandable and viewable; (2)
identify and address any challenges to
embedding the stimuli within the online
survey; and (3) ensure the study
questions are appropriate and meet the
study’s goals. Participants in the
pretests will be randomly assigned to
one of two versions of an ad. One
version will present information about
the price of the product relative to a
competitor for the same indication
(Price Comparison). Another version
will present this information with
additional contextual information that
the two drugs may not be comparable in
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Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices
Practitioners (e.g., Family Practice,
General Practice, Internal Medicine) and
Specialists (e.g., Endocrinology, Pain
Management). Pretest 2 has a two-fold
purpose. In addition to the
measurement and stimuli verification
issues identified above, we will also
conduct an experiment to evaluate the
impact of incentive level (level 1 vs.
terms of efficacy and safety and that the
acquisition costs do not necessarily
reflect actual prices paid (Price
Comparison + Additional Context).
Participants in Pretest 1 will be
consumers (n=400) who self-identify as
having been diagnosed with diabetes.
Pretest 2 will be conducted with
physicians (n=1,000) who are General
level 2) and study sponsorship (FDA vs.
Public Health Agency) disclosure on
physician response rates (see Exhibit 1).
Pretest 2 will therefore provide a
comparison of recruitment approaches,
identify ways to optimize response
rates, and provide a ‘‘dry run’’ of
experimental study recruitment
procedures.
EXHIBIT 1—PRETEST 2 DESIGN, INCENTIVE LEVEL BY STUDY SPONSORSHIP BY TYPE OF AD
Type of ad
Price comparison + additional
context
Price comparison
Study sponsor
Public Health
Agency
FDA
Total
Public Health
Agency
FDA
Incentive Level ...........................................
Level 1 ........
Level 2 ........
125
125
125
125
125
125
125
125
500
500
Total ....................................................
.....................
250
250
250
250
1,000
In the main study phase, physician
(n=1440) and consumer (n=1,500)
participants will be randomly assigned
to view one of three possible versions of
a DTC or professional ad for a fictitious
prescription drug for diabetic
neuropathy and will be asked to
complete an online survey to assess
their perceptions and understanding of
product safety and efficacy, perceptions
and understanding of the additional
contextual information, perceptions of
comparative safety and efficacy,
perceptions of the comparator product,
and intention to seek more information
about the product (see Exhibit 2). This
sample size will provide us with
sufficient power to detect small-tomedium sized effects.
In addition to the Price Comparison
and Price Comparison + Additional
Context ads used in pretesting, a third
ad version will have a claim about the
price of the product but will not present
information about the price relative to a
competitor, and will act as a control.
EXHIBIT 2—MAIN STUDY DESIGN
Type of price comparison
Price
comparison
Sample
Price
comparison +
additional
context
Price
information
only (no
comparison/
control)
Total
500
480
500
480
500
480
1,500
1,440
Total ..........................................................................................................
tkelley on DSK4VPTVN1PROD with NOTICES
Consumers (DTC ad) ......................................................................................
Physicians (Professional ad) ...........................................................................
980
980
980
2,940
Participants will be consumers who
self-identify as having been diagnosed
with diabetes and physicians who are
General Practitioners (e.g., Family
Practice, General Practice, Internal
Medicine) and Specialists (e.g.,
Endocrinology, Pain Management). All
participants will be 18 years of age or
older. We will exclude individuals from
the consumer sample who work in
healthcare, pharmaceutical, or
marketing settings because their
knowledge and experiences may not
reflect those of the average consumer.
Recruitment and administration of the
study will take place over the Internet.
Participation is estimated to take
approximately 30 minutes.
In the Federal Register of May 7, 2014
(79 FR 26255), FDA published a 60-day
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notice requesting public comment on
the proposed collection of information.
Two submissions were received; one
from Ms. Lenisse Lippert of Quality
Matrix Solutions, and one from AbbVie
biopharmaceutical company, which
contained multiple comments. We
summarize and respond to these
comments below.
(Comment 1 from Lenisse Lippert,
Quality Matrix Solutions) ‘‘I would like
to participate in the industry feedback
on a proposed study to better
understand direct-to-consumer
advertisements that compare drug
pricing, and how that information
affects a consumer’s perception of a
drug’s overall safety and efficacy versus
the comparator product.’’
