[Federal Register Volume 73, Number 241 (Monday, December 15, 2008)]
[Notices]
[Pages 76034-76037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0602]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of the Impact of Coupons Embedded 
in Direct-to-Consumer Prescription Drug Print Advertisements on 
Consumer Perceptions of Product Risks and Benefits

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

[[Page 76035]]

public comment in response to the notice. This notice solicits comments 
on a study of the impact of the presence of coupons offering price 
incentives or rebates on consumers' perceptions of product risks and 
benefits in direct-to-consumer (DTC) print ads.\1\ Notice of proposed 
information collection for this project was previously published on 
February 6, 2006 (71 FR 6077) and withdrawn. This revised notice 
replaces the previous notice.
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    \1\ While the Federal Food, Drug, and Cosmetic Act (the act) 
provides FDA with authority to regulate prescription drug 
advertisements that are false or misleading, the act does not 
provide FDA with the authority to regulate the pricing of 
prescription drugs. Thus, FDA is merely interested in studying the 
impact, if any, of the presence of coupons in DTC advertisements on 
consumers' perceptions of product risks and benefits, and recognizes 
that it does not actually regulate the dollar or other incentive 
amount of coupons, price incentives, or rebate offers with respect 
to how they affect the price of prescription drugs or biological 
products.

DATES: Submit written or electronic comments on the collection of 
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information by February 13, 2009.

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 (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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 the Impact of Coupons Embedded in Direct-to-
Consumer Prescription Drug Print Advertisements on Consumer Perceptions 
of Product Risks and Benefits

    FDA recognizes that the manufacturers, packers, and distributors 
(sponsors) of prescription human and animal drugs, including biological 
products for humans, have a First Amendment right to engage in the 
truthful and non-misleading advertising of their products. An 
advertisement is misleading, however, if it fails to disclose certain 
information about the advertised product's uses and risks. Thus, for 
prescription drugs and biologics, the act requires advertisements to 
contain ``information in brief summary relating to side effects, 
contraindications, and effectiveness'' (21 U.S.C. 352(n)). FDA is 
responsible for enforcing the act and implementing regulations.
    FDA regulations require that prescription drug advertisements that 
make claims about a product must also include risk information in a 
``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the 
content and presentation of the information. Advertisements that draw 
attention to the name of the product but do not make representations 
about the product's indication(s) or dosage recommendations are called 
reminder advertisements. As a general matter, reminder ads may mention 
the proprietary and established name of the product and (optionally) 
contain information about the product's ingredients, dosage form, 
quantity, price, and manufacturer (21 CFR 202.1(e)(2)(i)). Other 
written, printed, or graphic information is not prohibited in reminder 
ads as long as that information does not make a representation or 
suggestion relating to the product beyond those permitted.
    Reminder ads allow sponsors to distribute price sheets, pens, 
notepads and other minor giveaways featuring the name of the drug 
product to physicians and other healthcare professionals without 
requiring a full disclosure of the product's risks. As DTC promotion 
has increased, sponsors have chosen to create reminder ads for 
consumers.
    On November 1 and 2, 2005, the agency held a part 15 public hearing 
(70 FR 54054, September 13, 2005) on the topic of direct-to-consumer 
advertising of prescription drugs and restricted medical devices. 
During the hearing, the agency received several comments in connection 
with the potential impact of coupons and other price incentives on 
consumer perceptions of DTC-advertised products. Sponsors may use ads 
as a vehicle to offer price incentives to consumers (e.g., ``free 
trial,'' ``buy six get one free''). Coupon promotions are widely used 
in many product categories and have been the topic of many academic 
studies. Certain types of coupons, most notably those that appear in 
the body of an advertisement itself (i.e., are embedded in the 
advertisement), can positively affect perceptions of the brand.\2\
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    \2\ LeClerc, France and John D.C. Little, ``Can Advertising Copy 
Make FSI Coupons More Effective?'' Journal of Marketing Research, 
34(4), 473-484, 1997.
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    People tend to rate owned objects more favorably than those they do 
not own, even when those objects have been assigned to them at 
random.\3\ This has been termed the ``mere ownership'' or ``mere 
possession'' effect. An interesting extension of this effect is 
provided in research by Sen and Johnson \4\ which has shown that 
consumers rate a product more favorably when they are simply given a 
gift certificate or a coupon for that product or service. Other 
research has examined the effect of warranties. People who viewed an ad 
with a high warranty perceived the product as being less risky compared 
to people who saw an ad with a medium or low warranty.\5\
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    \3\ Beggan, James K., ``On the Social Nature of Nonsocial 
Perception: The Mere Ownership Effect,'' Journal of Personality and 
Social Psychology, 62(2), 229-237, 1992.
    \4\ Sen, Sankar and Eric J. Johnson, ``Mere-Possession Effects 
Without Possession in Consumer Choice,'' Journal of Consumer 
Research, 24 (June), 105-117, 1997.
    \5\ Shimp, Terrence A. and William O. Bearden, ``Warranty and 
Other Extrinsic Cue Effects on Consumers' Risk Perceptions,'' 
Journal of Consumer Research, 9 (June), 38-47, 1982.
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    Based on this body of consumer research, the inclusion of a coupon 
or other price incentive in the body of a DTC ad may affect consumers' 
perceptions of the risks and benefits of

