Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Empirical Study of Promotional Implications of Proprietary Prescription Drug Names, 14440-14445 [2021-05330]
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14440
Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05332 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5666]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Empirical Study of
Promotional Implications of
Proprietary Prescription Drug Names
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
(PRA).
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by April 15,
2021.
DATES:
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
‘‘Empirical Study of Promotional
Implications of Proprietary Prescription
Drug Names.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Empirical Study of Promotional
Implications of Proprietary
Prescription Drug Names
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: (1) Advertising
features, including content and format;
(2) target populations; and (3) 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 our research data through analytical
methodology development and
investigation of sampling and response
issues. This study will inform the first
two topic areas, advertising features and
target populations.
Because we recognize that the
strength of data and the confidence in
the robust nature of the findings is
improved by utilizing 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
homepage, which can be found at:
https://www.fda.gov/aboutfda/
centersoffices/
officeofmedicalproductsandtobacco/
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cder/ucm090276.htm. The website
includes links to the latest Federal
Register notices and peer-reviewed
publications produced by our office.
The website maintains information on
studies we have conducted, dating back
to a survey on direct-to-consumer
advertisements conducted in 1999.
During the prescription drug approval
process, sponsors propose proprietary
names for their products. These names
undergo a proprietary name review that
involves the Office of Drug Safety, the
relevant medical office, and OPDP.
OPDP reviews names to assess for
alignment with the FD&C Act, which,
among other things, provides that
labeling can misbrand a product if false
or misleading representations are made
(see 21 U.S.C. 321(n), 352(a)). A
proprietary name, which appears in
labeling, could result in such
misbranding if it is false or misleading.
OPDP focuses its review on identifying
names that overstate the efficacy or
safety of the drug, suggest drug
indications that are not accurate, suggest
superiority without substantiation, or
are of a fanciful nature that misleadingly
implies unique effectiveness or
composition. This research will focus
on the effect on consumers’ and/or
healthcare providers’ perceptions of a
drug product of names that overstate the
efficacy of the drug product. An
overstatement of efficacy can occur, for
example, in terms of level of efficacy, in
which the degree of relief is overstated,
or in terms of the type of effect, in
which case there is a mismatch with the
indication of the drug. The drug
products that are studied will be
fictitious, and whether the names
overstate the drug products’ efficacy
will be determined with regard to the
products’ fictitious degree of efficacy.
The proposed study is designed to
provide systematic, empirical evidence
to answer two research questions:
• Primary research question: How, if
at all, do names that suggest the medical
condition for which a drug is indicated
affect consumers’ and/or healthcare
providers’ perceptions of prescription
drugs?
• Secondary research question: How,
if at all, do names that suggest an
overstatement of the degree of efficacy
of the drug affect consumers’ and/or
healthcare providers’ perceptions of
prescription drugs?
The ideas generated in the
Prescription Drug User Fee
Amendments pilot project proprietary
name review concept paper of 2008 1
provided a starting point for the study.
1 https://www.regulations.gov/docket?D=FDA2008-N-0281.
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Based on ideas from that document, a
review of the linguistics and social
sciences literature, and an
environmental scan of existing
proprietary names, FDA developed and
pretested an extreme, explicitly
suggestive name (e.g., CuresFlux) and a
neutral name (e.g., Zerpexin) for two
medical conditions, high cholesterol
and gastroesophageal reflux disease
(GERD) (pretesting approved under
OMB control number 0910–0695). In the
proposed main study, approximately
500 consumers from the general
population and 500 healthcare
providers (including physicians, nurse
practitioners, and physician assistants)
will see these pretested extreme and
neutral names plus five target names per
indication (names that may suggest the
medical condition and vary in terms of
promise of effect) and answer questions
about the names, before and after they
have been told what each drug’s
indication is. Target names will vary
such that some efficacy implications are
more apparent than others, and some
will more clearly imply the medical
condition for which a drug is indicated
than others. Dependent variables will
include identification of the medical
condition for which a drug is indicated,
efficacy, and perceptions.
To our knowledge, this study is the
first to provide a systemic investigation
of a variety of proprietary prescription
drug names.
In the Federal Register of January 21,
2020 (85 FR 3392), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received seven
submissions that were PRA-related. One
submission was outside the scope of the
research and is not addressed further.
Within the remaining six submissions,
FDA received multiple comments that
the Agency has addressed below. For
brevity, some public comments are
paraphrased and therefore may not
include the exact language used by the
commenter. We assure commenters that
the entirety of their comments was
considered even if not fully captured by
our paraphrasing in this document. The
following acronyms are used here: HCP
= healthcare provider; FDA and Agency
= Food and Drug Administration; OPDP
= FDA’s Office of Prescription Drug
Promotion.
(Comment 1) Two comments
recommended that the study should
exclude consumers who work in the
healthcare, marketing, or branding
industries; primary care providers that
spend less than 50 percent of their time
on patient care; and the Department of
Health and Human Services employees.
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(Response 1) We agree and currently
have those exclusions included in the
screener.
(Comment 2) Two comments
recommended the screener should
include additional inclusion/exclusion
criteria, such as number of years in
practice and in what size facility they
work (HCPs), and whether consumers
have any of five diagnoses and how
many HCPs they see (consumers).
(Response 2) We plan to include most
of the screening criteria and
demographic data mentioned, including
years in practice (HCPs); amount of time
treating patients (HCPs); size of facility
(HCPs); age (consumers); and diagnosis
with one of the two illnesses which the
hypothetical drugs in this study are
indicated to treat—GERD and high
cholesterol (consumers). Some of the
other suggested questions for the
screener are beyond the scope of this
study. For this study, we have chosen to
focus on primary care providers, as
drugs for these two specific medical
conditions are prescribed by primary
care providers and should thus be
salient for them. Additionally, we will
ask relevant background questions of all
participants, both HCPs and consumers,
to determine age, sex, and race, as well
as familiarity with the target conditions.
(Comment 3) One comment
recommended that the complexity of the
target names should be equivalent
across indications.
(Response 3) We have attempted to
make these as similar as possible,
including having them reviewed by a
linguist and checking the number of
syllables across conditions.
(Comment 4) Three comments
recommend better clarity around what
the definitions of ‘‘typical’’ and
‘‘standard’’ and ‘‘extreme’’ and
‘‘neutral’’ mean when describing the
fictitious drug name and how these
categories were identified and validated.