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(Response) We thank Ms. Lippert for
her comment.
(Comment 2 from AbbVie) To prevent
fatigue, online market research surveys
do not generally exceed 20 minutes.
Given that FDA is trying to make the
most of their survey opportunity by
asking many questions, it would be wise
to place the meatier pricing related
questions earlier in the survey when
respondents are still engaged.
(Response) We take the survey length
very seriously. We are sensitive to
issues regarding respondent fatigue and
its impact upon completion rates and
thus have placed items that are most
likely to be influenced by respondent
fatigue (open-ended questions) at the
beginning of the survey. We have
employed similar online surveys on
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several previous studies, and we have
obtained high completion rates,
typically 90 percent or higher. For
example, on a recent study
(Experimental Study: Examination of
Corrective Direct-to-Consumer
Television Advertising [OMB control
number 0910–0737]), we had a pool of
1,071 eligible respondents, and only 14
of those respondents failed to complete
the survey. We anticipate that the
completion rate for this study will be
similar.
(Comment 3 from AbbVie) In both
surveys, respondents are asked many
questions about product X that appear
positively stated. Therefore, there is a
risk of a bias by asking the critical
pricing and language questions after the
respondent has already been exposed to
many product X questions and
supposed attributes. To avoid bias, the
most critical questions should appear as
up front in the surveys as possible.
(Response) Of greatest interest to FDA
is the question of whether presence or
absence of price comparison
information and contextual information
influences outcomes such as
perceptions of comparative safety and
efficacy, perceptions of the comparator
product, and intentions to seek more
information about the advertised
product. Placing pricing related
questions near the beginning of the
survey would likely bias participants to
think about pricing information more
than they would under natural
conditions, which may influence their
responses to the aforementioned critical
dependent variables. Although current
question ordering may bias responses to
pricing related questions, we believe
this outcome is less consequential than
the reverse, as suggested in this
comment. Consequently, we intend to
retain the current order of questions in
the survey.
(Comment 4 from AbbVie) It is
unclear if the drug examples (X and Y)
are real world medicines that could be
taken by the patient respondents. If so,
do respondents need to be aware of each
product? If they need not be aware, you
will need to balance the samples for any
differences between cells. In addition,
the cells will also need to be balanced
for current drug usage to prevent
additional bias.
(Response) We have constructed a
fictional product for use in this study to
control for effects that might result as a
consequence of having taken the
product in the past. The comparator is
a real product. We will measure
participants’ experience with
medication for this condition, prior
exposure to advertising for the
comparator, and prior experience taking
the comparator. Responses to these
questions can be used as covariates in
analysis.
(Comment 5 from AbbVie) The
questions on the physician survey
should be at a higher level language
versus the general population. We note
the questions in the patient
questionnaire seem to vary in reading
level required to comprehend them. We
recommend that FDA review the
questions for consistency so as not [to]
introduce a reading bias.
(Response) We appreciate this
comment. We have conducted cognitive
interviews (OMB control number 0910–
0695) to refine and improve the survey
questions. We will also be conducting
two rounds of pretesting which will
provide an additional opportunity to
identify and remove questions that do
not function as intended, further
refining the questionnaire prior to the
main study. These activities include
consideration of language level and
whether it is appropriate for the
participants being surveyed.
18409
(Comment 6 from AbbVie) We
recommend this ad explicitly present
contextual information that the two
drugs may not be comparable in terms
of efficacy and safety (i.e., the products
are not interchangeable)
notwithstanding price comparisons.
This would permit FDA to assess
whether it has provided enough
contextual information so that the
audience understands that the products
are not interchangeable. Consequently,
there would be a response choice in the
questionnaire that allows a respondent
to acknowledge the products are not
interchangeable. AbbVie suggests that
an option be added that reads, ‘‘The
brochure left the impression that Drug
X’s efficacy (and safety) should not be
compared to Drug Y’s; the products are
not interchangeable.’’
(Response) The context language is
based on feedback from the cognitive
interviews. We appreciate the comment
and have added a question to assess
participants’ attitudes about the context
with regard to interchangeability of the
products being compared.
