Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces, 34897-34902 [2019-15350]
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Federal Register / Vol. 84, No. 139 / Friday, July 19, 2019 / Notices
OMB control number. To be assured
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This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
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and associated materials (see
ADDRESSES).
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CMS–576A Organ Procurement
Organization’s (OPOs) Health
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Information Collection
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Request: Revision of a currently
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Dated: July 16, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–15426 Filed 7–18–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3163]
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
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concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Physician
Interpretation of Information About
Prescription Drugs in Scientific
Publications Versus Promotional
Pieces
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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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: Fax written comments on the
collection of information by August 19,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Physician Interpretation of
Information About Prescription Drugs in
Scientific Publications vs. Promotional
Pieces.’’ 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, PRAStaff@
fda.hhs.gov.
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.
Physician Interpretation of Information
About Prescription Drugs in Scientific
Publications vs. Promotional Pieces
OMB Control Number 0910–New
I. Background
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 FD&C Act prohibits the
dissemination of false or misleading
information about medications in
consumer-directed and professional
prescription drug promotion. As part of
its Federal mandate, FDA regulates
whether advertising of prescription drug
products is truthful, balanced, and
accurately communicated (see 21 U.S.C.
352(n)). FDA’s regulatory policies are
aligned with the principles of free
speech and due process in the U.S.
Constitution. To inform current and
future policies, and to seek to enhance
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audience comprehension, FDA’s Office
of Prescription Drug Promotion (OPDP)
conducts research focusing on: (1)
Advertising features including content
and format, (2) target populations, and
(3) research quality. This proposed
research focuses on healthcare
professionals (HCPs). The proposed
collection of information will
investigate how physician perception of
prescription drug information is
influenced by variations in information
context (presence of graphical elements
and information delivery vehicle—
medical journal abstract or sales aid),
methodologic rigor of the underlying
clinical study (high or low), and time
pressure (present versus absent).
A. Ways in Which Information Context
and Study Quality May Influence
Perceptions
Physicians gain knowledge about
medical product uses from a variety of
information vehicles including peerreviewed journal articles, compendia,
continuing medical education, and
physician-directed promotion by or on
behalf of manufacturers. Peer-reviewed
scientific publications may report the
results of a variety of studies, employing
a wide range of methodologies with
varying levels of rigor. As a result,
information of varying quality is
disseminated to the field. Physician
detailing sometimes includes
information derived from peer-reviewed
research that, in this context, serves a
dual purpose: To both inform and
market a particular product (Ref. 1).
Prior research has examined some
impacts of study quality and funding
source on physician perception. For
example, research by Kesselheim et al.
(Ref. 2) on study abstracts examined
how methodologic rigor (high, medium,
low) and information about the source
of funding (industry, National Institutes
of Health, none) affected physician
perceptions of study quality, prescribing
intentions, and interest in reading the
full article. Results indicated physician
participants were able to distinguish
between levels of methodologic rigor.
Physicians also used information about
the funding source to distinguish
materials. They reported less
willingness to prescribe the drugs or
read the full study from trials funded by
industry, regardless of study rigor. Thus,
funding source was a contextual factor
that impacted physicians’ perceptions of
the information.
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Research has also shown that
physician prescribing behavior can be
influenced by the context in which the
information is delivered. Spurling et al.
(Ref. 3) examined the way in which
information from a pharmaceutical
company was delivered (using
conventional promotional techniques
such as sales rep visits, journal
advertisements, or attendance at
pharmaceutical-sponsored meetings
versus not using conventional
promotional techniques such as
participation in company sponsored
trials and representatives’ visits for
nonpromotional purposes) and
prescribing outcome across 58 studies.
They found conventional promotional
techniques were associated with an
increase in prescribing and a decrease in
prescribing quality. We are proposing to
test a different type of contextual factor
in this study: Whether the drug
information appears in a medical
journal abstract or a sales aid.
B. Ways in Which Graphics May
Influence Perceptions
Promotional materials about
prescription drugs that are directed
toward physicians often include a
variety of visual elements beyond
simple text. In a study of professionally
directed prescription drug brochures left
for physicians by pharmaceutical
representatives, researchers found 95
percent contained a visual graphic
(including bar charts, line graphs, pie
charts, arrows) accompanying the
presentation of data (Ref. 4). An analysis
of professionally directed prescription
drug print advertisements in medical
journals found 80 percent of the ads
contained some type of image, and 21
percent contained data-related graphics.
A group of two physicians and one
pharmacist judged these ads. This group
found that of those ads that contained
images, 58 percent contained images
that minimized the risks of the product
and 24 percent of the images in the ads
misled about product efficacy (Ref. 5).
C. Ways in Which Time Pressure May
Influence Perceptions
We are also interested in how time
pressure may impact physician
perceptions. Time pressure can impact
processing of information (e.g., accuracy
and speed) as well as decision making.
Physicians are often under pressure to
split their work time between myriad
duties that may include clinical care,
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research, mentoring, teaching, and
administrative duties (Ref. 6).
Individuals under time pressure tend to
rely on previously formed attitudes for
decision making and have less cognitive
capacity to process information (Refs. 7
and 8). This results in different
decisions depending on the amount of
time available (Ref. 9). Research
suggests that in situations with high
time pressure or increased ambiguity,
experts use intuitive decision-making
strategies rather than structured
approaches (Refs. 10 and 11). Physicians
may therefore tend to rely on intuitive
processes rather than evidence-based
information under time pressure.
Research has also found that under
time pressure, physician adherence to
clinical practice guidelines concerning
history taking and advice giving can be
compromised (Ref. 12). One study that
assessed the reading habits of
physicians found that with limited time
available for critical reading,
practitioners relied heavily on abstracts
and prescreening of articles by editors
(Ref. 13). Thus, time pressure is an
element of physicians’ practice
environment that can impact
information gathering and,
consequently, decision making, and the
quality of health care delivered.
