[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]


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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 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, 
<a href="/cdn-cgi/l/email-protection#5e0e0c1f0d2a3f38381e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="f8a8aab9ab8c999e9eb89e9c99d690908bd69f978e">[email 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 
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:

<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 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


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