Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials, 40659-40662 [2020-14514]
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Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14512 Filed 7–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1307]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Examination of
Secondary Claim Disclosures and
Biosimilar Disclosures in Prescription
Drug Promotional Materials
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Examination of
Secondary Claim Disclosures and
Biosimilar Disclosures in Prescription
Drug Promotional Materials.’’
DATES: Submit either electronic or
written comments on the collection of
information by September 8, 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 September 8,
2020. The https://www.regulations.gov
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SUMMARY:
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electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 8, 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.
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
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identifies you in the body of your
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• If you want to submit a comment
with confidential information that you
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written/paper submission and in the
manner detailed (see ‘‘Written/Paper
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Written/Paper Submissions
Submit written/paper submissions as
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• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
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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–
2020–N–1307 for ‘‘Examination of
Secondary Claim Disclosures and
Biosimilar Disclosures in Prescription
Drug Promotional Materials.’’ 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
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40659
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
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‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
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claimed confidential information
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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
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the information at: https://
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Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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docket number, found in brackets in the
heading of this document, into the
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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.
For copies of the questionnaire
contact: Office of Prescription Drug
Promotion (OPDP) Research Team,
DTCresearch@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
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.
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Examination of Secondary Claim
Disclosures and Biosimilar Disclosures
in Prescription Drug Promotional
Materials
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 Office of Prescription Drug
Promotion’s (OPDP) mission 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
health care 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
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conducted research to evaluate the
aspects of prescription drug promotion
that are most central to our mission. Our
research focuses 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 our research
data through analytical methodology
development and investigation of
sampling and response issues. This
study will inform the first two topic
areas: Advertising features, including
content and format, and target
populations.
Because we recognize that the
strength of data and the confidence in
the robust nature of the findings is
improved by utilizing 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/officeofmedicalproducts
andtobacco/cder/ucm090276.htm. The
website includes links to the latest
Federal Register notices and peerreviewed publications produced by our
office. The website maintains
information on studies we have
conducted, dating back to a survey on
direct-to-consumer (DTC)
advertisements conducted in 1999.
The purpose of this research is to
build on prior FDA research on the
topic of disclosures by examining the
impact of disclosures of two different
types of information, detailed later in
this notice. The literature on disclosures
suggests their effectiveness is subject to
format, design, and audience factors,
among other things (Ref. 1). For
example, research on consumer
attitudes have found some people
believe that FDA evaluates certain
dietary supplement claims despite the
presence and consumer awareness of
language required by the Dietary
Supplement Health and Education Act,
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which clearly states that FDA has not
evaluated those claims (Refs. 2 and 3).
In the context of prescription drug
promotion, there is initial evidence
that—when noticed—disclosures may
effectively convey important
information (Refs. 4 to 6); however,
what role disclosures may play in
educating or correcting
misunderstanding warrants further
investigation.
In the new study proposed here, the
first type of disclosed information we
will examine is clinical benefit
information based on a secondary
endpoint reported in a product’s
approved labeling (a secondary claim).
In some cases, truthful and nonmisleading presentations about
secondary endpoints in well-designed
clinical studies can provide reliable
information about treatment effects that
may be distinct from the treatment
effects described in the product’s
indication statement. For example, a
product may be indicated to treat a
specific type of cancer based on a
primary endpoint of survival. However,
a secondary endpoint in the study of
that product may provide data about an
additional distinct benefit, such as
functional status.
Phase 1 of the proposed research will
examine the impact of adding a
disclosure about a secondary claim in
DTC and healthcare professional (HCP)directed promotion in the context of a
prescription drug website. We will also
examine the effect of the presence of a
comparative claim about the secondary
claim. Our proposed main outcome
measures are perceptions of and
attitudes toward the product, the
secondary claim, and the disclosure.
