Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Oncology Indications in Direct-to-Consumer Television Advertising, 29213-29216 [2019-13128]
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Federal Register / Vol. 84, No. 120 / Friday, June 21, 2019 / Notices
requests for pediatric studies, if
appropriate. The product under
consideration is ONC201, presentation
by Oncoceutics Inc.
On page 19789, in the third column,
the third sentence of the Procedure
portion of the document is changed to
read as follows:
Oral presentations from the public
will be scheduled between
approximately 10:50 a.m. and 11:20 a.m.
and 1:50 p.m. and 2:20 p.m.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13142 Filed 6–20–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2313]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Study of Oncology
Indications in Direct-to-Consumer
Television Advertising
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled ‘‘Study of Oncology
Indications in Direct-to-Consumer
Television Advertising.’’ This research
consists of two studies examining the
presentation of oncology indications in
direct-to-consumer (DTC) television ads.
DATES: Submit either electronic or
written comments on the collection of
information by August 20, 2019.
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 20,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
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SUMMARY:
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at the end of August 20, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–2313 for ‘‘Study of Oncology
Indications in Direct-to-Consumer
Television Advertising.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
PO 00000
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• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov. For copies of the
questionnaire contact: Office of
Prescription Drug Promotion (OPDP)
Research Team, DTCresearch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
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Federal Register / Vol. 84, No. 120 / Friday, June 21, 2019 / Notices
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.
Study of Oncology Indications in
Direct-to-Consumer Television
Advertising
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(OMB Control Number 0910–NEW)
I. Background
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(C)) authorizes
FDA to conduct research relating to
drugs and other FDA regulated products
in carrying out the provisions of the
FD&C Act.
OPDP’s mission is to protect the
public health by helping to ensure that
prescription drug information is
truthful, balanced, and accurately
communicated, so that patients and
healthcare providers can make informed
decisions about treatment options.
OPDP’s research program provides
scientific evidence to help ensure that
our policies related to prescription drug
promotion will have the greatest benefit
to public health. Toward that end, we
have consistently conducted research to
evaluate the aspects of prescription drug
promotion that we believe are most
central to our mission, focusing in
particular on three main topic areas:
Advertising features, including content
and format; target populations; and
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research quality. Through the evaluation
of advertising features we assess how
elements such as graphics, format, and
disease and product characteristics
impact the communication and
understanding of prescription drug risks
and benefits; focusing on target
populations allows us to evaluate how
understanding of prescription drug risks
and benefits may vary as a function of
audience; and our focus on research
quality aims at maximizing the quality
of research data through analytical
methodology development and
investigation of sampling and response
issues. This study falls under the topic
of advertising features (content and
format).
Oncology products are increasingly
being promoted to consumers via DTC
television advertising. Oncology
indications are often complicated and
supported by different clinical
endpoints such as overall survival,
overall response rate, and progressionfree survival (Ref. 1) that are referenced
in the DTC TV ads. The first objective
of this project is to determine whether
disclosing information about the nature
of the endpoints that support the
indications for oncology products helps
consumers understand the drug’s
efficacy. This objective complements
OPDP’s research examining disclosing
information about FDA’s accelerated
approval pathway to consumers (May 8,
2019, 84 FR 20148) and OPDP’s research
on disclosing oncology information to
healthcare professionals (OMB control
number 0910–0864—Disclosures of
Descriptive Presentations in
Professional Oncology Prescription Drug
Promotion). Although these studies all
contribute to our knowledge of the
communication of cancer treatment
information, the current study
specifically examines particular
endpoints that are well-known to the
professional oncology community and
are now used in DTC advertising.
Because of the length of some
indications, sponsors sometimes convey
some of the indication in superimposed
text rather than in the audio in the TV
ads. The second objective is to test
whether consumers adequately
comprehend indication statements
when portions of the indication are
presented only in the superimposed text
of television ads while other
information is conveyed in the audio.