(Response 4) The list of names was
developed by our multimedia and
creative services team who are wellversed in the practice of proprietary
name development. The list was
reviewed by the study team and also by
a consultant with a Ph.D. in linguistics,
who helped to screen for any overlap
between categories.
In July 2019, we conducted a pretest
of 120 healthcare providers and 121
consumers to establish the categories for
these names. We combined results of
four measures to determine the most
extreme and most neutral amongst a list
of names. These measures included
ability to identify the medical condition
for which the drug is indicated;
perceived benefit and perceived balance
of benefit and risk; and, finally, a
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ranking of most obvious benefit. Names
with the lowest joint rank across the
four measures were considered most
extreme and those with highest were
considered most neutral. The results
were consistent between HCPs and
consumers.
(Comment 5) One comment
recommended excluding ‘‘extreme,
explicitly suggestive’’ proprietary names
that FDA would never permit or names
that suggest the drug indication. The
comment suggested instead that FDA
use data that could assist the Agency in
determining impressions produced by
permissible proprietary names and
names that would marginally fail FDA’s
misbranding review.
(Response 5) The purpose of
including ‘‘extreme’’ names in this
study is not to have data on names that
do not mimic real-world conditions, but
to have something against which to
compare the target names, which are
similar to the kind of names that would
be submitted to FDA for approval. Our
findings may suggest that ‘‘extreme’’
and target names are very different and
that target names are similar to more
neutral names in their effects on
perceptions.
(Comment 6) One comment inquired
if FDA will be providing sound files
with the intended pronunciation of each
of the test names.
(Response 6) In consideration of this
comment, and after hearing from our
cognitive interview participants, we will
introduce sound files at the beginning of
the survey.
(Comment 7) One comment expressed
concerns about how the selection of
target names will represent the current
landscape—that is, it questioned how
FDA will generalize these study results
across therapeutic areas not tested if
only representing one or two
therapeutic areas.
(Response 7) We recognize that our
study is making use of only two
therapeutic areas. As one research
study, it cannot examine all possible
therapeutic areas. Although our two
divergent medical conditions will not
provide us with unlimited information,
they will provide limited
generalizability and provide important
information that may help inform the
proprietary name review process.
(Comment 8) Two comments were
concerned that the questionnaire would
take longer than the estimated 20
minutes.
(Response 8) See our response to
Comment 4 concerning the pretest that
we conducted in July 2019. In the
pretest, we successfully tested a total of
16 names across two indications in this
time frame. During cognitive testing, we
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examined burden and decided to
eliminate Q[uestion]7, which will speed
response. We will also conduct a soft
launch of the survey with
approximately 10 percent of the sample
and can look at actual length at that
time. This gives us the ability to pause
fielding of the survey and make further
cuts if the soft launch data suggest it is
necessary.
(Comment 9) Five comments
recommended that we add ‘‘none of the
above,’’ ‘‘no impression,’’ ‘‘no opinion’’
or ‘‘do not know’’ response options to
some questions.
(Response 9) The rationale usually
given for including ‘‘don’t know’’/‘‘no
opinion’’/‘‘none’’ options is to allow
participants who cannot form a relevant
judgment (e.g., due to insufficient
information) a way to indicate as much.
However, an unintended consequence
of including these options is that they
can facilitate satisficing, where
participants who have enough
information to form a relevant judgment
nonetheless choose ‘‘don’t know’’/‘‘no
opinion’’/‘‘none’’ because it takes less
effort. As a result, ‘‘don’t know’’/‘‘no
opinion’’/‘‘none’’ options do not tend to
improve measurement and tend to
increase item nonresponse (i.e., missing
data) (Ref. 1). For these reasons, we will
not add these options.
(Comment 10) Seven comments
suggested adding more open-ended
responses to explain why respondents
answered questions in certain ways.
(Response 10) As noted by two
comments the survey may be longer
than an average of 20 minutes, which
will cause us to remove questions after
cognitive testing. Unfortunately, it is
impractical to include many openended questions in this particular
research because of time constraints.
Qualitative research on this topic may
be a good idea for a future study.
(Comment 11) One comment
recommended checks to ensure that
respondents are not being careless in
their responses (e.g., just guessing,
providing random answers, straightlining).
(Response 11) We intend to check for
inattentive respondents by testing for
straight-lining and examining the
distribution of time to complete the
study for outliers. Participants who
complete the study plus or minus three
standard deviations from the sample
mean will be excluded from the main
analysis. We agree with the
recommendation to include speed traps/
attention checks in the questionnaire
and will add one to the study.
(Comment 12) Three comments
requested access to the screener or study
target names.
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(Response 12) We have described the
purpose of the study, the design, the
population of interest, and have
provided the questionnaire to numerous
individuals upon request. 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
the research. We strive to publish the
results of our research in peer-reviewed
journals and all stimuli will be available
at that time.
(Comment 13) One comment
recommended a specific approach for
addressing the issue of broadening the
indication that included an unaided ‘‘fit
to category’’ question and an openended ‘‘does the brand name tell you
anything about the product?’’ OR ‘‘what
does this name mean to you?’’—type
question for each name.
(Response 13) The approach
described in this comment is one
method to approach the issue of
broadening the indication and may be
useful for future research. However, in
the current study we aim to collect
information about multiple names,
which precludes open-ended questions
for each name in a single participant
session. Moreover, our initial
examination is focused on
overstatement of efficacy. Broadening of
the indication is another topic that
researchers could pursue.
(Comment 14) One comment
mentioned that we had no particular
items on the issue of unique
composition and suggested adding an
open-ended question regarding general
associations to determine whether a
particular ingredient or dosage
formulation is implied by a proprietary
name.
(Response 14) Our current research is
focused on the issue of overstatement of
efficacy in proposed proprietary drug
names. Future research could examine
issues related to composition and
dosage formulation, but that is beyond
the scope of the current research.
(Comment 15) One comment
suggested FDA should conduct two
survey pretests: One to assess whether
the survey answers the research
questions, and one that allows
respondents to complete the survey
under the supervision of a moderator,
who is able to converse with
respondents and gather feedback on
how participants interpret the
questions. Further, the comment
suggests FDA should consider
conducting qualitative followup
interviews with survey respondents to
gain deeper insight into how the sample
proprietary names affected their
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impressions of safety, efficacy and
indication.
(Response 15) We have accomplished
the goals recommended in this comment
by conducting cognitive interviewing.
During these cognitive interviews,
participants were encouraged to think
aloud as they reviewed and answered
the survey with prompts from a trained
moderator. These interviews enabled us
to capture deeper, more qualitative
responses from a small
nonrepresentative sample of individuals
in order to improve the questionnaire.
