Document ID: FDA-2021-N-1026-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Text Analysis of Proprietary Drug Name Interpretations
Posted Date: 2022-10-14T04:00Z

[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62426-62429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 ``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, 
[email protected].
    For copies of the questionnaire: Office of Prescription Drug 
Promotion (OPDP) Research Team, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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.
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     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
                                              ----------------------------------------------------------------------------------------------------------
    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