Agency Information Collection Activities; Proposed Collection; Comment Request; Targeted Mechanism of Action Presentations in Prescription Drug Promotion, 59735-59738 [2021-23507]
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Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices
[FR Doc. 2021–23500 Filed 10–27–21; 8:45 am]
jspears on DSK121TN23PROD with NOTICES1
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1050]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Targeted
Mechanism of Action Presentations in
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
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17:34 Oct 27, 2021
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ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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
SUMMARY:
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EN28OC21.002</GPH>
Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
59735
59736
Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices
solicits comments on a proposed study
entitled ‘‘Targeted Mechanism of Action
Presentations in Prescription Drug
Promotion.’’
Submit either electronic or
written comments on the collection of
information by December 27, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 27,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 27, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
jspears on DSK121TN23PROD with NOTICES1
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
VerDate Sep<11>2014
17:34 Oct 27, 2021
Jkt 256001
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–N–1050 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Targeted
Mechanism of Action Presentations in
Prescription Drug Promotion.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
PO 00000
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Sfmt 4703
Flint North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
For copies of the questionnaire: Office
of Prescription Drug Promotion (OPDP)
Research Team, DTCResearch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
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 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.
Targeted Mechanism of Action
Presentations in Prescription Drug
Promotion
OMB Control Number 0910—NEW
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 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (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.
The Office of Prescription Drug
Promotion’s (OPDP) mission is to
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Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices
protect the public health by helping to
ensure that prescription drug promotion
is truthful, balanced, and accurately
communicated. OPDP’s research
program provides scientific evidence to
help ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have consistently
conducted research to evaluate the
aspects of prescription drug promotion
that are most central to our mission. Our
research focuses in particular on three
main topic areas: Advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and disease and
product characteristics impact the
communication and understanding of
prescription drug risks and benefits.
Focusing on target populations allows
us to evaluate how understanding of
prescription drug risks and benefits may
vary as a function of audience, and our
focus on research quality aims at
maximizing the quality of research data
through analytical methodology
development and investigation of
sampling and response issues. This
study will inform the first two topic
areas, advertising features and target
populations.
Because we recognize the strength of
data and the confidence in the robust
nature of the findings are improved
through the results of multiple
converging studies, we continue to
develop evidence to inform our
thinking. We evaluate the results from
our studies within the broader context
of research and findings from other
scientific sources, and this larger body
of knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
home page, which can be found at:
https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/
office-prescription-drug-promotionopdp-research. The website includes
links to the latest Federal Register
notices and peer-reviewed publications
produced by our office.
In 2014, OPDP conducted focus
groups designed to provide insights on
how consumers and healthcare
providers (HCP), including physicians,
nurse practitioners, and physician
assistants, interpret the term ‘‘targeted’’
in prescription drug promotional
materials. Although diverse views were
voiced, there appeared to be some
tendency toward the impression that
products with promotional materials
using this term would be safer and more
effective than other similar treatments.
OPDP is also now conducting a
nationally representative survey
regarding the ways in which consumers
and primary care physicians (PCPs)
interpret terms and phrases commonly
used in prescription drug promotional
materials, including assessment of
impressions of the terms ‘‘targeted’’ and
‘‘targeted mechanism of action’’
(targeted MoA) (May 10, 2021, 86 FR
24867). Building upon this line of
research, the proposed study will
investigate the influence of targeted
MoA claims, graphics, and disclosures
that provide context about a drug’s
targeted MoA, utilizing an experimental
design with both consumer and HCP
samples. The experimental approach
described here is intended to
complement and augment the prior
research by facilitating assessment of
causality. Specifically, the proposed
study will explore how varied targeted
MoA presentations affect consumer and
HCP understanding of the MoA of a
drug, perception of drug benefits and
59737
risks, attention to risk information, and
interest in the drug.
Table 1 depicts the study design.