(Comment 16) One comment
suggested FDA consider the inverse
approach of our design by setting up the
research to examine how, if at all,
names that do suggest the drug’s
indication increase the chance for
proper usage, reduce the potential for
medication errors, do not mislead HCPs
or patients regarding non-approved use
of the drug, and increase the chance that
if a patient does ask an HCP about a
certain medication then that medication
would be one approved to treat a
condition with which the patient has
been diagnosed.
(Response 16) The purpose of the
current study is to provide evidence
about whether certain types of names
influence consumers’ perceptions, as
well as benefit and risk perceptions so
that FDA reviewers may better assess
names during premarket review. Other
effects of names are beyond the scope of
the current study but may be considered
in future research.
(Comment 17) One comment
suggested the ability of HCPs who
prescribe drug products to determine
whether a proprietary name overstates
the efficacy of that product without the
ability to review the respective package
insert labeling fails to meet the intent of
21 U.S.C. 321(n). The comment further
stated that OPDP and the sponsor of the
product are in the best position to
determine the relationship between the
proprietary name and the material facts
in the labeling of the product, which
sometimes is not available at the
investigational new drug (IND)
application stage when proprietary
names are developed and tested with
consumers and HCPs.
(Response 17) The purpose of the
current study is to determine whether a
proprietary name itself could play a role
in influencing consumer and HCP
perceptions of drug risks or benefits by
suggesting the medical condition for
which the drug is indicated or by
suggesting an overstatement of the
efficacy of the drug. Including the
package insert would confound any
potential results of this study, as it
would not be possible to tease apart
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whether perceptions were influenced by
the name itself or the accompanying
materials. We note that this is a largescale study examining multiple names
and that our purpose in conducting it
differs from that of a pharmaceutical
company engaged in developing and
testing the proprietary name of one of its
products.
(Comment 18) One comment
suggested that the proposed primary
research question, which is designed to
determine how, if at all, a proprietary
name that suggests the medical
condition for which it is indicated
affects perceptions of the drug, does not
determine whether a name overstates
the efficacy of the product.
(Response 18) We agree that whether
a name suggests the medical condition
for which a drug is indicated is a
separate question from whether the
name overstates the drug’s efficacy.
However, we aim, in part, to investigate
how individuals perceive the efficacy of
products when the names do suggest the
medical condition they are indicated to
treat. The purpose of this study is to
compare names that: (1) With varying
degrees of specificity, may suggest the
medical condition for which a drug is
indicated, with or without varied
promises of effect (target names); (2) we
know through pretesting overstate the
efficacy (extreme names); and (3) we
know to be neutral through pretesting.
Perceptions of consumers and HCPs are
important to consider when reviewing
proprietary names and thus, important
to test empirically.
(Comment 19) One comment
suggested that research is not necessary
because names should be evaluated by
those who have medical and regulatory
experience.
(Response 19) We agree that people
who are knowledgeable about the
relevant fields should make decisions
about proprietary names based on the
best information in their fields.
Determining how names are processed
and understood by consumers and HCPs
is important information to be
considered in the review of these
names. Therefore, this research is being
conducted to increase the body of
evidence upon which experts can rely
when assessing proposed proprietary
names for misbranding concerns.
(Comment 20) Three comments
mentioned the study sample size. One
comment stated that the reason for
selecting approximately 1000
respondents was not provided, and it
suggested that the size of such a study
on a proposed drug product would not
be reasonable or cost effective for the
pharmaceutical industry. One comment
recommended that an appropriate
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sample size be used, and another
comment remarked that the sample size
seemed appropriate.
(Response 20) The sample size was
selected based on power analysis. We
have set statistical power for the main
study to test five proposed names
against both the neutral control name
and the extreme control name, using a
7 × 7 Latin squares design. With a
Bonferroni correction for up to 10
pairwise comparisons, the study is
powered to detect conventionally small
effects (f ≥ 0.06, dz ≥ 0.21, or 0.14
difference in proportions) assuming a
family-wise alpha level of 0.005 and 90
percent power for all tests.
This is a large-scale study examining
multiple names, whose purpose differs
from that of one pharmaceutical
company assessing their chosen names.
(Comment 21) One comment
concurred that an automated online
survey would be the most efficient
means to conduct the research.
(Response 21) Thank you for this
comment.
(Comment 22) One comment asked
that we clarify what specific statistical
tests will be performed to determine
whether a particular target name has an
improper (biasing) impact on
perceptions of drug efficacy and/or
safety—and (possibly) on other
perceptions.
(Response 22) To compare names
based on the categorical name
recognition and perceived indication
questions, we will apply nonparametric
tests of dependent proportions. First, we
plan to conduct Cochran’s Q test
separately for each list of names, testing
whether the proportions of at least two
names per list are significantly different
from one another. We will follow up
significant Cochran’s Q tests with
McNemar’s pairwise tests, comparing
each target name against the neutral and
extreme names in each list.
To test for evidence of mean
differences by drug name on intervallevel outcomes (e.g., perceived efficacy
magnitude, perceived severity of risks,
and perceived balance of risks and
benefits), we will use repeated-measures
analyses of variance or mixed model
analysis. We will run separate models
for each list of names and study cohort.
We will follow-up significant omnibus
tests by conducting pairwise
comparisons between each of the target
names versus the neutral and extreme
names.
See information about the study’s
statistical power assumptions above.
(Comment 23) One comment asked for
clarity regarding what decision rule or
norm/standard will be used to conclude
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that there is or is not improper
suggestiveness.
(Response 23) There is an important
distinction between investigating the
effect of a prescription drug name on
perceptions and establishing that the
name is improperly suggestive. This
study is focused on the effect on
perceptions of: (1) Names that suggest
the medical condition for which a drug
is indicated with varying degrees of
explicitness and (2) names that suggest
an overstatement of the efficacy of the
drug with varying degrees of
explicitness. Determining whether what
a prescription drug name suggests or the
name’s degree of suggestiveness is
‘‘improper,’’ or could contribute to
misbranding the drug or to other
violation(s) of the FD&C Act and Agency
regulations, falls beyond the scope of
the current project.
(Comment 24) One comment
suggested clarifying the purpose and
intended use of the data and further
suggests that regardless of the purpose
of the proposed information collection,
in addressing use of the survey data,
FDA should account for the First
Amendment protection provided to
proprietary names.
