Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion, 84889-84894 [2024-24720]
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Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
necessary information, prepare, and
submit to FDA. We estimate that
sponsors with inactive applications will
spend 2 hours preparing their annual
antimicrobial animal drug sales and
distribution reports, whether
electronically or on paper.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping required by section 512(l)(3) of the FD&C
Act ....................................................................................
23
1
23
2
46
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Animal drug manufacturers are
already required to maintain
distribution records for their animal
drug products to comply with FDA’s
current good manufacturing regulations
for periodic drug reports under
§ 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)),
approved under OMB control number
0910–0284. Section 512(l)(3) of the
FD&C Act differs from § 514.80(b)(4)(i)
in that it requires that records include
separate information for each month of
the calendar year. In addition, under 21
CFR 211.196 (approved under OMB
control number 0910–0139),
manufacturers currently are required to
maintain distribution records that
include dosage form, and date drug is
distributed. Based on these
requirements, FDA believes that
manufacturers already keep detailed
records of the dates when antimicrobial
drugs are distributed for marketing and
recall purposes from which monthly
reports can be prepared as part of usual
and customary business practices.
However, FDA estimates an additional
recordkeeping burden of 46 hours for
further compliance with section
512(l)(3), as detailed in table 2.
After a review of the information
collection since our last request for
OMB approval, we have adjusted our
estimates based on our experience with
the antimicrobial animal drug
distribution reports program. Our
estimated burden for the information
collection reflects a decrease of 54
burden hours and a corresponding
decrease of 27 total annual responses.
We attribute this to respondents who
submitted by paper in previous years
and are now reporting electronically.
Dated: October 18, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24721 Filed 10–23–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3768]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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 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: Submit written comments
(including recommendations) on the
collection of information by November
25, 2024.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is
‘‘Adherence Potential and Patient
Preference in Prescription Drug
Promotion.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUMMARY:
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collection of information to OMB for
review and clearance.
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
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Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
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. The website
includes links to the latest Federal
Register notices and peer-reviewed
publications produced by our office.
The study described in this notice
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
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, 6,
and 8).
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 4),
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.
Research questions:
1. Does the presence or absence of an
implied adherence claim affect
consumers’ and primary care
physicians’ (PCPs’) behavioral
intentions or risk, benefit, and
adherence perceptions?
2. Does the presence or absence of an
adherence-related patient preference
claim affect consumers’ and PCPs’
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’ and
PCPs’ 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’
and PCPs’ behavioral intentions or risk,
benefit, and adherence perceptions?
To complete this research, we propose
the following design for a total of 8
study conditions: 2 (patient preference
claim) × 2 (adherence claim) × 2
(disclosure).
TABLE 1—STUDY DESIGN (IMPLIED ADHERENCE CLAIM) × 2 (PATIENT PREFERENCE CLAIM) × 2 (DISCLOSURE)
With disclosure 1
Without disclosure
Patient preference claim
Patient preference claim
Yes
Implied Adherence Claim
No
Yes
No
Yes.
No.
1 E.g.,
‘‘There is no evidence to suggest better adherence to Drug X compared with Drug Y.’’
We will recruit the following numbers
of participants for the pretest and main
study surveys:
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• 320 individuals for the pretest (n =
160 consumers and n = 160 PCPs);
and
• 720 individuals for the main study (n
= 360 consumers and n = 360 PCPs)
Each participant will see one of eight
versions of a static web page for a
fictitious prescription type 2 diabetes
treatment, as reflected in table 1. They
will answer a survey designed to take no
more than 15 minutes to complete
regarding their perception of the
product’s benefits, risks, and effect on
adherence. Consumers and PCPs will
receive slightly different versions of the
web page and survey, and their data will
be analyzed separately.
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In the Federal Register of October 12,
2023 (88 FR 70669), FDA published a
60-day notice entitled ‘‘Agency
Information Collection Activities;
Proposed Collection; Comment Request;
Adherence Potential and Patient
Preference in Prescription Drug
Promotion,’’ requesting public comment
on the proposed collection of
information. FDA received two
submissions, one of which included
multiple comments. Responses to all
comments follow. For brevity, some
public comments are paraphrased and,
therefore, may not state the exact
language used by the commenter. All
comments were considered even if not
fully captured by our paraphrasing in
this document. The following acronyms
are used here: healthcare professional
(HCP); Food and Drug Administration
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(FDA or Agency); and FDA’s Office of
Prescription Drug Promotion in the
Center for Drug Evaluation and Research
(OPDP).
(Comment 1) One comment supported
the OPDP research program and the
current proposed study, with a question
as to whether research on disclosures
has been previously conducted.
(Response 1) We appreciate this
comment for its support of this research
and our research program. In response
to the query in this comment, OPDP has
conducted studies on the topic of
disclosures in prescription drug
promotion (found at the website listed
previously in this document), but none
that have addressed disclosures specific
to adherence or preference claims.
(Comment 2) One comment inquired
whether the Agency intends to publish
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the results of this study. If so, the
comment inquired whether publication
will be in the form of a publicly
available report or a peer-reviewed
publication.