This objective extends OPDP’s previous
research on the use of dual-modality
risk presentations (presenting the
information in two modes at the same
time; OMB control numbers 0910–
0634—Experimental Evaluation of the
Impact of Distraction, 0910–0652—
Experimental Study: Toll-Free Number
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for Consumer Reporting of Drug Product
Side Effects in Direct-to-Consumer
Television Advertisements for
Prescription Drugs, and 0910–0772—
Eye Tracking Study of Direct-toConsumer Prescription Drug
Advertisement Viewing) to the context
of indication statements. This previous
research supports the use of dual
modality to increase consumers’
understanding of risk information
(January 27, 2012, 77 FR 4273) (Refs. 2
and 3).
We plan to conduct two rounds (one
for each objective) of nine 1-hour inperson cognitive interviews of adults 18
years of age or older to refine the
questionnaires and stimuli (18
participants total). We plan to conduct
two pretests (one for each objective) not
longer than 20 minutes, administered
via internet panel, to test the
experimental manipulations and pilot
the main study procedures.
We plan to conduct two main studies
(one for each objective) not longer than
20 minutes, administered via internet
panel. For Study 1, we will create two
television ads for fictitious oncology
prescription drugs to increase the
generalizability of the results (one solid
tumor indication and one hematology
indication). The ads will include audio
claims about overall survival, overall
response rate with and without a
disclosure, or progression-free survival
with and without a disclosure (see table
1 for the Study 1 design).
Some current television ads for
oncology products include disclosures
that are intended to help consumers
differentiate surrogate endpoints like
progression-free survival and overall
response rate from overall survival.
Examples include ‘‘At the time of
analysis, overall survival comparison
was not yet available’’ and ‘‘Clinical
trials are ongoing to determine if there
is an overall survival benefit.’’ The
disclosure we use in the study will be
based on disclosures currently in use
and will be informed by consumer
feedback elicited in focus groups
conducted prior to the cognitive testing
(approved under OMB control number
0910–0695). For example, the study
disclosure may include language such
as ‘‘We currently do not know if Drug
X helps people live longer.’’
Participants will be randomly
assigned to view one prescription drug
television ad and then complete a
questionnaire that assesses whether
participants noticed the disclosure, their
interpretations of the disclosure, their
retention of the endpoint, and their
perceptions of the drug’s benefits and
risks. We will also measure covariates
such as demographics, cancer history,
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Federal Register / Vol. 84, No. 120 / Friday, June 21, 2019 / Notices
condition; see tables 2 and 3 for the
Study 2 design). Participants will be
randomly assigned to view a
prescription drug television ad and then
complete a questionnaire that assesses
their retention and comprehension of
the information. Following previous
research on dual-modality
presentations, we hypothesize that
participants who view an ad with the
material information in the audio and
text will have greater retention of that
information than participants in any
other condition. We also hypothesize
that participants who view an ad with
the material information in the audio
only will have greater retention of that
information than participants in the
superimposed text condition and the
control condition. To test Study 1 and
2 hypotheses, we will conduct
inferential statistical tests such as
and literacy. Without a disclosure, we
hypothesize that participants will not
differentiate between overall survival,
overall response rate, and progressionfree survival. We hypothesize that a
disclosure will help participants
understand the surrogate endpoints (i.e.,
overall response rate and progressionfree survival) and thus will lead to
greater understanding of the drug’s
efficacy compared with conditions
without the disclosure. We will explore
unintended effects of the disclosure,
such as whether the disclosure lowers
perceived efficacy compared with the
overall survival condition.
For the second objective, in Study 2
we will vary the presentation of the
products’ indication, such that material
information related to the indication
will appear in superimposed text only,
in the audio only, in both superimposed
text and audio, or in neither (the control
29215
logistic regression and analysis of
variance.
The questionnaires are available upon
request from DTCresearch@fda.hhs.gov.
For all phases of this research, we will
recruit a general population sample of
adult volunteers 18 years of age or older.
We will exclude individuals who work
for the Department of Health and
Human Services or work in the
healthcare, marketing, or
pharmaceutical industries. We will use
literacy quotas to ensure that our sample
includes participants with a range of
literacy skills. We will also exclude
pretest participants from the main
studies, and participants will not be
able to participate in both Studies 1 and
2. With the sample sizes described
below, we will have sufficient power to
detect small-sized effects in Studies 1
and 2 (table 4).
TABLE 1—STUDY 1 DESIGN
Overall
survival
Indication
Overall
response
rate
Overall
response rate
with disclosure
Progressionfree survival
Progression-free
survival with
disclosure
Solid Tumor ..........................................................