II. Proposed Study
We propose to investigate how
physician perception of professional
prescription drug communications is
influenced by variations in information
context, methodologic rigor of the
underlying clinical study, and time
pressure. We propose to test three
different contextual presentations of
drug information (medical journal
abstract, sales aid without graphic
design elements, and sales aid with
graphic design elements), and two types
of study methodological rigor used by
Kesselheim et al. (classified as high or
low; Ref. 2). We have chosen to test a
mock sales aid presentation and a
medical journal abstract to examine the
potential differences in perception that
may arise by presenting the same
information in different vehicles.
Mirroring the time constraints of
practicing physicians, we will examine
the role of time pressure by randomly
assigning half of the study participants
to a limited amount of available time to
read the materials. Table 1 describes the
study design.
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TABLE 1—STUDY DESIGN
Information context
Medical journal
abstract
Limited Time to Read ............
Methodological Rigor 1 ...........
Unlimited Time to Read.
1 As
Sales aid
without graphic
design elements
Sales aid with
graphic design
elements 2
High.
Low.
High.
Low.
defined by Kesselheim et al. (Ref. 2).
example, colors and background images.
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2 For
For this proposed study, voluntary
participants will be board-certified
internists. To examine differences
between experimental conditions, we
will conduct inferential statistical tests
such as analysis of variance (ANOVA).
With the sample size described, we will
have sufficient power to detect small-tomedium sized effects in the main study.
We plan to conduct one pretest with
158 voluntary participants and one
main study with 566 voluntary
participants. The purpose of the pretest
is to ensure the manipulations are
working as intended, and to examine
the effectiveness of question wording. In
the pretest, participants will answer
questions about the study design and
questionnaire. The studies will be
conducted online. The pretest and main
studies will have the same design and
will follow the same procedure.
Participants will be randomly assigned
to one of 12 test conditions (see table 1).
Following exposure to the stimuli, they
will be asked to complete a
questionnaire that assesses
comprehension, perceptions,
prescribing intentions, and
demographics. We anticipate analyzing
the data as a full factorial design (main
effects and interactions) with two
primary comparisons for the
information context independent
variable: Journal abstract versus sales
aid without graphics and sales aid
without graphics versus sales aid with
graphics. We will also do an exploratory
comparison of journal abstract versus
sales aid with graphics.
This study will be conducted as part
of the research program of the OPDP.
OPDP’s mission is to protect the public
health by helping to ensure that
prescription drug information is
truthful, balanced, and accurately
communicated, so that patients and
health care providers can make
informed decisions about treatment
options. OPDP’s research program
supports this mission by providing
scientific evidence to help ensure that
our policies related to prescription drug
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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 we believe are most
central to our mission, focusing 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 falls under the topic of both target
populations and advertising features.
In the Federal Register of October 17,
2018 (83 FR 52490), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received three
comments that were PRA related.
Within those submissions, FDA
received multiple comments that the
Agency has addressed.
(Comment) Two comments asked for
clarity about the research objectives and
hypotheses. One comment asked how
FDA will use such knowledge to inform
the regulation of prescription drug
promotion in the future, particularly the
variable of time.
(Response) As described in the 60-day
Federal Register notice, we propose to
investigate how physician perception of
professional prescription drug
communications is influenced by
variations in information context,
methodologic rigor of the underlying
clinical study, and time pressure. We
propose to test three different contextual
presentations of drug information
(medical journal abstract, sales aid
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without graphic design elements, sales
aid with graphic design elements), and
two types of study methodological rigor
used by Kesselheim et al. (classified as
high or low; Ref. 2). We have chosen to
test a mock sales aid presentation and
a medical journal abstract to examine
the potential differences in perception
that may arise by presenting the same
information in different vehicles.
Mirroring the time constraints of
practicing physicians, we will examine
the role of time pressure by randomly
assigning half of the study participants
to a limited amount of available time to
read the materials. Our research
questions (RQs) are:
RQ 1: Does the information context in
which the information appears affect
processing of the information?
RQ 2: Does methodological rigor of the
study affect processing of the information?
RQ2a: Do physicians correctly interpret the
methodological rigor of the study?
RQ3: Does the time available to read the
information affect processing of the
information?
RQ4: What are the potential interactions
between these factors?
Thus, the goal of our study is to
understand the ways in which the
presentation of information,
methodological rigor, and time affect
how physicians interpret information
about drugs when it comes from
different sources. Although we cannot
speculate on any future action because
of our research studies, the Agency is
committed to examining and conducting
research that will ensure that any
changes are grounded in science and
will have the greatest benefit to public
health. For this reason, FDA
consistently conducts research to
evaluate the aspects of prescription drug
promotion that we believe are most
central to our mission, focusing on three
main topic areas: Advertising features,
including content and format; target
populations; and research quality.
Results from studies we conduct are
evaluated within the broader context of
research and findings from other
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sources. The broader body of knowledge
is used to inform both policy and
regulatory approaches.
(Comment) Six comments focused on
various aspects of the study design.
Comments asked for: (1) Clarity about
the reasoning behind inclusion of the
aspects of time pressure; (2) how time
pressure reflects the reality of the HCP
experience; (3) how time pressure will
be operationalized; (4) justification for
comparison of a sales aid to an abstract;
(5) a suggestion to remove one of the
sales aid conditions to simplify the
design; and (6) more detail about how
methodologic rigor will be defined and
represented in a sales aid or an abstract.
One comment (7) asserted graphics in
promotional materials are tested by
pharmaceutical companies through
market research to ensure correct
interpretation and so the presence or
absence of graphics cannot predict how
HCPs will interpret information in
promotional materials. This comment
also asserted the 1992 supporting
reference in the 60-day Federal Register
notice was outdated.
