Agency Information Collection Activities; Proposed Collection; Comment Request; Empirical Study of Promotional Implications of Proprietary Prescription Drug Names, 3392-3394 [2020-00823]
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Federal Register / Vol. 85, No. 13 / Tuesday, January 21, 2020 / Notices
submissions we received under the
regulations over the past 3 years.
We estimate the burden of this
collection of information as follows:
chairperson or chairpersons of each
individual RDRC, investigators, and
participants in the studies. The burden
estimates are based on our experience
with these reporting and recordkeeping
requirements and the number of
regulations and that human subject
safety is assured. If these studies were
not reviewed, human subjects could be
subjected to inappropriate radiation or
pharmacologic risks. Respondents to
this information collection are the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
21 CFR Section and applicable form
§ 361.1(c)(3) reports and
(c)(4) approval (Form FDA
2914: Membership Summary) 3.
§ 361.1(c)(3) reports (Form
FDA 2915: Study Summary) 4.
§ 361.1(d)(8) adverse events
Total ...............................
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden
per response
Total hours
62
1
62
1 ............................................
62
40
10
434
3.5 (3 hours, 30 minutes) .....
1,519
10
1
10
.5 (30 minutes) .....................
5
..............................
..............................
506
...............................................
1,586
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
3 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM094979.pdf.
4 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074720.pdf.
2 Numbers
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
21 CFR Section
Number of
records per
recordkeepers
Number of
recordkeepers
Total annual
records
Average burden
per recordkeeping
Total hours
§ 361.1(c)(2) RDRC ..............
§ 361.1(d)(5) human research subjects.
62
40
4
10
248
434
10 ..........................................
.75 (45 minutes) ...................
2,480
326
Total ...............................
..............................
..............................
682
...............................................
2,806
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
2 Numbers
We have adjusted our estimate for the
information collection to reflect an
annual decrease of 525 hours and 147
responses since last OMB review. This
adjustment corresponds to fewer
submissions we have received under the
information collection over the last few
years.
Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00873 Filed 1–17–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5666]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Empirical Study of
Promotional Implications of
Proprietary Prescription Drug Names
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 a proposed study
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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entitled ‘‘Empirical Study of
Promotional Implications of Proprietary
Prescription Drug Names.’’
DATES: Submit either electronic or
written comments on the collection of
information by March 23, 2020.
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 March 23,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 23, 2020. 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.
E:\FR\FM\21JAN1.SGM
21JAN1
Federal Register / Vol. 85, No. 13 / Tuesday, January 21, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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–5666 for ‘‘Empirical Study of
Promotional Implications of Proprietary
Prescription Drug Names.’’ 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
VerDate Sep<11>2014
18:20 Jan 17, 2020
Jkt 250001
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, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
PO 00000
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3393
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.
Empirical Study of Promotional
Implications of Proprietary
Prescription Drug Names
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 (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.
The mission of the Office of
Prescription Drug Promotion (OPDP) is
to protect the public health by helping
to ensure that prescription drug
promotional material is truthful,
balanced, and accurately
communicated, so that patients and
healthcare providers (HCPs) 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 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
E:\FR\FM\21JAN1.SGM
21JAN1
3394
Federal Register / Vol. 85, No. 13 / Tuesday, January 21, 2020 / Notices
study will inform the first two topic
areas.
Because we recognize the strength of
data and the confidence in the robust
nature of the findings is improved
through the results of multiple
converging studies, we continue to
develop evidence to inform our
thinking. We evaluate the results from
our studies within the broader context
of research and findings from other
sources, and this larger body of
knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
homepage, which can be found at:
https://www.fda.gov/aboutfda/
centersoffices/officeofmedical
productsandtobacco/cder/
ucm090276.htm. The website includes
links to the latest Federal Register
notices and peer-reviewed publications
produced by our office. The website
maintains information on studies we
have conducted, dating back to a directto-consumer (DTC) survey conducted in
1999.
During the prescription drug approval
process, sponsors propose proprietary
names for their products. These names
undergo a proprietary name review that
involves the Office of Drug Safety, the
relevant medical office, and the OPDP.
OPDP reviews names to assess for
alignment with the FD&C Act, which
provides that labeling or advertising can
misbrand a product if misleading
representations are made (see 21 U.S.C.
321(n)). A proprietary name, which
appears in labeling, could result in such
misbranding if it is false or misleading.
OPDP focuses its misbranding review on
identifying names that overstate the
efficacy or safety of the drug, expand
drug indications, suggest superiority
without substantiation, or are of a
fanciful nature that misleadingly
implies unique effectiveness or
composition. While there are several
ways proprietary names can be
misleading, this research will primarily
focus on overstatement of the efficacy of
the drug product.
The proposed study is designed to
provide systematic, empirical evidence
to answer two research questions:
• Primary research question: How, if
at all, do names that suggest the drug’s
indication affect consumers’ and/or
healthcare providers’ perceptions of the
prescription drug?
• Secondary research question: How,
if at all, do names that suggest an
overstatement of the efficacy of the drug
affect consumers’ and/or healthcare
providers’ perceptions of prescription
drugs?
The ideas generated in the
Prescription Drug User Fee
Amendments pilot project proprietary
name review concept paper of 2008 1
provided a starting point for the study.
Based on ideas from that document, a
review of the linguistics and social
sciences literature, and an
environmental scan, FDA developed
and pretested an extreme, explicitly
suggestive name (e.g., CureAll) and a
neutral name for two indications, high
cholesterol and gastroesophageal reflux
disease (OMB control number 0910–
0695). In the proposed main study,
approximately 500 consumers from the
general population and 500 HCPs
(including physicians, nurse
practitioners, and physician assistants)
will see these pretested extreme and
neutral names plus five target (to be
tested) names per indication and answer
questions about the names, before and
after they have been told what each
drug’s indication is. Target names will
vary such that some efficacy
implications are more apparent than
others and some will more clearly imply
indication or benefits than others.
