Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosures in Professional and Consumer Prescription Drug Promotion, 27268-27271 [2017-12329]
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Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
NEUROPACE RNS SYSTEM is 3,796
days. Of this time, 2,694 days occurred
during the testing phase of the
regulatory review period, while 1102
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360j(g)) involving this device
became effective: June 26, 2003. FDA
has verified the applicant’s claim that
the date the investigational device
exemption (IDE) required under section
520(g) of the FD&C Act for human tests
to begin became effective was June 26,
2003.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): November 9, 2010.
FDA has verified the applicant’s claim
that the premarket approval application
(PMA) for NEUROPACE RNS SYSTEM
(PMA P100026) was initially submitted
November 9, 2010.
3. The date the application was
approved: November 14, 2013. FDA has
verified the applicant’s claim that PMA
P100026 was approved on November
14, 2013.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
the applicant seeks 5 years of patent
term extension.
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III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES and
ADDRESSES) and contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
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305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12322 Filed 6–13–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
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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
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Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices
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: https://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, PRAStaff@
fda.hhs.gov.
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
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SUPPLEMENTARY INFORMATION:
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?
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
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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Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices
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
Level of disclosure
Type of claim
Weak
Strong
Control
Study A: HCPs
Scope of Treatment ....................................
Ease of Use ................................................
Statistical Significance ................................
Evidence Only ...........................................
Evidence Only ...........................................
Evidence Only ...........................................
Evidence + Conclusion ..............................
Evidence + Conclusion ..............................
Evidence + Conclusion ..............................
None.
None.
None.
Evidence + Conclusion ..............................
Evidence + Conclusion ..............................
Evidence + Conclusion ..............................
None.
None.
None.
Study B: Consumers
Scope of Treatment ....................................
Ease of Use ................................................
Statistical Significance ................................
Evidence Only ...........................................
Evidence Only ...........................................
Evidence Only ...........................................
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 ×
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
Number of
respondents
Activity 1
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 2
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Consumers
Pretest Screener .......................................................
Pretest .......................................................................
Eye-Tracking Screener .............................................
Eye-Tracking Study ..................................................
Main Study Screener ................................................
Main Study ................................................................
833
500
80
20
2,500
1,500
1
1
1
1
1
1
833
500
80
20
2,500
1,500
.03 (2 min.) ...............
0.33 (20 min.) ...........
.08 (5 min.) ...............
1 ................................
.03 (2 min.) ...............
0.33 (20 min.) ...........
25
165
7
20
75
495
1
735
.03 (2 min.) ...............
22
HCPs
Pretest Screener .......................................................
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27271
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity 1
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 2
Pretest .......................................................................
Eye-Tracking Screener .............................................
Eye-Tracking Study ..................................................
Main Study Screener ................................................
Main Study ................................................................
500
80
20
2,206
1,500
1
1
1
1
1
500
80
20
2,206
1,500
0.33 (20 min.) ...........
.08 (5 min.) ...............
1 ................................
.03 (2 min.) ...............
0.33 (20 min.) ...........
165
7
20
67
495
Total ...................................................................
........................
........................
........................
...................................
1,563
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the next full hour.
2 Rounded
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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. Oorni, 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).
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2903]
Data and Methods for Evaluating the
Impact of Opioid Formulations With
Properties Designed To Deter Abuse in
the Postmarket Setting: A Scientific
Discussion of Present and Future
Capabilities; Public Workshop; Issues
Paper; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public workshop
entitled ‘‘Data and Methods for
Evaluating the Impact of Opioid
Formulations with Properties Designed
to Deter Abuse in the Postmarket
Setting: A Scientific Discussion of
Present and Future Capabilities.’’ The
purpose of the public workshop is to
host a scientific discussion with expert
panel members and interested
stakeholders about the challenges in
using the currently available data and
methods for assessing the impact of
opioid formulations with properties
designed to deter abuse on opioid
misuse, abuse, addiction, overdose, and
death in the postmarket setting. The
goal of this meeting is to discuss ways
to improve the analysis and
interpretation of existing data, as well as
to discuss opportunities and challenges
for collecting and/or linking additional
data to improve national surveillance
and research capabilities in this area. To
SUMMARY:
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assist in the workshop discussion, FDA
is making available an issues paper that
provides a brief overview of the
currently available data resources used
for evaluating the impact of opioid
formulations with properties designed
to deter abuse; summarizes some of the
key methodological issues in this area;
and outlines the issues that we would
like to discuss during the upcoming
workshop, including enhancing existing
resources, applying new methodology,
and creating new resources.
DATES: The public workshop will be
held on July 10 and 11, 2017, from 8:30
a.m. to 5 p.m. Submit either electronic
or written comments on this public
workshop by September 11, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 11,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 11, 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. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the Sheraton Silver Spring
Hotel, 8777 Georgia Ave., Silver Spring,
MD 20910. The hotel’s phone number is
301–589–0800.
You may submit comments as
follows:
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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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,
PRAStaff@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.
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?
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Level of disclosure
Type of claim --------------------------------------------------------------------------
Weak Strong Control
----------------------------------------------------------------------------------------------------------------
Study A: HCPs
----------------------------------------------------------------------------------------------------------------
Scope of Treatment................... Evidence Only........... Evidence + Conclusion... None.
Ease of Use.......................... Evidence Only........... Evidence + Conclusion... None.
Statistical Significance............. Evidence Only........... Evidence + Conclusion... None.
----------------------------------------------------------------------------------------------------------------
Study B: Consumers
----------------------------------------------------------------------------------------------------------------
Scope of Treatment................... Evidence Only........... Evidence + Conclusion... None.
Ease of Use.......................... Evidence Only........... Evidence + Conclusion... None.
Statistical Significance............. Evidence Only........... Evidence + Conclusion... None.
----------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity \1\ Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consumers
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 1,563
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