(Response to 1–3) Prior research has
found that many physicians have
limited time to spend reading drug
information (Refs. 6–11). To imitate
physicians’ real-world experiences in
this study, half of the participants will
be randomly assigned to a condition in
which time pressure is present; the
other half will experience no time
pressure. Those in the time pressure
present condition will receive
instructions explaining they will have
two minutes to review the study
description, which will be reevaluated
after pretesting. Those without time
pressure will be told they have as much
time as they need to review the study
description.
(Response to 4–5) As described in the
60-day Federal Register notice, we have
two primary comparisons for the
information context independent
variable: Journal abstract versus sales
aid without graphics, and sales aid
without graphics versus sales aid with
graphics. We will also do an exploratory
comparison of journal abstract versus
sales aid with graphics. As further
described in the 60-day Federal Register
notice, we are examining the potential
differences in perception that may arise
by presenting the same information in
different vehicles. The same information
will be presented in the context of an
abstract and the context of a sales aid.
Described another way, we are
controlling the text of the information
and varying its ‘‘wrapper’’ to explore
whether the context in which the
information appears influences how the
information is perceived. A comparison
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of abstract to sales aid without graphics,
and sales aid without graphics to sales
aid with graphics will enable us to
examine perceptual differences that may
arise from the context in which the
information occurs. To control for
extraneous effects, we are not presenting
any other information in the sales aid.
(Response to 6) In addition to
studying the presentation of information
in different information vehicles (sales
aid versus abstract), we will also
examine two different levels of
methodological rigor, either high or low
quality (Ref. 2). Some key differences
between the levels of rigor are: Blinding,
representative population, and drug
safety reported (Ref. 2). For example, the
high rigor study that half of the
participants will view was a
randomized double-blind study that had
a representative patient population, and
the drug was reported to be safe (Ref. 2).
The low rigor study that the other half
of the participants will view was openlabel (no blinding), was not
representative of the patient population,
and there was no report of the safety of
the drug (Ref. 2). We used the same
criteria to develop our stimuli as did
Kesselheim et al. (Ref. 2). For example,
variables in the high rigor condition
included double-blind, active
comparator, and representative patient
population. Variables in the low rigor
condition included open-label, usual
care comparator, and a nonrepresentative patient population.
(Response to 7) It is possible that the
presence of graphics affects the
impressions of the product, which we
are assessing in this study. To address
the comment about the date of the
referenced research, we conducted an
additional search of the literature. In a
study by Othman et al. (Ref. 14), 28
percent of claims made in
pharmaceutical advertisements were
judged clear and not misleading. This
suggests that 72 percent were
misleading or unclear. We welcome the
opportunity to review unpublished
market research or other available data
to inform this study.
(Comment) One comment questioned
the sufficiency of the proposed analysis
plan based on the information provided
in the notice and asked for clarity about
the main dependent variables.
(Response) Our primary dependent
variables are: Likelihood to prescribe,
confidence in study results, interpret
data cautiously, would use data in
prescribing, credibility of data, bias of
data, and trust in promotion. We will
conduct ANOVAs (for continuous
variables) and logistic regressions (for
dichotomous variables) with interaction
terms and planned comparisons to test
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the research questions. We have
outlined our research questions above.
(Comment) Three comments
requested FDA disseminate the study
stimuli, and one comment requested
disseminating the questionnaire prior to
requesting comments.
(Response) We have described the
purpose of the study, the design, the
population of interest, and the estimated
burden. The 60-day notice published on
October 17, 2018, provided an email
address to obtain copies of the
questionnaire (83 FR 52490 at 52491,
column 3) and we provided the
questionnaire to individuals upon
request. The content of the stimuli is
taken from Kesselheim et al. (Ref. 2).
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.
(Comment) Two comments
questioned limiting the sample to boardcertified internists and not including
specialists, particularly those who
specialize in diabetes treatment and
endocrinologists. Relatedly, one
comment suggested a sample size of at
least 200 physicians.
(Response) Our study is a partial
replication of the Kesselheim et al. (Ref.
2) study. In that study, internists were
used as the target population and in
keeping with the replication, we chose
to evaluate internists as well. We
encourage future research to expand to
other physician specialties. The sample
will provide us enough power to detect
a medium-sized effect between the
study variables.
(Comment) Two comments suggested
changing the scale range of the
questions so that all of the questions use
a consistent scale range.
(Response) We are using several
questions that have been validated in
previous studies. Therefore, some of the
scales have various lengths. We chose to
maintain scale range to maintain
validation rather than editing scales for
consistency.
(Comment) Seven comments
suggested changes to the questionnaire.
These suggested changes included: (1)
Adjusting the wording of the question
that asks about the importance of the
target study ‘‘to ensure more consistent
interpretation by respondents, such as
importance of study findings on
respondent decision making, etc.’’; (2)
revising the question about perceptions
of bias to avoid the respondent making
the assumption that the data
presentation is biased; (3) deletion of
questions about perceptions of risk; (4)
deletion of the question about places
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where information about unapproved
drugs has been encountered because it
appears unrelated to the study goals; (5)
addition of a response choice to the
question measuring decision to include
colleagues as a source of information;
(6) addition of screening questions
about statistical training; and (7)
addition of a question about how much
time is typically spent reviewing
materials such as this.
(Responses) (1) The study importance
question is taken from Kesselheim et al.
(Ref. 2) and we did not encounter any
issues with this question during
cognitive interviews. (2) Perceptions of
the amount of potential bias is one of
our primary dependent measures. We
will change the wording of this question
to read ‘‘How unbiased or biased is the
study you saw?’’ [1 = very unbiased; 5
= very biased]. (3) We acknowledge
participants may have a difficult time
answering questions about risk. We
believe an overall risk-benefit
assessment is possible based on the
information provided. Thus, we have
decided to retain these questions as
variables of secondary interest. (4) The
question about where participants may
encounter information about
unapproved drugs is taken from the
Healthcare Professional Survey of
Professional Prescription Drug
Promotion (Docket No. FDA–2018–N–
0215). We have included it here so that
we may compare results across the two
populations in an exploratory manner.