Hematology ..........................................................
Note: The solid tumor condition will be non-small cell lung cancer. The hematology condition will be multiple myeloma. Claims and disclosures
are TBD, based on focus group feedback. Overall survival and progression-free survival claims will be the same for both indications. Study 1 will
use the control ad from Study 2.
TABLE 2—STUDY 2 DESIGN: SOLID TUMOR
Indication presentation
Material information in
superimposed text only
Material information in audio only
Material information in
superimposed text + audio
Material information not in
superimposed text or audio
(control)
Audio: Drug X is for adults with advanced non-small cell lung cancer.
Superimposed text: Drug X is for
adults with advanced non-small
cell lung cancer previously treated with platinum-based chemotherapy, who have a certain type
of ALK gene.
Audio: Drug X is for adults with
advanced non-small cell lung
cancer previously treated with
platinum-based chemotherapy,
who have a certain type of ALK
gene.
Superimposed text: Drug X is for
adults with advanced non-small
cell lung cancer.
Audio: Drug X is for adults with
advanced non-small cell lung
cancer previously treated with
platinum-based chemotherapy,
who have a certain type of ALK
gene.
Superimposed text: Drug X is for
adults with advanced non-small
cell lung cancer previously
treated with platinum-based
chemotherapy, who have a certain type of ALK gene.
Audio: Drug X is for adults with
advanced non-small cell lung
cancer.
Superimposed text: Drug X is for
adults with advanced non-small
cell lung cancer.
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Note. Study 2 will use the overall survival ad from Study 1.
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TABLE 3—STUDY 2 DESIGN: HEMATOLOGY
Indication presentation
Material information in
superimposed text only
Material information in audio only
Material information in
superimposed text + audio
Material information not in superimposed text or audio
(Control)
Audio: Drug Y is used to treat multiple myeloma.
Superimposed text: Drug Y is used
to treat multiple myeloma in
combination with dexamethasone, in people who have received at least three prior medicines to treat multiple myeloma.
Audio: Drug Y is used to treat
multiple myeloma in combination with dexamethasone, in
people who have received at
least three prior medicines to
treat multiple myeloma.
Superimposed text: Drug Y is
used to treat multiple myeloma.
Audio: Drug Y is used to treat
multiple myeloma in combination with dexamethasone, in
people who have received at
least three prior medicines to
treat multiple myeloma.
Superimposed text: Drug Y is
used to treat multiple myeloma
in combination with dexamethasone, in people who have received at least three prior medicines to treat multiple myeloma.
Audio: Drug Y is used to treat
multiple myeloma.
Superimposed text: Drug Y is
used to treat multiple myeloma.
Note. Study 2 will use the overall survival ad from Study 1.
FDA estimates the burden of this
collection of information as follows:
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total
annual
responses
Average burden per
response
Total
hours
Cognitive Interview screener ................................
Cognitive Interviews ..............................................
Pretests 1 and 2 screener ....................................
Pretests 1 and 2 ...................................................
Study 1 screener ..................................................
Study 1 ..................................................................
Study 2 screener ..................................................
Study 2 ..................................................................
30
18
200
120
1,167
700
867
520
1
1
1
1
1
1
1
1
30
18
200
120
1,167
700
867
520
0.08 (5 minutes) ...........
1 (60 minutes) ..............
0.08 (5 minutes) ...........
0.33 (20 minutes) .........
0.08 (5 minutes) ...........
0.33 (20 minutes) .........
0.08 (5 minutes) ...........
0.33 (20 minutes) .........
2.4
18
16
39.6
93.36
231
69.36
171.6
Total ...............................................................
........................
........................
........................
.......................................
641.32
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references are on
display with the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
jspears on DSK30JT082PROD with NOTICES
Number of
responses per
respondent
for Consumer Reporting of Side Effects
in Direct-to-Consumer Television
Advertisements.’’ Journal of Public
Policy & Marketing, 35(1):108–123, 2016.
