[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
[[Page 40303]]
[GRAPHIC] [TIFF OMITTED] TN06JY20.002
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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).
---------------------------------------------------------------------------------
Total..................... 1,600 .............. .............. ................ 812
----------------------------------------------------------------------------------------------------------------
\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