Agency Information Collection Activities; Proposed Collection; Comment Request; Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces, 52490-52494 [2018-22569]
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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding, among other
things, a chapter granting FDA authority
to regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 201(rr) of the FD&C Act (21
U.S.C.321(rr)), as amended, defines a
tobacco product as any product made or
derived from tobacco that is intended
for human consumption, including any
component, part, or accessory of a
tobacco product (except for raw
materials other than tobacco used in
manufacturing a component, part, or
accessory of a tobacco product). Section
910 of the FD&C Act (21 U.S.C. 387j)
sets out premarket requirements for new
tobacco products. The term new tobacco
product is defined as any tobacco
product (including those products in
test markets) that was not commercially
marketed in the United States as of
February 15, 2007, or any modification
(including a change in design, any
component, any part, or any constituent,
including a smoke constituent, or in the
content, delivery, or form of nicotine, or
any other additive or ingredient) of a
tobacco product where the modified
product was commercially marketed in
the United States after February 15,
2007 (section 910(a)(1) of the FD&C
Act).
The Tobacco Control Act also gave
FDA the authority to issue a regulation
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b))
of the FD&C Act). On May 10, 2016,
FDA issued that rule, extending FDA’s
tobacco product authority to all
products that meet the definition of
tobacco product in the law (except for
accessories of newly regulated tobacco
products), including electronic nicotine
delivery systems, cigars, hookah, pipe
tobacco, nicotine gels, dissolvables that
were not already subject to the FD&C
Act, and other tobacco products that
may be developed in the future (81 FR
28974 at 28976).
FDA refers to tobacco products that
were commercially marketed (other than
exclusively in test markets) in the
United States as of February 15, 2007,
as grandfathered tobacco products.
Grandfathered tobacco products are not
considered new tobacco products and
are not subject to the premarket
requirements of section 910 of the FD&C
Act. The guidance document provides
information on how a manufacturer may
establish that a tobacco product was
commercially marketed in the United
States as of February 15, 2007. A
grandfathered tobacco product may also
serve as the predicate tobacco product
in a section 905(j) report (intended to be
used toward demonstrating substantial
equivalence) for a new tobacco product
(section 905(j)(1)A)(i) of the FD&C Act
(21 U.S.C. 387e(j)(1)(A)(i))).
The guidance recommends that the
manufacturer submit information
adequate to demonstrate that the
tobacco product was commercially
marketed in the United States as of
February 15, 2007. Examples of such
information may include, but are not
limited to, the following: Dated copies
of advertisements, dated catalog pages,
dated promotional material, and dated
bills of lading.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FD&C Act sections or action
Submit evidence of commercial marketing in the United
States as of February 15, 2007 .......................................
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1 There
Number of
responses per
respondent
1,000
Average
burden per
response
(in hours)
Total
annual
responses
1
1,000
Total hours
5
5,000
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents is based on the fact that
requesting an Agency determination of
the grandfathered status of a tobacco
product under the guidance is not
required and also on the number of
grandfathered submissions received
from 2011 to June 2018. We estimate
submissions have increased due to the
effective date of the deeming rule. FDA
has stated that, for deemed combustible
products that were on the market as of
August 8, 2016, it does not intend to
initiate enforcement for failure to have
premarket authorization until August 8,
2021. FDA has also stated that, for
deemed noncombustible products that
were on the market as of August 2, 2016,
it does not intend to initiate
enforcement for failure to have
premarket authorization until August 8,
2022. When these compliance periods
end, FDA expects a drop in the number
of grandfathered submissions. The
number of hours to gather the evidence
is FDA’s estimate of how long it might
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take one to review, gather, and submit
dated information if making a request
for Agency determination.
FDA further estimates it would take a
manufacturer approximately 5 hours to
put together this collection of evidence
and to submit the package to FDA for
review. FDA estimates that it should
take approximately 5,000 hours
annually to respond to this collection of
information.
Our estimated burden for the
information collection reflects an
overall increase of 4,235 hours. We
attribute this adjustment to an updated
number of submissions received
through this approval and the number of
submissions expected in the next 3
years.
Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22578 Filed 10–16–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3163]
Agency Information Collection
Activities; Proposed Collection;
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) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
SUMMARY:
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information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled ‘‘Physician
Interpretation of Information About
Prescription Drugs in Scientific
Publications vs. Promotional Pieces.’’