[[Page 76036]]

the prescription drug. For instance, consumers may assign more weight 
to benefit claims in cases where a coupon or other price incentive is 
embedded in the advertisement. For ``simple'' consumer products, 
coupons and free trial offers may enable the customer to test new 
products while minimizing their financial risk of testing the product. 
For products that consumers can readily test and ones where performance 
can be adequately verified (termed ``search'' goods by economists), 
coupons and free trial offers provide both the consumer and 
manufacturer an efficient mechanism for matching consumers and 
products. For more complex products such as prescription drugs where 
supervision of a physician is required to evaluate both appropriateness 
and performance, coupons and free trial offers may send different 
signals.
    The proposed exploratory study will examine what impact, if any, 
the presence of coupons in DTC advertisements may have on consumers' 
perceptions of product risks and benefits and the overall impression of 
the product in DTC full-product and reminder advertisements.\6\
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    \6\ As noted previously in this document, FDA does not have the 
authority to regulate prescription drug pricing and we will not be 
examining prescription drug prices.
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Design Overview

    This study will employ a between-subjects crossed factorial design 
and will focus on consumer print advertising. Fifteen print 
advertisements will be created using three levels of ad type and five 
levels of promotional offer. Thus, the factors will be ad type (DTC 
print reminder; DTC print full product; over-the-counter (OTC) print 
full product) and offer type (free trial offer; buy one, get one free; 
money off prescription/purchase cost; money back guarantee; no 
promotion). Product name and indication will be constant across 
conditions. Side effect and risk information will be constant across 
full product DTC ad conditions. Participants will be asked to read a 
single print advertisement for a new drug. After reading the 
advertisement, they will be asked questions about their evaluation of 
the information presented in the advertisement.

Factors

    1. Participants: Consumers will be screened and recruited by the 
contractor to be currently diagnosed with insomnia or at risk of 
developing insomnia. Participants will be randomly assigned to 
experimental cells. Each condition will be balanced with respect to 
gender.
    Because this is the first investigation of this issue with DTC ads, 
we chose to limit our investigation to one disease condition. We chose 
to accept this decrease in generality to maximize our ability to detect 
a subtle difference between promotion types. Participants will be 
screened to represent a range of education levels (some college or less 
vs. completed college or more). Because the task presumes basic reading 
abilities, all participants will have English as their primary language 
and, as appropriate, be required to have reading glasses when 
participating in the study.
    2. Type of Ad: The following three types of ads will be tested: (1) 
A full-product ad for a prescription drug, (2) a reminder ad for a 
prescription drug, and (3) an ad for an OTC drug. An ad for an OTC 
drug, which typically includes benefit but not risk information, is 
included to see if prior research findings in the area of consumer 
package goods can be replicated.
    3. Type of Promotion: The following five types of promotions will 
be tested: (1) Free trial offer; (2) buy one, get one free; (3) money-
off prescription/purchase cost; (4) money back guarantee; and (5) a no 
promotion condition. With the exception of buy one, get one free, these 
are promotional variations that have been used in drug advertising. We 
ask for comment on other promotional types that could be tested.

Procedure

    Participants will be shown one ad, for example, a reminder ad for a 
prescription drug with a free-trial offer coupon embedded. Then the 
participant will be asked to answer questions examining a number of 
important perceptions about the product, including perceived riskiness 
of the drug, likelihood of benefits, and behavioral intent (talking to 
doctor, product purchase). Finally, demographic and health care 
utilization information will be collected.
    Interviews are expected to last approximately 15 minutes. A total 
of 1,350 participants will be involved. This will be a one-time (rather 
than annual) collection of information.
    FDA estimates the burden of this collection of information as 
follows:
    FDA estimates that 2,025 individuals will need to be screened to 
obtain a respondent sample of 1,350. The screener is expected to take 
30 seconds, for a total screener burden of 17 hours. The 1,350 
respondents will then be asked to respond to a series of questions 
about the advertisement. We estimate the response burden for the survey 
to be 15 minutes, for a burden of 337.5 hours. The estimated total 
burden for this data collection effort is 354.5 hours.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                       Annual Frequency     Total Annual        Hours per
         No. of  Respondents             per Response        Responses           Response         Total Hours
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2,025 (screener)                                      1              2,025               .008                 17
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1,350 (questionnaire)                                 1              1,350                .25              337.5
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Total                                 .................              3,375  .................              354.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


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    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29517 Filed 12-12-08; 8:45 am]
BILLING CODE 4160-01-S