(Response 24) As stated in the 60-day
notice, the purpose of this study is to
expand the body of knowledge by
answering questions about whether
names alone impact consumer and
provider perceptions of a drug. This
information will help inform the
proprietary name review process. 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, including the First
Amendment.
(Comment 25) One comment
suggested Q1 should have a timer
element (i.e., 15–20 seconds) for each
set of seven names that will help to
standardize the time spent by viewers
on both sets and mitigate viewers who
would quickly scan Set 1, only to spend
more time on Set 2 after realizing they
will be asked to recognize the names.
(Response 25) In addition to
counterbalancing the sets of names, we
will institute a time limit for each
viewing.
(Comment 26) Another comment
suggested that for Q1, we use names that
were found unacceptable due to
promotional reasons for foils.
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(Response 26) The purpose of Q1 is to
determine how well participants recall
the names they viewed. The foils are
used to help determine whether
participants are merely checking off the
complete list of names or marking ones
they truly saw on the previous screen.
Thus, we do not believe using actual
names as foils would add value.
(Comment 27) One comment
mentioned that Q3–Q7 introduce an
aided portion of the survey (by grouping
names into two specific medical
conditions and identifying those names
with each medical condition to the
respondents) and suggested that,
without seeing the product profile, ‘‘it
will be difficult to get responsible data
on efficacy perceptions of the
respondents.’’ Another comment
suggested that Q3 should ask a more
specific question, perhaps on unique
effectiveness or overstatement of
efficacy.
(Response 27) Our research questions
focus on whether the names alone result
in perceptions of risk or efficacy, thus,
Q3–Q7 are directly relevant to the
research questions. Regarding Q3, we do
not want to lead participants into
answers or confuse them by asking them
about regulatory terms with which they
are unfamiliar. We will delete Q7.
(Comment 28) Regarding Q2, one
comment suggested caution in terms of
handling responses in which
respondents presented with a particular
target name (e.g., ‘‘AltAFlux’’) fail to
identify the indication that the name is
hypothesized to be suggestive of (e.g.,
‘‘Acid Reflux’’), checking another
indication instead (e.g., ‘‘Asthma’’). In
such cases, it would be inappropriate to
interpret any observed effects on drug
perceptions to the name being overly
suggestive of a particular indication. A
conservative course of action would
therefore be to remove from subsequent
analyses all instances in which a target
name is not attributed to its
hypothesized indication.
(Response 28) The target names are
representative of the types of names that
are frequently submitted to FDA for
review. They may include information
about the medical condition for which
the drug is indicated, or both the
medical condition and efficacy. We do
not presuppose that a name’s effect on
perceptions of drug effectiveness are
dependent on recognition of the medical
condition for which the drug is
indicated, though we will consider this
mediation effect as we refine the
analysis plan for this project.
(Comment 29) One comment
suggested that Q4 does not seem
relevant since serious side effects of the
drug would normally be evaluated in
the context of the clinical studies or
post-marketing studies and would be
presented in the package insert labeling.
(Response 29) The question is
whether the name alone influences
perception of risk and benefit; thus, Q4
is directly relevant to answering those
questions.
(Comment 30) Three comments
suggested deleting Q5. For example, one
comment discussed that perceived
balance of risks and benefits is usually
communicated in advertising by
utilizing the approved labeling in
presenting fair balance and, thus, a
proprietary name would not normally
present risks and benefits. The comment
stated that names that do present
benefits within the name without
context to its risk would not be
considered misleading since the
approved labeling would represent
balance of risks and benefits.
(Response 30) Our research questions
focus on whether the proprietary name
alone affects consumer and HCP
perceptions of risk or efficacy of the
drug. Q5 helps to answer those research
questions by asking participants to
opine on whether the proprietary name
alone indicates to them that the benefits
of a product outweigh the risks. Our
research will not answer the question
whether a given name is misleading or
whether labeling or advertising
incorporating the name would violate
the FD&C Act and its implementing
regulations.
(Comment 31) One comment
suggested that measuring attitudes
toward each name (Q6) does not seem
to add anything toward measuring the
efficacy claims of a name and another
comment recommends changing
semantic differential endpoints for this
item.
(Response 31) Measuring attitudes
adds to our knowledge of how
individuals interpret particular drug
names. The semantic differential
endpoints used in the original attitude
question, as well as the proposed
replacements, are among those
recommended by prominent attitude
theorists (Ref. 2). We have used these
items in several studies without any
issues, including studies measuring
consumer and physician attitudes
toward prescription drugs. Nevertheless,
we will replace the negative-positive
item with an item using worthlessvaluable as endpoints.
(Comment 32) Five comments
suggested reducing or eliminating Q7,
which questions participants about their
attitudes toward the drug names.
(Response 32) As noted in Response
17, in the interest of reducing time
burden for participants, we will delete
this question.
(Comment 33) Two comments
questioned the utility of or
recommended deleting Q8.
(Response 33) We agree and will
delete this item.
(Comment 34) Two comments
suggested that Q9 and two comments
suggested that Q10 and Q11 are not
applicable to the objectives of this
survey.
(Response 34) Similarity, typicality,
and familiarity could reasonably
influence perceptions of drug names
independently of the experimental
manipulation. These measures are being
included in this study as potential
covariates.
(Comment 35) One comment
suggested that Q11 is confusing, as
respondents are asked to rate if they
‘‘have heard of each of the following
drug names before,’’ after being
previously told in the questionnaire
introduction that the drugs ‘‘have been
recently developed’’ and before being
informed in the debriefing that the
names are fictitious. Moreover, some
respondents could interpret the present
question as meaning ‘‘Were the
following names mentioned in this
survey?’’ which is presumably not the
intent of the question.
(Response 35) We agree that this item
as written was confusing, and this was
confirmed by cognitive testing. Thus,
we will alter the question to clarify that
we are interested in whether
respondents had heard the drug name
prior to the study. This question will be
used as a covariate in the study design.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Consumer Screener ..........................
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16:52 Mar 15, 2021
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Total annual
respondents
1
Fmt 4703
1,233
Sfmt 4703
Average burden per response
.08 (5 minutes) .................................
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Total hours
98.64
Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
14445
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Average burden per response
Total hours
HCP Screener ...................................
Consumer Study ...............................
HCP Study ........................................
1,233
493
493
1
1
1
1,233
493
493
.08 (5 minutes) .................................
.33 (20 minutes) ...............................
.33 (20 minutes) ...............................
98.64
162.69
162.69
Total ...........................................
........................
........................
........................
...........................................................