This study will examine important
public health issues in professionally
directed prescription drug print
promotion.
Submit either electronic or
written comments on the collection of
information by December 17, 2018.
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 December 17,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 17, 2018.
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.
DATES:
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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
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
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
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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–
2018–N–3163 for ‘‘Physician
Interpretation of Information About
Prescription Drugs in Scientific
Publications vs. Promotional Pieces.’’
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
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
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
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
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52491
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10:00 a.m.–12:00 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
For copies of the questionnaire
contact: Office of Prescription Drug
Promotion (OPDP) Research Team,
DTCresearch@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
‘‘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 (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Physician Interpretation of Information
About Prescription Drugs in Scientific
Publications Versus 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
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FDA to conduct research relating to
drugs and other FDA regulated products
in carrying out the provisions of the
FD&C Act. Under the FD&C Act and
implementing regulations, promotional
labeling and advertising about
prescription drugs are generally
required to be truthful, non-misleading,
and to reveal facts material to the
presentations made about the product
being promoted (see FD&C Act section
201(n) and 502(a) and (n) (21 U.S.C.
321(n) and 352(a) and (n)); see also 21
CFR 202.1). 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). This
will contribute to the body of
knowledge on perceptual influences,
including information summarized
below.
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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 quality. 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
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materials: They reported less
willingness to prescribe the drugs or
read the full study from trials funded by
industry, regardless of study quality.
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 advertisement in medical
journals found 80 percent of the ads
contained some type of image and 21
percent contained 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.
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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). Moreover, one
study that assessed the reading habits of
physicians found that given the limited
time available for critical reading, these
practitioners relied heavily on abstracts
and prescreening of articles by editors to
ensure they received rigorous and useful
information (Ref. 13). Thus, time
pressure is an element of physicians’
practice environment that can impact
decision making and, consequently,
quality of healthcare 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, 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 ......................................
Unlimited Time to Read ..................................
1 As
Methodological Rigor 1 ....................................
....................................................................
....................................................................
....................................................................
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.
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. With the
sample size described in this document,
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 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 1 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. In the pretest,
participants will also answer questions
about the study design and
questionnaire.
This study will be conducted as part
of the research program of FDA’s Office
of Prescription Drug Promotion (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
healthcare 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.
Because we recognize the strength of
data and the confidence in the robust
nature of the findings are improved
through the results of multiple
converging studies, we continue to
develop evidence to inform our
thinking. We evaluate the results from
our studies within the broader context
of research and findings from other
sources, and this larger body of
knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
homepage, which can be found at:
https://www.fda.gov/aboutfda/centers
offices/officeofmedicalproducts
andtobacco/cder/ucm090276.htm. The
website includes links to the latest
Federal Register documents and peerreviewed publications produced by our
office. The website maintains
information on studies we have
conducted, dating back to a direct-toconsumer survey conducted in 1999.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
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Number of
Responses
per
Respondent
Number of
respondents
Activity
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
Average
burden per
response
0.03
0.03
0.33
0.33
(2 minutes) ...............................
(2 minutes) ...............................
(20 minutes) .............................
(20 minutes) .............................
6
21
53
187
...........................................................
267
There are no capital costs or operating and maintenance costs associated with this collection of information.
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Total
hours
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III. References
The following references are on
display with the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; these are not available
electronically at https://
www.regulations.gov, as these references
are copyright protected. 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 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
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
Prioritization in Police Investigations,’’
Journal of Experimental Psychology.
Applied, 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., J.R. Busemeyer, and B. Basola,
‘‘Decision Making Under Time Pressure:
An Independent Test of Sequential
Sampling Models,’’ Memory & Cognition,
27:713–725, 1999.
11. Croskerry, P., ‘‘The Cognitive Imperative:
VerDate Sep<11>2014
19:46 Oct 16, 2018
Jkt 247001
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.
Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22569 Filed 10–16–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Immune System, Brain, and the
Visual System.
Date: November 2, 2018.
Time: 9:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alessandra C Rovescalli,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205
MSC7846, Bethesda, MD 20892, (301) 435–
1021, rovescaa@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cell Biology.
Date: November 5, 2018.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Thomas Y Cho, Ph.D.,
Scientific Review Officer, Center for
PO 00000
Frm 00119
Fmt 4703
Sfmt 4703
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, 301–402–4179,
thomas.cho@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Conflicts in
Gastrointestinal Immunology and Diseases.