(5) We will add a question about seeking
information in response to the data
participants see in the study that
includes a response choice that captures
desire to discuss drug information with
a colleague prior to prescribing. (6) We
will add a question about statistical
training to the demographic section of
the questionnaire. (7) We will add a
question about how long participants
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typically spend reading materials of this
type.
(Comment) One comment suggested
moving the non-terminating
demographic screener questions to the
end of the survey.
(Response) We appreciate this
suggestion. We have moved these
questions to the end of the survey.
(Comment) One comment asked that
the results be broadly and
systematically disseminated.
(Response) The Agency anticipates
disseminating the results of the study
after the final analyses of the data are
completed, reviewed, and cleared. The
exact timing and nature of any such
dissemination has not been determined,
but may include presentations at trade
and academic conferences, submissions
in publications, publishing articles, and
internet postings.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Pretest screener ..................................................
Main Study screener ...........................................
Completes, Pretest ..............................................
Completes, Main Study .......................................
197
700
158
566
1
1
1
1
197
700
158
566
Total .............................................................
1,621
........................
1,621
1 There
0.03
0.03
0.33
0.33
Total hours
(2 minutes) .............
(2 minutes) .............
(20 minutes) ...........
(20 minutes) ...........
6
21
53
187
........................................
267
are no capital costs or operating and maintenance costs associated with this collection of information.
III. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also
are available electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. 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.
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
1. Yi, J.C., G. Anandalingam, and L.A.
Sorrell, ‘‘An Expert System to PhysicianDetailing Planning,’’ Expert Systems with
Applications, 25:533–544, 2003.
2. Kesselheim, A.S., C.T. Robertson, J.A.
Myers, et al., ‘‘A Randomized Study of
How Physicians Interpret Research
VerDate Sep<11>2014
18:36 Jul 18, 2019
Jkt 247001
Funding Disclosures,’’ New England
Journal of Medicine, 367:1119–1127,
2012.
3.*Spurling, G.K., P.R. Mansfield, B.D.
Montgomery, et al., ‘‘Information from
Pharmaceutical Companies and the
Quality, Quantity, and Cost of
Physicians’ Prescribing: A Systematic
Review,’’ PLoS Medicine, 7:e1000352,
2010.
4. Cardarelli, R., J.C. Licciardone, and L.G.
Taylor, ‘‘A Cross-Sectional EvidenceBased Review of Pharmaceutical
Promotional Marketing Brochures and
Their Underlying Studies: Is What They
Tell Us Important and True?’’ BMC
Family Practice, 7:13, 2006.
5. Wilkes, M.S., B.H. Doblin, and M.F.
Shapiro, ‘‘Pharmaceutical
Advertisements in Leading Medical
Journals: Experts’ Assessments,’’ Annals
of Internal Medicine, 116:912–919, 1992.
6. Fassiotto, M., C. Simard, C. Sandborg, et.
al, ‘‘An Integrated Career Coaching and
Time-Banking System Promoting
Flexibility, Wellness, and Success: A
Pilot Program at Stanford University
School of Medicine,’’ Academic
Medicine, 93:881–887, 2018.
7. Alison, L., B. Doran, M.L. Long, et. al,
‘‘The Effects of Subjective Time Pressure
and Individual Differences on
Hypotheses Generation and Action
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Prioritization in Police Investigations,’’
Journal of Experimental Psychology.
19:83–93, 2013.
8. Ratneshwar, S. and S. Chaiken,
‘‘Comprehension’s Role in Persuasion:
The Case of Its Moderating Effect on the
Persuasive Impact of Source Cues,’’
Journal of Consumer Research, 18:52–62,
1991.
9. Moore, D.L., D. Hausknecht, and K.
Thamodaran, ‘‘Time Compression,
Response Opportunity, and Persuasion,’’
Journal of Consumer Research, 13:85–99,
1986.
10. Dror, I.E., B. Basola, and J.R. Busemeyer,
‘‘Decision Making Under Time Pressure:
An Independent Test of Sequential
Sampling Models,’’ Memory & Cognition,
27:713–725, 1999.
11. Croskerry, P., ‘‘The Cognitive Imperative
Thinking About How We Think,’’
Academic Emergency Medicine, 7:1223–
1231, 2000.
12. Tsiga, E., E. Panagopoulou, N. Sevdalis,
et. al, ‘‘The Influence of Time Pressure
on Adherence to Guidelines in Primary
Care: An Experimental Study,’’ BMJ
Open, 3:e002700, 2013.
13. Saint, S., D.A. Christakis, S. Saha, et. al,
‘‘Journal Reading Habits of Internists,’’
Journal of General Internal Medicine,
15:881–884, 2000.
14. *Othman, N., A. Vitry, and E.E.
E:\FR\FM\19JYN1.SGM
19JYN1
34902
Federal Register / Vol. 84, No. 139 / Friday, July 19, 2019 / Notices
Roughead, ‘‘Quality of Pharmaceutical
Advertisements in Medical Journals: A
Systematic Review,’’ PLoS Medicine,
4:e6350, https://doi.org/10.1371/
journal.pone.0006350, 2009.
Dated: July 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15350 Filed 7–18–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2870]
Electronic Submission; Data
Standards; Support for Geopolitical
Entities, Names, and Codes
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the adoption of the current
version of the Geopolitical Entities,
Names, and Codes (GENC) Standard on
December 17, 2020. The GENC Standard
is the U.S. Government profile of
International Organization for
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the Representation of Names of
Countries and Their Subdivisions.’’ It
specifies an authoritative set of country
codes and names for use by the U.S.
Government for information exchange,
using ISO 3166 names and code
elements wherever possible, with
modifications only when necessary to
comply with U.S. law and U.S.
