APPENDIX A - 60 Day FR Notice - Experimental Study of Comparative Direct

APPENDIX A

[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]

[Notices]

[Pages 38663-38666]

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

[FR Doc No: 2011-16628]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2011-N-0457]

Agency Information Collection Activities; Proposed Collection;

Comment Request; Experimental Study of Comparative Direct-to-Consumer

Advertising

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 the Experimental Study of Comparative

Direct-to-Consumer (DTC) Advertising. This study is designed to explore

how consumers understand and interpret DTC ads that explicitly compare

the efficacy, dosing, and risks, among other items, of two similar

drugs whether comparisons are named or unnamed.

DATES: Submit either electronic or written comments on the collection

of information by August 30, 2011.

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: Elizabeth Berbakos, Office of

Information Management, Food and Drug Administration, 1350 Piccard Dr.,

P150-400B, Rockville, MD 20850, 301-796-3792,

Elizabeth.Berbakos@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.

Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising

Regulatory Background--(OMB Control No. 0910-New)

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.

300u(a)(4)) authorizes the Food and Drug Administration (FDA) to

conduct research relating to health information. Section 903(b)(2)(c)

of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.

393(b)(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.

Regulations specify that sponsors cannot make comparative efficacy

claims in advertising for prescription drugs without substantial

evidence, most often in the form of well-controlled clinical trials, to

support such claims (21 U.S.C. 202.1(e)(6)(ii); 21 U.S.C. 314.126). FDA

has permitted some comparisons based on labeled attributes, such as

indication, dosing, and mechanism of action. When substantial evidence

does not yet exist, sponsors may use communication

[[Page 38664]]

techniques that invite implicit comparisons, such as making indirect

comparisons, using comparative visuals, and using vaguer language. This

study is designed to apply the existing comparative advertising

literature to DTC advertising, where little research has been conducted

to date.

Moreover, as part of the American Recovery and Reinvestment Act of

2009 (ARRA), the Agency for Healthcare Research and Quality (AHRQ) is

in the process of securing a large compendium of information on the

comparative effectiveness of medical treatments in 14 priority medical

conditions, including: Arthritis, cancer, dementia, depression,

diabetes, and substance abuse.\1\ As part of this process, they will

fund a set of CHOICE (Clinical and Health Outcomes Initiative in

Comparative Effectiveness) studies designed to explore comparative

effectiveness. When this large project is completed, FDA will have

additional information to consider when regulating DTC advertising. It

is possible that more DTC advertising will be comparative in nature. In

preparation for this change, FDA is embarking on the proposed research

to ensure that it has adequate information to assess whether

comparative DTC ads provide truthful and nonmisleading information to

consumers.

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\1\ http://www.ahrq.gov/fund/cerfactsheets/. Last accessed May

23, 2011.

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A. Comparative Advertising

Comparative advertisements typically compare two or more named or

recognizably presented brands of the same product category, although

some comparative advertisements implicitly compare a product to other

brands by making superiority statements (e.g., ``Only Brand A can be

cooked in five minutes or less.''). These ads are frequently used for

commercial products, such as electronics, food products, and

automobiles.

Marketing and advertising studies have investigated the influence

of comparative ads, particularly in contrast to noncomparative ads.\2\

Research specifically investigating the effects of comparative

advertising on consumer attitudes--including attitudes toward the ad,

the brand, and product use--has produced mixed results.\3\ The research

findings on the superiority of comparative versus noncomparative ads on

purchase intentions, however, have been more conclusive. Relative to

noncomparative ads, comparative ads were shown to result in greater

purchase intentions.\4\ Finally, other evidence suggests that there may

be more potential for consumers to confuse brands when viewing

comparative versus noncomparative ads. Brands advertised in a

comparative format were shown to be more likely to be perceived as

similar to the leading brand than brands advertised in a noncomparative

format.\5\

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\2\ Ang, S. H., and S. B. Leong (1994), ``Comparative

advertising: superiority despite interference?'', Asia Pacific

Journal of Management, 11(1), 33-46; Demirdjian, Z. S. (1983),

``Sales effectiveness of comparative advertising: An experimental

field investigation,'' Journal of Consumer Research, 10, 362-364;

Grewal, D., S. Kavanoor, E. F. Fern; C. Costley, and J. Barnes

(1997), ``Comparative versus noncomparative advertising: a meta-

analysis,'' Journal of Marketing, 61(4), 1-15; Priester, J. R., J.