522.66
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, HFA–305, Food and Drug
Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852, 240–
402–7500 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. Krosnick, J.A. and S. Presser,
‘‘Question and Questionnaire
Design.’’ In P.V. Marsden and J.D.
Wright (Eds.). Handbook of Survey
Research (2nd Ed.). Emerald:
Bingley, UK, 2010.
2. Fishbein, M. and I. Ajzen, Predicting
and Changing Behavior: The
Reasoned Action Approach. New
York, NY: Psychology Press, 2010.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05330 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–0340]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; HINTERMANN SERIES H3
TOTAL ANKLE REPLACEMENT
SYSTEM
jbell on DSKJLSW7X2PROD with NOTICES
Total annual
respondents
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
SUMMARY:
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
for HINTERMANN SERIES H3 TOTAL
ANKLE REPLACEMENT SYSTEM and
is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by May 17, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 13, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 17, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 17, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
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PO 00000
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third party may not wish to be posted,
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anyone else’s Social Security number, or
confidential business information, such
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that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–E–0340 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; HINTERMANN
SERIES H3 TOTAL ANKLE
REPLACEMENT SYSTEM.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
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Friday, 240–402–7500.
• Confidential Submissions—To
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comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
E:\FR\FM\16MRN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14440-14445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05330]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5666]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Empirical Study of
Promotional Implications of Proprietary Prescription Drug Names
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by April 15, 2021.
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 ``Empirical Study of Promotional Implications
of Proprietary Prescription Drug Names.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
Empirical Study of Promotional Implications of Proprietary Prescription
Drug Names
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: (1) Advertising features,
including content and format; (2) target populations; and (3) 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 our research data through
analytical methodology development and investigation of sampling and
response issues. This study will inform the first two topic areas,
advertising features and target populations.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings is improved by utilizing 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 homepage,
which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a survey on direct-to-
consumer advertisements conducted in 1999.
During the prescription drug approval process, sponsors propose
proprietary names for their products. These names undergo a proprietary
name review that involves the Office of Drug Safety, the relevant
medical office, and OPDP. OPDP reviews names to assess for alignment
with the FD&C Act, which, among other things, provides that labeling
can misbrand a product if false or misleading representations are made
(see 21 U.S.C. 321(n), 352(a)). A proprietary name, which appears in
labeling, could result in such misbranding if it is false or
misleading. OPDP focuses its review on identifying names that overstate
the efficacy or safety of the drug, suggest drug indications that are
not accurate, suggest superiority without substantiation, or are of a
fanciful nature that misleadingly implies unique effectiveness or
composition. This research will focus on the effect on consumers' and/
or healthcare providers' perceptions of a drug product of names that
overstate the efficacy of the drug product. An overstatement of
efficacy can occur, for example, in terms of level of efficacy, in
which the degree of relief is overstated, or in terms of the type of
effect, in which case there is a mismatch with the indication of the
drug. The drug products that are studied will be fictitious, and
whether the names overstate the drug products' efficacy will be
determined with regard to the products' fictitious degree of efficacy.
The proposed study is designed to provide systematic, empirical
evidence to answer two research questions:
Primary research question: How, if at all, do names that
suggest the medical condition for which a drug is indicated affect
consumers' and/or healthcare providers' perceptions of prescription
drugs?
Secondary research question: How, if at all, do names that
suggest an overstatement of the degree of efficacy of the drug affect
consumers' and/or healthcare providers' perceptions of prescription
drugs?
The ideas generated in the Prescription Drug User Fee Amendments
pilot project proprietary name review concept paper of 2008 \1\
provided a starting point for the study.
[[Page 14441]]
Based on ideas from that document, a review of the linguistics and
social sciences literature, and an environmental scan of existing
proprietary names, FDA developed and pretested an extreme, explicitly
suggestive name (e.g., CuresFlux) and a neutral name (e.g., Zerpexin)
for two medical conditions, high cholesterol and gastroesophageal
reflux disease (GERD) (pretesting approved under OMB control number
0910-0695). In the proposed main study, approximately 500 consumers
from the general population and 500 healthcare providers (including
physicians, nurse practitioners, and physician assistants) will see
these pretested extreme and neutral names plus five target names per
indication (names that may suggest the medical condition and vary in
terms of promise of effect) and answer questions about the names,
before and after they have been told what each drug's indication is.
Target names will vary such that some efficacy implications are more
apparent than others, and some will more clearly imply the medical
condition for which a drug is indicated than others. Dependent
variables will include identification of the medical condition for
which a drug is indicated, efficacy, and perceptions.
---------------------------------------------------------------------------
\1\ https://www.regulations.gov/docket?D=FDA-2008-N-0281.
---------------------------------------------------------------------------
To our knowledge, this study is the first to provide a systemic
investigation of a variety of proprietary prescription drug names.
In the Federal Register of January 21, 2020 (85 FR 3392), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received seven submissions that were
PRA-related. One submission was outside the scope of the research and
is not addressed further. Within the remaining six submissions, FDA
received multiple comments that the Agency has addressed below. For
brevity, some public comments are paraphrased and therefore may not
include the exact language used by the commenter. We assure commenters
that the entirety of their comments was considered even if not fully
captured by our paraphrasing in this document. The following acronyms
are used here: HCP = healthcare provider; FDA and Agency = Food and
Drug Administration; OPDP = FDA's Office of Prescription Drug
Promotion.
(Comment 1) Two comments recommended that the study should exclude
consumers who work in the healthcare, marketing, or branding
industries; primary care providers that spend less than 50 percent of
their time on patient care; and the Department of Health and Human
Services employees.
(Response 1) We agree and currently have those exclusions included
in the screener.
(Comment 2) Two comments recommended the screener should include
additional inclusion/exclusion criteria, such as number of years in
practice and in what size facility they work (HCPs), and whether
consumers have any of five diagnoses and how many HCPs they see
(consumers).
(Response 2) We plan to include most of the screening criteria and
demographic data mentioned, including years in practice (HCPs); amount
of time treating patients (HCPs); size of facility (HCPs); age
(consumers); and diagnosis with one of the two illnesses which the
hypothetical drugs in this study are indicated to treat--GERD and high
cholesterol (consumers). Some of the other suggested questions for the
screener are beyond the scope of this study. For this study, we have
chosen to focus on primary care providers, as drugs for these two
specific medical conditions are prescribed by primary care providers
and should thus be salient for them. Additionally, we will ask relevant
background questions of all participants, both HCPs and consumers, to
determine age, sex, and race, as well as familiarity with the target
conditions.
