
[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 
PRAStaff@fda.hhs.gov.

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:

----------------------------------------------------------------------------------------------------------------
                                                                          Specific disclosure
             Sample                General statement  ----------------------------------------------------------
                                                           Technical       Non-technical       No disclosure
----------------------------------------------------------------------------------------------------------------
Oncologists.....................  Present............                      Control.
                                  Absent.............                   
PCPs............................  Present............                      Control.
                                  Absent.............                   
Mid-Level Practitioners.........  Present............                      Control.
                                  Absent.............                   
----------------------------------------------------------------------------------------------------------------

    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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses                                                      \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                             -----------------------------------------------------------------------------------------------------------

[[Page 27848]]

 
    Total...................................  ..............  ..............  ..............  ..........................................             845
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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


