Agency Information Collection Activities; Proposed Collection; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion, 70669-70672 [2023-22586]
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
evaluation of diagnostic
radiopharmaceuticals in this
information collection is intended to
streamline overall information
collection burdens, particularly for
diagnostic radiopharmaceuticals that
may have well-established, low-risk
safety profiles by enabling
manufacturers to tailor information
submissions and avoid unnecessary
clinical trials.
In table 1, row 2, we estimate the
annual reporting burden for preparing
the safety and effectiveness sections of
a supplement to an approved
application. This estimate does not
include the time needed to conduct
studies and clinical trials or other
research from which the reported
information is obtained.
Based on past submissions of human
drug applications, new indication
supplements for diagnostic
radiopharmaceuticals, or both, we
estimate that one submission will be
received annually. We estimate the total
time needed to prepare complete
applications for supplements to new
applications for diagnostic
radiopharmaceuticals as approximately
between 500 and 1,000 hours. We
calculated the median of this estimate to
arrive at approximately 750 hours. We
further estimate that the total time
needed to prepare the portions of the
application that would be affected by
this information collection as 750 hours.
As previously stated, this information
collection does not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 750 hours,
because safety and effectiveness
information is already required in
§ 314.50 and has been approved under
OMB control number 0910–0001.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR NDAS AND SUPPLEMENTS TO APPROVED NDAS FOR
DIAGNOSTIC RADIOPHARMACEUTICALS 1
Manufacturers’ activity
(21 CFR section)
Average
burden per
response
Total annual
responses
Total hours
NDAs (§§ 315.4, 315.5, and 315.6) .....................................
Supplements to Approved NDAs (§§ 315.4, 315.5, and
315.6) ...............................................................................
3
1
3
2,000
6,000
1
1
1
750
750
Total ..............................................................................
........................
........................
........................
........................
6,750
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since our last OMB approval, our
estimated burden for the information
collection reflects an overall decrease of
11 responses with a corresponding
decrease of 12,000 burden hours. We
attribute this adjustment to a decrease in
the number of submissions for NDAs for
diagnostic radiopharmaceuticals and
new indication supplements for
diagnostic radiopharmaceuticals we
received over the past few years.
Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22460 Filed 10–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3768]
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Number of
responses per
respondent
Number of
respondents
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adherence
Potential and Patient Preference in
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
SUMMARY:
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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
solicits comments on a proposed study
entitled ‘‘Adherence Potential and
Patient Preference in Prescription Drug
Promotion.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by
December 11, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
December 11, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
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.
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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
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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–
2023–N–3768 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Adherence Potential and Patient
Preference 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.
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FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAstaff@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.
Adherence Potential and Patient
Preference 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 mission of the Office of
Prescription Drug Promotion (OPDP) is
to protect the public health by helping
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to ensure that prescription drug
promotion is truthful, balanced, and
accurately communicated so that
patients and healthcare providers can
make informed decisions about
treatment options. 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,
focusing 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 the
characteristics of the disease and
product 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. 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
topic area, advertising features.
Because we recognize that 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 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 at https://www.fda.gov/
about-fda/center-drug-evaluation-andresearch-cder/office-prescription-drugpromotion-opdp-research, which
includes links to the latest Federal
Register notices and peer-reviewed
publications produced by our office.
This study builds on OPDP’s portfolio
of research on market claims and
disclosures to explore the influence of
statements around patient adherence
and preference in prescription drug
promotion. Previous FDA-funded
research has shown that market claims
that advertise drug characteristics
unrelated to medicinal properties, such
as ‘‘#1 Prescribed,’’ influence consumer
and provider perceptions about a drug’s
efficacy (Ref. 1). In the same study,
results of a tradeoff analysis suggested
that patients prefer a drug over a
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competitor when this type of claim is
present, and a drug without this claim
required at least 1.23 percent greater
efficacy to be chosen over a drug with
this claim (Ref. 2). Treatment
preferences may also be influenced by
other drug characteristics, including its
impact on quality of life, complexity of
dosage regimens, administration mode,
and cost to family and self (Refs. 3–5).
