[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Notices]
[Pages 76978-76980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31609]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0457]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
9, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: (202) 395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910--New and 
title, ``Experimental Study of Comparative Direct-to-Consumer 
Advertising.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-7651, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Experimental Study of Comparative Direct-to-Consumer Advertising--(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 903(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.
    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 CFR 202.1(e)(6)(ii); 21 CFR 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 have used communication 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 direct-to-
consumer (DTC) advertising, where little research has been conducted to 
date.
    Moreover, as part of the American Recovery and Reinvestment Act of 
2009 (Pub. L. 111-5), the Agency for Healthcare Research and Quality 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 (Ref. 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.

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 
(Refs. 2 to 5). 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 
(Refs. 4 and 6). 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 (Refs. 2 to 4 
and7). 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 (Refs. 8 to 
10).

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 (Refs. 11 and 12), very little research has 
been conducted on comparative prescription drug advertisements (Ref. 
13). Consequently, it is unclear whether these findings are applicable 
to comparative drug ads or how such claims influence consumers' 
perceived efficacy of advertised drugs.
    Currently, most DTC ad comparisons focus on drug attributes, such 
as differences in dosing or administration method (see 21 CFR 314.126). 
Because few head-to-head clinical trials have been conducted, very few 
DTC ads include efficacy-based comparisons (Ref. 13). 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.

 C. Design Overview

    The proposed research will occur in two concurrent phases. The goal 
of Phase I is to: (1) Explore how consumers understand and interpret 
print and

[[Page 76979]]

broadcast ads that explicitly compare the efficacy of two similar 
drugs; and (2) learn whether named comparisons are more likely than 
unnamed comparisons to promote accurate recall, comprehension, and 
perceptions. For the purposes of the research described here, named 
comparisons are ones in which the ad explicitly compares the drug's 
efficacy to another named medication (e.g., Drug A was shown to be more 
effective than Drug B at lowering high cholesterol). Unnamed 
comparisons are ones in which the ad implicitly compares the drug's 
efficacy to other medications (e.g., Compared to other medications, 
Drug A lowered cholesterol in more patients). These different types of 
comparisons will be examined in print and television ads and will 
include appropriate control conditions in a 2 (ad type: print or 
broadcast) x 3 (comparison type: named, unnamed, or none) design as 
shown below.

                                                 Table 1--Design
----------------------------------------------------------------------------------------------------------------
              Ad type                  Named comparison     Unnamed comparison            Control group
----------------------------------------------------------------------------------------------------------------
Print Ad..........................  Arm 1.......  Arm 3......  Arm 5.
Broadcast Ad......................  Arm 2.......  Arm 4......  Arm 6.
----------------------------------------------------------------------------------------------------------------

    The goal of Phase II is to (1) determine if consumers infer that 
one drug is better or more effective than another from ads that include 
different types of drug label comparisons (i.e., indication, dosing, 
mechanism of action, drug risk), and (2) if consumers consider 
switching medications based on these comparisons in advertisements. We 
will examine four types of drug comparisons that are currently being 
used in DTC prescription drug ads. An indication-to-indication 
comparison highlights the approved indications of the advertised drug 
and the comparator drug (e,g., Drug X is approved to prevent and treat 
osteoporosis; Drug B is approved to treat osteoporosis). Dosing 
comparisons are those that compare the dosing schedule or dosing 
characteristics of two drugs (e.g., You can take Drug A in pill form; 
Drug B must be injected in a medical office). Mechanism of action 
comparisons involve differences in the way the two drugs work (e.g., 
Drug A works by targeting the build up of fat in the arteries; Drug B 
works by targeting that fat and by disintegrating tangier cells in the 
esophagus). Finally, risk comparisons involve ads that compare the risk 
profiles of more than one drug or the specific risks of more than one 
drug (e.g., Drug A has been known to cause liver failure in rats; Drug 
B has not shown liver damage in rats).
    We will also explore whether conveying these comparisons with 
visual images moderates these results. Half of the participants will 
examine a print ad and the other half will view a television ad. We 
propose two fully-factorial 2 (comparison type: named or unnamed) x 2 
(visual: present or absent) x 4 (drug aspect: indication, dosing, 
mechanism of action, drug risk) designs, one for print ads and one for 
television ads, as shown below. This design also includes two 
appropriate control groups.
    For print ads:

                                                              Table 2--Design for Print Ads
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Mechanism of
        Comparison type              Visual type         Indication            Dosing              action            Drug risks         Control group
--------------------------------------------------------------------------------------------------------------------------------------------------------
Named..........................  Visual............  Arm 1....  Arm 5....  Arm 9....  Arm 13...  Arm 17.
Unnamed........................  Visual............  Arm 2....  Arm 6....  Arm 10...  Arm 14...
Named..........................  No Visual.........  Arm 3....  Arm 7....  Arm 11...  Arm 15...
Unnamed........................  No Visual.........  Arm 4....  Arm 8....  Arm 12...  Arm 16...
--------------------------------------------------------------------------------------------------------------------------------------------------------

    For television ads:

