Notice2022-22301
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Text Analysis of Proprietary Drug Name Interpretations
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Published
October 14, 2022
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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<title>Federal Register, Volume 87 Issue 198 (Friday, October 14, 2022)</title>
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[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62426-62429]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22301]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1026]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Text Analysis of
Proprietary Drug Name Interpretations
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 14, 2022.
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 ``Text Analysis of Proprietary Drug Name
Interpretations.'' 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#a7f7f5e6f4d3c6c1c1e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="702022312304111616301614115e1818035e171f06">[email protected]</span></a>.
For copies of the questionnaire: Office of Prescription Drug
Promotion (OPDP) Research Team, <a href="/cdn-cgi/l/email-protection#703424330215031511021318301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="d2968691a0b7a1b7b3a0b1ba92b4b6b3fcbabaa1fcb5bda4">[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.
Text Analysis of Proprietary Drug Name Interpretations
OMB Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: advertising features, including
content and format; target populations; and research quality. Through
the evaluation of advertising features, we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform all three topic areas.
Because we recognize the strength of data and the confidence in the
robust nature of the findings are improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our home page,
which can be found at <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.
As part of the prescription drug regulatory review process,
sponsors propose proprietary names for their products. These names
undergo a proprietary name review that involves the Office of
Surveillance and Epidemiology, the relevant medical office, and OPDP.
OPDP reviews names to assess for alignment with the FD&C Act, which
provides, among other things, that labeling can misbrand a product if
false or misleading representations are made (see 21 U.S.C. 321(n) and
352(a)). A proprietary name that appears in labeling could result in
such misbranding if it is false or misleading. OPDP reviews, among
other things, whether names: (1) overstate the efficacy or safety of
the drug, (2) suggest drug indications that are not accurate, (3)
suggest superiority without substantiation, or (4) are of a fanciful
nature that misleadingly implies unique effectiveness or composition.
It would be helpful in OPDP's review of promotional implications of
proprietary names for data on consumer and prescriber interpretations
of proposed proprietary names to be more readily available for
consideration. The proposed research will use text analysis (e.g.,
topic modeling and sentiment analysis) to learn how consumer and
primary care physician (PCP) populations interpret prescription drug
names, which will assist OPDP's consideration of promotional
implications.
This proposed research builds upon and extends OPDP's research
entitled ``Empirical Study of Promotional Implications of Proprietary
Prescription Drug Names'' (86 FR 14440; March 16, 2021). That research
involves an experimental design intended to assess names that
potentially overstate the efficacy of a product. In contrast, the
proposed research involves a survey design that comprises primarily
open-ended questions intended to generate text for analysis, an
approach that is unrestricted in its ability to assess text with
different types of promotional implications (e.g., minimization of risk
and unsubstantiated claims of superiority, in addition to overstatement
of efficacy). The proposed research will add to the depth and breadth
of knowledge we can draw from during the review of proposed proprietary
drug names.
The key objectives of the proposed research are as follows:
1. To apply new techniques such as topic modeling and sentiment
analysis (forms of text analysis) to answer OPDP's research questions
about
[[Page 62427]]
consumer and PCP interpretations of proprietary prescription drug
names.
2. To help develop a methodological approach for assessing consumer
and prescriber interpretations of drug names, which can potentially be
used in the future as a standard assessment tool.
Our methodological approach will involve nationally representative
samples. Consumers will be recruited from Ipsos Public Affairs
KNOWLEDGEPANEL. PCPs will be recruited using a two-stage approach that
will begin with a purchased list of PCPs based on the American Medical
Association Physician Masterfile. These members will then be matched to
one or more sample provider lists to recruit PCP participants for this
study. We propose a sample of 300 consumers and 300 PCPs for the main
study. We have designed a within-subjects experiment in which
participants will be exposed to multiple drug names to maximize power
to find differences with this sample size. The stimuli will comprise 60
experimental names and 60 control names. Participants will be
randomized to 1 of 10 groups so that no one responds to more than 12
names in total. Each participant will see six experimental names and
six control names. The experimental names will be names with suspected
promotional implications, whereas the control names will not have
suspected promotional implications. Names will be viewed in random
order. Participants will respond in open-ended text boxes about their
perceptions of each drug name. Supplementary closed-ended questions may
also be presented. We will conduct text analysis of the responses and
present descriptive results for individual drug names by participant
cohort (i.e., consumers versus PCPs), and we will also code and compare
responses across types of drug names.
