[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85968-85972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0735]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Superimposed Text in 
Direct-to-Consumer Promotion of Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 29, 2016.

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 nd 
title Superimposed Text in Direct-to-Consumer Promotion of Prescription 
Drugs. Also include the FDA docket

[[Page 85969]]

number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

Superimposed Text in Direct-to-Consumer Promotion of Prescription 
Drugs--OMB Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes the FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (the 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 proposed study seeks to extend previous research on the effects 
of superimposed text (supers) in advertising to today's modern direct-
to-consumer (DTC) pharmaceutical promotion. Although earlier research 
on the effects of supers in other consumer settings suggests that 
altering text size can influence consumer comprehension of information, 
it is unclear if these findings extend to DTC promotion of prescription 
drugs and are applicable over 20 years later when viewing promotional 
materials using today's modern technologies (e.g., tablets). Moreover, 
other factors such as text/background contrast may also influence both 
the understanding of the superimposed information (Ref. 1) and the 
effects of text size. The proposed research seeks to update these 
earlier findings and also to answer new questions concerning 
presentation of supers.
    Part of FDA's public health mission is to ensure the safe use of 
prescription drugs; therefore it is important that the information 
provided in DTC promotion is clear and understandable for consumer 
audiences, avoids use of deceptive or misleading claims, and achieves 
``fair balance'' in presentation of benefits and risks. For example, 
varying presentation formats including type size, bulleting, amount of 
white space, and use of ``chunking'' or headlines can all influence 
consumer perceptions of information (Ref. 2). A systematic review of 
presentation formats in prescription drug labeling found that these 
``clear communication'' characteristics positively influenced 
consumer's comprehension of information and prescription drug behaviors 
(i.e., adherence) (Ref. 3). In one randomized controlled study, young 
and older adults were presented with 12 otherwise identical over-the-
counter drugs bottled with varied container labels along various 
dimensions, one of which was text size (7 vs 10 point). While younger 
participants performed equally well with both font sizes, elderly 
populations had significantly reduced recall and comprehension when 
exposed to the smaller text size (Ref. 4). Another study found that 
both young and older populations preferred the larger text size, and 
that patients read labels with larger font more rapidly and accurately 
than labels with smaller font (Ref. 5). Although these studies were 
specific to prescription drug container labels, it is plausible that 
the effects of font sizes would be applicable to drug promotion.
    Some early research in the late 1980s and 1990s examined the size 
of text information in advertising topics outside of prescription drugs 
(Refs. 6, 7, and 8). These studies all generally found that text size 
was associated with comprehension, such that larger text sizes 
increased understanding of the material (and, conversely, smaller text 
sizes interfered with comprehension). For example, Foxman and 
colleagues (Ref. 6) found that whereas ``small'' text size (<\1/2\ inch 
size) was associated with accurate comprehension for 59% of 
respondents, ``large'' text size (>\1/2\ inch size) was associated with 
comprehension for 79% of respondents. Studies by other researchers 
(Refs. 7 and 8) found similar patterns such that increasing the text 
size of supers generally corresponded with increased comprehension.
    We know of no studies that have examined other commonly variable 
factors, such as text/background contrast, that may interact with text 
size to influence comprehension. Early research on text readability 
determined that the contrast between text and background has a 
consistent but small effect. Specifically, while the contrast of color 
has a small effect (Ref. 9), the contrast in brightness, or luminance, 
makes the largest difference (Ref. 10). These studies showed that black 
text on a white background results in the highest readability (Ref. 
11), but that other effects of color contrasts are unclear (Ref .1). 
Some studies have demonstrated that contrast interacts with text size, 
such that contrast becomes a more important discriminator as the text 
size decreases (Ref. 12).
    The earlier research on supers is limited in their applicability to 
today's DTC promotion in several ways. None of these studies 
specifically focused on prescription drug promotion, but rather 
explored the effects of superimposed text in a variety of social and 
consumer advertising contexts. Another limitation is that these earlier 
studies were conducted with populations (i.e., undergraduate students) 
that are not representative of today's prescription drug users. It is 
not clear if the effects of supers would translate to older adult 
populations, who represent the greatest proportion of prescription drug 
users (Ref. 13). Perhaps most importantly, it is unknown if the effects 
of supers would be found today, considering the prevalent use of modern 
technologies, including large (40+ inches) TV screens and personal 
tablets. Our proposed study seeks to address these unanswered questions 
regarding the use of supers in prescription drug promotion.

General Research Questions

    1. Does the size of the superimposed text, the contrast behind the 
superimposed text, and/or the device type influence the noticeability, 
recall, and perceived importance of the super information?
    2. Does the size of the superimposed text, the contrast behind the 
superimposed text, and/or the device type influence the recall of and 
attitudes toward the promoted drug?
    3. Are there any interaction effects among any combination of 
independent variables?