(Comment 7 from AbbVie) It is not
clear what type of cost information is
being presented in these ads. We suggest
that the advertisement should make
clear what costs are being presented, for
what doses, and over what time frames
so that readers are comparing ‘apples to
apples’ when viewing the ads. If study
budget allows, it would be ideal to test
a variety of cost information.
(Response) The price comparison is
for the same indication on a yearly
basis. We agree that it would be
informative to expand the study to test
a variety of cost information but do not
have the resources to do so.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
respondents
Average burden
per response
Total hours
41,110
7,400
4,933
400
1,000
2,940
........................
1
........................
1
1
1
........................
7,400
........................
400
1,000
2,940
............................
0.03 (2 minutes)
............................
0.5 (30 minutes)
0.5 (30 minutes)
0.5 (30 minutes)
........................
222
........................
200
500
1,470
Total .........................................................................
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Sample outgo (pretests and main survey) ......................
Screener completes ........................................................
Eligible .............................................................................
Completes, Pretests Phase 1 .........................................
Completes, Pretest Phase 2 ...........................................
Completes, Main Study ...................................................
........................
........................
........................
............................
2,392
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
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18410
Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices
Dated: March 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07818 Filed 4–3–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1219]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey of Health
Care Practitioners for Device Labeling
Format and Content
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 May 6,
2015.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
title Survey of Health Care Practitioners
for Device Labeling Format and Content.
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
tkelley on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Survey of Health Care Practitioners for
Device Labeling Format and Content—
21 CFR Part 801 (OMB Control Number
0910–NEW)
The purpose of this study is to
compare existing device labeling from
approximately six different types of
medical devices with a standard content
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and format of the same labeling that
FDA researchers will develop using the
existing labeling as their source of the
information.
Building upon the research
methodology and success of the
approach FDA used to evaluate drug
labeling, we propose to measure the
usability and usefulness of a draft
standard content and format of device
labeling against existing manufacturer
labeling of the same device. This will
support our research that has already
been done to assess whether health care
practitioners (HCPs) find the format and
content of device labeling to be clear,
understandable, useful, and user
friendly (OMB control number 0910–
0715). Findings will provide evidence to
inform FDA’s planned regulatory
approach to standardizing medical
device labeling across the United States.
In the Federal Register of September
12, 2014 (79 FR 54727), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA used comments from
the medical device industry, health care
professionals, caregivers, and patients to
help formulate the objectives and define
the scope of this study. The received
comments are followed by FDA’s
responses as follows:
(Comment 1) One comment stated
that FDA should coordinate with the
American Society for Testing and
Materials (ASTM) as they already have
published a consensus standard (F2943)
on this topic. This standard resulted
from the work of a multi-stakeholder
working group.
(Response) FDA reviewed the
consensus standard (F2943) when we
drafted the outline for this study. We
consulted with a member of the ASTM
committee. We also requested a member
of the committee to be on our strategic
planning committee for this study.
(Comment 2) A comment stated that
FDA does not follow the guidance on
formative human factors and usability
studies. The guidance provides good
direction on appropriately choosing
representative end users, replicating the
intended user environment, and
evaluating the user-product interface
(see FDA draft guidance ‘‘Applying
Human Factors and Usability
Engineering to Optimize Medical Device
Design’’ issued on June 22, 2011).
(Response) FDA had designed the
protocol for this study with a human
factors expert and a social scientist. In
this particular study, we will be doing
a cognitive test of the health care
practitioners. They will be asked to find
a piece of information in the draft
outline of standard content of labeling,
or in the manufacturer’s existing
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labeling. They will not be interacting
with the device and this will be a
usability test; they will be responding to
scenarios to search for information.
(Comment 3) One comment stated
that FDA should ask the question,
particularly to physicians, whether the
standard of care requires them to read
the user instructions and understand the
product’s warning.
(Response) This study is the third part
of a three-part study. FDA performed
focus groups of health care practitioners
asking them what they want in labeling,
where do they find labeling, what are
the most important sections of labeling,
and whether they even look at labeling.