In the Federal Register of November 1, 2021 (86 FR 60254), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments that were
Paperwork Reduction Act (PRA) related. Within those submissions, FDA
received multiple comments that the Agency has addressed. 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 they were not fully captured by our paraphrasing in this document.
Comments and responses are numbered here for organizational purposes
only.
(Comment 1) One comment contended that FDA should revise the
questionnaire to capture real-world conditions more closely in which
PCPs and consumers form impressions of proprietary names. The comment
suggested that while FDA stated that ``[t]he experimental names will be
names with suspected promotional implications'' in the Federal Register
notice, the Agency does not approve proprietary names with ``suspected
promotional implications.'' The comment also stated that FDA's proposed
approach would not mimic the real-world conditions in which mention of
a drug's indication triggers a requirement to provide safety
information as well. The comment suggested that either FDA could
consider providing only the drug name in a way that is similar to the
information provided in reminder advertising, or it could provide a
balanced presentation as required under the relevant regulations.
(Response 1) As previously described, sponsors propose proprietary
names for their products, including those with promotional
implications, as part of the prescription drug regulatory review
process. One purpose of this study is to investigate methodological
options for collecting insights from consumers and providers during the
review process that might help FDA make determinations about whether
drug names have promotional implications that misbrand a product. As
for real-world conditions, our initial focus is on establishing
correlation or causation in a more controlled setting--such as a
randomized controlled trial or the type of rigorous experimental study
we have planned.
(Comment 2) One comment suggested that FDA does not state how the
information obtained from the specified study will be useful or how it
will be used to inform name reviews. The comment then asserted that the
link between this information and the implementation of FDA's
misbranding authorities and proprietary name review, and thus the
practical utility of the survey, is unclear.
(Response 2) FDA's review of proprietary names is conducted to help
ensure that proposed proprietary names do not contribute to misbranding
a drug or to other violation(s) of the FD&C Act and Agency regulations,
particularly when that proprietary name appears in labeling. (See,
e.g., 21 U.S.C. 321(n) and 352(a).) We conduct our review of
proprietary names in accordance with applicable legal authorities.
The existing study is a first step in exploring the utility of text
analysis for collection of data on proprietary prescription drug names.
Determining how names are processed and understood by consumers and
healthcare providers (HCPs) is important information to be considered
in the review of proposed prescription drug names. This program of
research is being conducted to increase the body of evidence upon which
experts can rely when assessing proposed proprietary names.
(Comment 3) One comment stated that FDA should revise question 1.
The comment advised that the instructions should make clear that the
respondent can write ``no impression'' if the name does not, in the
respondent's view, communicate any information related to the
particular attribute of the drug. In addition, the comment stated that
the last question, asking respondents to write a brief narrative, is
confusing and unnecessary and that the objective and practical utility
of this exercise are unclear.
(Response 3) It was clear in our cognitive interviews that if
respondents had no impression based on a drug name, they would be
likely to type ``nothing'' or ``no impression'' as their response. The
purpose of the last exercise is to examine the utility of an implicit
measure of attitudes for comparison with the more explicit measures. If
this measure proves to be unproductive in pre-testing, we may omit it
from the main study. For instance, this implicit measure might be
considered unproductive if it does not prompt any additional, unique
text relative to what is offered in response to the earlier open-ended
items.
(Comment 4) Two comments similarly claimed that questions two
through six are leading, potentially confusing, duplicative of another
question, or otherwise unnecessary. One comment recommended removing
these questions.
(Response 4) These questions have been included as a way of
validating the information recorded in question one. Based on other
comments, such as one that challenged the use of yes/no questions, we
have revised them to a 5-point Likert scale, ranging from strongly
disagree to strongly agree. We will assess these questions further as
part of pre-testing.
(Comment 5) One comment stated that FDA should limit patient and
PCP participation to those who have experience with the fictitious drug
indications. It further asserted that FDA should provide detail on how
the patients and PCPs will be selected and how FDA will help ensure
these participants have relevant experience. The comment suggested that
FDA could add an open-ended question requesting that PCPs provide
information about
[[Page 62428]]
their experiences in the disease areas for which the fictitious drugs
are intended, patient populations, and settings to understand the real-
world value of the responses.
(Response 5) Due to the large number of drug names and indications
to be included in this study, the comment's suggestion is not feasible.
