[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
                                                --------------------------------------------------------------------------------------------------------
    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