(Response 2) The exact timing and
nature of any such dissemination has
not been determined but may include
presentations at trade and academic
conferences, publications, articles, and
an internet posting.
(Comment 3) One comment inquired
whether the Agency intends to seek an
approval or exemption from an
Institutional Review Board (IRB) or
ethics committee.
(Response 3) The research will be
reviewed for exemption by the IRB of
record, which will be the FDA
contractor’s (Westat’s) IRB.
(Comment 4) One comment inquired
how the Agency will ensure that the
samples are representative of the
relevant populations, and it asked
whether there will be stratification of
the sample by specific demographic or
clinical characteristics.
(Response 4) The project will recruit
individuals from two populations: adult
consumers diagnosed with type 2
diabetes and PCPs. For each study
segment, internet vendor AllGlobal will
recruit study participants using their
proprietary panels. Several
methodologies are used by AllGlobal to
recruit panelists, including opt-in email,
co-registration, e-newsletter campaigns,
and internal and external affiliate
networks. To recruit consumers,
AllGlobal will use their LifePoints panel
of more than 5.5 million consumers. To
recruit PCPs, AllGlobal will use its
Global Professional Panel, which
includes access to over 2 million
physicians, nurses, and other interested
healthcare parties across a wide range of
therapy areas. AllGlobal uses various
metrics to track panel member activity
and engagement, which enhances the
efficiency of recruitment and quality of
survey data from their panelists.
Participants will be drawn from
convenience samples, rather than
probability-based samples. We will aim
for a diverse mix of participants in
terms of race/ethnicity, gender, age, and
other characteristics, but we will not
specifically stratify the data before
collecting it. Moreover, no weighting of
the data will be required because the
objective of the studies is to estimate the
causal effects of experimental
manipulations rather than to estimate
descriptive statistics for these
populations.
(Comment 5) One comment notes that
Questions 7 and 8 of the questionnaire
ask respondents whether HCPs and
patients prefer FENTIVA. Considering
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these questions, the comment suggests
that the web page include such
statements with appropriate context. For
example, the web page might post
language such as ‘‘more patients prefer
FENTIVA versus [Insert product].’’ In
addition, the comment suggests it would
be appropriate for the web page to also
include a statement referencing the
study from which this information was
derived. For example, the comment
notes that the preference information
presented on the website for RITUXAN
HYCELA (rituximab and hyaluronidase
human) injection includes the following
statement: ‘‘In a study of previously
untreated DLBCL and follicular
lymphoma patients, 77 percent of
patients preferred subcutaneous
administration of RITUXAN HYCELA
over intravenous rituximab as it
required less time in clinic.’’
The comment states that without
seeing the stimulus to which
participants will be asked to respond,
there is uncertainty about the purpose of
these questions. If these questions are
meant to assess participants’
understanding of the information on the
web page, then the comment suggests
that the question ask the participant to
choose the correct statement from a set
of statements in which all but one is
incorrect. The comment further suggests
that if these questions are meant to
assess the impression that a participant
gets from the information presented on
the web page, then responses to these
questions likely cannot be interpreted
directly.
Lastly, the comment recommends that
the Agency clarify the purpose of
Questions 7 and 8 and ensure that the
conclusions that will be drawn by the
responses to these questions can be
supported based on the questions
themselves and the response options
provided to participants.
(Response 5) We appreciate these
comments and offer a few points of
clarification. Questions 3–11 are
intended to assess participants’ recall of
information provided in the stimuli
(website). For example, the statement
‘‘Doctors prefer FENTIVA over other
medications to control blood sugar.’’
Question 7 was not mentioned on the
website and is asked as a foil. These
questions will allow us to determine
whether participants’ read the stimuli
carefully and thus serve as an attention
check.
Participants’ gist comprehension of
the information will be assessed through
a different series of questions using a
True/False format.
We also address the suggestion to
include a statement referencing the
study from which the preference
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information is derived (as is done with
the RITUXAN HYCELA website). A key
aim of our study is to test the effect of
a disclosure statement on perceptions
when no such evidence on adherence
exists (e.g., ‘‘There is no clinical
evidence suggesting better treatment
adherence with once-monthly FENTIVA
injection compared to daily tablets’’).
For this reason, we chose not to provide
clinical information on preference or
adherence in our study stimuli,
although we acknowledge that some
promotions indeed include this
information when available.
(Comment 6) One comment notes that
Question 7 reads, ‘‘Doctors prefer
FENTIVA over other medications to
control blood sugar.’’ The comment
suggests clarifying the wording.
Specifically, the comment suggests that
doctors do not have preferences for
medications. Instead, doctors ‘‘would be
more likely to choose to prescribe one
option over another.’’ In addition,
doctors prescribe medications to
patients with a condition. Therefore, the
comment suggests revising
‘‘medications to control blood sugar’’ to
read, ‘‘for patients who need to control
their blood sugar.’’
(Response 6) We appreciate the
second point and have changed
Question 7 to read: ‘‘Doctors prefer
FENTIVA over other medications for
patients who need to control their blood
sugar.’’ We also refer to our previous
explanation (Response 5) about the
intent of this item, which is to test recall
of information on the website, where the
statement about doctors’ preferences for
FENTIVA was not mentioned on the
website and thus included in this
survey as a foil.