Their responses indicated that they do
not look at labeling because it is
complicated and they typically cannot
find the information they want in one
section. They stated they would like an
abbreviated version of labeling in order
to find use information more easily,
they would like a standard content of
labeling, and they also would like to
find it electronically and in one place if
possible.
FDA does not regulate the practice of
medicine; we do, however, regulate
labeling that accompanies a device.
Based on the previous phases of the
studies already done, we now want to
test a standard content of labeling
against an existing piece of the same
labeling to see if health care
practitioners can find what they need in
a consistent and easy way. This is a
cognitive testing of a standard content of
labeling and does not include questions
regarding whether or not someone is
required to read the labeling before
using the device.
We will be using outside experts to
develop the protocol, develop the
scenarios, develop the draft
standardized labeling, perform the
testing, and provide a summary of the
study. This is being done through the
Entrepreneurs in Residence program
that is funded by the White House to
use outside experts and their special
knowledge and skills to work on an
innovative idea that helps the
government when faced with a unique
problem. Dr. Daryle Gardner-Bonneau is
a renowned social scientist and human
factors specialist who has worked with
the device industry, standards
organizations, and the National
Research Council on issues with
medical device labeling. Patricia
Kingsley is a former FDA employee who
worked on medical device labeling
issues. Nancy Ostrove is a former FDA
employee who worked on surveys and
studies with drug community when the
Center for Drug Evaluation and Research
was developing standardized labeling
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]]>Agencies
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18407-18410]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07818]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0554]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Comparative Price
Information in Direct-to-Consumer and Professional Prescription Drug
Advertisements
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 May 6,
2015.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title, ``Comparative Price Information in Direct-to-Consumer and
Professional Prescription Drug Advertisements.'' Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
Comparative Price Information in Direct-to-Consumer and Professional
Prescription Drug Advertisements--(0910-NEW)
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
By their very nature, medical and health decisions are comparative
(e.g., treat versus not treat). For consumers, these decisions may
include the use of prescription drug products versus over the counter
products versus herbal supplements, as well as one prescription brand
versus another prescription brand. Similarly, advertising is often
comparative. In prescription drug advertising, sponsors are permitted
to include truthful, non-misleading information about the price of
their products in promotion. This may extend to price comparison
information, wherein sponsors may include information about the price
of a competing product in order to make advantageous claims. Currently,
when price comparisons are made, the advertisement (ad) should also
include context that the two drugs may not be comparable in terms of
efficacy and safety and that the acquisition costs presented do not
necessarily reflect the actual prices paid by consumers, pharmacies, or
third party payers. Despite the inclusion of this additional
information, there is concern that adding contextual information about
efficacy or safety is not sufficient to correct the impression that the
products are interchangeable and that price is the main factor to
consider. The Office of Prescription Drug Promotion plans to
investigate, through empirical research, the impact of price comparison
information and additional contextual information on prescription drug
product perceptions. This will be investigated in direct-to-consumer
(DTC) and healthcare-directed professional advertising for prescription
drugs.
Design Overview and Procedure
The design consists of two pretests and a main study. We will
conduct two sequential pretest waves prior to main data collection. The
purpose the pretests are to: (1) Ensure the stimuli are understandable
and viewable; (2) identify and address any challenges to embedding the
stimuli within the online survey; and (3) ensure the study questions
are appropriate and meet the study's goals. Participants in the
pretests will be randomly assigned to one of two versions of an ad. One
version will present information about the price of the product
relative to a competitor for the same indication (Price Comparison).
Another version will present this information with additional
contextual information that the two drugs may not be comparable in
[[Page 18408]]
terms of efficacy and safety and that the acquisition costs do not
necessarily reflect actual prices paid (Price Comparison + Additional
Context).
Participants in Pretest 1 will be consumers (n=400) who self-
identify as having been diagnosed with diabetes. Pretest 2 will be
conducted with physicians (n=1,000) who are General Practitioners
(e.g., Family Practice, General Practice, Internal Medicine) and
Specialists (e.g., Endocrinology, Pain Management). Pretest 2 has a
two-fold purpose. In addition to the measurement and stimuli
verification issues identified above, we will also conduct an
experiment to evaluate the impact of incentive level (level 1 vs. level
2) and study sponsorship (FDA vs. Public Health Agency) disclosure on
physician response rates (see Exhibit 1). Pretest 2 will therefore
provide a comparison of recruitment approaches, identify ways to
optimize response rates, and provide a ``dry run'' of experimental
study recruitment procedures.
