[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27268-27271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0558]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Disclosures in Professional and Consumer Prescription 
Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on research entitled, ``Disclosures in 
Professional and Consumer Prescription Drug Promotion.''

DATES: Submit either electronic or written comments on the collection 
of information by August 14, 2017.

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 August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 14, 2017. 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2017-N-0558 for ``Disclosures in Professional and Consumer 
Prescription Drug Promotion.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management 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

[[Page 27269]]

redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezzuto, Office of 
Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-
14526, Silver Spring, MD 20993-0002, 301-796-3794, 
[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.

Disclosures in Professional and Consumer Prescription Drug Promotion--
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(b)(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.
    FDA regulates prescription drug promotion directed to healthcare 
professionals (HCPs) and consumers (section 502(n) of the FD&C Act (21 
U.S.C. 352(n)). In the course of promoting their products, 
pharmaceutical sponsors (sponsors) may present a variety of information 
including the indication, details about the administration of the 
product, efficacy information, and clinical trial data. In an effort to 
present often complicated information concisely, sponsors may not 
include relevant information in the body of the text or visual display 
of the claim. Additionally, sponsors may not always present limitations 
to the claim in the main body of the text or display. In these cases, 
sponsors typically include disclosures of information somewhere in the 
promotional piece.
    There is little or no published research on disclosures in 
prescription drug promotion, either directed to consumers or to HCPs. 
Previous research on the effectiveness of disclosures has been 
conducted primarily in the dietary supplement arena (Refs. 1-4). Thus, 
the proposed research will examine the effectiveness of clear and 
conspicuous disclosures in prescription drug promotion directed to both 
of these populations. The purpose of our study is to determine how 
useful disclosures regarding prescription drug information are when 
presented prominently and adjacent to claims.\1\ Specifically, are HCPs 
and consumers able to use disclosures to effectively frame information 
in efficacy claims in prescription drug promotion?
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    \1\ The Federal Trade Commission (FTC), which regulates the 
advertising of non-prescription drug products as well as other non-
FDA regulated products (e.g., package goods, cars, etc.), issued a 
specific position on disclosures (Ref. 5) for the advertising it 
regulates. Specifically, FTC explains that disclosures must be 
``clear and conspicuous''; in other words, in understandable 
language, located near the claim to be further clarified, and not 
hidden or minimized by small font or other distractions.
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    To address this research question, we have designed a set of 
studies that cover both consumers and HCPs, as well as three different 
types of claims: Scope of treatment, ease of use, and statistical 
significance (see table 1). The scope of treatment claim can be thought 
of as a disease-awareness claim; that is, a broader discussion of a 
medical condition that may include disease characteristics beyond what 
the promoted drug has been shown to treat, followed by a disclosure of 
this nature. The ease of use claim is a simple claim of easy drug 
administration that omits specific important details that contribute to 
a more difficult drug administration than suggested. Finally, the 
statistical significance claim will be

[[Page 27270]]

one in which the disclosure reveals that the presented analyses were 
not statistically significant, and thus must be viewed with 
considerable caution.

