[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]


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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.

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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
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     Phase 1: Secondary claim disclosure by comparative secondary claim in online prescription drug websites
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                                                            Secondary claim disclosure
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                                                                           ``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.''
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HCPs:
    Present: Compared to [xx] on
     Drug Y.
    Absent......................
Consumers:
    Present: Compared to [xx] on
     Drug Y.
    Absent......................
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    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\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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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
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\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