Godek, D.J. Nayakankuppum, and K. Park (2004), ``Brand congruity and

comparative advertising: When and why comparative advertisements

lead to greater elaboration,'' Journal of Consumer Psychology,

14(\1/2\), 115-123.

\3\ See, for example, Grewal, D., S. Kavanoor, E. F. Fern, C.

Costley, and J. Barnes (1997), ``Comparative versus noncomparative

advertising: A meta-analysis,'' Journal of Marketing, 61(4), 1-15;

Rogers, J. C., and T. G. Williams, (1989), ``Comparative advertising

effectiveness: Practitioners' perceptions versus academic research

findings,'' Journal of Advertising Research, 29(5), 22-37.

\4\ Ang, S. H., S. B. Leong (1994), ``Comparative advertising:

superiority despite interference?'', Asia Pacific Journal of

Management, 11(1), 33-46; Demirdjian, Z. S. (1983), ``Sales

effectiveness of comparative advertising: An experimental field

investigation,'' Journal of Consumer Research, 10, 362-364; Grewal,

D., S. Kavanoor, E. F. Fern, C. Costley, and J. Barnes (1997),

``Comparative versus noncomparative advertising: a meta-analysis,''

Journal of Marketing, 61(4), 1-15; Miniard, P. W., M. J. Barone, R.

L. Rose, and K. C. Manning (1994), ``A re-examination of the

relative persuasiveness of comparative and noncomparative

advertising,'' Advances in Consumer Research, 21(1), 299-303.

\5\ Droge, C. and R. Y. Darmon (1987), ``Associative positioning

strategies through comparative advertising: Attribute versus overall

similarity approaches,'' Journal of Marketing Research, 24, 377-388;

Gorn, G. J.and C.B. Weinberg (1984), ``The impact of comparative

advertising on perception and attitude: Some positive findings,

Journal of Consumer Research, 11, 719-727; Iyer, E. S. (1988), ``The

influence of verbal content and relative newness on the

effectiveness of comparative advertising,'' Journal of Advertising,,

17(3), 15-21.

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B. Comparative Prescription Drug Advertisements

Despite extensive research on comparative advertising of consumer

products and a limited number of studies on how DTC ads could help

consumers compare drugs,\6\ very little research has been conducted on

comparative prescription drug advertisements.\7\ Consequently, it is

unclear whether these findings are applicable to comparative drug ads

or how such claims influence consumers' perceived efficacy of

advertised drugs.

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\6\ See, for example, Schwartz, L. M., S. Woloshin, and H. G.

Welch (2009), ``Using a drug facts box to communicate drug benefits

and harms: two randomized trials,'' Annals of Internal Medicine,

150(8), 516-527; Hauber, A. B., A. F. Mohamed, F. R. Johnson, and H.

Falvey (2009), ``Treatment preferences and medication adherence of

people with Type 2 diabetes using oral glucose-lowering agents,''

Diabetic Medicine: A Journal of the British Diabetic Association,

26(4), 416-424.

\7\ Mitra, A., J. Swasy, and K. Aikin (2006), ``How do consumers

interpret market leadership claims in direct-to-consumer advertising

of prescription drugs?'', Advances in Consumer Research, 33, 381-

387.

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Currently, most DTC ad comparisons focus on drug attributes, such

as differences in dosing or administration method.\8\ Because few head-

to-head clinical trials have been conducted, very few DTC ads include

efficacy-based comparisons; \9\ however, this may change given the

current national focus on comparative effectiveness research. Given the

growing opportunities for comparative prescription drug advertising,

the present study aims to investigate how consumers interpret and react

to DTC comparative drug ads. Specifically, the study will explore two

types of drug comparisons in DTC ads: (1) Drug efficacy comparisons;

and (2) other evidence-based comparisons, such as dosing, mechanism of

action, and indication. The study findings will inform FDA of relevant

consumer issues relating to comparative DTC advertising.