Government recognition policy.
Adopting the GENC Standard will
enable FDA to be in conformance with
U.S. Government naming and
recognition policies. You may submit
comments at any time regarding the
appropriateness or timing of FDA’s
adoption of the GENC Standard.
ADDRESSES: You may submit either
electronic or written comments at any
time as follows:
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
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
solely responsible for ensuring that your
comment does not include any
VerDate Sep<11>2014
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Jkt 247001
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
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• 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’’).
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Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
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Drug Administration, 5630 Fishers
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• 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–
2019–N–2870 for ‘‘Electronic
Submission; Data Standards; Support
for Geopolitical Entities, Names, and
Codes.’’ Received comments 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.
• Confidential Submissions—To
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‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
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second copy, which will have the
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https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://www.regulations
.gov and insert the docket number,
found in brackets in the heading of this
document, into the ‘‘Search’’ box and
follow the prompts and/or go to the
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Chenoa Conley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, cderdatastandards@
fda.hhs.gov, or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION: On
December 17, 2015, FDA began
supporting GENC as the FDA standard
for representing countries and their
principal subdivisions. ISO is an
organization that creates standards
documents to provide requirements,
specifications, and guidelines that can
be followed by regulatory agencies and
industry (https://nsgreg.nga.mil/genc/
discovery). Before adopting GENC as its
standard, FDA represented countries
using ISO 3166–1 alpha-3 and
represented countries’ principal
subdivisions using ISO 3166–2. Before
adopting ISO 3166 as its standard, FDA
represented countries using Federal
Information Processing Standards (FIPS)
10–4 and represented principal
subdivisions of the United States using
FIPS 5–2 (https://nsgreg.nga.mil/doc/
view?i=2564). FIPS are publicly
announced standards developed by the
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systems by nonmilitary Government
Agencies and industry.
Public Law 80–242 (1947) requires the
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names that have been approved by the
U.S. Board on Geographic Names (BGN).
ISO 3166 contains a small set of country
E:\FR\FM\19JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 139 (Friday, July 19, 2019)]
[Notices]
[Pages 34897-34902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15350]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3163]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Physician
Interpretation of Information About Prescription Drugs in Scientific
Publications Versus Promotional Pieces
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: Fax written comments on the collection of information by August
19, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-New and
title ``Physician Interpretation of Information About Prescription
Drugs in Scientific Publications vs. Promotional Pieces.'' 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.
Physician Interpretation of Information About Prescription Drugs in
Scientific Publications vs. Promotional Pieces
OMB Control Number 0910-New
I. Background
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 FD&C Act prohibits the dissemination of false or misleading
information about medications in consumer-directed and professional
prescription drug promotion. As part of its Federal mandate, FDA
regulates whether advertising of prescription drug products is
truthful, balanced, and accurately communicated (see 21 U.S.C. 352(n)).
FDA's regulatory policies are aligned with the principles of free
speech and due process in the U.S. Constitution. To inform current and
future policies, and to seek to enhance
[[Page 34898]]
audience comprehension, FDA's Office of Prescription Drug Promotion
(OPDP) conducts research focusing on: (1) Advertising features
including content and format, (2) target populations, and (3) research
quality. This proposed research focuses on healthcare professionals
(HCPs). The proposed collection of information will investigate how
physician perception of prescription drug information is influenced by
variations in information context (presence of graphical elements and
information delivery vehicle--medical journal abstract or sales aid),
methodologic rigor of the underlying clinical study (high or low), and
time pressure (present versus absent).
A. Ways in Which Information Context and Study Quality May Influence
Perceptions
Physicians gain knowledge about medical product uses from a variety
of information vehicles including peer-reviewed journal articles,
compendia, continuing medical education, and physician-directed
promotion by or on behalf of manufacturers. Peer-reviewed scientific
publications may report the results of a variety of studies, employing
a wide range of methodologies with varying levels of rigor. As a
result, information of varying quality is disseminated to the field.
Physician detailing sometimes includes information derived from peer-
reviewed research that, in this context, serves a dual purpose: To both
inform and market a particular product (Ref. 1).
Prior research has examined some impacts of study quality and
funding source on physician perception. For example, research by
Kesselheim et al. (Ref. 2) on study abstracts examined how methodologic
rigor (high, medium, low) and information about the source of funding
(industry, National Institutes of Health, none) affected physician
perceptions of study quality, prescribing intentions, and interest in
reading the full article. Results indicated physician participants were
able to distinguish between levels of methodologic rigor. Physicians
also used information about the funding source to distinguish
materials. They reported less willingness to prescribe the drugs or
read the full study from trials funded by industry, regardless of study
rigor. Thus, funding source was a contextual factor that impacted
physicians' perceptions of the information.
Research has also shown that physician prescribing behavior can be
influenced by the context in which the information is delivered.
Spurling et al. (Ref. 3) examined the way in which information from a
pharmaceutical company was delivered (using conventional promotional
techniques such as sales rep visits, journal advertisements, or
attendance at pharmaceutical-sponsored meetings versus not using
conventional promotional techniques such as participation in company
sponsored trials and representatives' visits for nonpromotional
purposes) and prescribing outcome across 58 studies. They found
conventional promotional techniques were associated with an increase in
prescribing and a decrease in prescribing quality. We are proposing to
test a different type of contextual factor in this study: Whether the
drug information appears in a medical journal abstract or a sales aid.
B. Ways in Which Graphics May Influence Perceptions
Promotional materials about prescription drugs that are directed
toward physicians often include a variety of visual elements beyond
simple text. In a study of professionally directed prescription drug
brochures left for physicians by pharmaceutical representatives,
researchers found 95 percent contained a visual graphic (including bar
charts, line graphs, pie charts, arrows) accompanying the presentation
of data (Ref. 4). An analysis of professionally directed prescription
drug print advertisements in medical journals found 80 percent of the
ads contained some type of image, and 21 percent contained data-related
graphics. A group of two physicians and one pharmacist judged these
ads. This group found that of those ads that contained images, 58
percent contained images that minimized the risks of the product and 24
percent of the images in the ads misled about product efficacy (Ref.