Exhibit 1--Pretest 2 Design, Incentive Level by Study Sponsorship by Type of Ad
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type of ad
----------------------------------------------------------------
Price comparison Price comparison + additional
Study sponsor -------------------------------- context Total
--------------------------------
FDA Public Health Public Health
Agency FDA Agency
--------------------------------------------------------------------------------------------------------------------------------------------------------
Incentive Level.......................... Level 1...................... 125 125 125 125 500
Level 2...................... 125 125 125 125 500
-------------------------------------------------------------------------------
Total................................ ............................. 250 250 250 250 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
In the main study phase, physician (n=1440) and consumer (n=1,500)
participants will be randomly assigned to view one of three possible
versions of a DTC or professional ad for a fictitious prescription drug
for diabetic neuropathy and will be asked to complete an online survey
to assess their perceptions and understanding of product safety and
efficacy, perceptions and understanding of the additional contextual
information, perceptions of comparative safety and efficacy,
perceptions of the comparator product, and intention to seek more
information about the product (see Exhibit 2). This sample size will
provide us with sufficient power to detect small-to-medium sized
effects.
In addition to the Price Comparison and Price Comparison +
Additional Context ads used in pretesting, a third ad version will have
a claim about the price of the product but will not present information
about the price relative to a competitor, and will act as a control.
Exhibit 2--Main Study Design
----------------------------------------------------------------------------------------------------------------
Type of price comparison
-----------------------------------------------------------------------------------------------------------------
Price
Price information
Sample Price comparison + only (no Total
comparison additional comparison/
context control)
----------------------------------------------------------------------------------------------------------------
Consumers (DTC ad).............................. 500 500 500 1,500
Physicians (Professional ad).................... 480 480 480 1,440
---------------------------------------------------------------
Total....................................... 980 980 980 2,940
----------------------------------------------------------------------------------------------------------------
Participants will be consumers who self-identify as having been
diagnosed with diabetes and physicians who are General Practitioners
(e.g., Family Practice, General Practice, Internal Medicine) and
Specialists (e.g., Endocrinology, Pain Management). All participants
will be 18 years of age or older. We will exclude individuals from the
consumer sample who work in healthcare, pharmaceutical, or marketing
settings because their knowledge and experiences may not reflect those
of the average consumer. Recruitment and administration of the study
will take place over the Internet. Participation is estimated to take
approximately 30 minutes.
In the Federal Register of May 7, 2014 (79 FR 26255), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. Two submissions were received; one from Ms. Lenisse
Lippert of Quality Matrix Solutions, and one from AbbVie
biopharmaceutical company, which contained multiple comments. We
summarize and respond to these comments below.
(Comment 1 from Lenisse Lippert, Quality Matrix Solutions) ``I
would like to participate in the industry feedback on a proposed study
to better understand direct-to-consumer advertisements that compare
drug pricing, and how that information affects a consumer's perception
of a drug's overall safety and efficacy versus the comparator
product.''
(Response) We thank Ms. Lippert for her comment.
(Comment 2 from AbbVie) To prevent fatigue, online market research
surveys do not generally exceed 20 minutes. Given that FDA is trying to
make the most of their survey opportunity by asking many questions, it
would be wise to place the meatier pricing related questions earlier in
the survey when respondents are still engaged.
(Response) We take the survey length very seriously. We are
sensitive to issues regarding respondent fatigue and its impact upon
completion rates and thus have placed items that are most likely to be
influenced by respondent fatigue (open-ended questions) at the
beginning of the survey. We have employed similar online surveys on
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several previous studies, and we have obtained high completion rates,
typically 90 percent or higher. For example, on a recent study
(Experimental Study: Examination of Corrective Direct-to-Consumer
Television Advertising [OMB control number 0910-0737]), we had a pool
of 1,071 eligible respondents, and only 14 of those respondents failed
to complete the survey. We anticipate that the completion rate for this
study will be similar.
