[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: http://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