(Comment 3) One comment recommended that the complexity of the
target names should be equivalent across indications.
(Response 3) We have attempted to make these as similar as
possible, including having them reviewed by a linguist and checking the
number of syllables across conditions.
(Comment 4) Three comments recommend better clarity around what the
definitions of ``typical'' and ``standard'' and ``extreme'' and
``neutral'' mean when describing the fictitious drug name and how these
categories were identified and validated.
(Response 4) The list of names was developed by our multimedia and
creative services team who are well-versed in the practice of
proprietary name development. The list was reviewed by the study team
and also by a consultant with a Ph.D. in linguistics, who helped to
screen for any overlap between categories.
In July 2019, we conducted a pretest of 120 healthcare providers
and 121 consumers to establish the categories for these names. We
combined results of four measures to determine the most extreme and
most neutral amongst a list of names. These measures included ability
to identify the medical condition for which the drug is indicated;
perceived benefit and perceived balance of benefit and risk; and,
finally, a ranking of most obvious benefit. Names with the lowest joint
rank across the four measures were considered most extreme and those
with highest were considered most neutral. The results were consistent
between HCPs and consumers.
(Comment 5) One comment recommended excluding ``extreme, explicitly
suggestive'' proprietary names that FDA would never permit or names
that suggest the drug indication. The comment suggested instead that
FDA use data that could assist the Agency in determining impressions
produced by permissible proprietary names and names that would
marginally fail FDA's misbranding review.
(Response 5) The purpose of including ``extreme'' names in this
study is not to have data on names that do not mimic real-world
conditions, but to have something against which to compare the target
names, which are similar to the kind of names that would be submitted
to FDA for approval. Our findings may suggest that ``extreme'' and
target names are very different and that target names are similar to
more neutral names in their effects on perceptions.
(Comment 6) One comment inquired if FDA will be providing sound
files with the intended pronunciation of each of the test names.
(Response 6) In consideration of this comment, and after hearing
from our cognitive interview participants, we will introduce sound
files at the beginning of the survey.
(Comment 7) One comment expressed concerns about how the selection
of target names will represent the current landscape--that is, it
questioned how FDA will generalize these study results across
therapeutic areas not tested if only representing one or two
therapeutic areas.
(Response 7) We recognize that our study is making use of only two
therapeutic areas. As one research study, it cannot examine all
possible therapeutic areas. Although our two divergent medical
conditions will not provide us with unlimited information, they will
provide limited generalizability and provide important information that
may help inform the proprietary name review process.
(Comment 8) Two comments were concerned that the questionnaire
would take longer than the estimated 20 minutes.
(Response 8) See our response to Comment 4 concerning the pretest
that we conducted in July 2019. In the pretest, we successfully tested
a total of 16 names across two indications in this time frame. During
cognitive testing, we
[[Page 14442]]
examined burden and decided to eliminate Q[uestion]7, which will speed
response. We will also conduct a soft launch of the survey with
approximately 10 percent of the sample and can look at actual length at
that time. This gives us the ability to pause fielding of the survey
and make further cuts if the soft launch data suggest it is necessary.
(Comment 9) Five comments recommended that we add ``none of the
above,'' ``no impression,'' ``no opinion'' or ``do not know'' response
options to some questions.
(Response 9) The rationale usually given for including ``don't
know''/``no opinion''/``none'' options is to allow participants who
cannot form a relevant judgment (e.g., due to insufficient information)
a way to indicate as much. However, an unintended consequence of
including these options is that they can facilitate satisficing, where
participants who have enough information to form a relevant judgment
nonetheless choose ``don't know''/``no opinion''/``none'' because it
takes less effort. As a result, ``don't know''/``no opinion''/``none''
options do not tend to improve measurement and tend to increase item
nonresponse (i.e., missing data) (Ref. 1). For these reasons, we will
not add these options.
(Comment 10) Seven comments suggested adding more open-ended
responses to explain why respondents answered questions in certain
ways.
(Response 10) As noted by two comments the survey may be longer
than an average of 20 minutes, which will cause us to remove questions
after cognitive testing. Unfortunately, it is impractical to include
many open-ended questions in this particular research because of time
constraints. Qualitative research on this topic may be a good idea for
a future study.
(Comment 11) One comment recommended checks to ensure that
respondents are not being careless in their responses (e.g., just
guessing, providing random answers, straight-lining).
(Response 11) We intend to check for inattentive respondents by
testing for straight-lining and examining the distribution of time to
complete the study for outliers. Participants who complete the study
plus or minus three standard deviations from the sample mean will be
excluded from the main analysis. We agree with the recommendation to
include speed traps/attention checks in the questionnaire and will add
one to the study.
(Comment 12) Three comments requested access to the screener or
study target names.
(Response 12) We have described the purpose of the study, the
design, the population of interest, and have provided the questionnaire
to numerous individuals upon request. 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 the research. We strive to publish the
results of our research in peer-reviewed journals and all stimuli will
be available at that time.
(Comment 13) One comment recommended a specific approach for
addressing the issue of broadening the indication that included an
unaided ``fit to category'' question and an open-ended ``does the brand
name tell you anything about the product?'' OR ``what does this name
mean to you?''--type question for each name.
(Response 13) The approach described in this comment is one method
to approach the issue of broadening the indication and may be useful
for future research. However, in the current study we aim to collect
information about multiple names, which precludes open-ended questions
for each name in a single participant session. Moreover, our initial
examination is focused on overstatement of efficacy. Broadening of the
indication is another topic that researchers could pursue.
(Comment 14) One comment mentioned that we had no particular items
on the issue of unique composition and suggested adding an open-ended
question regarding general associations to determine whether a
particular ingredient or dosage formulation is implied by a proprietary
name.
(Response 14) Our current research is focused on the issue of
overstatement of efficacy in proposed proprietary drug names. Future
research could examine issues related to composition and dosage
formulation, but that is beyond the scope of the current research.
(Comment 15) One comment suggested FDA should conduct two survey
pretests: One to assess whether the survey answers the research
questions, and one that allows respondents to complete the survey under
the supervision of a moderator, who is able to converse with
respondents and gather feedback on how participants interpret the
questions. Further, the comment suggests FDA should consider conducting
qualitative followup interviews with survey respondents to gain deeper
insight into how the sample proprietary names affected their
impressions of safety, efficacy and indication.
(Response 15) We have accomplished the goals recommended in this
comment by conducting cognitive interviewing. During these cognitive
interviews, participants were encouraged to think aloud as they
reviewed and answered the survey with prompts from a trained moderator.