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\8\ Applications for FDA Approval to Market a New Drug, 21 CFR

314.126. (2008), retrieved from http://edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/21cfr314.126.pdf.

\9\ Mitra, A., J. Swasy, and K. Aikin (2006), ``How do consumers

interpret market leadership claims in direct-to-consumer advertising

of prescription drugs?'', Advances in Consumer Research, 33, 381-

387.

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C. Design Overview

This study will be conducted in two concurrent parts with random

assignment to experimental condition. The goal of Phase I is to: (a)

Explore how consumers understand and interpret ads that explicitly

compare the efficacy of two similar drugs; and (b) learn whether

including the name of the comparison drug affects comprehension and

perceptions. We have defined named comparisons as ads that explicitly

compare the drug's efficacy to another named medication. An example of

this is: ``Drug A was shown to be more effective than Drug B at

lowering high cholesterol.'' We have defined unnamed comparisons as ads

that implicitly compare the drug's efficacy to other medications. An

example of this is: ``Compared to other medications, Drug A lowered

cholesterol in more patients.'' The control condition will not include

a comparison to another drug.

We will explore the issue of named versus unnamed comparisons in

print ads and television ads in a 2x3 factorial design as follows:

[[Page 38665]]

Table 1--Proposed Design of Phase I (2 x 3)

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Type of Ad Labeling of Comparison Drug

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Named Unnamed Control

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Print............................ ........... ........... ...........

Television....................... ........... ........... ...........

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The goal of Phase II is to determine how ads that include evidence-

based comparisons are understood by consumers. These ads often compare

factual characteristics from the drug labels (e.g., dosing, mechanism

of action). These characteristics do not necessarily affect drug

efficacy, yet consumers may infer that one drug is better or more

effective than another. We will examine four such comparisons:

Indication, dosing, mechanism of action, and risk. In this phase, we

also examine the salience of the comparison drug by manipulating

whether the comparison drug is named in the ad or not. In this case, an

example of a named comparison is: ``Drug A is taken only once a month,

unlike Drug B, which you have to take every day.'' An example of a

relevant unnamed comparison is: ``Drug A is the only medication that

treats both high cholesterol and high blood pressure.'' Finally, we

will explore whether the presence of a visual aid alters the

understanding of these presentations. The control condition will not

include a comparison to another drug.

These factors will be combined in a (2[type of ad] x 2[labeling of

comparison drug] x 2[presence of visual] x 4[type of comparison] +

2[controls]) factorial design. For ease of illustration, the design is

shown separately for print and television ads.

[GRAPHIC] [TIFF OMITTED] TN01JY11.013

In both phases, we will examine the effects of these manipulated

variables on several dependent measures, including perceived benefit

and risk, comprehension of benefit and risk information, and behavioral

intentions. We will also include demographic variables (such as gender

and education level), and other variables such as health knowledge as

covariates to determine if they have any influence on the measures of

interest.

The sample will include approximately 8,000 participants who have

been diagnosed with osteoarthritis (Phase I) or high cholesterol (Phase

II). The protocol will take place via the Internet. Participants will

be randomly assigned to view one print or one television ad for a

fictitious prescription drug that treats either osteoarthritis or high

cholesterol and will answer questions about it. The entire process is

expected to take no longer than 20 minutes. This will be a one time

(rather than annual) collection of information.

FDA estimates the burden of this collection of information as

follows:

Table 4--Estimated Annual Reporting Burden \1\

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No. of

Activity No. of responses per Total annual Average burden Total hours

respondents respondent responses per response

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Screener........................ 16,000 1 16,000 .03 (2 min.) 480

Pretest......................... 600 1 600 .33 (20 min.) 200

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Main Study...................... 8,000 1 8,000 .33 (20 min.) 2,640

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Total....................... .............. .............. .............. .............. 3,320

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

Dated: June 28, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2011-16628 Filed 6-30-11; 8:45 am]

BILLING CODE 4160-01-P