The pretest and main studies for Phase
1 will have the same design, will be
conducted online, and will follow the
same procedure. We will examine four
levels of secondary claim disclosure to
explore the effects of disclosing that the
secondary benefit is not one of the
indicated uses of the product (e.g., not
a treatment for [the secondary benefit
claim], quantitative information about
claim, not a treatment for [claim] and
quantitative information about claim, or
no disclosure), and two levels (presence
or absence) of a comparative element
regarding the secondary claim, for a
total of eight experimental conditions
(see table 1). Participants will be
randomly assigned to one of these
conditions; they will view one version
of a website. This 4 × 2 design will be
replicated across two target populations
(HCPs and consumers).
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
TABLE 1—PHASE 1 STUDY DESIGN
Phase 1: Secondary claim disclosure by comparative secondary claim in online prescription drug websites
Secondary claim disclosure
Comparative secondary claim
‘‘Drug X is not a
treatment for [claim]’’
AND ‘‘In a clinical
trial, participants
[quantitative
information] on
Drug X.’’
‘‘In a clinical
trial, participants
[quantitative
information] on
Drug X’’
‘‘Drug X is not a
treatment for [claim]’’
None
(no secondary claim)
HCPs:
Present: Compared to [xx] on Drug Y.
Absent.
Consumers:
Present: Compared to [xx] on Drug Y.
Absent.
The second, independent phase of the
proposed research will examine
disclosures about a biosimilar product.
In both consumer and HCP audiences,
we will assess the impact of a disclosure
designating the product as a biosimilar
as well as varying basic factual
statements about biosimilars. Phase 2
will examine the impact of: (1) Adding
a disclosure designating the product as
a biosimilar; (2) adding general
informational statements about
biosimilars; and (3) naming a reference
product. This approach allows us to
examine the effect of disclosing
biosimilar status, examines the additive
effect of including one, two, or three
additional basic statements of
information about biosimilars, and
measures the effect of naming the
reference product. Our proposed main
outcome measures are perceptions of
generally (for example, ‘‘This biosimilar
is a biological product that is highly
similar to and has no clinically
meaningful differences from an existing
FDA-approved reference product’’). The
wording of the disclosure will be
tailored to the audience; for example,
the disclosures for the consumer
audience will avoid technical terms. A
control condition will also be included
in which no biosimilar statement or
additional information disclosure is
presented.
The pretest and main studies for
Phase 2 will have the same design, will
be conducted online, and will follow
the same procedure. Both phases will be
conducted concurrently. Sample sizes
were determined on the basis of power
analysis that will allow us to detect
medium effect sizes.
FDA estimates the burden of this
collection of information as follows:
and attitudes toward the biosimilar
product and the disclosure.
We propose to examine seven
different disclosure conditions plus a
control with no disclosure for a total of
eight test conditions. As a baseline, each
of the seven disclosure conditions will
include a statement that the drug is a
biosimilar. Six of the seven disclosure
conditions will include this baseline
statement and will vary the amount of
additional basic factual information
about biosimilar products in the
following way: (1) Two of the six
conditions have the baseline +
statement A; (2) two of the six
conditions have the baseline +
statement A + statement B; and (3) two
of the six conditions have the baseline
+ statement A + statement B + statement
C. Moreover, three of the six disclosure
conditions will name the specific
reference product while the other three
will refer to a reference product
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
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Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
Phase
1
1
1
1
2
2
2
2
1
1
1
1
2
2
2
2
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Pretest screener (HCPs) .....................
Pretest screener (consumers) ............
Pretest completes (HCPs) ..................
Pretest completes (consumers) ..........
Pretest screener (HCPs) .....................
Pretest screener (consumers) ............
Pretest completes (HCPs) ..................
Pretest completes (consumers) ..........
screener (HCPs) .................................
screener (consumers) .........................
completes (HCPs) ...............................
completes (consumers) .......................
screener (HCPs) .................................
screener (consumers) .........................
completes (HCPs) ...............................
completes (consumers) .......................