It is not known how claims that
appeal to the possibility for greater
adherence or to social norms around
what other patients or healthcare
providers prefer influence perceptions
of a drug. A related question is whether
including a disclosure stating the
uncertainty around such claims (e.g.,
there is no conclusive research on
whether DRUG A results in better
adherence) can mitigate any misleading
perceptions or influence preferences.
Some evidence suggests that disclosures
in prescription drug promotion are
typically noticed and may help
consumers and healthcare providers
understand information (Refs. 2 and 6),
but this topic has not been investigated
in the context of adherence claims.
The present research is designed to
complement previous research by
experimentally examining the role of
adherence and patient preference claims
in prescription drug promotion. We
have the following specific questions:
Research questions:
1. Does the presence or absence of an
implied-adherence claim affect
consumers’ behavioral intentions or
risk, benefit, and adherence
perceptions?
2. Does the presence or absence of an
adherence-related patient preference
claim affect consumers’ behavioral
intentions or risk, benefit, and
adherence perceptions?
3. Does the presence of both types of
claims (adherence and preference) have
a cumulative impact on consumers’
behavioral intentions or risk, benefit,
and adherence perceptions?
4. Does a disclosure of information to
the effect that there is no conclusive
research on whether the drug results in
better adherence mitigate consumers’
behavioral intentions or risk, benefit,
and adherence perceptions?
To complete this research, we will
show participants a website for a
fictitious prescription drug product for
type 2 diabetes. We propose the design
in table 1, which varies based on
whether the fictitious prescription drug
promotional communication includes a
claim about:
• implied adherence;
• patient preference; and
• a disclosure that there is no
conclusive research on adherence.
TABLE 1—DESIGN 2 (IMPLIED ADHERENCE CLAIM) × 2 (PATIENT PREFERENCE CLAIM) × 2 (DISCLOSURE)
Implied Adherence Claim ..........................................
1 E.g.,
With disclosure 1
Without disclosure
Patient preference claim
Patient preference claim
Yes
Yes
No
No
Yes.
No.
‘‘There is no conclusive research to suggest better adherence to Drug X compared with Drug Y.’’
Recruitment will occur by email
through an internet panel, and
participant eligibility will be
determined with a screener at the
beginning of the online survey. For the
pretest, we expect to screen 253
consumers and 294 primary care
physicians (PCPs) to reach our desired
number of completed surveys. We will
conduct complete pretest surveys with
160 consumers who self-identify as
having been diagnosed with diabetes
and 160 PCPs who treat diabetes (both
obtained from a web-based research
vendor) to ensure that the questionnaire
programming works as expected. For the
main study, we expect to screen 566
consumers and 660 PCPs to reach our
desired number of completed surveys.
Thus, for the main study final sample,
we will recruit 360 adult voluntary
participants aged 18 years or older who
self-identify as having been diagnosed
with diabetes and 360 voluntary
participants who are employed as PCPs
who treat diabetes. We will exclude
individuals who work in healthcare
settings, employees of the Department of
Health and Human Services, and
individuals who work in the marketing,
advertising, or pharmaceutical
industries.
The total annual estimated burden
imposed by this collection of
information is 520 hours (table 2). These
estimates account for over-recruitment
of 10 percent to account for survey
incompletes. 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.
Each participant will see one of eight
versions of a consumer web page for a
fictitious prescription diabetes
treatment, as reflected in table 1. They
will answer a questionnaire designed to
take no more than 20 minutes regarding
benefit and risk perceptions, adherence
perceptions, behavioral intentions,
adherence claim retention, and patient
preference claim retention. The survey
is available upon request at
DTCresearch@fda.hhs.gov.
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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Pretest:
Consumers: pretest screener completes (assumes 70% eligible).
Consumers: number of completes, pretest ...........
PCPs: pretest screener completes (assumes
60% eligible).
PCPs: number of completes, pretest ....................
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Number of
responses per
respondent
Average
burden per
response 2
Total annual
responses
Total hours
253
1
253
0.08 (5 min.) .........
20
176
294
1
1
176
294
0.33 (20 min.) .......
0.08 (5 min.) .........