However, we will add a measure to the screener to assess PCPs' and
consumers' experiences with each of the indications. This variable can
then be used as a covariate in analyses.
(Comment 6) One comment suggested that to ensure that the survey
isolates the impressions given by the proprietary name, FDA should use
only fictitious names for the survey.
(Response 6) We have removed all real drug names from the study and
replaced them with fictitious names.
(Comment 7) One comment recommended removing all yes/no questions
from the survey.
(Response 7) We have done so, changing the yes/no items to Likert
scale items.
(Comment 8) One comment recommended that FDA should acknowledge
that proposed names may include ``permissible suggestions'' and should
include such fictitious examples. The comment conjectured that the
survey appears to focus only on potential impermissible suggestions
that may result from a drug's proprietary name. The comment submitted
that proposed names should also be included that, for example, suggest
the dosage form, frequency of delivery, structure of the drug, or
general category of the drug's indications.
(Response 8) A previous study by this research team did include
names such as those suggested above (e.g., with the drug's indication
embedded in the name). Those names are not included here to avoid
duplication.
(Comment 9) One comment stated that FDA should explain its
methodology for the text analysis and allow for stakeholder feedback on
the proposed text analysis methodology.
(Response 9) We will examine and present descriptive results for
individual names. However, given our goals of understanding promotional
implications of prescription drug names across consumers and PCPs, we
are also interested in whether there are differences in topic
distributions across our treatment and control arms (control versus
promotional implications) and between populations (consumers and PCPs).
We will use topic modeling and sentiment analysis to answer those
questions. We have described the purpose of the study, the design, and
the population of interest, and we have provided the questionnaire to
numerous individuals upon request.
(Comment 10) One comment expressed concerns about how degrees or
levels of misbranding may be established or standardized for evaluating
proposed proprietary prescription drug names. It stated that no
information has yet been provided by FDA to inform how such
standardization will be developed.
(Response 10) This study is not intended either to establish
degrees or levels of misbranding or to standardize levels of
misbranding for the evaluation of proposed drug names. The key
objectives of the proposed research are to apply new techniques such as
topic modeling and sentiment analysis to answer OPDP's research
questions about consumer and PCP interpretations of proprietary
prescription drug names and to help develop a methodological approach
for assessing consumer and prescriber interpretations of drug names.
(Comment 11) A comment objected that FDA has not provided any
information on how it will select target names to include in the pre-
test and subsequently decide which target names will be used in the
main study. The comment expressed concerns that the pre-test will not
be able to develop multiple distinct levels of efficacy or indication
implication among target names that will be reliably identifiable by
HCPs or consumers. The comment asserted that a proprietary name may not
be reliably classified and separated into multiple levels of
implication.
(Response 11) Our full stimuli are under development during the PRA
process. We do not make draft stimuli public during this time because
of concerns that this may contaminate our participant pool and
compromise our research. In our research proposals, we describe the
purpose of the study, the design, the population of interest, and the
estimated burden.
Names will be intentionally developed to have promotional
implications (e.g., overstatement of efficacy). Many of the names were
used in our cognitive interviews. In addition, we will conduct up to
two pre-tests, at which point, if any names are not distinguishable
from those composed of random syllables, they will be replaced. A
similar process was used in another recent study, with reliable
results. Participants did distinguish between names created from random
syllables and those with promotional implications.
(Comment 12) One comment advised that the pronunciation offered to
a respondent would influence a respondent's impressions and that it
would be important for FDA to control for this influence. The comment
opined that the pronunciation should result in as neutral a reading as
possible, not emphasizing any particular aspect of a name.
(Response 12) All drug names were recorded by the same voiceover
specialist in as neutral a manner as possible.
(Comment 13) A comment similarly asserted that the impression
formed from a visual cue (drug name written out) would influence and be
influenced by an audio cue and vice versa. The comment contended that
there would be less bias introduced by listening first to an audio cue.
The comment also recommended that an audio cue first be provided,
followed by the question about hearing the name, and that the visual
image of the name would be presented followed by the question about
seeing the name.
(Response 13) We agree that people access both the orthographic and
phonological interpretations when they read. However, since our main
comparison is within subjects, it is likely that there is some
consistency in the order in which any one respondent listens to the
pronunciation versus reading the word, and so any variation that may
exist should not confound the effects of their own interpretation of
the drug names. In addition, the comment's suggestion would double the
number of open-ended questions for every drug name, increasing the
survey burden substantially.
