Agency Information Collection Activities; Proposed Collection; Comment Request; Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements, 26255-26257 [2014-10410]
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Federal Register / Vol. 79, No. 88 / Wednesday, May 7, 2014 / Notices
we estimate the current annual perproduct cost for innovator and generic
products as $1,429 and $859,
respectively. Therefore, we estimate that
the total incremental printing costs for
innovator and generic products are
approximately $1.1 million and $1.6
million, respectively, over the 5-year
period of the program.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN OVER A 5-YEAR PERIOD 1
Prescription drug labeling improvement and
enhancement initiative
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(hours)
Total
responses
Total hours
Total capital
costs
($million)
Total
operating and
maintenance
costs
($million)
Submitting a supplement to FDA for the
proposed PLR format
labeling .....................
Submitting a labeling
supplement to FDA
for generic drug products affected by the
RLD labeling change
375
2
750
196
147,000
$4.0
$1.1
233
8
1,864
27
50,328
10.1
1.6
Total ......................
........................
........................
........................
........................
197,328
14.1
2.7
1 Numbers
may not sum due to rounding.
Dated: May 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
professional advertising for prescription
drugs.
Submit either electronic or
written comments on the collection of
information by July 7, 2014.
DATES:
[FR Doc. 2014–10414 Filed 5–6–14; 8:45 am]
BILLING CODE 4160–01–P
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0554]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Comparative Price
Information in Direct-to-Consumer and
Professional Prescription Drug
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 ‘‘Comparative Price
Information in Direct-to-Consumer and
Professional Prescription Drug
Advertisements.’’ This study will
investigate the impact of price
comparison information in direct-toconsumer (DTC) and health care
pmangrum on DSK3VPTVN1PROD with NOTICES
15:11 May 06, 2014
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
SUPPLEMENTARY INFORMATION:
SUMMARY:
VerDate Mar<15>2010
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Jkt 232001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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.
Comparative Price Information in
Direct-to-Consumer and Professional
Prescription Drug Advertisements—
(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.
By their very nature, medical and
health decisions are comparative (e.g.,
treat versus not treat). For consumers,
these decisions may include the use of
prescription drug products versus over
the counter products versus herbal
E:\FR\FM\07MYN1.SGM
07MYN1
26256
Federal Register / Vol. 79, No. 88 / Wednesday, May 7, 2014 / Notices
supplements, as well as one
prescription brand versus another
prescription brand. Similarly,
advertising is often comparative. In
prescription drug advertising, sponsors
are permitted to include truthful, nonmisleading information about the price
of their products in promotion. This
may extend to price comparison
information, wherein sponsors may
include information about the price of a
competing product in order to make
advantageous claims. Currently, when
price comparisons are made, the ad
should also include context that the two
drugs may not be comparable in terms
of efficacy and safety and that the
acquisition costs presented do not
necessarily reflect the actual prices paid
by consumers, pharmacies, or third
party payers. Despite the inclusion of
this additional information, there is
concern that adding contextual
information about efficacy or safety is
not sufficient to correct the impression
that the products are interchangeable
and that price is the main factor to
consider. The Office of Prescription
Drug Promotion (OPDP) plans to
investigate, through empirical research,
the impact of price comparison
information and additional contextual
information on prescription drug
product perceptions. This will be
investigated in DTC and healthcaredirected professional advertising for
prescription drugs.
We will investigate perceptions about
overall drug safety and efficacy and
perceptions of the comparator product.
To examine differences between
experimental conditions, we will
conduct inferential statistical tests such
as analysis of variance. With the sample
size described in this document, we will
have sufficient power to detect small-tomedium sized effects in the main study.
Participants will be consumers who
self-identify as having been diagnosed
with diabetes and physicians who are
General Practitioners (e.g., Family
Practice, General Practice, Internal
Medicine) and Specialists (e.g.,
Endocrinology, Pain Management). All
participants will be 18 years of age or
older. We will exclude individuals from
the consumer sample who work in
healthcare or marketing settings because
their knowledge and experiences may
not reflect those of the average
consumer. Recruitment and
administration of the study will take
place over the Internet. Participation is
estimated to take approximately 30
minutes.
Physician and consumer participants
will be randomly assigned to view one
of three possible versions of an ad (DTC
or professional), as depicted in table 1.
One version will present information
about the price of the product relative
to a competitor for the same indication
(price comparison information).
Another version will present this
information with additional contextual
information that the two drugs may not
be comparable in terms of efficacy and
safety and that the acquisition costs do
not necessarily reflect actual prices
paid. A third version will have a claim
about the price of the product but will
not present information about the price
relative to a competitor, and will act as
a control.