58
24
176
1
176
0.33 (20 min.) .......
58
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Main Study:
Consumers: number of main study screener completes (assumes 70% eligible).
Consumers: number of completes, main study ....
PCPs: number of main study screener completes
(assumes 60% eligible).
PCPs: number of completes, main study .............
Total (rounded) ..............................................
1 There
Number of
responses per
respondent
Average
burden per
response 2
Total annual
responses
Total hours
566
1
566
0.08 (5 min.) .........
45
396
660
1
1
396
660
0.33 (20 min.) .......
0.08 (5 min.) .........
131
53
396
1
396
0.33 (20 min.) .......
131
........................
........................
........................
...............................
520
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
2 Burden
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References
The following references are on
display with the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Aikin, K.J., K.R. Betts, A. Keisler, and K.S.
Ziemer, ‘‘Market Claims and Efficacy
Information in Direct-to-Consumer
Prescription Drug Print Advertisements,’’
Psychology & Marketing, 36(8), 747–757,
2019a.
2. Aikin, K.J., K.R. Betts, K.S. Ziemer, and A.
Keisler, ‘‘Consumer Tradeoff of
Advertising Claim Versus Efficacy
Information in Direct-to-Consumer
Prescription Drug Ads,’’ Research in
Social and Administrative Pharmacy,
15(12), 1484–1488, 2019b.
3. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, D.
Prefasi, et al. ‘‘Conjoint Analysis To
Understand Preferences of Patients With
Multiple Sclerosis for Disease-Modifying
Therapy Attributes in Spain: A CrossSectional Observational Study,’’ BMJ
Open, 7(3), e014433, 2017.
4. Fraenkel, L., L. Suter, C.E. Cunningham,
and G. Hawker, ‘‘Understanding
Preferences for Disease-Modifying Drugs
in Osteoarthritis,’’ Arthritis Care
Research, 66(8), 1186–1192, 2014.
5. Wouters, H., G.A. Maatman, L. Van Dijk,
M.L. Bouvy, et al. ‘‘Trade-Off Preferences
Regarding Adjuvant Endocrine Therapy
Among Women With Estrogen ReceptorPositive Breast Cancer,’’ Annals of
Oncology, 24(9), 2324–2329, 2013.
6. Betts, K.R., V. Boudewyns, K.J. Aikin, C.
Squire, et al. ‘‘Serious and Actionable
Risks, Plus Disclosure: Investigating an
Alternative Approach for Presenting Risk
Information in Prescription Drug
Television Advertisements,’’ Research in
Social and Administrative Pharmacy,
14(10), 951–963, 2018.
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Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22586 Filed 10–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0008]
Request for Nominations for Voting
Members for the Digital Health
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting nominations for voting
members, excluding consumer and
industry representatives, to serve on the
Digital Health Advisory Committee (the
Committee) in the Center for Devices
and Radiological Health. Nominations
will be accepted for current vacancies
effective with this notice. FDA seeks to
include the views of members of all
gender groups, members of all racial and
ethnic groups, and individuals with and
without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Nominations received on or
before December 11, 2023 will be given
first consideration for membership on
the Committee. Nominations received
after December 11, 2023 will be
considered for nomination to the
committee as later vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Committee Membership
Nomination Portal (https://
www.accessdata.fda.gov/scripts/
SUMMARY:
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FACTRSPortal/FACTRS/index.cfm) and
selecting Academician/Practitioner from
the dropdown menu (regardless of
whether Academician/Practitioner
accurately describes the nominee), or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
James Swink, Office of Management,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5211, Silver Spring, MD 20993–
0002, 301–796–6313, James.Swink@
fda.hhs.gov.
FDA is
requesting nominations for voting
members to fill current vacancies on the
Digital Health Advisory Committee.
This notice does not include consumer
and industry representative
nominations. The Agency will publish
two separate notices announcing the
vacancy of a representative of consumer
interests and a vacancy of
representatives of interests of the device
manufacturing industry.