                       Table 1--Identical Study Designs for Samples of HCPs and Consumers
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                                                                  Level of disclosure
            Type of claim             --------------------------------------------------------------------------
                                                 Weak                     Strong                  Control
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                                                  Study A: HCPs
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Scope of Treatment...................  Evidence Only...........  Evidence + Conclusion...  None.
Ease of Use..........................  Evidence Only...........  Evidence + Conclusion...  None.
Statistical Significance.............  Evidence Only...........  Evidence + Conclusion...  None.
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                                               Study B: Consumers
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Scope of Treatment...................  Evidence Only...........  Evidence + Conclusion...  None.
Ease of Use..........................  Evidence Only...........  Evidence + Conclusion...  None.
Statistical Significance.............  Evidence Only...........  Evidence + Conclusion...  None.
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    Each participant will view three different mock promotional print 
pieces for different prescription drug products. For each of the three 
promotional pieces, they will be randomized to see an ad with a weak 
disclosure, a strong disclosure, or no disclosure. We will manipulate 
the strength of disclosure by including additional concluding 
information (strong) or not (weak) in the disclosure statement. In all 
cases, disclosures will be adjacent to claims and written in font clear 
enough to be detected.
    Technically speaking, these designs can be viewed as 3 within-
subjects 1 x 3 designs with level of disclosure as a between subject 
factor. In other words, we will analyze the results of the scope of 
treatment disclosures independently of the ease of use disclosures and 
statistical significance disclosures, even though each participant will 
see one of each. The claims and disclosures are different enough that 
practice effects should be moderated, but we will counterbalance the 
order of ads shown to minimize potential bias.
    Because promotional pieces intended for HCPs and consumers have 
different levels of complexity and medical depth, and because the 
amount of knowledge expected between the two groups differs, the 
studies will use separate mock promotional pieces and ask slightly 
different comprehension questions of each group. We will maintain as 
much similarity across groups as possible for descriptive comparisons.
    Both consumers and HCPs will be recruited from Internet panels. 
Because promotional pieces will represent three different medical 
conditions, we will obtain a general population sample of consumers and 
a HCP sample of primary care physicians. Eligible participants who 
agree to participate will view mock promotional pieces and answer 
questions about their comprehension of the main messages in the 
promotion, perceptions of the product, attention to disclosures and 
intention to ask a HCP about it (consumers) or to prescribe the product 
(HCPs). Questionnaires are available upon request.
    Pretests will be conducted before conducting the main studies in 
order to ensure the mock promotional pieces are realistic and that the 
questionnaire flows well and questions are reasonable. We will 
supplement the findings of the pretests with two small eye-tracking 
studies. Researchers use eye-tracking technology to capture viewing 
behavior that is independent of self-report. The technology measures 
where and for how long participants glanced at or examined particular 
parts of a display. It has been used in studies of consumer print 
advertising (Refs. 6-8) and Internet promotion (Refs. 9-10). To our 
knowledge, there is little or no published research using eye-tracking 
technology with HCPs.
    We will use these small eye-tracking studies to determine what 
parts of each promotional piece consumers and HCPs actually viewed. 
Specifically, we will be able to determine whether they looked at the 
disclosure statement at all, and we can obtain a rough idea of how long 
they looked at it. This data will complement the self-reported items on 
the questionnaire. Moreover, we will use this data, as well as the 
pretest data, to improve the main studies. For this part of the study, 
20 consumers and 20 HCPs will view the promotional pieces.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                Activity \1\                     Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses                                                      \2\
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                                                                        Consumers
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Pretest Screener............................             833               1             833  .03 (2 min.)..............................              25
Pretest.....................................             500               1             500  0.33 (20 min.)............................             165
Eye-Tracking Screener.......................              80               1              80  .08 (5 min.)..............................               7
Eye-Tracking Study..........................              20               1              20  1.........................................              20
Main Study Screener.........................           2,500               1           2,500  .03 (2 min.)..............................              75
Main Study..................................           1,500               1           1,500  0.33 (20 min.)............................             495
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                                                                          HCPs
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Pretest Screener............................             735               1             735  .03 (2 min.)..............................              22

[[Page 27271]]

 
Pretest.....................................             500               1             500  0.33 (20 min.)............................             165
Eye-Tracking Screener.......................              80               1              80  .08 (5 min.)..............................               7
Eye-Tracking Study..........................              20               1              20  1.........................................              20
Main Study Screener.........................           2,206               1           2,206  .03 (2 min.)..............................              67
Main Study..................................           1,500               1           1,500  0.33 (20 min.)............................             495
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    Total...................................  ..............  ..............  ..............  ..........................................           1,563
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the next full hour.

References

1. Dodge, T. and A. Kaufman. ``What Makes Consumers Think Dietary 
Supplements Are Safe and Effective? The Role of Disclaimers and FDA 
Approval.'' Health Psychology, 26(4), 513-517. (2007).
2. Dodge, T., D. Litt, and A. Kaufman. ``Influence of the Dietary 
Supplement Health and Education Act on Consumer Beliefs About the 
Safety and Effectiveness of Dietary Supplements.'' Journal of Health 
Communication: International Perspectives. 16(3), 230-244. (2011).
3. Mason, M.J., D.L. Scammon, and X. Feng. ``The Impact of Warnings, 
Disclaimers and Product Experience on Consumers' Perceptions of 
Dietary Supplements.'' Journal of Consumer Affairs, 41(1), 74-99. 
(2007).
4. France, K.R. and P.F. Bone. ``Policy Makers' Paradigms and 
Evidence from Consumer Interpretations of Dietary Supplement 
Labels.'' Journal of Consumer Affairs, 39(1), 27-51. (2005).
5. FTC. ``Full Disclosure.'' Accessed at: https://www.ftc.gov/news-events/blogs/business-blog/2014/09/full-disclosure (September 23, 
2014).
6. Higgins, E., M. Leinenger, and K. Rayner. ``Eye Movements When 
Viewing Advertisements.'' Frontiers in Psychology, 5, 210. (2014).
7. Pieters, R., M. Wedel, and R. Batra. ``The Stopping Power of 
Advertising: Measures and Effects of Visual Complexity.'' Journal of 
Marketing, 74(5), 48-60. (2010).
8. Thomsen, S. and K. Fulton. ``Adolescents' Attention to 
Responsibility Messages in Magazine Alcohol Advertisements: An Eye-
Tracking Approach.'' Journal of Adolescent Health, 41, 27-34. 
(2007).
9. Simola, J., J. Kuisma, A. [Ouml][ouml]rni, L. Uusitalo, et al. 
``The Impact of Salient Advertisements on Reading and Attention on 
Web pages.'' Journal of Experimental Psychology: Applied, 17(2), 
174-190. (2011).
10. Wedel, M. and R. Pieters. ``A Review of Eye-Tracking Research in 
Marketing.'' In Review of Marketing Research, Vol. 4 (pp. 123-147), 
N.K. Malhotra (Ed.). Armonk, New York: M.E. Sharpe. (2008).

    Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12329 Filed 6-13-17; 8:45 am]
 BILLING CODE 4164-01-P