[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42823-42825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17725]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2406]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Market Claims in Direct-to-Consumer Prescription Drug
Print Ads
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, ``Market Claims in
Direct-to-Consumer Prescription Drug Print Ads.'' This study will
examine the impact of market claim information in direct-to-consumer
(DTC) print advertising for prescription drugs.
DATES: Submit either electronic or written comments on the collection
of information by September 18, 2015.
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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [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
[[Page 42824]]
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.
Market Claims in Direct-to-Consumer Prescription Drug Print Ads--OMB
Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the 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.
The marketing literature divides product attributes (``cues'') into
intrinsic and extrinsic. Intrinsic cues are physical characteristics of
the product (e.g., size, shape), whereas extrinsic cues are product-
related but not part of the product (e.g., price and brand name) (Refs.
1, 2). Research has found that both intrinsic and extrinsic cues can
influence perceptions of product quality (Ref. 3). Consumers may rely
on product cues in the absence of explicit quality information. The
objective quality of prescription drugs is not easily obtained from
promotional claims in DTC ads; thus consumers may rely upon extrinsic
cues to inform their decisions. Market claims such as ``#1 prescribed''
and ``new'' may act as extrinsic cues about the product's quality,
independent of the product's intrinsic characteristics. Prior research
has found that market leadership claims can affect consumer beliefs
about product efficacy, as well as their beliefs about doctors'
judgments about product efficacy (Ref. 4). One limitation of these
prior studies is the lack of quantitative information about product
efficacy in the information provided to respondents. Research indicates
that providing consumers with efficacy information generally improves
understanding and facilitates decisionmaking (Refs. 5, 6). Efficacy
information may moderate the effect of the extrinsic cue by providing
insight into characteristics that would otherwise be unknown. Other
research has shown that consumers are able to use information about
efficacy to inform judgments about the product (Refs. 6, 7).
The Office of Prescription Drug Promotion plans to investigate,
through empirical research, the impact of market claims on prescription
drug product perceptions with and without quantitative information
about product efficacy. This will be investigated in DTC print
advertising for prescription drugs.
The project consists of two parts; a main study and a followup
study. Pretesting will be conducted to assess and identify problems
with the questionnaire, stimuli, and procedures. Participants will be
consumers who self-identify as having been diagnosed with diabetes. 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 no more than 30 minutes.
In the main study, participants will be randomly assigned to view
one of nine possible versions of an ad, as depicted in table 1. The two
variables of interest are type of market claim (#1 Prescribed, New) and
level of efficacy information (high, low, or none). Efficacy
information will be operationalized in the form of simple quantitative
information (for example, product X can provide 50 percent relief for
up to 60 percent of patients). We will investigate memory, perception,
and understanding of product risks and benefits; perception and
understanding of the market claim; perception of product quality;
perceptions of product acceptance by doctor, intention to seek more
information about the product; and perceptions of trust/skepticism
regarding product claims and the sponsor. To examine differences
between experimental conditions, we will conduct inferential
statistical tests such as analysis of variance. With the sample size
described below, we will have sufficient power to detect small- to
medium-sized effects in the main study.
Table 1--Main Study Design Type of Market Claim
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#1 Prescribed New None (control)
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Efficacy Level Information:
High............................................ A B C
Low............................................. D E F
None (control).................................. G H I
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The followup study will examine the tradeoff between efficacy level
and market share claim using decision analysis techniques. Participants
will be asked to choose between two different DTC print ads over 48
trials. One set of DTC ads will feature the two claims from the main
study. The other set of DTC ads will depict 48 different levels of
product efficacy. Participants will be asked to choose one product on
one or more dependent measures.
FDA estimates the burden of this collection of information as
follows:
[[Page 42825]]
Table 2--Estimated Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent respondents
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Sample outgo (pretests and main survey)........ 16,384 .............. .............. ....................................... ..............
Screener completes............................. 1,638 1 1,638 .03 (2 minutes)........................ 49
Eligible....................................... 1,556 .............. .............. ....................................... ..............
Completes, Pretest 1........................... 252 1 252 .5 (30 minutes)........................ 126
Completes, Pretest 2........................... 252 1 252 .5 (30 minutes)........................ 126
Completes, Main Study.......................... 495 1 495 .5 (30 minutes)........................ 248
Completes, Pretest 3........................... 108 1 108 .25 (15 minutes)....................... 27
Completes, Followup Study...................... 216 1 216 .25 (15 minutes)....................... 54
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Total...................................... .............. .............. .............. ....................................... 630
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.
1. Lee, M. and Y.C. Lou, ``Consumer Reliance on Intrinsic and
Extrinsic Cues in Product Evaluations: A Conjoint Approach,''
Journal of Applied Business Research, 12(1), pp. 21-29 (2011).
2. Teas, R.K. and S. Agarwal, ``The Effects of Extrinsic Product
Cues on Consumers' Perceptions of Quality, Sacrifice, and Value,''
Journal of the Academy of Marketing Science, 28(2), pp. 278-290
(2000).
3. Rao, A.R. and K.B. Monroe, ``The Effect of Price, Brand Name, and
Store Name on Buyers' Perceptions of Product Quality: An Integrative
Review,'' Journal of Marketing Research, pp. 351-357 (1989).
4. Mitra, A., J.L. Swasy, and K.J. Aikin, ``How Do Consumers
Interpret Market Leadership Claims in Direct-to-Consumer Advertising
of Prescription Drugs?'' Advances in Consumer Research, 33, pp. 381-
387 (2006).
5. O'Donoghue, A., H.K. Sullivan, D. Aikin, R. Chowdhury, et al.,
``Presenting Efficacy Information in Direct to Consumer Prescription
Drug Advertisements,'' Patient Education Counsel, 95(2), pp. 271-80
(2014).
6. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug Facts
Box to Communicate Drug Benefits and Harmstwo Randomized Trials,''
Annals of Internal Medicine, 150(8), pp. 516-527 (2009).
7. Sullivan, H.W., A. C. O'Donoghue, and K.J. Aikin, ``Presenting
Quantitative Information About Placebo Rates to Patients,'' JAMA
Internal Medicine, doi: 10.1001/jamainternmed.2013.10399 (2013).
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17725 Filed 7-17-15; 8:45 am]
BILLING CODE 4164-01-P