432
432
238
238
112
112
62
62
720
720
396
396
1,040
1,040
572
572
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
432
432
238
238
112
112
62
62
720
720
396
396
1,040
1,040
572
572
.08
.08
.33
.33
.08
.08
.33
.33
.08
.08
.33
.33
.08
.08
.33
.33
(5 minutes) ..................................................
(5 minutes) ..................................................
(20 minutes) ................................................
(20 minutes) ................................................
(5 minutes) ..................................................
(5 minutes) ..................................................
(20 minutes) ................................................
(20 minutes) ................................................
(5 minutes) ..................................................
(5 minutes) ..................................................
(20 minutes) ................................................
(20 minutes) ................................................
(5 minutes) ..................................................
(5 minutes) ..................................................
(20 minutes) ................................................
(20 minutes) ................................................
35
35
79
79
9
9
21
21
58
58
131
131
83
83
189
189
Total ............................................................
7,144
........................
7,144
...........................................................................
1,210
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
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. Andrews, J.C. (2011). ‘‘Warnings and
Disclosures.’’ In Communicating Risks
and Benefits: An Evidence-Based User’s
Guide. Fischhoff, B., N.T. Brewer, and
J.S. Downs, (Eds). FDA: Silver Spring,
MD, pp. 149–161.
2. Russo France, K. and P. Fitzgerald Bone
(2005). ‘‘Policy Makers’ Paradigms and
Evidence from Consumer Interpretations
of Dietary Supplement Labels.’’ Journal
of Consumer Affairs, 39(1), 27–51.
3. Mason, M.J. and D.L. Scammon (2011).
‘‘Unintended Consequences of Health
Supplement Information Regulations:
The Importance of Recognizing
Consumer Motivations.’’ Journal of
Consumer Affairs, 45(2), 201–223.
4. Betts, K.R., K.J. Aikin, V. Boudewyns, M.
Johnson, et al. (2017). ‘‘Physician
Response to Contextualized PriceComparison Claims in Prescription Drug
Advertising.’’ Journal of Communication
in Healthcare, 10(3), 195–204.
5. Betts, K.R., V. Boudewyns, K.J. Aikin, C.
Squire, et al. (2018). ‘‘Serious and
Actionable Risks, Plus Disclosure:
Investigating an Alternative Approach
for Presenting Risk Information in
Prescription Drug Television
Advertisements.’’ Research in Social and
Administrative Pharmacy, 14(10), 951–
963.
6. Sullivan, H.W., A.C. O’Donoghue, K.T.
David, and N.J. Patel (2018). ‘‘Disclosing
Accelerated Approval on
Direct-To-Consumer Prescription Drug
websites.’’ Pharmacoepidemiology and
Drug Safety, 27(11), 1277–1280.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14514 Filed 7–6–20; 8:45 am]
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BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Prescription Drug User Fee Act;
Stakeholder Consultation Meetings on
the Prescription Drug User Fee Act
Reauthorization; Request for
Notification of Stakeholder Intention to
Participate
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
issuing this notice to request that public
stakeholders—including patient and
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts—notify FDA of their
intent to participate in periodic
consultation meetings on the
reauthorization of the Prescription Drug
User Fee Act (PDUFA). The statutory
authority for PDUFA expires in
September 2022. At that time, new
legislation will be required for FDA to
continue collecting user fees for the
prescription drug program. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act) requires that FDA consult with a
range of stakeholders in developing
recommendations for the next PDUFA
program. The FD&C Act also requires
that FDA hold discussions (at least
every month) with patient and
consumer advocacy groups during
FDA’s negotiations with the regulated
industry. The purpose of this request for
notification is to ensure continuity and
progress in these monthly discussions
by establishing consistent stakeholder
representation.