(Comment 3 from AbbVie) In both surveys, respondents are asked many
questions about product X that appear positively stated. Therefore,
there is a risk of a bias by asking the critical pricing and language
questions after the respondent has already been exposed to many product
X questions and supposed attributes. To avoid bias, the most critical
questions should appear as up front in the surveys as possible.
(Response) Of greatest interest to FDA is the question of whether
presence or absence of price comparison information and contextual
information influences outcomes such as perceptions of comparative
safety and efficacy, perceptions of the comparator product, and
intentions to seek more information about the advertised product.
Placing pricing related questions near the beginning of the survey
would likely bias participants to think about pricing information more
than they would under natural conditions, which may influence their
responses to the aforementioned critical dependent variables. Although
current question ordering may bias responses to pricing related
questions, we believe this outcome is less consequential than the
reverse, as suggested in this comment. Consequently, we intend to
retain the current order of questions in the survey.
(Comment 4 from AbbVie) It is unclear if the drug examples (X and
Y) are real world medicines that could be taken by the patient
respondents. If so, do respondents need to be aware of each product? If
they need not be aware, you will need to balance the samples for any
differences between cells. In addition, the cells will also need to be
balanced for current drug usage to prevent additional bias.
(Response) We have constructed a fictional product for use in this
study to control for effects that might result as a consequence of
having taken the product in the past. The comparator is a real product.
We will measure participants' experience with medication for this
condition, prior exposure to advertising for the comparator, and prior
experience taking the comparator. Responses to these questions can be
used as covariates in analysis.
(Comment 5 from AbbVie) The questions on the physician survey
should be at a higher level language versus the general population. We
note the questions in the patient questionnaire seem to vary in reading
level required to comprehend them. We recommend that FDA review the
questions for consistency so as not [to] introduce a reading bias.
(Response) We appreciate this comment. We have conducted cognitive
interviews (OMB control number 0910-0695) to refine and improve the
survey questions. We will also be conducting two rounds of pretesting
which will provide an additional opportunity to identify and remove
questions that do not function as intended, further refining the
questionnaire prior to the main study. These activities include
consideration of language level and whether it is appropriate for the
participants being surveyed.
(Comment 6 from AbbVie) We recommend this ad explicitly present
contextual information that the two drugs may not be comparable in
terms of efficacy and safety (i.e., the products are not
interchangeable) notwithstanding price comparisons. This would permit
FDA to assess whether it has provided enough contextual information so
that the audience understands that the products are not
interchangeable. Consequently, there would be a response choice in the
questionnaire that allows a respondent to acknowledge the products are
not interchangeable. AbbVie suggests that an option be added that
reads, ``The brochure left the impression that Drug X's efficacy (and
safety) should not be compared to Drug Y's; the products are not
interchangeable.''
(Response) The context language is based on feedback from the
cognitive interviews. We appreciate the comment and have added a
question to assess participants' attitudes about the context with
regard to interchangeability of the products being compared.
(Comment 7 from AbbVie) It is not clear what type of cost
information is being presented in these ads. We suggest that the
advertisement should make clear what costs are being presented, for
what doses, and over what time frames so that readers are comparing
`apples to apples' when viewing the ads. If study budget allows, it
would be ideal to test a variety of cost information.
(Response) The price comparison is for the same indication on a
yearly basis. We agree that it would be informative to expand the study
to test a variety of cost information but do not have the resources to
do so.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample outgo (pretests and main survey)........ 41,110 .............. .............. ....................................... ..............
Screener completes............................. 7,400 1 7,400 0.03 (2 minutes)....................... 222
Eligible....................................... 4,933 .............. .............. ....................................... ..............
Completes, Pretests Phase 1.................... 400 1 400 0.5 (30 minutes)....................... 200
Completes, Pretest Phase 2..................... 1,000 1 1,000 0.5 (30 minutes)....................... 500
Completes, Main Study.......................... 2,940 1 2,940 0.5 (30 minutes)....................... 1,470
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. ....................................... 2,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 18410]]
Dated: March 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07818 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P