                                                           Table 3--Design for Television Ads
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Mechanism of
        Comparison type              Visual type         Indication            Dosing              action            Drug risks         Control group
--------------------------------------------------------------------------------------------------------------------------------------------------------
Named..........................  Visual............  Arm 1....  Arm 5....  Arm 9....  Arm 13...  Arm 17.
Unnamed........................  Visual............  Arm 2....  Arm 6....  Arm 10...  Arm 14...
Named..........................  No Visual.........  Arm 3....  Arm 7....  Arm 11...  Arm 15...
Unnamed........................  No Visual.........  Arm 4....  Arm 8....  Arm 12...  Arm 16...
--------------------------------------------------------------------------------------------------------------------------------------------------------

    All parts of this study will be administered over the Internet. 
Participants will be randomly assigned to view one version of a DTC 
prescription drug print ad or a prescription drug television ad. 
Following their perusal of this document or video, they will answer 
questions about their recall and understanding of the benefit and risk 
information, their perceptions of the benefits and risks of the drug, 
and their intent to ask a doctor about the medication. The entire 
procedure is expected to last approximately 20 minutes. A total of 
9,560 participants will be involved in the study. This will be a one-
time (rather than annual) information collection.
    In the Federal Register of July 1, 2011 (76 FR 38663), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two public comments. One 
commenter failed to attach any comment, and the other commenter 
discussed issues far outside the scope of the proposed research (i.e., 
about morning-after contraception). Thus, the

[[Page 76980]]

design presented in this notice reflects only changes suggested by 
external peer reviewers and further discussion among research team 
members.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 4--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of
                           Activity                                 Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener......................................................            19,120                 1            19,120              0.03               637
                                                                                                                              (2 min.)
Pretest.......................................................               900                 1               900              0.33               300
                                                                                                                             (20 min.)
Main Study....................................................             8,660                 1             8,660              0.33             2,887
                                                                                                                             (20 min.)
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................             3,824
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. Agency for Healthcare Research and Quality (AHRQ), AHRQ Home 
Page, ``Fact Sheets on Recovery Act Investments in Comparative 
Effectiveness Research'' (http://www.ahrq.gov/fund/cerfactsheets/). 
Last accessed May 23, 2011.
2. Ang, S.H. and S.B. Leong, ``Comparative Advertising: Superiority 
Despite Interference?'' Asia Pacific Journal of Management, vol. 11, 
pp. 33-46, 1994.
3. Demirdjian, Z.S., ``Sales Effectiveness of Comparative 
Advertising: An Experimental Field Investigation,'' Journal of 
Consumer Research, vol. 10, pp. 362-364, 1983.
4. Grewal, D., S. Kavanoor, E.F. Fern, et al., ``Comparative Versus 
Noncomparative Advertising: A Meta-Analysis,'' Journal of Marketing, 
vol. 61, pp. 1-15, 1997.
5. Priester, J.R., J. Godek, D.J. Nayakankuppum, et al., ``Brand 
Congruity and Comparative Advertising: When and Why Comparative 
Advertisements Lead to Greater Elaboration,'' Journal of Consumer 
Psychology, vol. 14, pp. 115-123, 2004.
6. Rogers, J.C. and T.G. Williams, ``Comparative Advertising 
Effectiveness: Practitioners' Perceptions Versus Academic Research 
Findings,'' Journal of Advertising Research, vol. 29, pp. 22-37, 
1989.
7. Miniard, P.W., M.J. Barone, R.L. Rose, et al., ``A Re-Examination 
of the Relative Persuasiveness of Comparative and Noncomparative 
Advertising,'' Advances in Consumer Research, vol. 21, pp. 299-303, 
1994.
8. Droge, C. and R.Y. Darmon, ``Associative Positioning Strategies 
Through Comparative Advertising: Attribute Versus Overall Similarity 
Approaches,'' Journal of Marketing Research, vol. 24, pp. 377-388, 
1987.
9. Gorn, G.J. and C.B.Weinberg, ``The Impact of Comparative 
Advertising on Perception and Attitude: Some Positive Findings,'' 
Journal of Consumer Research, vol. 11, pp. 719-727, 1984.
10. Iyer, E.S. ``The Influence of Verbal Content and Relative 
Newness on the Effectiveness of Comparative Advertising,'' Journal 
of Advertising, vol. 17, pp. 15-21, 1988.
11. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug 
Facts Box to Communicate Drug Benefits and Harms: Two Randomized 
Trials.'' Annals of Internal Medicine, vol. 150, pp. 516-527, 2009.
12. Hauber, A.B., A.F. Mohamed, F.R. Johnson, et al., ``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, vol. 26, pp. 416-424, 2009.
13. Mitra, A., J. Swasy,, and K. Aikin, ``How Do Consumers Interpret 
Market Leadership Claims in Direct-to-Consumer Advertising of 
Prescription Drugs?'' Advances in Consumer Research, vol. 33, pp. 
381-387, 2006.

    Dated: December 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31609 Filed 12-8-11; 8:45 am]
BILLING CODE 4160-01-P