Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study; Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements, etc.

This Notice document was issued by the Food and Drug Administration (FDA)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0465]

Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions

Agency

Food and Drug Administration, HHS.

Action

Notice.

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 theFederal Registerconcerning 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: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions. This study is designed to investigate the impact of the presence of coupons offering purchase incentives such as free-trial offers, discounts, and money-back guarantees 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 in theFederal Registerof December 15, 2008 (73 FR 76034). This notice is being republished due to significant revisions in the burden and study design.

Dates

Submit either electronic or written comments on the collection of information by November 22, 2010.

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., PI50-400B, 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 theOffice 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 theFederal Registerconcerning 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: Effect of Promotional Offers in Direct-to-Consumer (DTC) Prescription Drug Print Advertisements on Consumer Product Perceptions—New

Regulatory Background—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 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.

FDA regulations require that an advertisement that makes claims about a prescription drug include a “fair balance” of information about the benefits and risks of the advertised product, in terms of both content and presentation (21 CFR 202.1(e)(5)(ii)). In part, “[a]n advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading* * * if it [c]ontains a representation or suggestion, not approved or permitted for use in the labeling, that a drug is better, more effective, useful in a broader range of conditions or patients* * *safer, has fewer, or less incidence of, or less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience* * *whether or not such representations are made by comparison with other drugs or treatments, and whether or not such a representation or suggestion is made directly” (21 CFR 202.1(e)(6)(i)). Further, the regulations state that an advertisement may be misleading if it “[u]ses headline, subheadline, or pictorial or other graphic matter in a way that is misleading” (21 CFR 202.1(e)(6)(xviii)).

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.

Rationale. A topic of ongoing interest for consumer product manufacturers and retailers is the use of consumer-oriented sales promotions such as free trial offers, discounts, money-back guarantees, rebates, and sweepstakes. Coupon promotions are widely used in many product categories, including prescription drugs.

Prior research has demonstrated that the type of promotion offered can affect how consumers respond to the promotion. 2 For example, a price incentive may not only act as an economic incentive to buy the product, but may also artificially enhance consumers' perceptions of the product's quality. 3 In cases where consumers can readily test the performance of the products (termed “experience” goods 4), this misperception is quickly corrected through the consumer's use of the product. However, because prescription drugs are both more complex and riskier than simpler experience products, misperceptions before product use are a serious concern.

Price incentives may mislead consumers because consumers may use the incentives as cues about product quality. For example, if length of warranty is strongly believed to be a good predictor of quality, then consumers may perceive a product as higher quality when a long warranty is present than when one is not present. 5 Thus, price incentives may have the potential to act as an “inference rule” (or heuristic 6) and, when present, they may preempt consumers from thinking carefully about the product information contained in the advertisement (i.e., fully elaborating on the information). This could result in either favorable or unfavorable beliefs about the product. 7 If the promotional offer is used as a mental heuristic in such a way as to result in a misleading impression of the product, however, this raises concerns.

It may be possible to encourage more thorough processing of information and reduce reliance on heuristics through the inclusion of additional information designed to qualify and be processed at the same time as the claim in question. For example, disclosures (statements that qualify, limit, or explain a particular claim) are intended to be an information remedy to combat potential deception. 8 Research is mixed on theeffectiveness of disclosures, particularly those that take the form of a disclaimer. 9 However, there may be other ways to add information that is effective in changing processing. One possibility is including specific information about a prescription drug product's efficacy from labeling. This information may act as a signal with regard to the quality of the information (good or bad). By extension, this signal may affect the use of processing heuristics. Depending on the type of signal and the extent to which consumers process the signal, full elaboration of the product information may be enhanced (as use of heuristics decreases).

Consumers vary in their reactions to promotions such as coupons and researchers and economists have proposed a number of explanations for why some consumers are sensitive to these tactics. Two such traits are “price consciousness” and “belief in the price-quality relationship.” Price consciousness is defined as the degree to which the consumer focuses exclusively on paying low prices. Belief in the price-quality relationship is defined as the degree to which one believes a higher price indicates superior quality. 10 A broader trait of “value consciousness” has also been used. This trait involves assumptions about the construct of perceived value and its relationship (a ratio) with the constructs of perceived quality and perceived price.

