Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion

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Published

October 24, 2024

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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.

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[Federal Register Volume 89, Number 206 (Thursday, October 24, 2024)]
[Notices]
[Pages 84889-84894]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24720]

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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.

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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#5e0e0c1f0d2a3f38381e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="f8a8aab9ab8c999e9eb89e9c99d690908bd69f978e">[email&#160;protected]</span></a>.

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
<a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research</a>. 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:

<bullet> 320 individuals for the pretest (n = 160 consumers and n = 160
PCPs); and
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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

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