Design

    To test these research questions, we will conduct one randomized 
controlled study. We will examine reactions to supers in a fictitious 
DTC prescription drug promotional video on two types of viewing devices 
with a general population sample. The study design will be a 3 x 2 x 2 
factorial design, where participants are randomly assigned to one of 12 
experimental study arms differentiated by:
     Super text size (small, medium, large);
     Device type (television, tablet);
     Super text contrast (high, low).

[[Page 85970]]



                                                      Table 1--Design and Cell Sizes for Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
               Device type                                      TV                                            Tablet
-----------------------------------------------------------------------------------------------------------------------------------------      Total
               Super size                      Small          Medium           Large           Small          Medium           Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contrast:
    High................................             106             106             106             106             106             106             636
    Low.................................             106             106             106             106             106             106             636
                                         ---------------------------------------------------------------------------------------------------------------
        Total...........................             212             212             212             212             212             212           1,272
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The sample will be split evenly across three cities (Los Angeles, CA; Cincinnati, OH; and Tampa, FL), with 424 participants per city.

    For both the pretest and main study, we will work with two market 
research firms to recruit adult participants and conduct in-person data 
collection in three U.S. cities: Los Angeles, CA, Cincinnati, OH, and 
Tampa, FL. In addition to our aim for regional variation, we selected 
these three cities with the aim of recruiting a sample that is diverse 
on gender, race/ethnicity, education, and age characteristics.
    Participants from the general population will be invited to a 
market research facility to watch one video for a fictional 
prescription drug that treats asthma. In-person administration of study 
procedures will enable us to control the television and tablet watching 
experience in terms of size, distance, and other variables. 
Participants will watch the video twice and then answer questions 
addressing recall of risks and benefits, perceptions of risks and 
benefits, and questions regarding the salience of information in text. 
The questionnaire is available upon request. Participation is estimated 
to take approximately 20 minutes.
    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance 
(ANOVA).
    Pretesting will take place before the main study to select super 
sizes for the main study and to evaluate the procedures and measures 
that will be used. We will exclude individuals who work in healthcare 
or marketing settings because their knowledge and experiences may not 
reflect those of the average consumer. We conducted a priori power 
analyses to determine sample sizes for the pretest and the main study.
    In the Federal Register of March 9, 2016 (81 FR 12503), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received 10 comments total. Six comments 
were outside the scope of the proposed research (``Ban DTC''), leaving 
four substantive comments.
1. Abbvie
    a. Comment: Mobile users can change font size and viewing size--we 
should incorporate this into our study.
    Response: Although the font size for certain text (such as 
newspaper articles) or closed captioning text size can be changed on a 
tablet, supers within a developed video cannot be manipulated. 
Participants will be allowed to hold the tablet as they normally would, 
but it is important to establish experimental control over many user 
settings to avoid threats to internal validity. Thus, font and viewing 
size will be standardized for this study.
    b. Comment: Recommend looking at use of TV and mobile devices 
concurrently, as some people use them this way.
    Response: This is a good suggestion for future research, but is out 
of scope for the current study.
2. Lilly
    a. Comment: Generally supportive; research objectives and study 
approach are reasonable.
    Response: Thank you.
    b. Comment: Recommend showing supers in black box at bottom of the 
screen and not superimposing them over moving, contrasting color field 
to mimic common practices in television commercial advertising.
    Response: Our high contrast condition indeed presents the supers in 
white font on a black background at the bottom of the screen. Our low 
contrast condition shows lettering over the moving scenes because not 
all advertisements show their supers in a black banner.
    c. Comment: Lilly requests clarity about how the size of text and 
level of contrast were developed when the agency reports the results of 
the study.
    Response: We used cognitive interviews and will use the pretest to 
make these determinations. We will be sure to include this information 
when we report the results of the study.
    d. Comment: Recommend qualitative pre-test instead of quantitative 
pretest.
    Response: We fulfilled this suggested purpose with a set of nine 
cognitive interviews that were conducted in April.
    e. Comment: Request clarity about quota sampling and other 
techniques we may plan to use to ensure a diverse sample. Also suggest 
groups of at least 50 in each cell for analysis purposes.
    Response: As this study is not intended to be nationally 
representative, we will not employ strict quota sampling procedures. 
However, we will work closely with our recruitment firms to monitor 
recruitment and ensure that our sample is diverse with regard to 
factors including race, education, age and gender. Further, selection 
of our three U.S. cities for data collection (Los Angeles, Cincinnati 
and Tampa) was purposive to help achieve diversity on these factors.
    To answer the second part of the comment, we are aware of no 
statistical or research standard that specifies that groups must 
contain 50 individuals. However, we conducted power analyses and 
determined that in order to have enough power for the proposed 
statistical tests, we will exceed this number per experimental cell.
    f. Comment: Recommends replacing the pre-test question about the 
importance of the text information (Question 5) with a question such as 
``how noticeable or legible was the text information?''
    Response: We agree that the noticeability and legibility of the 
text information is important, and we have other questions that address 
this. We are specifically interested in the perceived importance of the 
text information as a moderator variable.
    g. Comment: Recommends removing semantic differential questions 
(Question 9) and essentially any questions that ask about perceptions 
because it is a pretest.
    Response: Our pretest study is not designed to test the main study 
questionnaire. Rather, the main purposes of the pretest are to (1) test 
consumer perceptions of superimposed-text size with the aim of choosing 
perceptibly different levels of size (small, medium, large) for use in 
the main study; and (2) test our planned