SUMMARY:
Submit notification of intention
to participate in these series of meetings
by August 17, 2020. Stakeholder
meetings will be held monthly. It is
anticipated that they will commence in
September 2020. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The meetings will take
place virtually and will be held by
webcast only. Submit notification of
intention to participate in monthly
stakeholder meetings by email to
PDUFAReauthorization@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 301–
DATES:
PO 00000
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SUPPLEMENTARY INFORMATION:
I. Background
[Docket No. FDA–2020–N–1538]
AGENCY:
796–5003, Graham.Thompson@
fda.hhs.gov.
FDA is requesting that public
stakeholders—including patient and
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts—notify the Agency of
their intent to participate in periodic
stakeholder consultation meetings on
the reauthorization of PDUFA. PDUFA
authorizes FDA to collect user fees from
the regulated industry for the process
for the review of human drugs. The
authorization for the current program
(PDUFA VI) expires in September 2022.
Without new legislation, FDA will no
longer be able to collect user fees for
future fiscal years to fund the human
drug review process.
Section 736B(f)(1) of the FD&C Act
(21 U.S.C. 379h–2(f)(1)) requires that
FDA consult with a range of
stakeholders, including representatives
from patient and consumer groups,
healthcare professionals, and scientific
and academic experts, in developing
recommendations for the next PDUFA
program. FDA will initiate the
reauthorization process by holding a
public meeting on July 23, 2020, where
stakeholders and other members of the
public will be given an opportunity to
present their views on the
reauthorization. The FD&C Act further
requires that FDA continue meeting
with these stakeholders at least once
every month during negotiations with
the regulated industry to continue
discussions of stakeholder views on the
reauthorization. It is anticipated that
these monthly stakeholder consultation
meetings will commence in September
2020.
FDA is issuing this Federal Register
notice to request that stakeholder
representatives from patient and
consumer groups, healthcare
professional associations, as well as
scientific and academic experts, notify
FDA of their intent to participate in the
periodic stakeholder consultation
meetings on PDUFA reauthorization.
FDA believes that consistent
stakeholder representation at these
meetings will be important to ensure
progress in these discussions. If you
wish to participate in the stakeholder
consultation meetings, please designate
one or more representatives from your
organization who will commit to
attending these meetings and preparing
for the discussions. Stakeholders who
identify themselves through this notice
will be included in all stakeholder
consultation discussions while FDA
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Agencies
[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40659-40662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14514]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1307]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Examination of Secondary Claim Disclosures and
Biosimilar Disclosures in Prescription Drug Promotional Materials
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled, ``Examination of
Secondary Claim Disclosures and Biosimilar Disclosures in Prescription
Drug Promotional Materials.''
DATES: Submit either electronic or written comments on the collection
of information by September 8, 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 September 8, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 8, 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. 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-2020-N-1307 for ``Examination of Secondary Claim Disclosures and
Biosimilar Disclosures in Prescription Drug Promotional Materials.''
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.govinfo.gov/content/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].
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. 3501-3521), 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
[[Page 40660]]
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.
Examination of Secondary Claim Disclosures and Biosimilar Disclosures
in Prescription Drug Promotional Materials
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 Office of Prescription Drug Promotion's (OPDP) mission 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 health care 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 are most
central to our mission. Our research focuses 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 our research data through analytical methodology development
and investigation of sampling and response issues. This study will
inform the first two topic areas: Advertising features, including
content and format, and target populations.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings is improved by utilizing 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 survey on direct-to-
consumer (DTC) advertisements conducted in 1999.
The purpose of this research is to build on prior FDA research on
the topic of disclosures by examining the impact of disclosures of two
different types of information, detailed later in this notice. The
literature on disclosures suggests their effectiveness is subject to
format, design, and audience factors, among other things (Ref. 1). For
example, research on consumer attitudes have found some people believe
that FDA evaluates certain dietary supplement claims despite the
presence and consumer awareness of language required by the Dietary
Supplement Health and Education Act, which clearly states that FDA has
not evaluated those claims (Refs. 2 and 3). In the context of
prescription drug promotion, there is initial evidence that--when
noticed--disclosures may effectively convey important information
(Refs. 4 to 6); however, what role disclosures may play in educating or
correcting misunderstanding warrants further investigation.
