Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion, 27845-27848 [2017-12599]
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Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
27845
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Pilot screener ............................................................
Study 1 screener ......................................................
Study 2 screener ......................................................
Completes, Pilot ........................................................
Completes, Study 1 ..................................................
Completes, Study 2 ..................................................
120
600
600
40
200
200
1
1
1
1
1
1
120
600
600
40
200
200
0.03 (2 minutes) .......
0.03 (2 minutes) .......
0.03 (2 minutes) .......
1 ................................
1 ................................
1 ................................
4
18
18
40
200
200
Total ...................................................................
........................
........................
........................
...................................
480
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The following references are on
display in 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; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. McGuire, L.C., ‘‘Remembering What the
Doctor Said: Organization and Older
Adults’ Memory for Medical
Information.’’ Experimental Aging
Research, 22, 403–428 (1996).
2. Aikin, K.J., J.L. Swasy, and A.C. Braman,
‘‘Patient and Physician Attitudes and
Behaviors Associated with DTC
Promotion of Prescription Drugs:
Summary of FDA Survey Research
Results’’ (2004). Available at https://
www.fda.gov/downloads/Drugs/
ScienceResearch/ResearchAreas/
DrugMarketingAdvertisingand
CommunicationsResearch/
UCM152860.pdf.
3. Warnings and Risk Communication (2005).
Wogalter, M.S., D. DeJoy, and K.R.
Laughery (Eds.). Philadelphia: Taylor &
Francis, Inc.
4. Conzola, V.C., and M.S. Wogalter, ‘‘A
Communication-Human Information
Processing (C–HIP) Approach to Warning
Effectiveness in the Workplace.’’ Journal
of Risk Research, 4(4), 309–322; (2001).
5. Wogalter, M.S., and K.R Laughery,
‘‘Warning! Sign and Label
Effectiveness.’’ Current Directions in
Psychological Science, 5(2), 33–37;
(1996).
6. Wogalter, M.S., T.L. Smith-Jackson, B.J.
Mills, and C.S. Paine, ‘‘The Effects of
Print Format in Direct-to-Consumer
Prescription Drug Advertisements on
Risk Knowledge and Preference.’’ Drug
Information Journal, 36(3), 693–705,
2002.
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Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12600 Filed 6–16–17; 8:45 am]
BILLING CODE 4164–01–P
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
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before that date.
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1779]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Disclosures of
Descriptive Presentations in
Professional Oncology Prescription
Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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
‘‘Disclosures of Descriptive
Presentations in Professional Oncology
Prescription Drug Promotion.’’
DATES: Submit either electronic or
written comments on the collection of
information by August 18, 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 18,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 18, 2017.
SUMMARY:
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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
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27846
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–1779 for ‘‘Disclosures of
Descriptive Presentations in
Professional Oncology Prescription Drug
Promotion.’’ 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/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.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
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St., North Bethesda, MD 20852, 301–
796–7726, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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 of Descriptive Presentations
in Professional Oncology 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 FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
Under the FD&C Act and
implementing regulations, promotional
labeling and advertising about
prescription drugs are generally
required to be truthful, non-misleading,
and to reveal facts material to the
presentations made about the product
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being promoted (see sections 502(a) and
(n), and 201(n) of the FD&C Act (21
U.S.C. 352(a) and (n), and 321(n)); see
also 21 CFR 202.1). As a part of the
ongoing evaluation of FDA’s regulations
in this area, FDA is proposing to study
the impact of disclosures as they relate
to presentations of preliminary or
descriptive scientific and clinical data
in promotional labeling and advertising
for oncology products. The use of
disclosures is one method of
communicating information to health
care professionals about scientific and
clinical data, the limitations of that data,
and practical utility of that information
for use in treatment. These disclosures
may influence prescriber
comprehension and decisionmaking,
and may affect how and what treatment
they prescribe for their patients.
Pharmaceutical companies market
directly to physicians through
publishing advertisements in medical
journals, exhibit booths at physician
meetings or events, sending unsolicited
promotional materials to doctors’
offices, or presentations (‘‘detailing’’) by
pharmaceutical representatives (Ref. 1).
Detail aids may contain carefully
extracted data from clinical studies that,
taken out of context, can exaggerate the
benefits of a drug (Ref. 2) or contribute
to physicians prescribing the drug for an
inappropriate patient population.