These interviews enabled us to capture deeper, more qualitative
responses from a small nonrepresentative sample of individuals in order
to improve the questionnaire.
(Comment 16) One comment suggested FDA consider the inverse
approach of our design by setting up the research to examine how, if at
all, names that do suggest the drug's indication increase the chance
for proper usage, reduce the potential for medication errors, do not
mislead HCPs or patients regarding non-approved use of the drug, and
increase the chance that if a patient does ask an HCP about a certain
medication then that medication would be one approved to treat a
condition with which the patient has been diagnosed.
(Response 16) The purpose of the current study is to provide
evidence about whether certain types of names influence consumers'
perceptions, as well as benefit and risk perceptions so that FDA
reviewers may better assess names during premarket review. Other
effects of names are beyond the scope of the current study but may be
considered in future research.
(Comment 17) One comment suggested the ability of HCPs who
prescribe drug products to determine whether a proprietary name
overstates the efficacy of that product without the ability to review
the respective package insert labeling fails to meet the intent of 21
U.S.C. 321(n). The comment further stated that OPDP and the sponsor of
the product are in the best position to determine the relationship
between the proprietary name and the material facts in the labeling of
the product, which sometimes is not available at the investigational
new drug (IND) application stage when proprietary names are developed
and tested with consumers and HCPs.
(Response 17) The purpose of the current study is to determine
whether a proprietary name itself could play a role in influencing
consumer and HCP perceptions of drug risks or benefits by suggesting
the medical condition for which the drug is indicated or by suggesting
an overstatement of the efficacy of the drug. Including the package
insert would confound any potential results of this study, as it would
not be possible to tease apart
[[Page 14443]]
whether perceptions were influenced by the name itself or the
accompanying materials. We note that this is a large-scale study
examining multiple names and that our purpose in conducting it differs
from that of a pharmaceutical company engaged in developing and testing
the proprietary name of one of its products.
(Comment 18) One comment suggested that the proposed primary
research question, which is designed to determine how, if at all, a
proprietary name that suggests the medical condition for which it is
indicated affects perceptions of the drug, does not determine whether a
name overstates the efficacy of the product.
(Response 18) We agree that whether a name suggests the medical
condition for which a drug is indicated is a separate question from
whether the name overstates the drug's efficacy. However, we aim, in
part, to investigate how individuals perceive the efficacy of products
when the names do suggest the medical condition they are indicated to
treat. The purpose of this study is to compare names that: (1) With
varying degrees of specificity, may suggest the medical condition for
which a drug is indicated, with or without varied promises of effect
(target names); (2) we know through pretesting overstate the efficacy
(extreme names); and (3) we know to be neutral through pretesting.
Perceptions of consumers and HCPs are important to consider when
reviewing proprietary names and thus, important to test empirically.
(Comment 19) One comment suggested that research is not necessary
because names should be evaluated by those who have medical and
regulatory experience.
(Response 19) We agree that people who are knowledgeable about the
relevant fields should make decisions about proprietary names based on
the best information in their fields. Determining how names are
processed and understood by consumers and HCPs is important information
to be considered in the review of these names. Therefore, this research
is being conducted to increase the body of evidence upon which experts
can rely when assessing proposed proprietary names for misbranding
concerns.
(Comment 20) Three comments mentioned the study sample size. One
comment stated that the reason for selecting approximately 1000
respondents was not provided, and it suggested that the size of such a
study on a proposed drug product would not be reasonable or cost
effective for the pharmaceutical industry. One comment recommended that
an appropriate sample size be used, and another comment remarked that
the sample size seemed appropriate.
(Response 20) The sample size was selected based on power analysis.
We have set statistical power for the main study to test five proposed
names against both the neutral control name and the extreme control
name, using a 7 x 7 Latin squares design. With a Bonferroni correction
for up to 10 pairwise comparisons, the study is powered to detect
conventionally small effects (f >= 0.06, dz >= 0.21, or 0.14 difference
in proportions) assuming a family-wise alpha level of 0.005 and 90
percent power for all tests.
This is a large-scale study examining multiple names, whose purpose
differs from that of one pharmaceutical company assessing their chosen
names.
(Comment 21) One comment concurred that an automated online survey
would be the most efficient means to conduct the research.
(Response 21) Thank you for this comment.
(Comment 22) One comment asked that we clarify what specific
statistical tests will be performed to determine whether a particular
target name has an improper (biasing) impact on perceptions of drug
efficacy and/or safety--and (possibly) on other perceptions.
(Response 22) To compare names based on the categorical name
recognition and perceived indication questions, we will apply
nonparametric tests of dependent proportions. First, we plan to conduct
Cochran's Q test separately for each list of names, testing whether the
proportions of at least two names per list are significantly different
from one another. We will follow up significant Cochran's Q tests with
McNemar's pairwise tests, comparing each target name against the
neutral and extreme names in each list.
To test for evidence of mean differences by drug name on interval-
level outcomes (e.g., perceived efficacy magnitude, perceived severity
of risks, and perceived balance of risks and benefits), we will use
repeated-measures analyses of variance or mixed model analysis. We will
run separate models for each list of names and study cohort. We will
follow-up significant omnibus tests by conducting pairwise comparisons
between each of the target names versus the neutral and extreme names.
See information about the study's statistical power assumptions
above.
(Comment 23) One comment asked for clarity regarding what decision
rule or norm/standard will be used to conclude that there is or is not
improper suggestiveness.
(Response 23) There is an important distinction between
investigating the effect of a prescription drug name on perceptions and
establishing that the name is improperly suggestive. This study is
focused on the effect on perceptions of: (1) Names that suggest the
medical condition for which a drug is indicated with varying degrees of
explicitness and (2) names that suggest an overstatement of the
efficacy of the drug with varying degrees of explicitness. Determining
whether what a prescription drug name suggests or the name's degree of
suggestiveness is ``improper,'' or could contribute to misbranding the
drug or to other violation(s) of the FD&C Act and Agency regulations,
falls beyond the scope of the current project.
(Comment 24) One comment suggested clarifying the purpose and
intended use of the data and further suggests that regardless of the
purpose of the proposed information collection, in addressing use of
the survey data, FDA should account for the First Amendment protection
provided to proprietary names.
(Response 24) As stated in the 60-day notice, the purpose of this
study is to expand the body of knowledge by answering questions about
whether names alone impact consumer and provider perceptions of a drug.