5).
C. Ways in Which Time Pressure May Influence Perceptions
We are also interested in how time pressure may impact physician
perceptions. Time pressure can impact processing of information (e.g.,
accuracy and speed) as well as decision making. Physicians are often
under pressure to split their work time between myriad duties that may
include clinical care, research, mentoring, teaching, and
administrative duties (Ref. 6). Individuals under time pressure tend to
rely on previously formed attitudes for decision making and have less
cognitive capacity to process information (Refs. 7 and 8). This results
in different decisions depending on the amount of time available (Ref.
9). Research suggests that in situations with high time pressure or
increased ambiguity, experts use intuitive decision-making strategies
rather than structured approaches (Refs. 10 and 11). Physicians may
therefore tend to rely on intuitive processes rather than evidence-
based information under time pressure.
Research has also found that under time pressure, physician
adherence to clinical practice guidelines concerning history taking and
advice giving can be compromised (Ref. 12). One study that assessed the
reading habits of physicians found that with limited time available for
critical reading, practitioners relied heavily on abstracts and
prescreening of articles by editors (Ref. 13). Thus, time pressure is
an element of physicians' practice environment that can impact
information gathering and, consequently, decision making, and the
quality of health care delivered.
II. Proposed Study
We propose to investigate how physician perception of professional
prescription drug communications is influenced by variations in
information context, methodologic rigor of the underlying clinical
study, and time pressure. We propose to test three different contextual
presentations of drug information (medical journal abstract, sales aid
without graphic design elements, and sales aid with graphic design
elements), and two types of study methodological rigor used by
Kesselheim et al. (classified as high or low; Ref. 2). We have chosen
to test a mock sales aid presentation and a medical journal abstract to
examine the potential differences in perception that may arise by
presenting the same information in different vehicles. Mirroring the
time constraints of practicing physicians, we will examine the role of
time pressure by randomly assigning half of the study participants to a
limited amount of available time to read the materials. Table 1
describes the study design.
[[Page 34899]]
Table 1--Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information context
------------------------------------------------------------------------------------------------------------------
Medical journal Sales aid Sales aid with
abstract without graphic graphic design
design elements elements \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Limited Time to Read................. Methodological Rigor \1\ High.
Low.....................
-------------------------------------- ----------------------------------------------------------------------------------------
Unlimited Time to Read. High.
Low.....................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ As defined by Kesselheim et al. (Ref. 2).
\2\ For example, colors and background images.
For this proposed study, voluntary participants will be board-
certified internists. To examine differences between experimental
conditions, we will conduct inferential statistical tests such as
analysis of variance (ANOVA). With the sample size described, we will
have sufficient power to detect small-to-medium sized effects in the
main study.
We plan to conduct one pretest with 158 voluntary participants and
one main study with 566 voluntary participants. The purpose of the
pretest is to ensure the manipulations are working as intended, and to
examine the effectiveness of question wording. In the pretest,
participants will answer questions about the study design and
questionnaire. The studies will be conducted online. The pretest and
main studies will have the same design and will follow the same
procedure. Participants will be randomly assigned to one of 12 test
conditions (see table 1). Following exposure to the stimuli, they will
be asked to complete a questionnaire that assesses comprehension,
perceptions, prescribing intentions, and demographics. We anticipate
analyzing the data as a full factorial design (main effects and
interactions) with two primary comparisons for the information context
independent variable: Journal abstract versus sales aid without
graphics and sales aid without graphics versus sales aid with graphics.
We will also do an exploratory comparison of journal abstract versus
sales aid with graphics.
This study will be conducted as part of the research program of the
OPDP. OPDP's mission is to protect the public health by helping to
ensure that prescription drug information is truthful, balanced, and
accurately communicated, so that patients and health care providers can
make informed decisions about treatment options. OPDP's research
program supports this mission by providing 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 we believe are most central to our mission,
focusing 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 falls under the topic of both target populations and advertising
features.
In the Federal Register of October 17, 2018 (83 FR 52490), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three comments that were PRA
related. Within those submissions, FDA received multiple comments that
the Agency has addressed.
(Comment) Two comments asked for clarity about the research
objectives and hypotheses. One comment asked how FDA will use such
knowledge to inform the regulation of prescription drug promotion in
the future, particularly the variable of time.
(Response) As described in the 60-day Federal Register notice, we
propose to investigate how physician perception of professional
prescription drug communications is influenced by variations in
information context, methodologic rigor of the underlying clinical
study, and time pressure. We propose to test three different contextual
presentations of drug information (medical journal abstract, sales aid
without graphic design elements, sales aid with graphic design
elements), and two types of study methodological rigor used by
Kesselheim et al. (classified as high or low; Ref. 2). We have chosen
to test a mock sales aid presentation and a medical journal abstract to
examine the potential differences in perception that may arise by
presenting the same information in different vehicles. Mirroring the
time constraints of practicing physicians, we will examine the role of
time pressure by randomly assigning half of the study participants to a
limited amount of available time to read the materials. Our research
questions (RQs) are:
RQ 1: Does the information context in which the information
appears affect processing of the information?
RQ 2: Does methodological rigor of the study affect processing
of the information?
RQ2a: Do physicians correctly interpret the methodological rigor
of the study?
RQ3: Does the time available to read the information affect
processing of the information?
RQ4: What are the potential interactions between these factors?
Thus, the goal of our study is to understand the ways in which the
presentation of information, methodological rigor, and time affect how
physicians interpret information about drugs when it comes from
different sources. Although we cannot speculate on any future action
because of our research studies, the Agency is committed to examining
and conducting research that will ensure that any changes are grounded
in science and will have the greatest benefit to public health. For
this reason, FDA consistently conducts research to evaluate the aspects
of prescription drug promotion that we believe are most central to our
mission, focusing on three main topic areas: Advertising features,
including content and format; target populations; and research quality.
