[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6077-6079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1521]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0029]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Impact of Coupons on Consumer Perceptions of Products 
in Prescription Drugs in Direct-to-Consumer Prescription Drug Print 
Advertisements

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 a 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 a study of the impact of coupons (such as 
price incentives or rebate offers) on consumers' perceptions of product 
risks and benefits in direct-to-consumer (DTC) print ads.

DATES: Submit written or electronic comments on the collection of 
information by April 7, 2006.

[[Page 6078]]


ADDRESSES: Submit electric comments on the collection of information 
to: http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
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: Karen Nelson, Office Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collections 
of information set forth in this document.
    With respect to each of the following collections of information, 
FDA invites comments on: (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.

Impact of Coupons on Consumer Perceptions of Products in Direct-to-
Consumer Prescription Drug Print Advertisements

    The Federal Food, Drug, and Cosmetic Act (the act) requires that 
manufacturers, packers, and distributors (sponsors) who advertise 
prescription human and animal drugs, including biological products for 
humans, disclose in advertisements certain information about the 
advertised product's uses and risks. 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. 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, or 
manufacturer (21 CFR 202.1(e)(2)(i)). Graphic presentation and 
information is not prohibited in reminder ads as long as that 
information does not make a representation or suggestion about the 
product beyond those permitted.
    The exemption for reminder ads was originally intended to allow 
distribution of 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.
    Sponsors may use ads as a vehicle to offer price incentives or 
coupons 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. Coupons are primarily offered 
to increase the sales of the brand relative to their level without 
coupons.\1\ Certain types of coupons, most notably those that appear in 
the body of an advertisement itself, can positively impact perceptions 
of the brand.
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    \1\ 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.\2\ 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 \3\ 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.\4\
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    \2\ 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.
    \3\ Sen, Sankar and Eric J. Johnson, ``Mere-possession effects 
without possession in consumer choice,'' Journal of Consumer 
Research, 24 (June), 105-117, 1997.
    \4\ 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 coupons 
or other price incentives in DTC ads may impact consumers' perceptions 
of the risks and benefits of the prescription drug. 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. These signals may foster consumer misperceptions 
about the advertised prescription drug product by exploiting general 
beliefs. Thus, prescription drugs promoted with coupons or free trial 
offers may be seen as more widely indicated, more appropriate and/or 
less risky than they really are. Inclusion of a mechanism that affects 
consumers' perception of the product's risks is especially problematic 
in reminder ads because this type of ad contains no accompanying risk 
information. Furthermore, coupons and price promotions may imply 
superior drug efficacy.
    The proposed study will examine the impact coupons have on 
consumers' perceptions of risks and benefits and the overall impression 
of the product in DTC full-product and reminder

[[Page 6079]]

advertisements. To justify future regulatory changes, we need to have 
better empirical data about consumers' perceptions of the information 
in both types of ads and how inclusion of such promotional devices can 
impact consumers' perceptions of the risks and benefits of advertised 
prescription drugs.
    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 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. Three types of ads will be tested: A full-product 
ad for a prescription drug, a reminder ad for a prescription drug, and 
an ad for an over-the-counter (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. It is expected that consumer processing of information in 
the ad may vary by presence of a promotion. For instance, consumers may 
assign more weight to benefit claims in cases where a promotional 
coupon is included.
    (3) Type of Promotion. Five types of promotion will be tested: Free 
trial offer, buy one, get one free, money-off prescription/purchase 
cost, money back guarantee, and 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 
attached. 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 
consumer part of 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. The respondent burden chart is listed below:

                                        Estimated Annual Reporting Burden
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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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Footnote: there are no capital costs or operating and maintenance costs associated with this data collection.


    Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1521 Filed 2-3-06; 8:45 am]
BILLING CODE 4160-01-S