Promotional labeling and advertising
for cancer drugs deserve specific
attention. Oncology drugs represented
26 percent of the 649 compounds under
clinical trial investigation from 2006 to
2011 (Ref. 3). The past decade has seen
a dramatic rise in the number of
oncology drugs brought to market. In the
past 18 months, FDA has approved 27
cancer drugs (Ref. 4). Although overall
survival remains the gold standard for
demonstrating clinical benefit of a drug,
several additional endpoints are
accepted as surrogates illustrating
clinical benefit with regard to cancer
and many drugs are granted expedited
approval on their basis. These include
disease-free survival, objective response
rate, complete response rate,
progression-free survival, and time to
progression (Ref. 5). For clinicians who
are not specifically trained in clinical
trial design, interpreting these
endpoints may be challenging.
Pharmaceutical companies invest
heavily in the development and
distribution of promotional materials to
educate oncologists about favorable
clinical trial results.
When communicating scientific and
clinical data, a disclosure (a specific
statement that modifies or qualifies a
claim) could be used to convey the
limitations of the data and practical
E:\FR\FM\19JNN1.SGM
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Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
utility of the information for treatment.
Much of the prior research on
disclosures in this topic area has been
limited to the dietary supplement arena
with consumers (Refs. 6–9). Disclosures
in professional pieces could influence
prescriber comprehension as well as
subsequent decisionmaking; however,
no published data exist regarding how
prescribers use and understand
scientific claims in conjunction with
qualifying disclosures.
Different aspects of disclosures may
influence their effectiveness. For
example, despite the advanced
education of health care providers, in a
busy practice they may not be willing or
able to process the disclosures
thoroughly. Thus, the level of
technicality in the disclosure may play
a role in their use of the disclosure to
contextualize the data display.
Additionally, the addition of a general
summary statement to frame the
disclosure may help or hinder the
processing of the disclosure and
therefore the entire data display.
Finally, it is possible that the impact of
disclosure statements on prescriber
comprehension, perceptions, and
intentions to prescribe the promoted
product will vary based on the level of
clinical training. Although oncologists
and primary care physicians (PCPs) will
have more experience with clinical data,
mid-level practitioners have reported
having significantly more formal
training on pharmaceutical marketing
tactics than specialists and PCPs (Ref.
10). Therefore, it is unclear whether any
one group would be more or less
affected by both the claims made in
promotional materials or by the
disclosures that accompany those
claims.
The proposed study seeks to address
the following research questions:
1. Do disclosures mitigate potentially
misleading presentations of preliminary
or descriptive data in oncology drug
product promotion?
2. Does the language (technical, nontechnical) of the disclosure influence
the effectiveness of the disclosure?
3. Does the presence of a general
statement about the clinical utility of
the data in addition to a specific
disclosure influence processing of
claims and disclosures?
4. Do PCPs, oncologists, and mid-level
practitioners (nurse practitioners,
physician assistants) differ in their
processing of claims and disclosures
about preliminary or descriptive data?
5. Which disclosures do physicians
prefer?
To address these questions, FDA has
designed a study that will be conducted
in three independent phases, each phase
examining a data display in a
promotional piece for a unique
oncological product. Independent
variables will include: (1) Specific
disclosure (technical, non-technical,
none), (2) general statement (present,
absent), and (3) specialty (oncologists,
PCPs, mid-level practitioners). Each
phase will have the following design:
Specific disclosure
Sample
General statement
Technical
Oncologists ...........................................................................
PCPs ....................................................................................
Mid-Level Practitioners .........................................................
Specific disclosures will include
material information specifically related
to the particular data display in
question. As such, each specific
disclosure may include clinical or
statistical information related to the trial
design, the statistical analysis plan of
the trial, or any other material statistical
or clinical information necessary for
evaluation or interpretation of the data.
The team developing the disclosures
includes social science analysts,
pharmacists, oncological medical
officers, and an oncology nurse. An
example of the general statement is
‘‘This presentation includes exploratory
information of uncertain clinical utility
Present .................................
Absent ...................................
Present .................................
Absent ...................................
Present .................................
Absent ...................................
and should be interpreted cautiously
when used to make treatment
decisions.’’
Outcome variables will focus on the
assessment of the data display as a
whole as well as attention to the
disclosure, if present. Specifically, we
will examine recognition of the clinical
endpoint in the data display,
comprehension of the data display,
perceptions of the exploratory nature of
the data, and the perceived credibility of
the promotional piece. We will also look
at attention to the specific disclosure
and the general statement, prescriber
decisions, and prescriber preferences.
This latter outcome variable will be
Non-technical
•
•
•
•
•
•
•
•
•
•
•
•
No disclosure
Control.
Control.
Control.
determined by a secondary task at the
end of the questionnaire that shows
each participant all disclosure options
and asks them to choose their preferred
version.