Results from studies we conduct are evaluated within the broader
context of research and findings from other
[[Page 34900]]
sources. The broader body of knowledge is used to inform both policy
and regulatory approaches.
(Comment) Six comments focused on various aspects of the study
design. Comments asked for: (1) Clarity about the reasoning behind
inclusion of the aspects of time pressure; (2) how time pressure
reflects the reality of the HCP experience; (3) how time pressure will
be operationalized; (4) justification for comparison of a sales aid to
an abstract; (5) a suggestion to remove one of the sales aid conditions
to simplify the design; and (6) more detail about how methodologic
rigor will be defined and represented in a sales aid or an abstract.
One comment (7) asserted graphics in promotional materials are tested
by pharmaceutical companies through market research to ensure correct
interpretation and so the presence or absence of graphics cannot
predict how HCPs will interpret information in promotional materials.
This comment also asserted the 1992 supporting reference in the 60-day
Federal Register notice was outdated.
(Response to 1-3) Prior research has found that many physicians
have limited time to spend reading drug information (Refs. 6-11). To
imitate physicians' real-world experiences in this study, half of the
participants will be randomly assigned to a condition in which time
pressure is present; the other half will experience no time pressure.
Those in the time pressure present condition will receive instructions
explaining they will have two minutes to review the study description,
which will be reevaluated after pretesting. Those without time pressure
will be told they have as much time as they need to review the study
description.
(Response to 4-5) As described in the 60-day Federal Register
notice, we have two primary comparisons for the information context
independent variable: Journal abstract versus sales aid without
graphics, and sales aid without graphics versus sales aid with
graphics. We will also do an exploratory comparison of journal abstract
versus sales aid with graphics. As further described in the 60-day
Federal Register notice, we are examining the potential differences in
perception that may arise by presenting the same information in
different vehicles. The same information will be presented in the
context of an abstract and the context of a sales aid. Described
another way, we are controlling the text of the information and varying
its ``wrapper'' to explore whether the context in which the information
appears influences how the information is perceived. A comparison of
abstract to sales aid without graphics, and sales aid without graphics
to sales aid with graphics will enable us to examine perceptual
differences that may arise from the context in which the information
occurs. To control for extraneous effects, we are not presenting any
other information in the sales aid.
(Response to 6) In addition to studying the presentation of
information in different information vehicles (sales aid versus
abstract), we will also examine two different levels of methodological
rigor, either high or low quality (Ref. 2). Some key differences
between the levels of rigor are: Blinding, representative population,
and drug safety reported (Ref. 2). For example, the high rigor study
that half of the participants will view was a randomized double-blind
study that had a representative patient population, and the drug was
reported to be safe (Ref. 2). The low rigor study that the other half
of the participants will view was open-label (no blinding), was not
representative of the patient population, and there was no report of
the safety of the drug (Ref. 2). We used the same criteria to develop
our stimuli as did Kesselheim et al. (Ref. 2). For example, variables
in the high rigor condition included double-blind, active comparator,
and representative patient population. Variables in the low rigor
condition included open-label, usual care comparator, and a non-
representative patient population.
(Response to 7) It is possible that the presence of graphics
affects the impressions of the product, which we are assessing in this
study. To address the comment about the date of the referenced
research, we conducted an additional search of the literature. In a
study by Othman et al. (Ref. 14), 28 percent of claims made in
pharmaceutical advertisements were judged clear and not misleading.
This suggests that 72 percent were misleading or unclear. We welcome
the opportunity to review unpublished market research or other
available data to inform this study.
(Comment) One comment questioned the sufficiency of the proposed
analysis plan based on the information provided in the notice and asked
for clarity about the main dependent variables.
(Response) Our primary dependent variables are: Likelihood to
prescribe, confidence in study results, interpret data cautiously,
would use data in prescribing, credibility of data, bias of data, and
trust in promotion. We will conduct ANOVAs (for continuous variables)
and logistic regressions (for dichotomous variables) with interaction
terms and planned comparisons to test the research questions. We have
outlined our research questions above.
(Comment) Three comments requested FDA disseminate the study
stimuli, and one comment requested disseminating the questionnaire
prior to requesting comments.
(Response) We have described the purpose of the study, the design,
the population of interest, and the estimated burden. The 60-day notice
published on October 17, 2018, provided an email address to obtain
copies of the questionnaire (83 FR 52490 at 52491, column 3) and we
provided the questionnaire to individuals upon request. The content of
the stimuli is taken from Kesselheim et al. (Ref. 2). 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.
(Comment) Two comments questioned limiting the sample to board-
certified internists and not including specialists, particularly those
who specialize in diabetes treatment and endocrinologists. Relatedly,
one comment suggested a sample size of at least 200 physicians.
(Response) Our study is a partial replication of the Kesselheim et
al. (Ref. 2) study. In that study, internists were used as the target
population and in keeping with the replication, we chose to evaluate
internists as well. We encourage future research to expand to other
physician specialties. The sample will provide us enough power to
detect a medium-sized effect between the study variables.
(Comment) Two comments suggested changing the scale range of the
questions so that all of the questions use a consistent scale range.
(Response) We are using several questions that have been validated
in previous studies. Therefore, some of the scales have various
lengths. We chose to maintain scale range to maintain validation rather
than editing scales for consistency.
(Comment) Seven comments suggested changes to the questionnaire.