In the new study proposed here, the first type of disclosed
information we will examine is clinical benefit information based on a
secondary endpoint reported in a product's approved labeling (a
secondary claim). In some cases, truthful and non-misleading
presentations about secondary endpoints in well-designed clinical
studies can provide reliable information about treatment effects that
may be distinct from the treatment effects described in the product's
indication statement. For example, a product may be indicated to treat
a specific type of cancer based on a primary endpoint of survival.
However, a secondary endpoint in the study of that product may provide
data about an additional distinct benefit, such as functional status.
Phase 1 of the proposed research will examine the impact of adding
a disclosure about a secondary claim in DTC and healthcare professional
(HCP)-directed promotion in the context of a prescription drug website.
We will also examine the effect of the presence of a comparative claim
about the secondary claim. Our proposed main outcome measures are
perceptions of and attitudes toward the product, the secondary claim,
and the disclosure. The pretest and main studies for Phase 1 will have
the same design, will be conducted online, and will follow the same
procedure. We will examine four levels of secondary claim disclosure to
explore the effects of disclosing that the secondary benefit is not one
of the indicated uses of the product (e.g., not a treatment for [the
secondary benefit claim], quantitative information about claim, not a
treatment for [claim] and quantitative information about claim, or no
disclosure), and two levels (presence or absence) of a comparative
element regarding the secondary claim, for a total of eight
experimental conditions (see table 1). Participants will be randomly
assigned to one of these conditions; they will view one version of a
website. This 4 x 2 design will be replicated across two target
populations (HCPs and consumers).
[[Page 40661]]
Table 1--Phase 1 Study Design
----------------------------------------------------------------------------------------------------------------
Phase 1: Secondary claim disclosure by comparative secondary claim in online prescription drug websites
-----------------------------------------------------------------------------------------------------------------
Secondary claim disclosure
-------------------------------------------------------------------------------
``Drug X is not a
treatment for
``In a clinical [claim]'' AND
Comparative secondary claim ``Drug X is not a trial, ``In a clinical
treatment for participants trial, None (no
[claim]'' [quantitative participants secondary claim)
information] on [quantitative
Drug X'' information] on
Drug X.''
----------------------------------------------------------------------------------------------------------------
HCPs:
Present: Compared to [xx] on
Drug Y.
Absent......................
Consumers:
Present: Compared to [xx] on
Drug Y.
Absent......................
----------------------------------------------------------------------------------------------------------------
The second, independent phase of the proposed research will examine
disclosures about a biosimilar product. In both consumer and HCP
audiences, we will assess the impact of a disclosure designating the
product as a biosimilar as well as varying basic factual statements
about biosimilars. Phase 2 will examine the impact of: (1) Adding a
disclosure designating the product as a biosimilar; (2) adding general
informational statements about biosimilars; and (3) naming a reference
product. This approach allows us to examine the effect of disclosing
biosimilar status, examines the additive effect of including one, two,
or three additional basic statements of information about biosimilars,
and measures the effect of naming the reference product. Our proposed
main outcome measures are perceptions of and attitudes toward the
biosimilar product and the disclosure.
We propose to examine seven different disclosure conditions plus a
control with no disclosure for a total of eight test conditions. As a
baseline, each of the seven disclosure conditions will include a
statement that the drug is a biosimilar. Six of the seven disclosure
conditions will include this baseline statement and will vary the
amount of additional basic factual information about biosimilar
products in the following way: (1) Two of the six conditions have the
baseline + statement A; (2) two of the six conditions have the baseline
+ statement A + statement B; and (3) two of the six conditions have the
baseline + statement A + statement B + statement C. Moreover, three of
the six disclosure conditions will name the specific reference product
while the other three will refer to a reference product generally (for
example, ``This biosimilar is a biological product that is highly
similar to and has no clinically meaningful differences from an
existing FDA-approved reference product''). The wording of the
disclosure will be tailored to the audience; for example, the
disclosures for the consumer audience will avoid technical terms. A
control condition will also be included in which no biosimilar
statement or additional information disclosure is presented.