(Comment 14) One comment suggested altering the order of the
prompts so that after gaining impressions following the audio and
visual cues, the brief story or narrative prompt follows.
(Response 14) The currently proposed questionnaire follows this
order.
(Comment 15) One comment argued that prompts should not be
``double-barreled'' and should not lead or prime the respondent to find
benefits or other meanings where there may be none. The comment
suggested that questions should ask separately about benefits and how
well the drug would work and then also ask separately about risks and
side effects. The comment suggested rephrasing to ``Does the drug name
suggest the drug may have a benefit?'' or ``Does the drug name make you
think about how well it might work?''.
(Response 15) We have edited the open-ended section of the study so
that these questions are no longer separate items but merely
instructions preceding the first question. The phrasing the
[[Page 62429]]
comment suggested is likely to lead to one-word answers ``yes'' or
``no,'' which does not provide the type of text response that is needed
to conduct text analysis on the data. We did find in cognitive
interviews that participants who did not perceive any meaning from a
specific drug name said they would be likely to type ``nothing'' into
the open-ended text box. Thus, we believe the study in its current form
does allow for this possibility.
(Comment 16) One comment suggested very general questions should be
asked first and then those that are more specific.
(Response 16) We have ordered the prompts from general to specific
in line with the suggested comment.
(Comment 17) One comment proposed that researchers may want to
consider reducing the number of drugs queried in the survey from 12 to
6 to elicit the richest text data from respondents and that it may be
helpful to give a minimum word count for text responses.
(Response 17) Six drugs will not allow for enough power to make
comparisons between the groups. However, if we find that we get many
breakoffs (participants who begin the survey but do not complete it) in
the pre-test (suggesting the survey burden is too high), we will
reconsider the study design.
(Comment 18) One comment recommended that an iterative plan for
analysis be developed such that there are checks for both internal and
external validity at specified intervals. It further proposed that
researchers may want to consider a context-specific analysis plan and
argued that one common analysis approach or dictionary may not measure
risk, side effects, and other constructs accurately across all drugs.
(Response 18) Though the topic modeling approach is designed to be
exploratory for this study, we will calculate coherence metrics to
assess model fit as well as perform validation exercises to assess if
the generated topics can be easily interpreted.
(Comment 19) One comment recommended that an iterative plan for
analysis be created based on a set of preliminary data along with the
other research materials, such as the questionnaire, sampling plan,
etc., so that it can be reviewed before execution of the full research.
(Response 19) We appreciate the comment. The pre-test will provide
the valuable insight to create a specific analysis plan for the main
study. The pilot data will help us assess assumptions about how
respondents will respond to target names.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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General Consumer Population
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Pretest 1 screener (assumes 80% eligible).... 22 1 22 0.08 (5 minutes)......................... 1.8
Pretest 1 survey............................. 17 1 17 0.33 (20 minutes)........................ 5.6
Pretest 2 screener (assumes 80% eligible).... 22 1 22 0.08 (5 minutes)......................... 1.8
Pretest 2 survey............................. 17 1 17 0.33 (20 minutes)........................ 5.6
Main study screener (assumes 80% eligible)... 413 1 413 0.08 (5 minutes)......................... 33
Main study survey completes.................. 330 1 330 0.33 (20 minutes)........................ 108.9
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PCP Population
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Pretest 1 screener (assumes 30% eligible).... 57 1 57 0.08 (5 minutes)......................... 4.6
Pretest 1 survey............................. 17 1 17 0.33 (20 minutes)........................ 5.6
Pretest 2 screener (assumes 30% eligible).... 57 1 57 0.08 (5 minutes)......................... 4.6
Pretest 2 survey............................. 17 1 17 0.33 (20 minutes)........................ 5.6
Main study screener (assumes 30% eligible)... 1,100 1 1,100 0.08 (5 minutes)......................... 88
Main study survey completes.................. 330 1 330 0.33 (20 minutes)........................ 108.9
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Total.................................... .............. .............. .............. ......................................... 374
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
As with most online and mail surveys, it is always possible that
some participants are in the process of completing the survey when the
target number is reached and that those surveys will be completed and
received before the survey is closed out. To account for this, we have
estimated approximately 10 percent overage for both samples in the
study.
Dated: October 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22301 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P
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