Participants will be randomly assigned
to 1 of 12 experimental conditions in
which the presence versus absence of:
(1) A targeted MoA claim, (2) a graphic
depicting a targeted MoA, and (3) a
disclosure that provides context about
the targeted MoA of the drug are varied
in a branded website for a fictitious
prescription drug indicated to treat
bladder cancer and cancers of the
urinary tract (renal pelvis, ureter, or
urethra) that have spread or cannot be
removed by surgery. We selected cancer
as the medical condition for study given
the prevalence of targeted MoA
presentations in promotional materials
for prescription drugs indicated to treat
various forms of cancer. Notably, there
will be three variations related to the
targeted MoA graphic: (1) No graphic,
(2) an inaccurate graphic (graphic 1)
showing only the effect of the drug on
cancerous cells but not on healthy cells,
and (3) an accurate graphic (graphic 2)
that will show the effect of the drug on
both cancerous and healthy cells. The
design will be replicated in both the
consumer and HCP samples with
stimuli specifically created for each
audience. Draft stimuli were informed
by, but not identical to, actual targeted
MoA presentations from a marketplace
evaluation conducted under FDA
guidance. Draft stimuli were also
informed by an FDA subject matter
expert’s review. Following exposure to
the stimuli, the participants will
complete a questionnaire designed to
assess relevant outcome measures. A
copy of the questionnaire is available
upon request. All aspects of this study
will be completed online. Participation
is estimated to take approximately 20
minutes, excluding the screener’s time.
TABLE 1—STUDY DESIGN
Targeted MoA graphic 1
Sample
HCP .......................................
Disclosure
Targeted MoA claim
Present .................................
Absent ...................................
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Consumer ..............................
Present .................................
Absent ...................................
1 Each
Present .................................
Absent ...................................
Present .................................
Absent ...................................
Present .................................
Absent ...................................
Present .................................
Absent ...................................
Present
(graphic 1—
inaccurate)
Present
(graphic 2—
accurate)
Absent
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D
D symbol represents an experimental condition.
For the HCP sample, we will recruit
oncologists, PCPs with oncology
experience, and nurse practitioners and
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physician assistants who specialize in
oncology. We will also recruit a general
population sample of adult volunteers
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18 years or older for the consumer
sample. A general population, rather
than a diagnosed consumer sample, was
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Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices
selected because of concerns about
being able to recruit a sufficient number
of participants for this particular study
if we selected a cancer-specific sample.
We will ask consumers to consider a
hypothetical scenario in which they
have recently been diagnosed with
cancer and are actively looking for
available treatments. HCPs will be asked
to consider a scenario in which they are
actively looking for available treatments
for a patient who has been diagnosed
with cancer. We will also ask consumers
if they have ever been diagnosed with
cancer. HCP participants will be drawn
from online HCP panels and general
population consumer participants will
be drawn from online consumer panels.
Informed by power analyses, we will
recruit a sample of 540 HCPs and 540
consumers for the main study.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents 2
Activity
Total
annual
responses
Average
burden per
response 3
Total hours
Pretest
General population: Pretest screener completes (assumes
75% eligible) .....................................................................
528
1
528
General population: Number of completes, pretest .............
396
1
396
HCP: Pretest screener completes (assumes 60% eligible)
660
1
660
HCP: Number of completes, pretest ....................................
396
1
396
0.08 (5
minutes)
0.33 (20
minutes)
0.08 (5
minutes)
0.33 (20
minutes)
42.2
130.7
52.8
130.7
Main Study
General population: Number of main study screener completes (assumes 75% eligible) .........................................
792
1
792
General population: Number of completes, main study ......
594
1
594
HCP: Number of main study screener completes (assumes 60% eligible) .........................................................
990
1
990
HCP: Number of completes, main study .............................
594
1
594
Total ..............................................................................
........................
........................
........................
0.08 (5
minutes)
0.33 (20
minutes)
0.08 (5
minutes)
0.33 (20
minutes)
........................
63.4
196.0
79.2
196.0
891
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target
number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for both samples in the study.