Oncologists, PCPs, and non-oncology
mid-level practitioners will be recruited
to participate via the Internet, and the
study is expected to take approximately
20 minutes. Participants will view
professionally developed promotional
pieces that mimic currently available
promotion and answer questions. The
questionnaire is available upon request.
FDA estimates the burden of this
collection of information as follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Pretest Screener .......................................................
Pretest .......................................................................
Main Study Screener ................................................
Main Study ................................................................
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Number of
responses per
respondent
134
90
3,134
2,115
Frm 00066
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1
1
1
1
Sfmt 4703
Total annual
responses
134
90
3,134
2,115
E:\FR\FM\19JNN1.SGM
Average burden
per response
0.03
0.33
0.03
0.33
(2 minutes) .......
(20 minutes) .....
(2 minutes) .......
(20 minutes) .....
19JNN1
Total hours 2
5
30
105
705
27848
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Total ...................................................................
Number of
responses per
respondent
Total annual
responses
Average burden
per response
........................
........................
........................
...................................
Total hours 2
845
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the next full hour.
Drug Administration’s Bad Ad Program
and Education Regarding Pharmaceutical
Advertising: A National Survey of
Prescribers in Ambulatory Care
Settings,’’ Journal of Health
Communication, 20:1330–1336, 2015.
II. References
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The following references are on
display in 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; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. Johar, K., ‘‘An Insider’s Perspective:
Defense of the Pharmaceutical Industry’s
Marketing Practices,’’ Albany Law
Review, 76:299–334, 2012–2013.
2. Wick, C., M. Egger, S. Trelle, et al., ‘‘The
Characteristics of Unsolicited Clinical
Oncology Literature Provided by
Pharmaceutical Industry,’’ Annals of
Oncology, 18:1580–1582, 2007.
3. Fisher, J.A., M.D. Cottingham, and C.A.
Kalbaugh, ‘‘Peering Into the
Pharmaceutical ‘Pipeline’:
Investigational Drugs, Clinical Trials,
and Industry Priorities,’’ Social Science
& Medicine, 131:322–330, 2015.
4. Centerwatch, ‘‘FDA Approved Drugs for
Oncology,’’ https://
www.centerwatch.com/druginformation/fda-approved-drugs/
therapeutic-area/12/oncology (accessed
on March 2, 2017).
5. Pazdur, R., ‘‘Endpoints for Assessing Drug
Activity in Clinical Trials,’’ The
Oncologist, 13:19–21, 2008.
6. Dodge, T. and A. Kaufman, ‘‘What Makes
Consumers Think Dietary Supplements
Are Safe and Effective? The Role of
Disclaimers and FDA Approval,’’ Health
Psychology, 26:513–517, 2007.
7. 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,
16:230–244, 2011.
8. Mason, M.J., D.L. Scammon, and X. Fang,
‘‘The Impact of Warnings, Disclaimers,
and Product Experience on Consumers’
Perceptions of Dietary Supplements,’’
The Journal of Consumer Affairs, 41:74–
99, 2007.
9. France, K.R. and P.F. Bone, ‘‘Policy
Makers’ Paradigms and Evidence From
Consumer Interpretations of Dietary
Supplement Labels,’’ The Journal of
Consumer Affairs, 39:27–51, 2005.
10. O’Donoghue, A.C., V. Boudewyns, K.J.
Aikin, et al., ‘‘Awareness of the Food and
VerDate Sep<11>2014
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Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12599 Filed 6–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA Panel:
Revision Applications for U.S.-South Africa
Program for Collaborative Biomedical
Research.
Date: June 29, 2017.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
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Name of Committee: AIDS and Related
Research Integrated Review Group; AIDS
Molecular and Cellular Biology Study
Section.
Date: July 10, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Kenneth A. Roebuck,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AIDS and
Related Research Member Conflict.
Date: July 10, 2017.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Shalanda A. Bynum,
Ph.D., MPH, Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
Bethesda, MD 20892, 301–755–4355,
bynumsa@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 16–
257: Predicting Behavioral Responses to
Population Level Cancer Control Strategies
(R21).
Date: July 11, 2017.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Karin F. Helmers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3148,
MSC 7770, Bethesda, MD 20892, (301) 254–
9975, helmersk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 15–
287: Opportunities for Collaborative Research
at the NIH Clinical Center.
Date: July 11, 2017.
Time: 1:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Fungai Chanetsa, MPH,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
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]]>Agencies
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27845-27848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12599]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1779]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Disclosures of Descriptive Presentations in
Professional Oncology Prescription Drug Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 ``Disclosures of Descriptive
Presentations in Professional Oncology Prescription Drug Promotion.''