(Comment 7) One comment suggests
that Question 9 is difficult to evaluate
without seeing the materials that will be
presented to participants. Specifically,
the comment notes that if the web page
does not say explicitly that the patient
doesn’t have to think about taking
medication every day, but instead says
that FENTIVA is taken once a month
rather than every day, whether a patient
‘‘no longer has to think about taking
medication’’ could be considered
leading, and interpreting the results of
this question could be problematic.
Therefore, the comment recommends
that the Agency clarify the purpose of
Question 9 and ensure that there is no
ambiguity in how the responses to the
question will be interpreted.
(Response 7) As explained above,
items 3–11 assess recall of information
that may or may not have been
presented on the website. The statement
‘‘With once-monthly FENTIVA
injections, I no longer have to think
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about taking medication every day’’ is
presented on the website. The intent of
the question is to assess whether
participants read and paid attention to
key statements.
(Comment 8) One comment opines
that Questions 10 and 11 are difficult to
interpret without seeing the information
that will be provided to participants.
However, the comment continues, the
pair of questions taken together seem to
indicate that one statement is correct
while the other is not. If the purpose of
the questions is to test recall, then it
would be more appropriate to include
both statements in a single question and
ask respondents which is correct. If the
purpose of the questions is to test the
impression that participants get from
the information presented in the web
page, then there may be no objectively
correct answer to the question that does
not mirror exactly what is stated in the
web page. Therefore, the comment
recommends that the Agency clarify the
purpose of Questions 10 and 11 and
ensure that there is no ambiguity in how
the answers to these questions will be
interpreted.
(Response 8) We refer to our previous
explanation (Response 5) about the
intent of these items. To clarify further,
consumers and PCPs will receive
slightly different versions of the same
disclosure statement on the website.
Thus, only the consumer group will be
asked Question 10 and only the PCP
group will be asked Question 11.
(Comment 9) One comment notes that
Question 14 asks whether it is true or
false that ‘‘FENTIVA is given as a shot
with a needle.’’ The comment states that
this statement could be interpreted that
FENTIVA is administered using a
syringe with an exposed needle. If the
web page states that the medication is
given using an autoinjector, pen, or
another device, it may be technically
true that the medication is given as a
shot with a needle. But it is also
plausible that a reasonable person
would say that this is untrue because
they interpret ‘‘shot with a needle’’ to
describe only a syringe with an exposed
needle. The comment recommends that
the Agency review this question to
ensure that there is no ambiguity in
participant’s interpretation of the
statement or in the Agency’s
interpretation of the results.
(Response 9) We agree with the
concern raised in this comment and
have since revised this item to read:
‘‘FENTIVA is given as an injection
under the skin’’ (True/False) as a
measure of comprehension.
(Comment 10) One comment notes
that Question 15 asks participants to
indicate ‘‘what you know.’’ The
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comment states that because FENTIVA
is a hypothetical product and
participants are responding to a specific
set of information, asking participants
‘‘what you know’’ may be an imprecise
question. Therefore, the comment
recommends that the Agency consider
revising the question to read: ‘‘Please
indicate which of the following
statements best describes what you
understand about FENTIVA based on
the information provided in the web
page.’’
(Response 10) We have revised the
question to read: ‘‘Please indicate which
of the phrases below best completes this
statement about FENTIVA, based on
what you read on the website.’’
(Comment 11) One comment notes
that Question 16 presents two
statements which are suggested to come
from the stimulus material. The
comment notes that both statements
could be considered incomplete because
they mention a specific injection
product (‘‘FENTIVA’’) contrasted with
an unnamed oral medication. The
implication is that the oral tablets are an
alternative to FENTIVA for achieving
the same clinical outcome. However, the
comment notes that this conclusion is
not included in the stimulus material
and recommends that the use of the oral
tablet as an alternative for the same
condition be stated explicitly.
(Response 11) The language presented
in Question 16 refers to the disclosure
statements as they appear on the
stimuli: ‘‘There is no evidence that
patients who choose once-monthly
FENTIVA injections are more likely to
follow their prescribed treatment plan
compared to those who choose daily
tablets’’ (consumer version) or ‘‘There is
no clinical evidence suggesting better
treatment adherence with once-monthly
FENTIVA injection compared to daily
tablets’’ (HCP version). We intentionally
do not state that FENTIVA injection
achieves the same clinical benefit as
oral daily tablets, as we ask later about
participants’ perceptions of comparative
efficacy, based on the information
provided in the stimuli.
(Comment 12) One comment notes
that in Questions 17–19, the questions
related to importance and usefulness
likely require context—important in
what way and/or useful in what way?
The comment suggests that without
clarification, the interpretation of the
responses to these questions would be
subject to ambiguity and recommends
changing ‘‘useful’’ to ‘‘useful in . . .’’
and ‘‘important’’ to ‘‘important for
. . . .’’