3 Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23507 Filed 10–27–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1584]
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Authorization of Emergency Use of
Certain Medical Devices During
COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of Emergency Use
Authorizations (EUAs) (the
SUMMARY:
VerDate Sep<11>2014
17:34 Oct 27, 2021
Jkt 256001
Authorizations) for certain medical
devices related to the Coronavirus
Disease 2019 (COVID–19) public health
emergency. FDA has issued the
Authorizations listed in this document
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). These
Authorizations contain, among other
things, conditions on the emergency use
of the authorized products. The
Authorizations follow the February 4,
2020, determination by the Secretary of
Health and Human Services (HHS) that
there is a public health emergency that
has a significant potential to affect
national security or the health and
security of U.S. citizens living abroad,
and that involves the virus that causes
COVID–19, and the subsequent
declarations on February 4, 2020, March
2, 2020, and March 24, 2020, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection and/or
PO 00000
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diagnosis of the virus that causes
COVID–19, personal respiratory
protective devices, and medical devices,
including alternative products used as
medical devices, respectively, subject to
the terms of any authorization issued
under the FD&C Act. These
Authorizations, which include an
explanation of the reasons for issuance,
are listed in this document, and can be
accessed on FDA’s website from the
links indicated.
DATES: These Authorizations are
effective on their date of issuance.
ADDRESSES: Submit written requests for
single copies of an EUA to the Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4338, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request or include a fax number to
which the Authorization may be sent.
E:\FR\FM\28OCN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59735-59738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23507]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1050]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Targeted Mechanism of Action Presentations in
Prescription Drug Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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
[[Page 59736]]
solicits comments on a proposed study entitled ``Targeted Mechanism of
Action Presentations in Prescription Drug Promotion.''
DATES: Submit either electronic or written comments on the collection
of information by December 27, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 27, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 27, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-1050 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Targeted Mechanism of Action
Presentations in Prescription Drug Promotion.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
For copies of the questionnaire: Office of Prescription Drug
Promotion (OPDP) Research Team, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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 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.
Targeted Mechanism of Action Presentations in Prescription Drug
Promotion
OMB Control Number 0910--NEW
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 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (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.
The Office of Prescription Drug Promotion's (OPDP) mission is to
[[Page 59737]]
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: Advertising features, including
content and format; target populations; and research quality. Through
the evaluation of advertising features, we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform the first two topic areas, advertising features and
target populations.
Because we recognize the strength of data and the confidence in the
robust nature of the findings are improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other scientific sources,
and this larger body of knowledge collectively informs our policies as
well as our research program. Our research is documented on our home
page, which can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
In 2014, OPDP conducted focus groups designed to provide insights
on how consumers and healthcare providers (HCP), including physicians,
nurse practitioners, and physician assistants, interpret the term
``targeted'' in prescription drug promotional materials. Although
diverse views were voiced, there appeared to be some tendency toward
the impression that products with promotional materials using this term
would be safer and more effective than other similar treatments. OPDP
is also now conducting a nationally representative survey regarding the
ways in which consumers and primary care physicians (PCPs) interpret
terms and phrases commonly used in prescription drug promotional
materials, including assessment of impressions of the terms
``targeted'' and ``targeted mechanism of action'' (targeted MoA) (May
10, 2021, 86 FR 24867). Building upon this line of research, the
proposed study will investigate the influence of targeted MoA claims,
graphics, and disclosures that provide context about a drug's targeted
MoA, utilizing an experimental design with both consumer and HCP
samples. The experimental approach described here is intended to
complement and augment the prior research by facilitating assessment of
causality. Specifically, the proposed study will explore how varied
targeted MoA presentations affect consumer and HCP understanding of the
MoA of a drug, perception of drug benefits and risks, attention to risk
information, and interest in the drug.