This information will help inform the proprietary name review process.
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, including the
First Amendment.
(Comment 25) One comment suggested Q1 should have a timer element
(i.e., 15-20 seconds) for each set of seven names that will help to
standardize the time spent by viewers on both sets and mitigate viewers
who would quickly scan Set 1, only to spend more time on Set 2 after
realizing they will be asked to recognize the names.
(Response 25) In addition to counterbalancing the sets of names, we
will institute a time limit for each viewing.
(Comment 26) Another comment suggested that for Q1, we use names
that were found unacceptable due to promotional reasons for foils.
[[Page 14444]]
(Response 26) The purpose of Q1 is to determine how well
participants recall the names they viewed. The foils are used to help
determine whether participants are merely checking off the complete
list of names or marking ones they truly saw on the previous screen.
Thus, we do not believe using actual names as foils would add value.
(Comment 27) One comment mentioned that Q3-Q7 introduce an aided
portion of the survey (by grouping names into two specific medical
conditions and identifying those names with each medical condition to
the respondents) and suggested that, without seeing the product
profile, ``it will be difficult to get responsible data on efficacy
perceptions of the respondents.'' Another comment suggested that Q3
should ask a more specific question, perhaps on unique effectiveness or
overstatement of efficacy.
(Response 27) Our research questions focus on whether the names
alone result in perceptions of risk or efficacy, thus, Q3-Q7 are
directly relevant to the research questions. Regarding Q3, we do not
want to lead participants into answers or confuse them by asking them
about regulatory terms with which they are unfamiliar. We will delete
Q7.
(Comment 28) Regarding Q2, one comment suggested caution in terms
of handling responses in which respondents presented with a particular
target name (e.g., ``AltAFlux'') fail to identify the indication that
the name is hypothesized to be suggestive of (e.g., ``Acid Reflux''),
checking another indication instead (e.g., ``Asthma''). In such cases,
it would be inappropriate to interpret any observed effects on drug
perceptions to the name being overly suggestive of a particular
indication. A conservative course of action would therefore be to
remove from subsequent analyses all instances in which a target name is
not attributed to its hypothesized indication.
(Response 28) The target names are representative of the types of
names that are frequently submitted to FDA for review. They may include
information about the medical condition for which the drug is
indicated, or both the medical condition and efficacy. We do not
presuppose that a name's effect on perceptions of drug effectiveness
are dependent on recognition of the medical condition for which the
drug is indicated, though we will consider this mediation effect as we
refine the analysis plan for this project.
(Comment 29) One comment suggested that Q4 does not seem relevant
since serious side effects of the drug would normally be evaluated in
the context of the clinical studies or post-marketing studies and would
be presented in the package insert labeling.
(Response 29) The question is whether the name alone influences
perception of risk and benefit; thus, Q4 is directly relevant to
answering those questions.
(Comment 30) Three comments suggested deleting Q5. For example, one
comment discussed that perceived balance of risks and benefits is
usually communicated in advertising by utilizing the approved labeling
in presenting fair balance and, thus, a proprietary name would not
normally present risks and benefits. The comment stated that names that
do present benefits within the name without context to its risk would
not be considered misleading since the approved labeling would
represent balance of risks and benefits.
(Response 30) Our research questions focus on whether the
proprietary name alone affects consumer and HCP perceptions of risk or
efficacy of the drug. Q5 helps to answer those research questions by
asking participants to opine on whether the proprietary name alone
indicates to them that the benefits of a product outweigh the risks.
Our research will not answer the question whether a given name is
misleading or whether labeling or advertising incorporating the name
would violate the FD&C Act and its implementing regulations.
(Comment 31) One comment suggested that measuring attitudes toward
each name (Q6) does not seem to add anything toward measuring the
efficacy claims of a name and another comment recommends changing
semantic differential endpoints for this item.
(Response 31) Measuring attitudes adds to our knowledge of how
individuals interpret particular drug names. The semantic differential
endpoints used in the original attitude question, as well as the
proposed replacements, are among those recommended by prominent
attitude theorists (Ref. 2). We have used these items in several
studies without any issues, including studies measuring consumer and
physician attitudes toward prescription drugs. Nevertheless, we will
replace the negative-positive item with an item using worthless-
valuable as endpoints.
(Comment 32) Five comments suggested reducing or eliminating Q7,
which questions participants about their attitudes toward the drug
names.
(Response 32) As noted in Response 17, in the interest of reducing
time burden for participants, we will delete this question.
(Comment 33) Two comments questioned the utility of or recommended
deleting Q8.
(Response 33) We agree and will delete this item.
(Comment 34) Two comments suggested that Q9 and two comments
suggested that Q10 and Q11 are not applicable to the objectives of this
survey.
(Response 34) Similarity, typicality, and familiarity could
reasonably influence perceptions of drug names independently of the
experimental manipulation. These measures are being included in this
study as potential covariates.
(Comment 35) One comment suggested that Q11 is confusing, as
respondents are asked to rate if they ``have heard of each of the
following drug names before,'' after being previously told in the
questionnaire introduction that the drugs ``have been recently
developed'' and before being informed in the debriefing that the names
are fictitious. Moreover, some respondents could interpret the present
question as meaning ``Were the following names mentioned in this
survey?'' which is presumably not the intent of the question.
(Response 35) We agree that this item as written was confusing, and
this was confirmed by cognitive testing. Thus, we will alter the
question to clarify that we are interested in whether respondents had
heard the drug name prior to the study. This question will be used as a
covariate in the study design.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total annual Average burden Total hours
respondents respondent respondents per response
----------------------------------------------------------------------------------------------------------------
Consumer Screener............. 1,233 1 1,233 .08 (5 minutes). 98.64
[[Page 14445]]
HCP Screener.................. 1,233 1 1,233 .08 (5 minutes). 98.64
Consumer Study................ 493 1 493 .33 (20 minutes) 162.69
HCP Study..................... 493 1 493 .33 (20 minutes) 162.69
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 522.66
----------------------------------------------------------------------------------------------------------------
\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, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room
1061, Rockville, MD 20852, 240-402-7500 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. Krosnick, J.A. and S. Presser, ``Question and Questionnaire
Design.'' In P.V. Marsden and J.D. Wright (Eds.). Handbook of Survey
Research (2nd Ed.). Emerald: Bingley, UK, 2010.
2. Fishbein, M. and I. Ajzen, Predicting and Changing Behavior: The
Reasoned Action Approach. New York, NY: Psychology Press, 2010.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05330 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P