SUPPLEMENTARY INFORMATION:
I. General Description of the Committee
Duties
The Committee provides advice on
complex scientific and technical issues
related to Digital Health Technologies
(DHTs). This also may include advice
on the regulation of DHTs, and/or their
use, including use of DHTs in clinical
trials or postmarket studies subject to
FDA regulation. Topics relating to
DHTs, such as artificial intelligence/
machine learning, augmented reality,
virtual reality, digital therapeutics,
wearables, remote patient monitoring,
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]]>Agencies
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70669-70672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22586]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3768]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adherence Potential and Patient Preference 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 solicits comments on a proposed study entitled ``Adherence
Potential and Patient Preference in Prescription Drug Promotion.''
DATES: Either electronic or written comments on the collection of
information must be submitted by December 11, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 11, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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
[[Page 70670]]
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-2023-N-3768 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Adherence Potential and Patient
Preference 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Adherence Potential and Patient Preference 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 mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotion is truthful, balanced, and accurately communicated so
that patients and healthcare providers can make informed decisions
about treatment options. 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,
focusing 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 the characteristics of the
disease and product 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. 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 topic area,
advertising features.
Because we recognize that 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 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 at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
This study builds on OPDP's portfolio of research on market claims
and disclosures to explore the influence of statements around patient
adherence and preference in prescription drug promotion. Previous FDA-
funded research has shown that market claims that advertise drug
characteristics unrelated to medicinal properties, such as ``#1
Prescribed,'' influence consumer and provider perceptions about a
drug's efficacy (Ref. 1). In the same study, results of a tradeoff
analysis suggested that patients prefer a drug over a
[[Page 70671]]
competitor when this type of claim is present, and a drug without this
claim required at least 1.23 percent greater efficacy to be chosen over
a drug with this claim (Ref. 2). Treatment preferences may also be
influenced by other drug characteristics, including its impact on
quality of life, complexity of dosage regimens, administration mode,
and cost to family and self (Refs. 3-5).
It is not known how claims that appeal to the possibility for
greater adherence or to social norms around what other patients or
healthcare providers prefer influence perceptions of a drug. A related
question is whether including a disclosure stating the uncertainty
around such claims (e.g., there is no conclusive research on whether
DRUG A results in better adherence) can mitigate any misleading
perceptions or influence preferences. Some evidence suggests that
disclosures in prescription drug promotion are typically noticed and
may help consumers and healthcare providers understand information
(Refs. 2 and 6), but this topic has not been investigated in the
context of adherence claims.
The present research is designed to complement previous research by
experimentally examining the role of adherence and patient preference
claims in prescription drug promotion. We have the following specific
questions:
Research questions:
1. Does the presence or absence of an implied-adherence claim
affect consumers' behavioral intentions or risk, benefit, and adherence
perceptions?
2. Does the presence or absence of an adherence-related patient
preference claim affect consumers' behavioral intentions or risk,
benefit, and adherence perceptions?
3. Does the presence of both types of claims (adherence and
preference) have a cumulative impact on consumers' behavioral
intentions or risk, benefit, and adherence perceptions?
4. Does a disclosure of information to the effect that there is no
conclusive research on whether the drug results in better adherence
mitigate consumers' behavioral intentions or risk, benefit, and
adherence perceptions?
To complete this research, we will show participants a website for
a fictitious prescription drug product for type 2 diabetes. We propose
the design in table 1, which varies based on whether the fictitious
prescription drug promotional communication includes a claim about:
implied adherence;
patient preference; and
a disclosure that there is no conclusive research on
adherence.
Table 1--Design 2 (Implied Adherence Claim) x 2 (Patient Preference Claim) x 2 (Disclosure)
--------------------------------------------------------------------------------------------------------------------------------------------------------
With disclosure \1\ Without disclosure
---------------------------------------------------------------------------
Patient preference claim Patient preference claim
---------------------------------------------------------------------------
Yes No Yes No
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implied Adherence Claim........................ Yes.
No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ E.g., ``There is no conclusive research to suggest better adherence to Drug X compared with Drug Y.''