(Response 12) These questions are
derived from theory and validated
scales on ‘‘perceived message
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effectiveness.’’ This construct is often
measured as a set of close-ended
judgments such as ‘‘useful/not useful’’
and estimate the degree to which
recipients of that message will favorably
(or unfavorably) evaluate a message.
Identifying why or how the message is
considered useful/relevant could be
assessed with further questions but is
not a focus of this research. Rather, we
are interested in participants’ more
general perceptions of message
effectiveness and will compare
responses across study arms (Ref. 5).
(Comment 13) One comment suggests
that Questions 20–24 include language
that could be considered leading.
Therefore, the comment recommends
changing the questions to capture
whether the participant assessed the
statement to be true or false and
changing the response options to ‘‘true,’’
‘‘false,’’ or ‘‘I don’t know.’’
(Response 13) We have chosen to use
a Likert scale (1 = would not help at all/
5 = would help very much) rather than
a true/false scale for these items as the
intent is to assess the extent to which
participants perceive the drug to be
beneficial/efficacious. We also note that
these items were adapted from validated
scales on perceived benefit and risk
(Ref. 7).
(Comment 14) One comment suggests
that Question 27 includes language that
could be considered leading and
recommends changing the question to
capture whether the participant
assessed the statement to be true or false
and changing the response options to
‘‘true,’’ ‘‘false,’’ or ‘‘I don’t know.’’
(Response 14) See Response 13 and
the referenced citation above. We have
chosen to measure benefit and risk
perception using Likert scales and note
that these measures come from
validated scales.
(Comment 15) One comment suggests
clarifying whether in Questions 29 and
30, ‘‘other daily prescription drugs that
treat type 2 diabetes,’’ includes insulin
or other injectable options or is limited
to oral options only.
(Response 15) These questions are
intended to assess perceptions of the
convenience of FENTIVA compared to
any other type 2 diabetes drug taken
daily.
(Comment 16) One comment suggests
that the language in Question 31 could
be considered leading. The question
asks about likely adherence to a
medication over a long period of time
during which a patient may experience
side effects or lack of efficacy.
Therefore, a likelihood to get injections
every month assumes that a patient does
not have a reason for discontinuing. In
addition, the comment notes that it is
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not clear whether the injections are
prescribed instead of an alternative or in
addition to an alternative. The comment
recommends that the Agency make the
assumptions behind the question
explicit to the participant.
(Response 16) The reasons mentioned
in this comment are the reasons OPDP
found it valuable to conduct this study.
Those are possible reasons that it could
be misleading to suggest that receiving
a monthly injection is easier or results
in greater adherence than a daily pill.
FDA has designed this study to keep our
questions as simple as possible,
consistent with good practices, to
reduce burden on participants. We
specifically keep extraneous factors out
of the questions to glean what we intend
to study. Here, we are interested to
know if behavioral intentions around
adherence vary by experimental arm.
Would information on the website
around patient preference or disclosure
about the lack of evidence on adherence
influence behavioral intentions?
(Comment 17) One comment suggests
that Questions 33–35 likely overstate
the type of evidence that would be used
for this purpose and recommends
rephrasing the question in each case to
read, ‘‘Knowing that more patients
preferred FENTIVA monthly injections
than other daily prescription drugs
. . . .’’
(Response 17) We have removed these
items from the survey.
The total annual estimated burden
imposed by this collection of
information is 1,293 hours (table 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
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survey is closed out. To account for this,
we have estimated approximately 10
percent overage for both participant
samples in the study.
Note that this burden chart differs in
certain respects from the chart
published in the 60-day Federal
Register notice. The previous burden
chart assumed a 70 percent estimated
eligibility for the consumer group; the
current chart has adjusted this estimate
to 5 percent. The previous chart
incorrectly assumed that the vendor
already had eligibility information for
this panel, and we could specifically
target those with this medical condition.
Thus, the larger burden estimate is the
more accurate, as we will need to screen
a larger number of people. We also
adjusted the HCP estimate to reflect
what we believe is a more accurate
projected eligibility of 50 percent.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
PCPs:
Pretest screener completes (assumes 50
percent eligibility rate).
Pretest number of completes .......................
Main study screener completes (assumes
50 percent eligibility rate).
Main study number of completes ................
Consumers:
Pretest screener completes (assumes 5 percent
eligibility rate).
Pretest number of completes .......................
Main study screener completes (assumes 5
percent eligibility rate).
Main study number of completes ................
Total ......................................................
lotter on DSK11XQN23PROD with NOTICES1
1 There
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total
hours
352
1
352
0.08 (5 min.) .................
28
176
792
1
1
176
792
0.25 (15 min.) ...............
0.08 (5 min.) .................
44
63
396
1
396
0.25 (15 min.) ...............
99
3,520
1
3,520
0.08 (5 min.) .................
282
176
7,920
1
1
176
7,920
0.25 (15 min.) ...............
0.08 (5 min.) .................
44
634
396
1
396
0.25 (15 min.) ...............
99
........................
..........................
........................
......................................
1,293
are no capital costs or operating and maintenance costs associated with this collection of information.
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
(2019).
2. Aikin, K.J., K.R. Betts, K.S. Ziemer, and A.
VerDate Sep<11>2014
17:56 Oct 23, 2024
Jkt 265001
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 (2019).