[[Page 85971]]

procedures for implementation of the intervention (TV and tablet) and 
in-person data collection. However, to make the most use of our 
resources, we also plan to test the properties of certain main study 
survey items (e.g., means, ranges, etc.) to ensure the utility of the 
items for use in the main study.
    h. Comment: Calls out an inconsistency in terms of how many times 
participants will view the ad.
    Response: Thank you for noting that discrepancy. Participants will 
view the ad once. We have corrected all materials to reflect this 
change. Lilly recommends showing it twice. We agree that if the goal is 
to learn about user experience (preferences and such, or trying to 
improve the presentation) then two or more viewings makes sense. 
However, our goal is to test differences in cognitive processing based 
on the varied size/contrast presentations of the supers. Thus, we do 
not want to artificially enhance the scrutiny participants pay to the 
ad above and beyond the experimental situation. For example, small 
supers may interfere with cognitive processing as hypothesized, but 
this interference may be overcome upon a second viewing. In a real 
world viewing situation, consumers rarely see an ad two times in a row.
    i. Comment: Question 12: Attributes are very similar and will be 
duplicative.
    Response: The three survey items for question 12 (attitudes towards 
the ad) are conceptually similar and will be used as a multi-item 
scale. Conventionally, three items is the minimum recommended to assess 
inter-item reliability.
    j. Comment: Question 12 and 14: Suggest bolding or underlining 
``drug'' or ``ad'' in these questions to differentiate them for 
participants.
    Response: We agree and have added language to the survey items to 
better make this distinction. For items specific to attitudes towards 
the drug we now begin the item with ``Overall, DRUG X is . . .'' 
whereas items about the ad begin with ``Overall, the ad was . . .''
    k. Comment: Would be interesting to include an open-ended question 
about whether any additional information could have or should have been 
provided in the ad, such as accessibility to the drug, information 
about the disease, etc.
    Response: These are great ideas and would provide additional 
information about various communication issues relevant to DTC 
television promotion. However, we regret that we must make difficult 
choices about what to include and not include in this study and these 
issues fall outside the scope of the current research questions.
3. Merck
    a. Comment: FDA's execution may not yield useful data. For example, 
we are examining TV and tablet use, but people may be viewing promotion 
on mobile devices.
    Response: We agree that the ways in which people view their media 
are multiplying and that we have not captured all of them. However, 
rather than simply study superimposed text on a television screen, we 
opted to add an examination of viewing on a tablet, which is an 
increasingly popular option for viewing shows. We regret that we do not 
have the opportunity to explore viewing on all possible new 
technologies, but we believe that the current study will offer insights 
above and beyond the television screen.
    b. Comment: Prior to the implementation of results from individual 
studies on the content, format, and presentation of information in DTC 
advertisements on television, FDA should conduct research on the 
combination of all of the individual factors.
    Response: This comment is outside the scope of the present project. 
It is not directed at the improvement of the study and does not appear 
to require the abandonment of the current study.
4. GlaxoSmithKline (GSK)
    a. Comment: Allowing participants to view the TV at the distance 
they usually view it and to interact with the tablet the way they 
ordinarily do would better reflect a real-world experience.
    Response: We agree that these details are important to consider 
when conducting valid research. We must make a decision between the 
trade-off of experimental control and real-world generalizability. We 
have attempted to do this by setting up the television and chair in the 
room at the average distance that people tend to sit from their 
televisions in their living room and instructing participants to wear 
glasses or contact lenses if needed. Television viewing is a more fixed 
experience than more modern technologies. We also agree that allowing 
individuals to hold the tablet or place it on a table as they normally 
would is appropriate for both experimental control and ecological 
generalizability.
    b. Comment: Including a medium contrast instead of just a high and 
low contrast may be informative.
    Response: We appreciate this comment because we considered it when 
designing the study. We decided to use only high and low contrast in 
the study because our main variable of interest in this particular 
study is the size of the text. Thus, we are expending resources to 
attempt to determine multiple sizes of text to test in order to get a 
fuller appreciation of the role of text size in DTC promotion. We have 
found in past studies that identifying a medium level is difficult 
(e.g., OMB Control No. 0910-0695) and chose in this study to focus on 
size rather than contrast. That said, we do feel that contrast is 
valuable enough to add as a variable of interest, so we are planning to 
devote two conditions to it.
    c. Comment: It would be useful if the questionnaire is posted along 
with the notice on regulations.gov.
    Response: We are happy to provide the questionnaire to anyone who 
requests it.
    d. Comment: Suggests an FDA-Industry working group might be helpful 
in the furtherance of this research.
    Response: This is an intriguing idea and may have merit after we 
obtain empirical data that is specifically applicable to DTC promotion. 
Without this data, it is unclear what this working group would 
contribute. We will consider this idea in further detail upon 
interpretation of results.
    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  (in hours)     Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Pretesting
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to complete the screener (assumes 50%             338               1             338  0.08 (5 minutes)..........................              27
 eligible).