After viewing the ad, participants will
respond to questions about information
in the ad. Preliminary measures are
designed to assess perception and
understanding of product safety and
efficacy; perception and understanding
of the additional contextual
information; perceptions of comparative
safety and efficacy; and intention to
seek more information about the
product. The questionnaire is available
upon request.
TABLE 1—STUDY DESIGN
Type of price comparison
Sample
Price information
only
No comparison
information
(control)
..............................
Consumers (DTC ad)
Physicians (Professional ad)
Price information
+
additional context
..............................
..............................
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
41,110
7,400
4,933
400
1,000
2,940
........................
1
........................
1
1
1
........................
7,400
........................
400
1,000
2,940
....................................
.03 (2 minutes) ..........
....................................
0.5 (30 minutes) ........
0.5 (30 minutes) ........
0.5 (30 minutes) ........
........................
222
........................
200
500
1,470
Total ..................................................................
pmangrum on DSK3VPTVN1PROD with NOTICES
Sample outgo (pretests and main survey) ..............
Screener completes .................................................
Eligible ......................................................................
Completes, Pretests Phase 1 ..................................
Completes, Pretest Phase 2 ....................................
Completes, Main Study ............................................
........................
........................
........................
....................................
2,392
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
15:11 May 06, 2014
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E:\FR\FM\07MYN1.SGM
07MYN1
Federal Register / Vol. 79, No. 88 / Wednesday, May 7, 2014 / Notices
Dated: May 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–10410 Filed 5–6–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0589]
Draft Guidance for Industry on
Hospital-Acquired Bacterial
Pneumonia and Ventilator-Associated
Bacterial Pneumonia: Developing
Drugs for Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Hospital-Acquired
Bacterial Pneumonia and VentilatorAssociated Bacterial Pneumonia:
Developing Drugs for Treatment.’’ The
purpose of this draft guidance is to
assist clinical trial sponsors and
investigators in the development of
antibacterial drugs for the treatment of
hospital-acquired bacterial pneumonia
and ventilator-associated bacterial
pneumonia (HABP/VABP). The science
of clinical trial design and our
understanding of this disease have
advanced in recent years, and this draft
guidance informs sponsors of our
current recommendations for clinical
development. FDA is specifically
requesting comment on critical areas of
scientific interest including the
appropriate primary efficacy endpoints,
the use of an intent-to-treat (ITT)
population for the primary analysis
population, and the use of antibacterial
therapy by patients before participating
in clinical trials. This draft guidance
revises the draft guidance of the same
name that published November 29,
2010.
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 5, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
pmangrum on DSK3VPTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
15:11 May 06, 2014
Jkt 232001
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Hospital-Acquired Bacterial
Pneumonia and Ventilator-Associated
Bacterial Pneumonia: Developing Drugs
for Treatment.’’ The purpose of this
draft guidance is to assist clinical trial
sponsors and investigators in the
development of antibacterial drugs for
the treatment of HABP/VABP. Issues in
HABP/VABP clinical trials were
discussed at a 2009 workshop
cosponsored by FDA and professional
societies. Recently, there have been
additional discussions about clinical
trial design and endpoints for HABP/
VABP at a meeting of the Anti-Infective
Drugs Advisory Committee. As a result
of these public discussions, the science
of clinical trial design and our
understanding of endpoints and
approaches to clinical development
have advanced.
This draft guidance revises the draft
guidance published in November 2010
(75 FR 73107) and informs sponsors of
the changes in our recommendations.
We acknowledge the challenges in
conducting clinical trials of
investigational antibacterial drugs in
HABP/VABP. This revised draft
guidance incorporates changes intended
to attain a greater degree of balance
between the practicability of conducting
HABP/VABP clinical trials and the trial
procedures needed for a scientifically
sound and interpretable trial. We are
requesting input from the public on
these changes, for consideration before
finalizing the guidance. Specifically, the
changes from the 2010 draft guidance
include:
• A description of two potential
primary efficacy endpoints for HABP/
VABP clinical trials: (1) All-cause
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26257
mortality and (2) all-cause mortality or
disease-related complications.
• A justification for a noninferiority
margin based on all-cause mortality.
• Suggestions for efficacy analyses
based on: (1) An overall ITT population
and (2) a microbiological ITT
population consisting of those patients
who have a documented bacterial
pathogen known to cause HABP/VABP.
• Recommendations for enrolling
patients who have received prior
effective antibacterial drug therapy.
