[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