The pretest and main studies for Phase 2 will have the same design,
will be conducted online, and will follow the same procedure. Both
phases will be conducted concurrently. Sample sizes were determined on
the basis of power analysis that will allow us to detect medium effect
sizes.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Phase 1 Pretest screener 432 1 432 .08 (5 minutes). 35
(HCPs).
Phase 1 Pretest screener 432 1 432 .08 (5 minutes). 35
(consumers).
Phase 1 Pretest completes 238 1 238 .33 (20 minutes) 79
(HCPs).
Phase 1 Pretest completes 238 1 238 .33 (20 minutes) 79
(consumers).
Phase 2 Pretest screener 112 1 112 .08 (5 minutes). 9
(HCPs).
Phase 2 Pretest screener 112 1 112 .08 (5 minutes). 9
(consumers).
Phase 2 Pretest completes 62 1 62 .33 (20 minutes) 21
(HCPs).
Phase 2 Pretest completes 62 1 62 .33 (20 minutes) 21
(consumers).
Phase 1 screener (HCPs)....... 720 1 720 .08 (5 minutes). 58
Phase 1 screener (consumers).. 720 1 720 .08 (5 minutes). 58
Phase 1 completes (HCPs)...... 396 1 396 .33 (20 minutes) 131
Phase 1 completes (consumers). 396 1 396 .33 (20 minutes) 131
Phase 2 screener (HCPs)....... 1,040 1 1,040 .08 (5 minutes). 83
Phase 2 screener (consumers).. 1,040 1 1,040 .08 (5 minutes). 83
Phase 2 completes (HCPs)...... 572 1 572 .33 (20 minutes) 189
Phase 2 completes (consumers). 572 1 572 .33 (20 minutes) 189
---------------------------------------------------------------------------------
Total..................... 7,144 .............. 7,144 ................ 1,210
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 40662]]
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. Andrews, J.C. (2011). ``Warnings and Disclosures.'' In
Communicating Risks and Benefits: An Evidence-Based User's Guide.
Fischhoff, B., N.T. Brewer, and J.S. Downs, (Eds). FDA: Silver
Spring, MD, pp. 149-161.
2. Russo France, K. and P. Fitzgerald Bone (2005). ``Policy Makers'
Paradigms and Evidence from Consumer Interpretations of Dietary
Supplement Labels.'' Journal of Consumer Affairs, 39(1), 27-51.
3. Mason, M.J. and D.L. Scammon (2011). ``Unintended Consequences of
Health Supplement Information Regulations: The Importance of
Recognizing Consumer Motivations.'' Journal of Consumer Affairs,
45(2), 201-223.
4. Betts, K.R., K.J. Aikin, V. Boudewyns, M. Johnson, et al. (2017).
``Physician Response to Contextualized Price-Comparison Claims in
Prescription Drug Advertising.'' Journal of Communication in
Healthcare, 10(3), 195-204.
5. Betts, K.R., V. Boudewyns, K.J. Aikin, C. Squire, et al. (2018).
``Serious and Actionable Risks, Plus Disclosure: Investigating an
Alternative Approach for Presenting Risk Information in Prescription
Drug Television Advertisements.'' Research in Social and
Administrative Pharmacy, 14(10), 951-963.
6. Sullivan, H.W., A.C. O'Donoghue, K.T. David, and N.J. Patel
(2018). ``Disclosing Accelerated Approval on
Direct[hyphen]To[hyphen]Consumer Prescription Drug websites.''
Pharmacoepidemiology and Drug Safety, 27(11), 1277-1280.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14514 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P