[[Page 85972]]

 
Number of completes.........................             240               1             240  0.42 (25 minutes).........................             101
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to complete the screener (assumes 50%           1,785               1           1,785  0.08 (5 minutes)..........................             143
 eligibility).
Number of completes.........................           1,272               1           1,272  0.42 (25 minutes).........................             534
                                             -----------------------------------------------------------------------------------------------------------
    Total hours.............................  ..............  ..............  ..............  ..........................................             805
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

References

    The following references are on display in the Division of Dockets 
Management (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 are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Hall R.H. and P. Hanna ``The Impact of Web page Text-background 
Colour Combinations on Readability, Retention, Aesthetics, and 
Behavioural Intention.'' Behavior & Information Technology. vol. 23 
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2. Baur C and C. Prue ``The CDC Clear Communication Index is a Tool 
to Prepare and Review Health Information.'' Health Promotion 
Practice. vol.15 pp. 629-37, 2014.
3. Shrank W, J. Avorn, C. Rolon, and P.Shekelle ``Effect of Content 
and Format of Prescription Drug Labels on Readability, 
Understanding, and Medication Use: A Systematic Review.'' Annals of 
Pharmacotherapy. vol. 41 pp. 783-801, 2007.
4. Wogalter, M.S. and W.J. Vigilante. ``Effects of Label Format on 
Knowledge Acquisition and Perceived Readability by Younger and Older 
Adults.'' Ergonomics. vol. 46 pp. 327-344, 2003.
5. Smither, J.A.A. and C.C. Braun ``Readability of Prescription Drug 
Labels by Older and Younger Adults.'' Journal of Clinical Psychology 
in Medical Settings. vol. 1 pp. 149-59, 1994.
6. Foxman, E.R., D.D. Muehling and P.A. Moore. ``Disclaimer 
Footnotes in Ads: Discrepancies Between Purpose and Performance.'' 
Journal of Public Policy and Marketing. vol. 7 pp. 127-37, 1988.
7. Murray N.M., L.A. Manrai and A.K. Manrai. ``Public Policy 
Relating to Consumer Comprehension of Television Commercials: A 
Review and Some Empirical Results.'' Journal of Consumer Policy. 
vol. 16 pp. 145-170, 1993.
8. Manrai, L.A., A.K. Manrai and N. Murray. ``Comprehension of Info-
aid Supers in Television Advertising for Social Ideas: Implications 
for Public Policy''. Journal of Business Research. vol. 30 pp. 75-
84, 1994.
9. Hill A. and L. Scharff. ``Readability of Computer Displays as a 
Function of Colour, Saturation, and Background Texture.'' In D. 
Harns (Ed.) Engineering Psychology and Cognitive Ergonomics (vol. 4) 
Ashgate, Aldershot, United Kingdom.
10. Shieh K-K. and C-C. Lin. ``Effects of Screen Type, Ambient 
Illumination, and Color Combination on VDT Visual Performance and 
Subjective Preference.'' International Journal of Industrial 
Ergonomics. vol. 26 pp. 527-36, 2000.
11. Tinker M.A. and D.G. Paterson. ``Studies of Typographical 
Factors Influencing Speed of Reading. VII. Variations in Color of 
Print and Background.'' Journal of Applied Psychology. vol. 15 pp. 
471-9, 1931.
12. Legge G.E., G.S. Rubin and A. Luebner ``Psychophysics of 
reading. V. The Role of Contrast in Normal Vision.'' Vision Research 
vol. 27 pp. 1165-77, 1987.
13. Kaufman D.W., J.P. Kelly, L. Rosenberg, T.E. Anderson and A.A. 
Mitchell. ``Recent Patterns of Medication Use in the Ambulatory 
Adult Population of the United States: The Slone Survey.'' Journal 
of the American Medical Association vol. 287 pp. 337-344, 2002.

    Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28733 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P