DATES: Submit either electronic or written comments on the collection
of information by August 18, 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 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 18, 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): 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
[[Page 27846]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-1779 for ``Disclosures of Descriptive Presentations in
Professional Oncology Prescription Drug Promotion.'' 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, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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 of Descriptive Presentations in Professional Oncology
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 FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
Under the FD&C Act and implementing regulations, promotional
labeling and advertising about prescription drugs are generally
required to be truthful, non-misleading, and to reveal facts material
to the presentations made about the product being promoted (see
sections 502(a) and (n), and 201(n) of the FD&C Act (21 U.S.C. 352(a)
and (n), and 321(n)); see also 21 CFR 202.1). As a part of the ongoing
evaluation of FDA's regulations in this area, FDA is proposing to study
the impact of disclosures as they relate to presentations of
preliminary or descriptive scientific and clinical data in promotional
labeling and advertising for oncology products. The use of disclosures
is one method of communicating information to health care professionals
about scientific and clinical data, the limitations of that data, and
practical utility of that information for use in treatment. These
disclosures may influence prescriber comprehension and decisionmaking,
and may affect how and what treatment they prescribe for their
patients.
Pharmaceutical companies market directly to physicians through
publishing advertisements in medical journals, exhibit booths at
physician meetings or events, sending unsolicited promotional materials
to doctors' offices, or presentations (``detailing'') by pharmaceutical
representatives (Ref. 1). Detail aids may contain carefully extracted
data from clinical studies that, taken out of context, can exaggerate
the benefits of a drug (Ref. 2) or contribute to physicians prescribing
the drug for an inappropriate patient population.
Promotional labeling and advertising for cancer drugs deserve
specific attention. Oncology drugs represented 26 percent of the 649
compounds under clinical trial investigation from 2006 to 2011 (Ref.
3). The past decade has seen a dramatic rise in the number of oncology
drugs brought to market. In the past 18 months, FDA has approved 27
cancer drugs (Ref. 4). Although overall survival remains the gold
standard for demonstrating clinical benefit of a drug, several
additional endpoints are accepted as surrogates illustrating clinical
benefit with regard to cancer and many drugs are granted expedited
approval on their basis. These include disease-free survival, objective
response rate, complete response rate, progression-free survival, and
time to progression (Ref. 5). For clinicians who are not specifically
trained in clinical trial design, interpreting these endpoints may be
challenging. Pharmaceutical companies invest heavily in the development
and distribution of promotional materials to educate oncologists about
favorable clinical trial results.
When communicating scientific and clinical data, a disclosure (a
specific statement that modifies or qualifies a claim) could be used to
convey the limitations of the data and practical
[[Page 27847]]
utility of the information for treatment. Much of the prior research on
disclosures in this topic area has been limited to the dietary
supplement arena with consumers (Refs. 6-9). Disclosures in
professional pieces could influence prescriber comprehension as well as
subsequent decisionmaking; however, no published data exist regarding
how prescribers use and understand scientific claims in conjunction
with qualifying disclosures.
Different aspects of disclosures may influence their effectiveness.
For example, despite the advanced education of health care providers,
in a busy practice they may not be willing or able to process the
disclosures thoroughly. Thus, the level of technicality in the
disclosure may play a role in their use of the disclosure to
contextualize the data display. Additionally, the addition of a general
summary statement to frame the disclosure may help or hinder the
processing of the disclosure and therefore the entire data display.
Finally, it is possible that the impact of disclosure statements on
prescriber comprehension, perceptions, and intentions to prescribe the
promoted product will vary based on the level of clinical training.
Although oncologists and primary care physicians (PCPs) will have more
experience with clinical data, mid-level practitioners have reported
having significantly more formal training on pharmaceutical marketing
tactics than specialists and PCPs (Ref. 10). Therefore, it is unclear
whether any one group would be more or less affected by both the claims
made in promotional materials or by the disclosures that accompany
those claims.
The proposed study seeks to address the following research
questions:
1. Do disclosures mitigate potentially misleading presentations of
preliminary or descriptive data in oncology drug product promotion?
2. Does the language (technical, non-technical) of the disclosure
influence the effectiveness of the disclosure?
3. Does the presence of a general statement about the clinical
utility of the data in addition to a specific disclosure influence
processing of claims and disclosures?
4. Do PCPs, oncologists, and mid-level practitioners (nurse
practitioners, physician assistants) differ in their processing of
claims and disclosures about preliminary or descriptive data?
5. Which disclosures do physicians prefer?
To address these questions, FDA has designed a study that will be
conducted in three independent phases, each phase examining a data
display in a promotional piece for a unique oncological product.