Date: November 6, 2018.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Jonathan K Ivins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2190,
MSC 7850, Bethesda, MD 20892, (301) 594–
1245, ivinsj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Conflicts in
Integrative Gastroenterology.
Date: November 7, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Jonathan K Ivins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2190,
MSC 7850, Bethesda, MD 20892, (301) 594–
1245, ivinsj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cell Biology.
Date: November 8, 2018.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Jessica Smith, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, jessica.smith6@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Shared
Instrumentation for Genomics Research.
Date: November 8, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Methode Bacanamwo,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2200,
Bethesda, MD 20892, 301–827–7088,
methode.bacanamwo@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Biological Chemistry and
Macromolecular Biophysics Chemistry.
Date: November 9, 2018.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\17OCN1.SGM
17OCN1
]]>Agencies
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52490-52494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22569]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3163]
Agency Information Collection Activities; Proposed Collection;
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of
[[Page 52491]]
information and to allow 60 days for public comment in response to the
notice. This notice solicits comments on research entitled ``Physician
Interpretation of Information About Prescription Drugs in Scientific
Publications vs. Promotional Pieces.'' This study will examine
important public health issues in professionally directed prescription
drug print promotion.
DATES: Submit either electronic or written comments on the collection
of information by December 17, 2018.
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 December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 17, 2018. 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 solely responsible for ensuring that your comment
does not include any 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 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-2018-N-3163 for ``Physician Interpretation of Information About
Prescription Drugs in Scientific Publications vs. Promotional Pieces.''
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 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on 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 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/2015-23389.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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10:00 a.m.-12:00
p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
For copies of the questionnaire contact: Office of Prescription
Drug Promotion (OPDP) Research Team, [email protected].
SUPPLEMENTARY INFORMATION: 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.
``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 (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Physician Interpretation of Information About Prescription Drugs in
Scientific Publications Versus 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
[[Page 52492]]
FDA to conduct research relating to drugs and other FDA regulated
products in carrying out the provisions of the FD&C Act. Under the FD&C
Act and implementing regulations, promotional labeling and advertising
about prescription drugs are generally required to be truthful, non-
misleading, and to reveal facts material to the presentations made
about the product being promoted (see FD&C Act section 201(n) and
502(a) and (n) (21 U.S.C. 321(n) and 352(a) and (n)); see also 21 CFR
202.1). 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). This will contribute to the body
of knowledge on perceptual influences, including information summarized
below.
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 quality. 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
quality. 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 advertisement in medical journals found 80 percent of the
ads contained some type of image and 21 percent contained 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). Moreover, one study that
assessed the reading habits of physicians found that given the limited
time available for critical reading, these practitioners relied heavily
on abstracts and prescreening of articles by editors to ensure they
received rigorous and useful information (Ref. 13). Thus, time pressure
is an element of physicians' practice environment that can impact
decision making and, consequently, quality of healthcare 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, 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 52493]]
Table 1--Study Design
----------------------------------------------------------------------------------------------------------------
Information context
--------------------------------------------------
Sales aid Sales aid with
Medical journal without graphic graphic design
abstract design elements elements \2\
----------------------------------------------------------------------------------------------------------------
Limited Time to Read.......... Methodological High
Rigor \1\.
................. 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. With the sample size described in this document,
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 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 1 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. In the pretest, participants
will also answer questions about the study design and questionnaire.
This study will be conducted as part of the research program of
FDA's Office of Prescription Drug Promotion (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 healthcare 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.
Because we recognize the strength of data and the confidence in the
robust nature of the findings are improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our 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 documents and peer-
reviewed publications produced by our office. The website maintains
information on studies we have conducted, dating back to a direct-to-
consumer survey conducted in 1999.
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 Total hours
respondents Respondent responses per response
----------------------------------------------------------------------------------------------------------------
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 53
minutes).
Completes, Main Study......... 566 1 566 0.33 (20 187
minutes).
---------------------------------------------------------------------------------
Total..................... 1,621 .............. 1,621 ................ 267
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 52494]]
III. References
The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov, as these
references are copyright protected. 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. Applied, 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., J.R. Busemeyer, and B. Basola, ``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.
Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22569 Filed 10-16-18; 8:45 am]
BILLING CODE 4164-01-P