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. 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).
5. Dillard, J.P., K.M. Weber, and R.G. Vail,
‘‘The Relationship Between the
Perceived and Actual Effectiveness of
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Persuasive Messages: A Meta-Analysis
With Implications for Formative
Campaign Research,’’ Journal of
Communication, 57(4), 613–631 (2007).
6. 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).
7. Kelly, B.J., D.J. Rupert, K.J. Aikin, H.W.
Sullivan, et al., ‘‘Development and
Validation of Prescription Drug Risk,
Efficacy, and Benefit Perception
Measures in the Context of Direct-toConsumer Prescription,’’ Research in
Social and Administrative Pharmacy,
17(5), 942–955 (2021).
8. 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).
E:\FR\FM\24OCN1.SGM
24OCN1
84894
Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
Dated: October 18, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24720 Filed 10–23–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4732]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
lotter on DSK11XQN23PROD with NOTICES1
Electronic Submissions
The Food and Drug
Administration (FDA or we) announces
a forthcoming public advisory
committee meeting of the Vaccines and
Related Biological Products Advisory
Committee (the Committee). The general
function of the Committee is to provide
advice and recommendations to FDA on
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discuss Considerations for Respiratory
Syncytial Virus (RSV) Vaccine Safety in
Pediatric Populations and will also hear
overviews of the Laboratory of
Immunoregulation (LI) and Laboratory
of Retroviruses (LR) research programs
in the Center for Biologics Evaluation
and Research. At least one portion of the
meeting will be closed to the public.
FDA is establishing a docket for public
comment on this document.
DATES: The meeting will be held
virtually on December 12, 2024, from
8:30 a.m. to 5:30 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
The online web conference meeting
will be available at the following link on
the day of the meeting: https://
youtube.com/live/f0bNPpqAy-M.
Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
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AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–4732.
The docket will close on December 11,
2024. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
SUMMARY:
VerDate Sep<11>2014
17:56 Oct 23, 2024
Jkt 265001
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 11, 2024.
Comments received by mail/hand
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Comments received on or before
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the Committee. Comments received after
that date will be taken into
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applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
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Submit electronic comments in the
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Submit written/paper submissions as
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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.’’
PO 00000
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Fmt 4703
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Instructions: All submissions received
must include the Docket No. FDA–
2024–N–4732 for ‘‘Vaccines and Related
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• Confidential Submissions—To
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E:\FR\FM\24OCN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 206 (Thursday, October 24, 2024)]
[Notices]
[Pages 84889-84894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24720]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3768]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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: Submit written comments (including recommendations) on the
collection of information by November 25, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Adherence Potential and Patient Preference
in Prescription Drug Promotion.'' Also include the FDA docket number
found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
[[Page 84890]]
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. The website includes
links to the latest Federal Register notices and peer-reviewed
publications produced by our office.
The study described in this notice 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
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, 6, and 8).
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 4), 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.
Research questions:
1. Does the presence or absence of an implied adherence claim
affect consumers' and primary care physicians' (PCPs') behavioral
intentions or risk, benefit, and adherence perceptions?
2. Does the presence or absence of an adherence-related patient
preference claim affect consumers' and PCPs' 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' and PCPs' 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' and PCPs' behavioral intentions or risk, benefit,
and adherence perceptions?
To complete this research, we propose the following design for a
total of 8 study conditions: 2 (patient preference claim) x 2
(adherence claim) x 2 (disclosure).
Table 1--Study Design (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 evidence to suggest better adherence to Drug X compared with Drug Y.''
We will recruit the following numbers of participants for the
pretest and main study surveys:
320 individuals for the pretest (n = 160 consumers and n = 160
PCPs); and
720 individuals for the main study (n = 360 consumers and n =
360 PCPs)
Each participant will see one of eight versions of a static web
page for a fictitious prescription type 2 diabetes treatment, as
reflected in table 1. They will answer a survey designed to take no
more than 15 minutes to complete regarding their perception of the
product's benefits, risks, and effect on adherence. Consumers and PCPs
will receive slightly different versions of the web page and survey,
and their data will be analyzed separately.
In the Federal Register of October 12, 2023 (88 FR 70669), FDA
published a 60-day notice entitled ``Agency Information Collection
Activities; Proposed Collection; Comment Request; Adherence Potential
and Patient Preference in Prescription Drug Promotion,'' requesting
public comment on the proposed collection of information. FDA received
two submissions, one of which included multiple comments. Responses to
all comments follow. For brevity, some public comments are paraphrased
and, therefore, may not state the exact language used by the commenter.
All comments were considered even if not fully captured by our
paraphrasing in this document. The following acronyms are used here:
healthcare professional (HCP); Food and Drug Administration (FDA or
Agency); and FDA's Office of Prescription Drug Promotion in the Center
for Drug Evaluation and Research (OPDP).
(Comment 1) One comment supported the OPDP research program and the
current proposed study, with a question as to whether research on
disclosures has been previously conducted.