These suggested changes included: (1) Adjusting the wording of the
question that asks about the importance of the target study ``to ensure
more consistent interpretation by respondents, such as importance of
study findings on respondent decision making, etc.''; (2) revising the
question about perceptions of bias to avoid the respondent making the
assumption that the data presentation is biased; (3) deletion of
questions about perceptions of risk; (4) deletion of the question about
places
[[Page 34901]]
where information about unapproved drugs has been encountered because
it appears unrelated to the study goals; (5) addition of a response
choice to the question measuring decision to include colleagues as a
source of information; (6) addition of screening questions about
statistical training; and (7) addition of a question about how much
time is typically spent reviewing materials such as this.
(Responses) (1) The study importance question is taken from
Kesselheim et al. (Ref. 2) and we did not encounter any issues with
this question during cognitive interviews. (2) Perceptions of the
amount of potential bias is one of our primary dependent measures. We
will change the wording of this question to read ``How unbiased or
biased is the study you saw?'' [1 = very unbiased; 5 = very biased].
(3) We acknowledge participants may have a difficult time answering
questions about risk. We believe an overall risk-benefit assessment is
possible based on the information provided. Thus, we have decided to
retain these questions as variables of secondary interest. (4) The
question about where participants may encounter information about
unapproved drugs is taken from the Healthcare Professional Survey of
Professional Prescription Drug Promotion (Docket No. FDA-2018-N-0215).
We have included it here so that we may compare results across the two
populations in an exploratory manner. (5) We will add a question about
seeking information in response to the data participants see in the
study that includes a response choice that captures desire to discuss
drug information with a colleague prior to prescribing. (6) We will add
a question about statistical training to the demographic section of the
questionnaire. (7) We will add a question about how long participants
typically spend reading materials of this type.
(Comment) One comment suggested moving the non-terminating
demographic screener questions to the end of the survey.
(Response) We appreciate this suggestion. We have moved these
questions to the end of the survey.
(Comment) One comment asked that the results be broadly and
systematically disseminated.
(Response) The Agency anticipates disseminating the results of the
study after the final analyses of the data are completed, reviewed, and
cleared. The exact timing and nature of any such dissemination has not
been determined, but may include presentations at trade and academic
conferences, submissions in publications, publishing articles, and
internet postings.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest screener.......................... 197 1 197 0.03 (2 minutes)............................ 6
Main Study screener....................... 700 1 700 0.03 (2 minutes)............................ 21
Completes, Pretest........................ 158 1 158 0.33 (20 minutes)........................... 53
Completes, Main Study..................... 566 1 566 0.33 (20 minutes)........................... 187
-------------------------------------------------------------------------------------------------------------
Total................................. 1,621 .............. 1,621 ............................................ 267
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and
are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. 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. Yi, J.C., G. Anandalingam, and L.A. Sorrell, ``An Expert System
to Physician-Detailing Planning,'' Expert Systems with Applications,
25:533-544, 2003.
2. Kesselheim, A.S., C.T. Robertson, J.A. Myers, et al., ``A
Randomized Study of How Physicians Interpret Research Funding
Disclosures,'' New England Journal of Medicine, 367:1119-1127, 2012.
3.*Spurling, G.K., P.R. Mansfield, B.D. Montgomery, et al.,
``Information from Pharmaceutical Companies and the Quality,
Quantity, and Cost of Physicians' Prescribing: A Systematic
Review,'' PLoS Medicine, 7:e1000352, 2010.
4. Cardarelli, R., J.C. Licciardone, and L.G. Taylor, ``A Cross-
Sectional Evidence-Based Review of Pharmaceutical Promotional
Marketing Brochures and Their Underlying Studies: Is What They Tell
Us Important and True?'' BMC Family Practice, 7:13, 2006.
5. Wilkes, M.S., B.H. Doblin, and M.F. Shapiro, ``Pharmaceutical
Advertisements in Leading Medical Journals: Experts' Assessments,''
Annals of Internal Medicine, 116:912-919, 1992.
6. Fassiotto, M., C. Simard, C. Sandborg, et. al, ``An Integrated
Career Coaching and Time-Banking System Promoting Flexibility,
Wellness, and Success: A Pilot Program at Stanford University School
of Medicine,'' Academic Medicine, 93:881-887, 2018.
7. Alison, L., B. Doran, M.L. Long, et. al, ``The Effects of
Subjective Time Pressure and Individual Differences on Hypotheses
Generation and Action Prioritization in Police Investigations,''
Journal of Experimental Psychology. 19:83-93, 2013.
8. Ratneshwar, S. and S. Chaiken, ``Comprehension's Role in
Persuasion: The Case of Its Moderating Effect on the Persuasive
Impact of Source Cues,'' Journal of Consumer Research, 18:52-62,
1991.
9. Moore, D.L., D. Hausknecht, and K. Thamodaran, ``Time
Compression, Response Opportunity, and Persuasion,'' Journal of
Consumer Research, 13:85-99, 1986.
10. Dror, I.E., B. Basola, and J.R. Busemeyer, ``Decision Making
Under Time Pressure: An Independent Test of Sequential Sampling
Models,'' Memory & Cognition, 27:713-725, 1999.
11. Croskerry, P., ``The Cognitive Imperative Thinking About How We
Think,'' Academic Emergency Medicine, 7:1223-1231, 2000.
12. Tsiga, E., E. Panagopoulou, N. Sevdalis, et. al, ``The Influence
of Time Pressure on Adherence to Guidelines in Primary Care: An
Experimental Study,'' BMJ Open, 3:e002700, 2013.
13. Saint, S., D.A. Christakis, S. Saha, et. al, ``Journal Reading
Habits of Internists,'' Journal of General Internal Medicine,
15:881-884, 2000.
14. *Othman, N., A. Vitry, and E.E.
[[Page 34902]]
Roughead, ``Quality of Pharmaceutical Advertisements in Medical
Journals: A Systematic Review,'' PLoS Medicine, 4:e6350, https://doi.org/10.1371/journal.pone.0006350, 2009.
Dated: July 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15350 Filed 7-18-19; 8:45 am]
BILLING CODE 4164-01-P