Recruitment will occur by email through an internet panel, and
participant eligibility will be determined with a screener at the
beginning of the online survey. For the pretest, we expect to screen
253 consumers and 294 primary care physicians (PCPs) to reach our
desired number of completed surveys. We will conduct complete pretest
surveys with 160 consumers who self-identify as having been diagnosed
with diabetes and 160 PCPs who treat diabetes (both obtained from a
web-based research vendor) to ensure that the questionnaire programming
works as expected. For the main study, we expect to screen 566
consumers and 660 PCPs to reach our desired number of completed
surveys. Thus, for the main study final sample, we will recruit 360
adult voluntary participants aged 18 years or older who self-identify
as having been diagnosed with diabetes and 360 voluntary participants
who are employed as PCPs who treat diabetes. We will exclude
individuals who work in healthcare settings, employees of the
Department of Health and Human Services, and individuals who work in
the marketing, advertising, or pharmaceutical industries.
The total annual estimated burden imposed by this collection of
information is 520 hours (table 2). These estimates account for over-
recruitment of 10 percent to account for survey incompletes. 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.
Each participant will see one of eight versions of a consumer web
page for a fictitious prescription diabetes treatment, as reflected in
table 1. They will answer a questionnaire designed to take no more than
20 minutes regarding benefit and risk perceptions, adherence
perceptions, behavioral intentions, adherence claim retention, and
patient preference claim retention. The survey is available upon
request at [email protected].
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest:
Consumers: pretest screener completes 253 1 253 0.08 (5 min.)........................... 20
(assumes 70% eligible).
Consumers: number of completes, pretest... 176 1 176 0.33 (20 min.).......................... 58
PCPs: pretest screener completes (assumes 294 1 294 0.08 (5 min.)........................... 24
60% eligible).
PCPs: number of completes, pretest........ 176 1 176 0.33 (20 min.).......................... 58
[[Page 70672]]
Main Study:
Consumers: number of main study screener 566 1 566 0.08 (5 min.)........................... 45
completes (assumes 70% eligible).
Consumers: number of completes, main study 396 1 396 0.33 (20 min.).......................... 131
PCPs: number of main study screener 660 1 660 0.08 (5 min.)........................... 53
completes (assumes 60% eligible).
PCPs: number of completes, main study..... 396 1 396 0.33 (20 min.).......................... 131
---------------------------------------------------------------------------------------------------------
Total (rounded)....................... .............. .............. .............. ........................................ 520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
References
The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Aikin, K.J., K.R. Betts, A. Keisler, and K.S. Ziemer, ``Market
Claims and Efficacy Information in Direct-to-Consumer Prescription
Drug Print Advertisements,'' Psychology & Marketing, 36(8), 747-757,
2019a.
2. Aikin, K.J., K.R. Betts, K.S. Ziemer, and A. Keisler, ``Consumer
Tradeoff of Advertising Claim Versus Efficacy Information in Direct-
to-Consumer Prescription Drug Ads,'' Research in Social and
Administrative Pharmacy, 15(12), 1484-1488, 2019b.
3. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, D. Prefasi, et al.
``Conjoint Analysis To Understand Preferences of Patients With
Multiple Sclerosis for Disease-Modifying Therapy Attributes in
Spain: A Cross-Sectional Observational Study,'' BMJ Open, 7(3),
e014433, 2017.
4. Fraenkel, L., L. Suter, C.E. Cunningham, and G. Hawker,
``Understanding Preferences for Disease-Modifying Drugs in
Osteoarthritis,'' Arthritis Care Research, 66(8), 1186-1192, 2014.
5. Wouters, H., G.A. Maatman, L. Van Dijk, M.L. Bouvy, et al.
``Trade-Off Preferences Regarding Adjuvant Endocrine Therapy Among
Women With Estrogen Receptor-Positive Breast Cancer,'' Annals of
Oncology, 24(9), 2324-2329, 2013.
6. Betts, K.R., V. Boudewyns, K.J. Aikin, C. Squire, et al.
``Serious and Actionable Risks, Plus Disclosure: Investigating an
Alternative Approach for Presenting Risk Information in Prescription
Drug Television Advertisements,'' Research in Social and
Administrative Pharmacy, 14(10), 951-963, 2018.
Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22586 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