3. Sullivan, H.W., V. Boudewyns, A.C.
O’Donoghue, et al., ‘‘Attention to and
Distraction from Risk Information in
Prescription Drug Advertising: An EyeTracking Study.’’ Journal of Public Policy
& Marketing, 36(2):236–245, 2017.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
18:30 Jun 20, 2019
Jkt 247001
Food and Drug Administration
[Docket No. FDA–2012–N–0021]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Substances
Generally Recognized as Safe:
Notification Procedure
AGENCY:
[FR Doc. 2019–13128 Filed 6–20–19; 8:45 am]
HHS.
BILLING CODE 4164–01–P
ACTION:
1. Kim, J., J. Gao, L. Amiri-Kordestani, et al.,
‘‘Patient-Friendly Language to Facilitate
Treatment Choice for Patients with
Cancer.’’ The Oncologist, 10.1634/
theoncologist.2018-0761, 2019. Available
from: https://
theoncologist.alphamedpress.org/
content/early/2019/05/16/
theoncologist.2018-0761.short?rss=1.
2. Aikin, K.J., A.C. O’Donoghue, C.M. Squire,
et al., ‘‘An Empirical Examination of the
FDAAA-Mandated Toll-Free Statement
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Food and Drug Administration,
Notice.
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 July 22,
2019.
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29213-29216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13128]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2313]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Study of Oncology Indications in Direct-to-Consumer
Television Advertising
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on research entitled ``Study of Oncology Indications
in Direct-to-Consumer Television Advertising.'' This research consists
of two studies examining the presentation of oncology indications in
direct-to-consumer (DTC) television ads.
DATES: Submit either electronic or written comments on the collection
of information by August 20, 2019.
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 20, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 20, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-2313 for ``Study of Oncology Indications in Direct-to-
Consumer Television Advertising.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected]. For copies of the questionnaire contact: Office
of Prescription Drug Promotion (OPDP) Research Team,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the
[[Page 29214]]
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.
Study of Oncology Indications in Direct-to-Consumer Television
Advertising
(OMB Control Number 0910-NEW)
I. Background
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
OPDP's mission is to protect the public health by helping to ensure
that prescription drug information is truthful, balanced, and
accurately communicated, so that patients and healthcare providers can
make informed decisions about treatment options. OPDP's research
program provides scientific evidence to help ensure that our policies
related to prescription drug promotion will have the greatest benefit
to public health. Toward that end, we have consistently conducted
research to evaluate the aspects of prescription drug promotion that we
believe are most central to our mission, focusing in particular on
three main topic areas: Advertising features, including content and
format; target populations; and research quality. Through the
evaluation of advertising features we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits; focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience; and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study falls under the topic of advertising features (content and
format).
Oncology products are increasingly being promoted to consumers via
DTC television advertising. Oncology indications are often complicated
and supported by different clinical endpoints such as overall survival,
overall response rate, and progression-free survival (Ref. 1) that are
referenced in the DTC TV ads. The first objective of this project is to
determine whether disclosing information about the nature of the
endpoints that support the indications for oncology products helps
consumers understand the drug's efficacy. This objective complements
OPDP's research examining disclosing information about FDA's
accelerated approval pathway to consumers (May 8, 2019, 84 FR 20148)
and OPDP's research on disclosing oncology information to healthcare
professionals (OMB control number 0910-0864--Disclosures of Descriptive
Presentations in Professional Oncology Prescription Drug Promotion).
Although these studies all contribute to our knowledge of the
communication of cancer treatment information, the current study
specifically examines particular endpoints that are well-known to the
professional oncology community and are now used in DTC advertising.
Because of the length of some indications, sponsors sometimes
convey some of the indication in superimposed text rather than in the
audio in the TV ads. The second objective is to test whether consumers
adequately comprehend indication statements when portions of the
indication are presented only in the superimposed text of television
ads while other information is conveyed in the audio. This objective
extends OPDP's previous research on the use of dual-modality risk
presentations (presenting the information in two modes at the same
time; OMB control numbers 0910-0634--Experimental Evaluation of the
Impact of Distraction, 0910-0652--Experimental Study: Toll-Free Number
for Consumer Reporting of Drug Product Side Effects in Direct-to-
Consumer Television Advertisements for Prescription Drugs, and 0910-
0772--Eye Tracking Study of Direct-to-Consumer Prescription Drug
Advertisement Viewing) to the context of indication statements. This
previous research supports the use of dual modality to increase
consumers' understanding of risk information (January 27, 2012, 77 FR
4273) (Refs. 2 and 3).