(Response 1) We appreciate this comment for its support of this
research and our research program. In response to the query in this
comment, OPDP has conducted studies on the topic of disclosures in
prescription drug promotion (found at the website listed previously in
this document), but none that have addressed disclosures specific to
adherence or preference claims.
(Comment 2) One comment inquired whether the Agency intends to
publish
[[Page 84891]]
the results of this study. If so, the comment inquired whether
publication will be in the form of a publicly available report or a
peer-reviewed publication.
(Response 2) The exact timing and nature of any such dissemination
has not been determined but may include presentations at trade and
academic conferences, publications, articles, and an internet posting.
(Comment 3) One comment inquired whether the Agency intends to seek
an approval or exemption from an Institutional Review Board (IRB) or
ethics committee.
(Response 3) The research will be reviewed for exemption by the IRB
of record, which will be the FDA contractor's (Westat's) IRB.
(Comment 4) One comment inquired how the Agency will ensure that
the samples are representative of the relevant populations, and it
asked whether there will be stratification of the sample by specific
demographic or clinical characteristics.
(Response 4) The project will recruit individuals from two
populations: adult consumers diagnosed with type 2 diabetes and PCPs.
For each study segment, internet vendor AllGlobal will recruit study
participants using their proprietary panels. Several methodologies are
used by AllGlobal to recruit panelists, including opt-in email, co-
registration, e-newsletter campaigns, and internal and external
affiliate networks. To recruit consumers, AllGlobal will use their
LifePoints panel of more than 5.5 million consumers. To recruit PCPs,
AllGlobal will use its Global Professional Panel, which includes access
to over 2 million physicians, nurses, and other interested healthcare
parties across a wide range of therapy areas. AllGlobal uses various
metrics to track panel member activity and engagement, which enhances
the efficiency of recruitment and quality of survey data from their
panelists.
Participants will be drawn from convenience samples, rather than
probability-based samples. We will aim for a diverse mix of
participants in terms of race/ethnicity, gender, age, and other
characteristics, but we will not specifically stratify the data before
collecting it. Moreover, no weighting of the data will be required
because the objective of the studies is to estimate the causal effects
of experimental manipulations rather than to estimate descriptive
statistics for these populations.
(Comment 5) One comment notes that Questions 7 and 8 of the
questionnaire ask respondents whether HCPs and patients prefer FENTIVA.
Considering these questions, the comment suggests that the web page
include such statements with appropriate context. For example, the web
page might post language such as ``more patients prefer FENTIVA versus
[Insert product].'' In addition, the comment suggests it would be
appropriate for the web page to also include a statement referencing
the study from which this information was derived. For example, the
comment notes that the preference information presented on the website
for RITUXAN HYCELA (rituximab and hyaluronidase human) injection
includes the following statement: ``In a study of previously untreated
DLBCL and follicular lymphoma patients, 77 percent of patients
preferred subcutaneous administration of RITUXAN HYCELA over
intravenous rituximab as it required less time in clinic.''
The comment states that without seeing the stimulus to which
participants will be asked to respond, there is uncertainty about the
purpose of these questions. If these questions are meant to assess
participants' understanding of the information on the web page, then
the comment suggests that the question ask the participant to choose
the correct statement from a set of statements in which all but one is
incorrect. The comment further suggests that if these questions are
meant to assess the impression that a participant gets from the
information presented on the web page, then responses to these
questions likely cannot be interpreted directly.
Lastly, the comment recommends that the Agency clarify the purpose
of Questions 7 and 8 and ensure that the conclusions that will be drawn
by the responses to these questions can be supported based on the
questions themselves and the response options provided to participants.
(Response 5) We appreciate these comments and offer a few points of
clarification. Questions 3-11 are intended to assess participants'
recall of information provided in the stimuli (website). For example,
the statement ``Doctors prefer FENTIVA over other medications to
control blood sugar.'' Question 7 was not mentioned on the website and
is asked as a foil. These questions will allow us to determine whether
participants' read the stimuli carefully and thus serve as an attention
check.
Participants' gist comprehension of the information will be
assessed through a different series of questions using a True/False
format.
We also address the suggestion to include a statement referencing
the study from which the preference information is derived (as is done
with the RITUXAN HYCELA website). A key aim of our study is to test the
effect of a disclosure statement on perceptions when no such evidence
on adherence exists (e.g., ``There is no clinical evidence suggesting
better treatment adherence with once-monthly FENTIVA injection compared
to daily tablets''). For this reason, we chose not to provide clinical
information on preference or adherence in our study stimuli, although
we acknowledge that some promotions indeed include this information
when available.
(Comment 6) One comment notes that Question 7 reads, ``Doctors
prefer FENTIVA over other medications to control blood sugar.'' The
comment suggests clarifying the wording. Specifically, the comment
suggests that doctors do not have preferences for medications. Instead,
doctors ``would be more likely to choose to prescribe one option over
another.'' In addition, doctors prescribe medications to patients with
a condition. Therefore, the comment suggests revising ``medications to
control blood sugar'' to read, ``for patients who need to control their
blood sugar.''