Issuance of this guidance fulfills a
portion of the requirements of title VIII,
section 804 of the Food and Drug
Administration Safety and Innovation
Act of 2012 (Pub. L. 112–144), which
requires FDA to ‘‘review and, as
appropriate, revise not fewer than 3
guidance documents per year . . . for
the conduct of clinical trials with
respect to antibacterial and antifungal
drugs. . . . ’’
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulation.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014 and the collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Notices]
[Pages 26255-26257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10410]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0554]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Comparative Price Information in Direct-to-Consumer
and Professional Prescription Drug Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 ``Comparative Price
Information in Direct-to-Consumer and Professional Prescription Drug
Advertisements.'' This study will investigate the impact of price
comparison information in direct-to-consumer (DTC) and health care
professional advertising for prescription drugs.
DATES: Submit either electronic or written comments on the collection
of information by July 7, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
Comparative Price Information in Direct-to-Consumer and Professional
Prescription Drug Advertisements--(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.
By their very nature, medical and health decisions are comparative
(e.g., treat versus not treat). For consumers, these decisions may
include the use of prescription drug products versus over the counter
products versus herbal
[[Page 26256]]
supplements, as well as one prescription brand versus another
prescription brand. Similarly, advertising is often comparative. In
prescription drug advertising, sponsors are permitted to include
truthful, non-misleading information about the price of their products
in promotion. This may extend to price comparison information, wherein
sponsors may include information about the price of a competing product
in order to make advantageous claims. Currently, when price comparisons
are made, the ad should also include context that the two drugs may not
be comparable in terms of efficacy and safety and that the acquisition
costs presented do not necessarily reflect the actual prices paid by
consumers, pharmacies, or third party payers. Despite the inclusion of
this additional information, there is concern that adding contextual
information about efficacy or safety is not sufficient to correct the
impression that the products are interchangeable and that price is the
main factor to consider. The Office of Prescription Drug Promotion
(OPDP) plans to investigate, through empirical research, the impact of
price comparison information and additional contextual information on
prescription drug product perceptions. This will be investigated in DTC
and healthcare-directed professional advertising for prescription
drugs.
We will investigate perceptions about overall drug safety and
efficacy and perceptions of the comparator product. To examine
differences between experimental conditions, we will conduct
inferential statistical tests such as analysis of variance. With the
sample size described in this document, we will have sufficient power
to detect small-to-medium sized effects in the main study.
Participants will be consumers who self-identify as having been
diagnosed with diabetes and physicians who are General Practitioners
(e.g., Family Practice, General Practice, Internal Medicine) and
Specialists (e.g., Endocrinology, Pain Management). All participants
will be 18 years of age or older. We will exclude individuals from the
consumer sample who work in healthcare or marketing settings because
their knowledge and experiences may not reflect those of the average
consumer. Recruitment and administration of the study will take place
over the Internet. Participation is estimated to take approximately 30
minutes.
Physician and consumer participants will be randomly assigned to
view one of three possible versions of an ad (DTC or professional), as
depicted in table 1. One version will present information about the
price of the product relative to a competitor for the same indication
(price comparison information). Another version will present this
information with additional contextual information that the two drugs
may not be comparable in terms of efficacy and safety and that the
acquisition costs do not necessarily reflect actual prices paid. A
third version will have a claim about the price of the product but will
not present information about the price relative to a competitor, and
will act as a control.
After viewing the ad, participants will respond to questions about
information in the ad. Preliminary measures are designed to assess
perception and understanding of product safety and efficacy; perception
and understanding of the additional contextual information; perceptions
of comparative safety and efficacy; and intention to seek more
information about the product. The questionnaire is available upon
request.
Table 1--Study Design
----------------------------------------------------------------------------------------------------------------
Type of price comparison
--------------------------------------------------------
Sample Price information No comparison
Price information + additional information
only context (control)
----------------------------------------------------------------------------------------------------------------
Consumers (DTC ad)
Physicians (Professional ad) ................. ................. .................
----------------------------------------------------------------------------------------------------------------
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample outgo (pretests and main survey)..... 41,110 .............. .............. .......................................... ..............
Screener completes.......................... 7,400 1 7,400 .03 (2 minutes)........................... 222
Eligible.................................... 4,933 .............. .............. .......................................... ..............
Completes, Pretests Phase 1................. 400 1 400 0.5 (30 minutes).......................... 200
Completes, Pretest Phase 2.................. 1,000 1 1,000 0.5 (30 minutes).......................... 500
Completes, Main Study....................... 2,940 1 2,940 0.5 (30 minutes).......................... 1,470
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 2,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 26257]]
Dated: May 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10410 Filed 5-6-14; 8:45 am]
BILLING CODE 4160-01-P