We plan to conduct two rounds (one for each objective) of nine 1-
hour in-person cognitive interviews of adults 18 years of age or older
to refine the questionnaires and stimuli (18 participants total). We
plan to conduct two pretests (one for each objective) not longer than
20 minutes, administered via internet panel, to test the experimental
manipulations and pilot the main study procedures.
We plan to conduct two main studies (one for each objective) not
longer than 20 minutes, administered via internet panel. For Study 1,
we will create two television ads for fictitious oncology prescription
drugs to increase the generalizability of the results (one solid tumor
indication and one hematology indication). The ads will include audio
claims about overall survival, overall response rate with and without a
disclosure, or progression-free survival with and without a disclosure
(see table 1 for the Study 1 design).
Some current television ads for oncology products include
disclosures that are intended to help consumers differentiate surrogate
endpoints like progression-free survival and overall response rate from
overall survival. Examples include ``At the time of analysis, overall
survival comparison was not yet available'' and ``Clinical trials are
ongoing to determine if there is an overall survival benefit.'' The
disclosure we use in the study will be based on disclosures currently
in use and will be informed by consumer feedback elicited in focus
groups conducted prior to the cognitive testing (approved under OMB
control number 0910-0695). For example, the study disclosure may
include language such as ``We currently do not know if Drug X helps
people live longer.''
Participants will be randomly assigned to view one prescription
drug television ad and then complete a questionnaire that assesses
whether participants noticed the disclosure, their interpretations of
the disclosure, their retention of the endpoint, and their perceptions
of the drug's benefits and risks. We will also measure covariates such
as demographics, cancer history,
[[Page 29215]]
and literacy. Without a disclosure, we hypothesize that participants
will not differentiate between overall survival, overall response rate,
and progression-free survival. We hypothesize that a disclosure will
help participants understand the surrogate endpoints (i.e., overall
response rate and progression-free survival) and thus will lead to
greater understanding of the drug's efficacy compared with conditions
without the disclosure. We will explore unintended effects of the
disclosure, such as whether the disclosure lowers perceived efficacy
compared with the overall survival condition.
For the second objective, in Study 2 we will vary the presentation
of the products' indication, such that material information related to
the indication will appear in superimposed text only, in the audio
only, in both superimposed text and audio, or in neither (the control
condition; see tables 2 and 3 for the Study 2 design). Participants
will be randomly assigned to view a prescription drug television ad and
then complete a questionnaire that assesses their retention and
comprehension of the information. Following previous research on dual-
modality presentations, we hypothesize that participants who view an ad
with the material information in the audio and text will have greater
retention of that information than participants in any other condition.
We also hypothesize that participants who view an ad with the material
information in the audio only will have greater retention of that
information than participants in the superimposed text condition and
the control condition. To test Study 1 and 2 hypotheses, we will
conduct inferential statistical tests such as logistic regression and
analysis of variance.
The questionnaires are available upon request from
[email protected].
For all phases of this research, we will recruit a general
population sample of adult volunteers 18 years of age or older. We will
exclude individuals who work for the Department of Health and Human
Services or work in the healthcare, marketing, or pharmaceutical
industries. We will use literacy quotas to ensure that our sample
includes participants with a range of literacy skills. We will also
exclude pretest participants from the main studies, and participants
will not be able to participate in both Studies 1 and 2. With the
sample sizes described below, we will have sufficient power to detect
small-sized effects in Studies 1 and 2 (table 4).
Table 1--Study 1 Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
Overall Overall response Progression-free
Indication Overall response rate with Progression- free survival with
survival rate disclosure survival disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Solid Tumor.......................................................
Hematology........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The solid tumor condition will be non-small cell lung cancer. The hematology condition will be multiple myeloma. Claims and disclosures are TBD,
based on focus group feedback. Overall survival and progression-free survival claims will be the same for both indications. Study 1 will use the
control ad from Study 2.