(Response 6) We appreciate the second point and have changed
Question 7 to read: ``Doctors prefer FENTIVA over other medications for
patients who need to control their blood sugar.'' We also refer to our
previous explanation (Response 5) about the intent of this item, which
is to test recall of information on the website, where the statement
about doctors' preferences for FENTIVA was not mentioned on the website
and thus included in this survey as a foil.
(Comment 7) One comment suggests that Question 9 is difficult to
evaluate without seeing the materials that will be presented to
participants. Specifically, the comment notes that if the web page does
not say explicitly that the patient doesn't have to think about taking
medication every day, but instead says that FENTIVA is taken once a
month rather than every day, whether a patient ``no longer has to think
about taking medication'' could be considered leading, and interpreting
the results of this question could be problematic. Therefore, the
comment recommends that the Agency clarify the purpose of Question 9
and ensure that there is no ambiguity in how the responses to the
question will be interpreted.
(Response 7) As explained above, items 3-11 assess recall of
information that may or may not have been presented on the website. The
statement ``With once-monthly FENTIVA injections, I no longer have to
think
[[Page 84892]]
about taking medication every day'' is presented on the website. The
intent of the question is to assess whether participants read and paid
attention to key statements.
(Comment 8) One comment opines that Questions 10 and 11 are
difficult to interpret without seeing the information that will be
provided to participants. However, the comment continues, the pair of
questions taken together seem to indicate that one statement is correct
while the other is not. If the purpose of the questions is to test
recall, then it would be more appropriate to include both statements in
a single question and ask respondents which is correct. If the purpose
of the questions is to test the impression that participants get from
the information presented in the web page, then there may be no
objectively correct answer to the question that does not mirror exactly
what is stated in the web page. Therefore, the comment recommends that
the Agency clarify the purpose of Questions 10 and 11 and ensure that
there is no ambiguity in how the answers to these questions will be
interpreted.
(Response 8) We refer to our previous explanation (Response 5)
about the intent of these items. To clarify further, consumers and PCPs
will receive slightly different versions of the same disclosure
statement on the website. Thus, only the consumer group will be asked
Question 10 and only the PCP group will be asked Question 11.
(Comment 9) One comment notes that Question 14 asks whether it is
true or false that ``FENTIVA is given as a shot with a needle.'' The
comment states that this statement could be interpreted that FENTIVA is
administered using a syringe with an exposed needle. If the web page
states that the medication is given using an autoinjector, pen, or
another device, it may be technically true that the medication is given
as a shot with a needle. But it is also plausible that a reasonable
person would say that this is untrue because they interpret ``shot with
a needle'' to describe only a syringe with an exposed needle. The
comment recommends that the Agency review this question to ensure that
there is no ambiguity in participant's interpretation of the statement
or in the Agency's interpretation of the results.
(Response 9) We agree with the concern raised in this comment and
have since revised this item to read: ``FENTIVA is given as an
injection under the skin'' (True/False) as a measure of comprehension.
(Comment 10) One comment notes that Question 15 asks participants
to indicate ``what you know.'' The comment states that because FENTIVA
is a hypothetical product and participants are responding to a specific
set of information, asking participants ``what you know'' may be an
imprecise question. Therefore, the comment recommends that the Agency
consider revising the question to read: ``Please indicate which of the
following statements best describes what you understand about FENTIVA
based on the information provided in the web page.''
(Response 10) We have revised the question to read: ``Please
indicate which of the phrases below best completes this statement about
FENTIVA, based on what you read on the website.''
(Comment 11) One comment notes that Question 16 presents two
statements which are suggested to come from the stimulus material. The
comment notes that both statements could be considered incomplete
because they mention a specific injection product (``FENTIVA'')
contrasted with an unnamed oral medication. The implication is that the
oral tablets are an alternative to FENTIVA for achieving the same
clinical outcome. However, the comment notes that this conclusion is
not included in the stimulus material and recommends that the use of
the oral tablet as an alternative for the same condition be stated
explicitly.
(Response 11) The language presented in Question 16 refers to the
disclosure statements as they appear on the stimuli: ``There is no
evidence that patients who choose once-monthly FENTIVA injections are
more likely to follow their prescribed treatment plan compared to those
who choose daily tablets'' (consumer version) or ``There is no clinical
evidence suggesting better treatment adherence with once-monthly
FENTIVA injection compared to daily tablets'' (HCP version). We
intentionally do not state that FENTIVA injection achieves the same
clinical benefit as oral daily tablets, as we ask later about
participants' perceptions of comparative efficacy, based on the
information provided in the stimuli.
(Comment 12) One comment notes that in Questions 17-19, the
questions related to importance and usefulness likely require context--
important in what way and/or useful in what way? The comment suggests
that without clarification, the interpretation of the responses to
these questions would be subject to ambiguity and recommends changing
``useful'' to ``useful in . . .'' and ``important'' to ``important for
. . . .''
(Response 12) These questions are derived from theory and validated
scales on ``perceived message effectiveness.'' This construct is often
measured as a set of close-ended judgments such as ``useful/not
useful'' and estimate the degree to which recipients of that message
will favorably (or unfavorably) evaluate a message. Identifying why or
how the message is considered useful/relevant could be assessed with
further questions but is not a focus of this research. Rather, we are
interested in participants' more general perceptions of message
effectiveness and will compare responses across study arms (Ref. 5).