Table 1 depicts the study design. Participants will be randomly
assigned to 1 of 12 experimental conditions in which the presence
versus absence of: (1) A targeted MoA claim, (2) a graphic depicting a
targeted MoA, and (3) a disclosure that provides context about the
targeted MoA of the drug are varied in a branded website for a
fictitious prescription drug indicated to treat bladder cancer and
cancers of the urinary tract (renal pelvis, ureter, or urethra) that
have spread or cannot be removed by surgery. We selected cancer as the
medical condition for study given the prevalence of targeted MoA
presentations in promotional materials for prescription drugs indicated
to treat various forms of cancer. Notably, there will be three
variations related to the targeted MoA graphic: (1) No graphic, (2) an
inaccurate graphic (graphic 1) showing only the effect of the drug on
cancerous cells but not on healthy cells, and (3) an accurate graphic
(graphic 2) that will show the effect of the drug on both cancerous and
healthy cells. The design will be replicated in both the consumer and
HCP samples with stimuli specifically created for each audience. Draft
stimuli were informed by, but not identical to, actual targeted MoA
presentations from a marketplace evaluation conducted under FDA
guidance. Draft stimuli were also informed by an FDA subject matter
expert's review. Following exposure to the stimuli, the participants
will complete a questionnaire designed to assess relevant outcome
measures. A copy of the questionnaire is available upon request. All
aspects of this study will be completed online. Participation is
estimated to take approximately 20 minutes, excluding the screener's
time.
Table 1--Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
Targeted MoA graphic \1\
--------------------------------------------------
Sample Disclosure Targeted MoA claim Present Present
(graphic 1-- (graphic 2-- Absent
inaccurate) accurate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCP...................................... Present..................... Present..................... [ssquf] [ssquf] [ssquf]
Absent...................... [ssquf] [ssquf] [ssquf]
Absent...................... Present..................... [ssquf] [ssquf] [ssquf]
Absent...................... [ssquf] [ssquf] [ssquf]
Consumer................................. Present..................... Present..................... [ssquf] [ssquf] [ssquf]
Absent...................... [ssquf] [ssquf] [ssquf]
Absent...................... Present..................... [ssquf] [ssquf] [ssquf]
Absent...................... [ssquf] [ssquf] [ssquf]
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Each [ssquf] symbol represents an experimental condition.
For the HCP sample, we will recruit oncologists, PCPs with oncology
experience, and nurse practitioners and physician assistants who
specialize in oncology. We will also recruit a general population
sample of adult volunteers 18 years or older for the consumer sample. A
general population, rather than a diagnosed consumer sample, was
[[Page 59738]]
selected because of concerns about being able to recruit a sufficient
number of participants for this particular study if we selected a
cancer-specific sample.
We will ask consumers to consider a hypothetical scenario in which
they have recently been diagnosed with cancer and are actively looking
for available treatments. HCPs will be asked to consider a scenario in
which they are actively looking for available treatments for a patient
who has been diagnosed with cancer. We will also ask consumers if they
have ever been diagnosed with cancer. HCP participants will be drawn
from online HCP panels and general population consumer participants
will be drawn from online consumer panels. Informed by power analyses,
we will recruit a sample of 540 HCPs and 540 consumers for the main
study.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Number of Average burden
Activity respondents responses per Total annual per response Total hours
\2\ respondent responses \3\
----------------------------------------------------------------------------------------------------------------
Pretest
----------------------------------------------------------------------------------------------------------------
General population: Pretest 528 1 528 0.08 (5 42.2
screener completes (assumes 75% minutes)
eligible)......................
General population: Number of 396 1 396 0.33 (20 130.7
completes, pretest............. minutes)
HCP: Pretest screener completes 660 1 660 0.08 (5 52.8
(assumes 60% eligible)......... minutes)
HCP: Number of completes, 396 1 396 0.33 (20 130.7
pretest........................ minutes)
----------------------------------------------------------------------------------------------------------------
Main Study
----------------------------------------------------------------------------------------------------------------
General population: Number of 792 1 792 0.08 (5 63.4
main study screener completes minutes)
(assumes 75% eligible).........
General population: Number of 594 1 594 0.33 (20 196.0
completes, main study.......... minutes)
HCP: Number of main study 990 1 990 0.08 (5 79.2
screener completes (assumes 60% minutes)
eligible)......................
HCP: Number of completes, main 594 1 594 0.33 (20 196.0
study.......................... minutes)
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 891
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ As with most online and mail surveys, it is always possible that some participants are in the process of
completing the survey when the target number is reached and that those surveys will be completed and received
before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for
both samples in the study.
\3\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23507 Filed 10-27-21; 8:45 am]
BILLING CODE 4164-01-P