Table 2--Study 2 Design: Solid Tumor
----------------------------------------------------------------------------------------------------------------
Indication presentation
-----------------------------------------------------------------------------------------------------------------
Material information
Material information in superimposed Material information in Material information in not in superimposed
text only audio only superimposed text + text or audio
audio (control)
----------------------------------------------------------------------------------------------------------------
Audio: Drug X is for adults with Audio: Drug X is for Audio: Drug X is for Audio: Drug X is for
advanced non-small cell lung cancer. adults with advanced adults with advanced adults with advanced
Superimposed text: Drug X is for non-small cell lung non-small cell lung non-small cell lung
adults with advanced non-small cell cancer previously cancer previously cancer.
lung cancer previously treated with treated with platinum- treated with platinum- Superimposed text: Drug
platinum-based chemotherapy, who based chemotherapy, based chemotherapy, X is for adults with
have a certain type of ALK gene. who have a certain who have a certain advanced non-small
type of ALK gene. type of ALK gene. cell lung cancer.
Superimposed text: Drug Superimposed text: Drug
X is for adults with X is for adults with
advanced non-small advanced non-small
cell lung cancer. cell lung cancer
previously treated
with platinum-based
chemotherapy, who have
a certain type of ALK
gene.
----------------------------------------------------------------------------------------------------------------
Note. Study 2 will use the overall survival ad from Study 1.
[[Page 29216]]
Table 3--Study 2 Design: Hematology
----------------------------------------------------------------------------------------------------------------
Indication presentation
-----------------------------------------------------------------------------------------------------------------
Material information
Material information in superimposed Material information in Material information in not in superimposed
text only audio only superimposed text + text or audio
audio (Control)
----------------------------------------------------------------------------------------------------------------
Audio: Drug Y is used to treat Audio: Drug Y is used Audio: Drug Y is used Audio: Drug Y is used
multiple myeloma. to treat multiple to treat multiple to treat multiple
Superimposed text: Drug Y is used to myeloma in combination myeloma in combination myeloma.
treat multiple myeloma in with dexamethasone, in with dexamethasone, in Superimposed text: Drug
combination with dexamethasone, in people who have people who have Y is used to treat
people who have received at least received at least received at least multiple myeloma.
three prior medicines to treat three prior medicines three prior medicines
multiple myeloma. to treat multiple to treat multiple
myeloma. myeloma.
Superimposed text: Drug Superimposed text: Drug
Y is used to treat Y is used to treat
multiple myeloma. multiple myeloma in
combination with
dexamethasone, in
people who have
received at least
three prior medicines
to treat multiple
myeloma.
----------------------------------------------------------------------------------------------------------------
Note. Study 2 will use the overall survival ad from Study 1.
FDA estimates the burden of this collection of information as
follows:
Table 4--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Cognitive Interview screener.. 30 1 30 0.08 (5 minutes) 2.4
Cognitive Interviews.......... 18 1 18 1 (60 minutes).. 18
Pretests 1 and 2 screener..... 200 1 200 0.08 (5 minutes) 16
Pretests 1 and 2.............. 120 1 120 0.33 (20 39.6
minutes).
Study 1 screener.............. 1,167 1 1,167 0.08 (5 minutes) 93.36
Study 1....................... 700 1 700 0.33 (20 231
minutes).
Study 2 screener.............. 867 1 867 0.08 (5 minutes) 69.36
Study 2....................... 520 1 520 0.33 (20 171.6
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 641.32
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
II. References
The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Kim, J., J. Gao, L. Amiri-Kordestani, et al., ``Patient-Friendly
Language to Facilitate Treatment Choice for Patients with Cancer.''
The Oncologist, 10.1634/theoncologist.2018-0761, 2019. Available
from: https://theoncologist.alphamedpress.org/content/early/2019/05/16/theoncologist.2018-0761.short?rss=1.
2. Aikin, K.J., A.C. O'Donoghue, C.M. Squire, et al., ``An Empirical
Examination of the FDAAA-Mandated Toll-Free Statement for Consumer
Reporting of Side Effects in Direct-to-Consumer Television
Advertisements.'' Journal of Public Policy & Marketing, 35(1):108-
123, 2016.
3. Sullivan, H.W., V. Boudewyns, A.C. O'Donoghue, et al.,
``Attention to and Distraction from Risk Information in Prescription
Drug Advertising: An Eye-Tracking Study.'' Journal of Public Policy
& Marketing, 36(2):236-245, 2017.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13128 Filed 6-20-19; 8:45 am]
BILLING CODE 4164-01-P