Dependent variables will include
indication identification, efficacy, and
perceptions.
To our knowledge, this study is the
first to provide a systemic investigation
of a variety of proprietary prescription
drug names.
The questionnaire is available upon
request from DTCResearch@fda.hhs.gov.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response 2
Consumer Screener ....................................................
HCP Screener .............................................................
Consumer Study ..........................................................
HCP Study ...................................................................
1,233
1,233
493
493
1
1
1
1
1,233
1,233
493
493
Total ......................................................................
........................
........................
........................
0.08
0.08
0.33
0.33
Total hours
(5 minutes) .....
(5 minutes) .....
(20 minutes) ..
(20 minutes) ...
99
99
163
163
................................
524
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
Dated: January 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00823 Filed 1–17–20; 8:45 am]
BILLING CODE 4164–01–P
jbell on DSKJLSW7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY:
Office of the Secretary, HHS.
ACTION:
Notice.
Findings of research
misconduct have been made against
Ozgur Tataroglu, Ph.D. (Respondent),
former postdoctoral fellow, Department
of Neurobiology, University of
Massachusetts Medical School (UMMS).
Dr. Tataroglu engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically National Institute of General
Medical Sciences (NIGMS), National
Institutes of Health (NIH), grants R01
SUMMARY:
GM066777 and R01 GM079182. The
administrative actions, including
supervision for a period of three (3)
years, were implemented beginning on
December 30, 2019, and are detailed
below.
FOR FURTHER INFORMATION CONTACT:
Elisabeth A. Handley, Interim Director,
Office of Research Integrity, 1101
Wootton Parkway, Suite 240, Rockville,
MD 20852, (240) 453–8200.
Notice is
hereby given that the Office of Research
SUPPLEMENTARY INFORMATION:
1 https://www.regulations.gov/docket?D=FDA2008-N-0281.
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21JAN1
]]>Agencies
[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3392-3394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00823]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5666]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Empirical Study of Promotional Implications of
Proprietary Prescription Drug Names
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 a proposed study entitled ``Empirical Study of
Promotional Implications of Proprietary Prescription Drug Names.''
DATES: Submit either electronic or written comments on the collection
of information by March 23, 2020.
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 March 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 23, 2020. 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.
[[Page 3393]]
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-5666 for ``Empirical Study of Promotional Implications of
Proprietary Prescription Drug Names.'' 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, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Empirical Study of Promotional Implications of Proprietary Prescription
Drug Names
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 (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.
The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotional material is truthful, balanced, and accurately
communicated, so that patients and healthcare providers (HCPs) 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 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
[[Page 3394]]
study will inform the first two topic areas.
Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our homepage, which
can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a direct-to-consumer (DTC)
survey conducted in 1999.
During the prescription drug approval process, sponsors propose
proprietary names for their products. These names undergo a proprietary
name review that involves the Office of Drug Safety, the relevant
medical office, and the OPDP. OPDP reviews names to assess for
alignment with the FD&C Act, which provides that labeling or
advertising can misbrand a product if misleading representations are
made (see 21 U.S.C. 321(n)). A proprietary name, which appears in
labeling, could result in such misbranding if it is false or
misleading. OPDP focuses its misbranding review on identifying names
that overstate the efficacy or safety of the drug, expand drug
indications, suggest superiority without substantiation, or are of a
fanciful nature that misleadingly implies unique effectiveness or
composition. While there are several ways proprietary names can be
misleading, this research will primarily focus on overstatement of the
efficacy of the drug product.
The proposed study is designed to provide systematic, empirical
evidence to answer two research questions:
Primary research question: How, if at all, do names that
suggest the drug's indication affect consumers' and/or healthcare
providers' perceptions of the prescription drug?
Secondary research question: How, if at all, do names that
suggest an overstatement of the efficacy of the drug affect consumers'
and/or healthcare providers' perceptions of prescription drugs?
The ideas generated in the Prescription Drug User Fee Amendments
pilot project proprietary name review concept paper of 2008 \1\
provided a starting point for the study. Based on ideas from that
document, a review of the linguistics and social sciences literature,
and an environmental scan, FDA developed and pretested an extreme,
explicitly suggestive name (e.g., CureAll) and a neutral name for two
indications, high cholesterol and gastroesophageal reflux disease (OMB
control number 0910-0695). In the proposed main study, approximately
500 consumers from the general population and 500 HCPs (including
physicians, nurse practitioners, and physician assistants) will see
these pretested extreme and neutral names plus five target (to be
tested) names per indication and answer questions about the names,
before and after they have been told what each drug's indication is.
Target names will vary such that some efficacy implications are more
apparent than others and some will more clearly imply indication or
benefits than others. Dependent variables will include indication
identification, efficacy, and perceptions.
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\1\ https://www.regulations.gov/docket?D=FDA-2008-N-0281.
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To our knowledge, this study is the first to provide a systemic
investigation of a variety of proprietary prescription drug names.
The questionnaire is available upon request from
[email protected].
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
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Consumer Screener............................ 1,233 1 1,233 0.08 (5 minutes)......................... 99
HCP Screener................................. 1,233 1 1,233 0.08 (5 minutes)......................... 99
Consumer Study............................... 493 1 493 0.33 (20 minutes)........................ 163
HCP Study.................................... 493 1 493 0.33 (20 minutes)........................ 163
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Total.................................... .............. .............. .............. ......................................... 524
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
Dated: January 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00823 Filed 1-17-20; 8:45 am]
BILLING CODE 4164-01-P