Independent variables will include: (1) Specific disclosure (technical,
non-technical, none), (2) general statement (present, absent), and (3)
specialty (oncologists, PCPs, mid-level practitioners). Each phase will
have the following design:
----------------------------------------------------------------------------------------------------------------
Specific disclosure
Sample General statement ----------------------------------------------------------
Technical Non-technical No disclosure
----------------------------------------------------------------------------------------------------------------
Oncologists..................... Present............ Control.
Absent.............
PCPs............................ Present............ Control.
Absent.............
Mid-Level Practitioners......... Present............ Control.
Absent.............
----------------------------------------------------------------------------------------------------------------
Specific disclosures will include material information specifically
related to the particular data display in question. As such, each
specific disclosure may include clinical or statistical information
related to the trial design, the statistical analysis plan of the
trial, or any other material statistical or clinical information
necessary for evaluation or interpretation of the data. The team
developing the disclosures includes social science analysts,
pharmacists, oncological medical officers, and an oncology nurse. An
example of the general statement is ``This presentation includes
exploratory information of uncertain clinical utility and should be
interpreted cautiously when used to make treatment decisions.''
Outcome variables will focus on the assessment of the data display
as a whole as well as attention to the disclosure, if present.
Specifically, we will examine recognition of the clinical endpoint in
the data display, comprehension of the data display, perceptions of the
exploratory nature of the data, and the perceived credibility of the
promotional piece. We will also look at attention to the specific
disclosure and the general statement, prescriber decisions, and
prescriber preferences. This latter outcome variable will be determined
by a secondary task at the end of the questionnaire that shows each
participant all disclosure options and asks them to choose their
preferred version.
Oncologists, PCPs, and non-oncology mid-level practitioners will be
recruited to participate via the Internet, and the study is expected to
take approximately 20 minutes. Participants will view professionally
developed promotional pieces that mimic currently available promotion
and answer questions. The questionnaire is available upon request.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Screener............................ 134 1 134 0.03 (2 minutes).......................... 5
Pretest..................................... 90 1 90 0.33 (20 minutes)......................... 30
Main Study Screener......................... 3,134 1 3,134 0.03 (2 minutes).......................... 105
Main Study.................................. 2,115 1 2,115 0.33 (20 minutes)......................... 705
-----------------------------------------------------------------------------------------------------------
[[Page 27848]]
Total................................... .............. .............. .............. .......................................... 845
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the next full hour.
II. References
The following references are on display in 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; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. Johar, K., ``An Insider's Perspective: Defense of the
Pharmaceutical Industry's Marketing Practices,'' Albany Law Review,
76:299-334, 2012-2013.
2. Wick, C., M. Egger, S. Trelle, et al., ``The Characteristics of
Unsolicited Clinical Oncology Literature Provided by Pharmaceutical
Industry,'' Annals of Oncology, 18:1580-1582, 2007.
3. Fisher, J.A., M.D. Cottingham, and C.A. Kalbaugh, ``Peering Into
the Pharmaceutical `Pipeline': Investigational Drugs, Clinical
Trials, and Industry Priorities,'' Social Science & Medicine,
131:322-330, 2015.
4. Centerwatch, ``FDA Approved Drugs for Oncology,'' https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-area/12/oncology (accessed on March 2, 2017).
5. Pazdur, R., ``Endpoints for Assessing Drug Activity in Clinical
Trials,'' The Oncologist, 13:19-21, 2008.
6. Dodge, T. and A. Kaufman, ``What Makes Consumers Think Dietary
Supplements Are Safe and Effective? The Role of Disclaimers and FDA
Approval,'' Health Psychology, 26:513-517, 2007.
7. 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, 16:230-244, 2011.
8. Mason, M.J., D.L. Scammon, and X. Fang, ``The Impact of Warnings,
Disclaimers, and Product Experience on Consumers' Perceptions of
Dietary Supplements,'' The Journal of Consumer Affairs, 41:74-99,
2007.
9. France, K.R. and P.F. Bone, ``Policy Makers' Paradigms and
Evidence From Consumer Interpretations of Dietary Supplement
Labels,'' The Journal of Consumer Affairs, 39:27-51, 2005.
10. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al., ``Awareness
of the Food and Drug Administration's Bad Ad Program and Education
Regarding Pharmaceutical Advertising: A National Survey of
Prescribers in Ambulatory Care Settings,'' Journal of Health
Communication, 20:1330-1336, 2015.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12599 Filed 6-16-17; 8:45 am]
BILLING CODE 4164-01-P
