[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Notices]
[Pages 26255-26257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10410]
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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.
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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 http://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, [email protected].
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
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Type of price comparison
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Sample Price information No comparison
Price information + additional information
only context (control)
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Consumers (DTC ad)
Physicians (Professional ad) ................. ................. .................
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FDA estimates the burden of this collection of information as
follows:
Table 2--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
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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
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Total................................... .............. .............. .............. .......................................... 2,392
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\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