[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27845-27848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12599]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1779]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Disclosures of Descriptive Presentations in
Professional Oncology Prescription Drug Promotion
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 ``Disclosures of Descriptive
Presentations in Professional Oncology Prescription Drug Promotion.''
DATES: Submit either electronic or written comments on the collection
of information by August 18, 2017.
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 August 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 18, 2017. 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
[[Page 27846]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-1779 for ``Disclosures of Descriptive Presentations in
Professional Oncology Prescription Drug Promotion.'' 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: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501-3520), 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.
Disclosures of Descriptive Presentations in Professional Oncology
Prescription Drug Promotion; 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 (the 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.
Under the FD&C Act and implementing regulations, promotional
labeling and advertising about prescription drugs are generally
required to be truthful, non-misleading, and to reveal facts material
to the presentations made about the product being promoted (see
sections 502(a) and (n), and 201(n) of the FD&C Act (21 U.S.C. 352(a)
and (n), and 321(n)); see also 21 CFR 202.1). As a part of the ongoing
evaluation of FDA's regulations in this area, FDA is proposing to study
the impact of disclosures as they relate to presentations of
preliminary or descriptive scientific and clinical data in promotional
labeling and advertising for oncology products. The use of disclosures
is one method of communicating information to health care professionals
about scientific and clinical data, the limitations of that data, and
practical utility of that information for use in treatment. These
disclosures may influence prescriber comprehension and decisionmaking,
and may affect how and what treatment they prescribe for their
patients.
Pharmaceutical companies market directly to physicians through
publishing advertisements in medical journals, exhibit booths at
physician meetings or events, sending unsolicited promotional materials
to doctors' offices, or presentations (``detailing'') by pharmaceutical
representatives (Ref. 1). Detail aids may contain carefully extracted
data from clinical studies that, taken out of context, can exaggerate
the benefits of a drug (Ref. 2) or contribute to physicians prescribing
the drug for an inappropriate patient population.
Promotional labeling and advertising for cancer drugs deserve
specific attention. Oncology drugs represented 26 percent of the 649
compounds under clinical trial investigation from 2006 to 2011 (Ref.
3). The past decade has seen a dramatic rise in the number of oncology
drugs brought to market. In the past 18 months, FDA has approved 27
cancer drugs (Ref. 4). Although overall survival remains the gold
standard for demonstrating clinical benefit of a drug, several
additional endpoints are accepted as surrogates illustrating clinical
benefit with regard to cancer and many drugs are granted expedited
approval on their basis. These include disease-free survival, objective
response rate, complete response rate, progression-free survival, and
time to progression (Ref. 5). For clinicians who are not specifically
trained in clinical trial design, interpreting these endpoints may be
challenging. Pharmaceutical companies invest heavily in the development
and distribution of promotional materials to educate oncologists about
favorable clinical trial results.
When communicating scientific and clinical data, a disclosure (a
specific statement that modifies or qualifies a claim) could be used to
convey the limitations of the data and practical
[[Page 27847]]
utility of the information for treatment. Much of the prior research on
disclosures in this topic area has been limited to the dietary
supplement arena with consumers (Refs. 6-9). Disclosures in
professional pieces could influence prescriber comprehension as well as
subsequent decisionmaking; however, no published data exist regarding
how prescribers use and understand scientific claims in conjunction
with qualifying disclosures.
Different aspects of disclosures may influence their effectiveness.
For example, despite the advanced education of health care providers,
in a busy practice they may not be willing or able to process the
disclosures thoroughly. Thus, the level of technicality in the
disclosure may play a role in their use of the disclosure to
contextualize the data display. Additionally, the addition of a general
summary statement to frame the disclosure may help or hinder the
processing of the disclosure and therefore the entire data display.
Finally, it is possible that the impact of disclosure statements on
prescriber comprehension, perceptions, and intentions to prescribe the
promoted product will vary based on the level of clinical training.
Although oncologists and primary care physicians (PCPs) will have more
experience with clinical data, mid-level practitioners have reported
having significantly more formal training on pharmaceutical marketing
tactics than specialists and PCPs (Ref. 10). Therefore, it is unclear
whether any one group would be more or less affected by both the claims
made in promotional materials or by the disclosures that accompany
those claims.
The proposed study seeks to address the following research
questions:
1. Do disclosures mitigate potentially misleading presentations of
preliminary or descriptive data in oncology drug product promotion?
2. Does the language (technical, non-technical) of the disclosure
influence the effectiveness of the disclosure?
3. Does the presence of a general statement about the clinical
utility of the data in addition to a specific disclosure influence
processing of claims and disclosures?
4. Do PCPs, oncologists, and mid-level practitioners (nurse
practitioners, physician assistants) differ in their processing of
claims and disclosures about preliminary or descriptive data?