(Comment 13) One comment suggests that Questions 20-24 include
language that could be considered leading. Therefore, the comment
recommends changing the questions to capture whether the participant
assessed the statement to be true or false and changing the response
options to ``true,'' ``false,'' or ``I don't know.''
(Response 13) We have chosen to use a Likert scale (1 = would not
help at all/5 = would help very much) rather than a true/false scale
for these items as the intent is to assess the extent to which
participants perceive the drug to be beneficial/efficacious. We also
note that these items were adapted from validated scales on perceived
benefit and risk (Ref. 7).
(Comment 14) One comment suggests that Question 27 includes
language that could be considered leading and recommends changing the
question to capture whether the participant assessed the statement to
be true or false and changing the response options to ``true,''
``false,'' or ``I don't know.''
(Response 14) See Response 13 and the referenced citation above. We
have chosen to measure benefit and risk perception using Likert scales
and note that these measures come from validated scales.
(Comment 15) One comment suggests clarifying whether in Questions
29 and 30, ``other daily prescription drugs that treat type 2
diabetes,'' includes insulin or other injectable options or is limited
to oral options only.
(Response 15) These questions are intended to assess perceptions of
the convenience of FENTIVA compared to any other type 2 diabetes drug
taken daily.
(Comment 16) One comment suggests that the language in Question 31
could be considered leading. The question asks about likely adherence
to a medication over a long period of time during which a patient may
experience side effects or lack of efficacy. Therefore, a likelihood to
get injections every month assumes that a patient does not have a
reason for discontinuing. In addition, the comment notes that it is
[[Page 84893]]
not clear whether the injections are prescribed instead of an
alternative or in addition to an alternative. The comment recommends
that the Agency make the assumptions behind the question explicit to
the participant.
(Response 16) The reasons mentioned in this comment are the reasons
OPDP found it valuable to conduct this study. Those are possible
reasons that it could be misleading to suggest that receiving a monthly
injection is easier or results in greater adherence than a daily pill.
FDA has designed this study to keep our questions as simple as
possible, consistent with good practices, to reduce burden on
participants. We specifically keep extraneous factors out of the
questions to glean what we intend to study. Here, we are interested to
know if behavioral intentions around adherence vary by experimental
arm. Would information on the website around patient preference or
disclosure about the lack of evidence on adherence influence behavioral
intentions?
(Comment 17) One comment suggests that Questions 33-35 likely
overstate the type of evidence that would be used for this purpose and
recommends rephrasing the question in each case to read, ``Knowing that
more patients preferred FENTIVA monthly injections than other daily
prescription drugs . . . .''
(Response 17) We have removed these items from the survey.
The total annual estimated burden imposed by this collection of
information is 1,293 hours (table 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 participant samples in the study.
Note that this burden chart differs in certain respects from the
chart published in the 60-day Federal Register notice. The previous
burden chart assumed a 70 percent estimated eligibility for the
consumer group; the current chart has adjusted this estimate to 5
percent. The previous chart incorrectly assumed that the vendor already
had eligibility information for this panel, and we could specifically
target those with this medical condition. Thus, the larger burden
estimate is the more accurate, as we will need to screen a larger
number of people. We also adjusted the HCP estimate to reflect what we
believe is a more accurate projected eligibility of 50 percent.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
PCPs:
Pretest screener 352 1 352 0.08 (5 min.)... 28
completes (assumes 50
percent eligibility
rate).
Pretest number of 176 1 176 0.25 (15 min.).. 44
completes.
Main study screener 792 1 792 0.08 (5 min.)... 63
completes (assumes 50
percent eligibility
rate).
Main study number of 396 1 396 0.25 (15 min.).. 99
completes.
Consumers:
Pretest screener completes 3,520 1 3,520 0.08 (5 min.)... 282
(assumes 5 percent
eligibility rate).
Pretest number of 176 1 176 0.25 (15 min.).. 44
completes.
Main study screener 7,920 1 7,920 0.08 (5 min.)... 634
completes (assumes 5
percent eligibility
rate).
Main study number of 396 1 396 0.25 (15 min.).. 99
completes.
----------------------------------------------------------------------------------
Total................ .............. ............... .............. ................ 1,293
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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
(2019).
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 (2019).
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. 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).
5. Dillard, J.P., K.M. Weber, and R.G. Vail, ``The Relationship
Between the Perceived and Actual Effectiveness of Persuasive
Messages: A Meta-Analysis With Implications for Formative Campaign
Research,'' Journal of Communication, 57(4), 613-631 (2007).
6. 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).
7. Kelly, B.J., D.J. Rupert, K.J. Aikin, H.W. Sullivan, et al.,
``Development and Validation of Prescription Drug Risk, Efficacy,
and Benefit Perception Measures in the Context of Direct-to-Consumer
Prescription,'' Research in Social and Administrative Pharmacy,
17(5), 942-955 (2021).
8. 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).
[[Page 84894]]
Dated: October 18, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24720 Filed 10-23-24; 8:45 am]
BILLING CODE 4164-01-P
