[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Pages 40300-40303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1261]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Study of Disclosures to Health Care Providers 
Regarding Data that Do Not Support Unapproved Use of an Approved 
Prescription Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on research entitled ``Study of Disclosures to Health 
Care Providers Regarding Data that Do Not Support Unapproved Use of an 
Approved Prescription Drug.''

DATES: Submit either electronic or written comments on the collection 
of information by September 4, 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 4, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 4, 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-1261 for ``Study of Disclosures to Health Care Providers 
Regarding Data that Do Not Support Unapproved Use of an Approved 
Prescription Drug.'' 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

[[Page 40301]]

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 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.

Study of Disclosures to Health Care Providers Regarding Data That Do 
Not Support Unapproved Use of an Approved Prescription Drug

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.
    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 advertisements conducted in 1999.
    The revised draft guidance entitled ``Distributing Scientific and 
Medical Publications on Unapproved New Uses--Recommended Practices'' 
(2014),\1\ recommends that information such as reprints, clinical 
practice guidelines, and textbooks that discuss unapproved uses of 
approved drug products be disseminated with a representative 
publication that reaches contrary or different conclusions, when

[[Page 40302]]

such information exists. Similarly, the draft guidance entitled 
``Responding to Unsolicited Requests for Off-Label Information About 
Prescription Drugs and Medical Devices'' (2011) \2\ recommends that 
when conclusions of articles or texts that are disseminated in response 
to an unsolicited request have been specifically called into question 
by other articles or texts, a firm should disseminate representative 
publications that reach contrary or different conclusions regarding the 
use at issue.
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    \1\ ``Distributing Scientific and Medical Publications on 
Unapproved New Uses--Recommended Practices; Revised Draft Guidance'' 
(2014). Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/distributing-scientific-and-medical-publications-unapproved-new-uses-recommended-practices-revised.When 
final, this guidance will represent FDA's current thinking on this 
topic.
    \2\ ``Responding to Unsolicited Requests for Off-Label 
Information About Prescription Drugs and Medical Devices; Draft 
Guidance'' (2011). Available at: https://www.fda.gov/media/82660/download. When final, this guidance will represent FDA's current 
thinking on this topic.
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    Pharmaceutical firms sometimes choose to disseminate publications 
to health care professionals (HCPs) that include data that appear to 
support an unapproved use of an approved product. At the same time, 
published data that are not supportive of that unapproved use may also 
exist. For example, unsupportive published information could describe 
an increased risk of negative outcomes (e.g., death, relapse) from the 
unapproved use of the approved product, suggesting that the unapproved 
use does not have a positive benefit-risk ratio. The purpose of this 
research is to examine HCPs' perceptions and behavioral intentions 
about an unapproved new use of an approved prescription drug when made 
aware of other data that are not supportive of the unapproved use. This 
research will also evaluate the effectiveness of various disclosure 
approaches for communicating the unsupportive information. We will use 
the results of this research to better understand: (1) HCPs' 
perceptions of an unapproved use of a prescription drug; (2) HCPs' 
perceptions about an unapproved use of an approved prescription drug 
when they are aware of the existence of unsupportive information about 
it; (3) HCPs' perceptions of disclosures referencing the existence of 
unsupportive information about that particular use; and (4) examine the 
utility and effectiveness of various approaches to the communication of 
this information. In particular, we plan to examine how different 
approaches to the communication of unsupportive information affect 
physician's thoughts and attitudes about the unapproved use. Five 
approaches will be examined: (1) The provision of the unsupportive data 
in the form of a representative publication; (2) a disclosure 
summarizing the unsupportive data and including a citation to the 
representative publication; (3) a disclosure that does not include a 
summary of the unsupportive data but does acknowledge that unsupportive 
data exist and includes a citation to the representative publication; 
(4) a general disclosure that unsupportive data may exist, without 
conceding that such data do exist; or (5) nothing--the absence of any 
presentation of unsupportive data or any disclosure about such data 
(control condition). We have four research questions:
    RQ1: When considering a presentation of data about an unapproved 
use of an approved drug product, how does the existence of unsupportive 
data impact HCP perceptions and intentions with regard to that 
unapproved use?
    RQ2: Without presenting the specific unsupportive data, how does 
the way in which the existence of unsupportive data is communicated 
impact HCPs' perceptions and intentions with regard to an unapproved 
use of an approved drug product?
    RQ3: How are HCP perceptions of and intentions towards an 
unapproved use of an approved drug product affected by the disclosure 
of specific unsupportive data versus disclosure statements about this 
data that do not include the data itself?
    RQ4: Do other variables (e.g., demographics) have an impact on 
these effects?
    These research questions will be examined in two medical 
conditions.
    We plan to conduct one pretest with 180 voluntary adult 
participants and one main study with 1,600 voluntary adult 
participants. Participants in the main study will be 510 oncologists in 
the oncology medical condition and 1,090 primary care physicians in the 
diabetes medical condition. All participants will be physicians who 
engage in patient care at least 50 percent of the time and do not work 
for a pharmaceutical company, marketing firm, or the Department of 
Health and Human Services. The gender, race/ethnicity, and ages of the 
participating HCPs will be self-identified by participants. We will aim 
to include a mix of demographic segments to ensure a diversity of 
viewpoints and backgrounds. Power analyses were conducted to ensure 
adequate sample sizes to detect small to medium effects.
    The studies will be conducted online. The pretest and main studies 
will have the same design and will follow the same procedure. The base 
stimulus in both the pretest and main studies will consist of a sample 
publication supporting an unapproved use of an approved drug product. 
Within each medical condition, participants will be randomly assigned 
to one of five test conditions (see Figure 1). Following exposure to 
the stimuli, they will be asked to complete a questionnaire that 
assesses comprehension, perceptions, prescribing intentions, and 
demographics. In the pretest, participants will also answer questions 
about the study design and questionnaire.

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[GRAPHIC] [TIFF OMITTED] TN06JY20.002

    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     Total hours
                                  respondents     respondent       responses      per response
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Pretest screener..............             290               1             290  0.08 (5 minutes)              23
Pretest completes.............             180               1             180  0.33 (20                      59
                                                                                 minutes).
Main study screener...........           2,526               1           2,526  0.08 (5 minutes)             202
Main study completes, Medical              510               1             510  0.33 (20                     168
 Condition 1.                                                                    minutes).
Main study completes, Medical            1,090               1           1,090  0.33 (20                     360
 Condition 2.                                                                    minutes).
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    Total.....................           1,600  ..............  ..............  ................             812
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14372 Filed 7-2-20; 8:45 am]
BILLING CODE 4164-01-P