5. Which disclosures do physicians prefer?
To address these questions, FDA has designed a study that will be
conducted in three independent phases, each phase examining a data
display in a promotional piece for a unique oncological product.
Independent variables will include: (1) Specific disclosure (technical,
non-technical, none), (2) general statement (present, absent), and (3)
specialty (oncologists, PCPs, mid-level practitioners). Each phase will
have the following design:
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Specific disclosure
Sample General statement ----------------------------------------------------------
Technical Non-technical No disclosure
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Oncologists..................... Present............ Control.
Absent.............
PCPs............................ Present............ Control.
Absent.............
Mid-Level Practitioners......... Present............ Control.
Absent.............
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Specific disclosures will include material information specifically
related to the particular data display in question. As such, each
specific disclosure may include clinical or statistical information
related to the trial design, the statistical analysis plan of the
trial, or any other material statistical or clinical information
necessary for evaluation or interpretation of the data. The team
developing the disclosures includes social science analysts,
pharmacists, oncological medical officers, and an oncology nurse. An
example of the general statement is ``This presentation includes
exploratory information of uncertain clinical utility and should be
interpreted cautiously when used to make treatment decisions.''
Outcome variables will focus on the assessment of the data display
as a whole as well as attention to the disclosure, if present.
Specifically, we will examine recognition of the clinical endpoint in
the data display, comprehension of the data display, perceptions of the
exploratory nature of the data, and the perceived credibility of the
promotional piece. We will also look at attention to the specific
disclosure and the general statement, prescriber decisions, and
prescriber preferences. This latter outcome variable will be determined
by a secondary task at the end of the questionnaire that shows each
participant all disclosure options and asks them to choose their
preferred version.
Oncologists, PCPs, and non-oncology mid-level practitioners will be
recruited to participate via the Internet, and the study is expected to
take approximately 20 minutes. Participants will view professionally
developed promotional pieces that mimic currently available promotion
and answer questions. The questionnaire is available upon request.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
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Pretest Screener............................ 134 1 134 0.03 (2 minutes).......................... 5
Pretest..................................... 90 1 90 0.33 (20 minutes)......................... 30
Main Study Screener......................... 3,134 1 3,134 0.03 (2 minutes).......................... 105
Main Study.................................. 2,115 1 2,115 0.33 (20 minutes)......................... 705
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[[Page 27848]]
Total................................... .............. .............. .............. .......................................... 845
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the next full hour.
II. References
The following references are on display in 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; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. Johar, K., ``An Insider's Perspective: Defense of the
Pharmaceutical Industry's Marketing Practices,'' Albany Law Review,
76:299-334, 2012-2013.
2. Wick, C., M. Egger, S. Trelle, et al., ``The Characteristics of
Unsolicited Clinical Oncology Literature Provided by Pharmaceutical
Industry,'' Annals of Oncology, 18:1580-1582, 2007.
3. Fisher, J.A., M.D. Cottingham, and C.A. Kalbaugh, ``Peering Into
the Pharmaceutical `Pipeline': Investigational Drugs, Clinical
Trials, and Industry Priorities,'' Social Science & Medicine,
131:322-330, 2015.
4. Centerwatch, ``FDA Approved Drugs for Oncology,'' https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-area/12/oncology (accessed on March 2, 2017).
5. Pazdur, R., ``Endpoints for Assessing Drug Activity in Clinical
Trials,'' The Oncologist, 13:19-21, 2008.
6. Dodge, T. and A. Kaufman, ``What Makes Consumers Think Dietary
Supplements Are Safe and Effective? The Role of Disclaimers and FDA
Approval,'' Health Psychology, 26:513-517, 2007.
7. Dodge, T., D. Litt, and A. Kaufman, ``Influence of the Dietary
Supplement Health and Education Act on Consumer Beliefs About the
Safety and Effectiveness of Dietary Supplements,'' Journal of Health
Communication, 16:230-244, 2011.
8. Mason, M.J., D.L. Scammon, and X. Fang, ``The Impact of Warnings,
Disclaimers, and Product Experience on Consumers' Perceptions of
Dietary Supplements,'' The Journal of Consumer Affairs, 41:74-99,
2007.
9. France, K.R. and P.F. Bone, ``Policy Makers' Paradigms and
Evidence From Consumer Interpretations of Dietary Supplement
Labels,'' The Journal of Consumer Affairs, 39:27-51, 2005.
10. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al., ``Awareness
of the Food and Drug Administration's Bad Ad Program and Education
Regarding Pharmaceutical Advertising: A National Survey of
Prescribers in Ambulatory Care Settings,'' Journal of Health
Communication, 20:1330-1336, 2015.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12599 Filed 6-16-17; 8:45 am]
BILLING CODE 4164-01-P