While promotions have been extensively studied in the context of package goods, information on their effects in DTC prescription drug ads is limited. One relevant study 11 found that a free-trial offer in a DTC ad for a high cholesterol drug resulted in more favorable perceptions of the product and the ad (both rated as good/bad, favorable/unfavorable, and pleasant/unpleasant), perceptions of the product and greater intentions to ask about the product. No differences were found in terms of perceived product risk. However, the study did not measure perceptions of product risk and benefit separately, or comprehension of risk and benefit information. Additionally, no attempt was made to control for factors that may predispose individuals toward coupon use nor was the study conducted with the target population (high cholesterol sufferers). The current study will expand on this initial study by investigating a variety of promotional offers, recruiting a wider range of the target audience from malls and online, measuring traits that may predispose individuals to be susceptible to coupon influence, and by exploring the effects of disclosures on the processing of product information.

The current study will examine what effect, if any, the presence of promotional offers in DTC prescription drug ads have on the following: (1) Consumers' perceptions of product risks and benefits, (2) comprehension of product risks and benefits, and (3) strongly held beliefs that may act as potential moderators. The study will also explore ways in which additional contextual information can be used to enhance processing of the product information in the advertisement. 12

Design Overview

This study will examine type of promotional offer (for example, free trial offer; money off cost; money back guarantee; buy one, get one free; and no offer) in three types of drug advertisements (prescription drug reminder ad, prescription drug full product ad, and over-the-counter (OTC) drug ad 13) in a medium prevalence medical condition (defined as 10 percent prevalence in the adult U.S. population). The study will be administered in two modes, online and mall-intercept, in order to assess the effects of mode on study results. The following table illustrates the design; the specific promotional offers examined will be determined through pretesting. This study is experimental in method: participants will be randomly assigned to condition.

Main Study Design

Promotional Offer(examples)Type of AdvertisementFull ProductReminderOTC
Free trial offerOnlineMallOnlineMallOnlineMall
Buy one, get one freeOnlineMallOnlineMallOnlineMall
Money off costOnlineMallOnlineMallOnlineMall
Money back guaranteeOnlineMallOnlineMallOnlineMall
Control: No offerOnlineMallOnlineMallOnlineMall

We also propose to conduct a supplementary exploratory study to examine the influence of additional information as a form of context. The supplementary study will examine the effect of some forms of qualifying context in a full product prescription drug ad. This supplementary study will examine type of context (for example, additional information about product risks, additional information about product benefits, additional informationabout both risks and benefits, and no additional information) in three different promotional offers (money back guarantee and two others) in a medium prevalence medical condition (defined previously). This supplemental study will be conducted online. One type of offer examined will be money back guarantee; we will choose the other two types of promotional offers based on the results of the main study. The exact wording of the qualifying context to be examined will be determined through pretesting. This study is experimental in method: Participants will be randomly assigned to condition.

Supplementary Study Design

Type of Context(examples)Type of OfferMoney BackGuaranteeOffer 2To be determinedOffer 3To be determined
Additional information about risk
Additional information about efficacy
Additional information about efficacy and risk
Control: No Context

Interviews are expected to last no more than 20 minutes. A total of 10,000 participants will be involved in the pretesting and two phases of the study. This will be a one time (rather than annual) collection of information.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden 1
21 CFR SectionNo. ofRespondentsAnnual Frequencyper ResponseTotal AnnualResponsesHours perResponseTotal Hours
Pretests1,00011,000.33330
Main study: online3,75013,750.331,238
Main study: mall intercept2,25012,250.33743
Supplementary study3,00013,000.33990
Total10,0003,301
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23632 Filed 9-21-10; 8:45 am]
BILLING CODE 4160-01-S

Footnotes

(1) While the Federal Food, Drug and Cosmetic Act (the FD&C Act) provides FDA with authority to regulate prescription drug advertisements that are false or misleading, the FD&C Act does not provide FDA with the authority to regulate the pricing of prescription drugs. Thus, FDA is merely interested in studying the effects, if any, of the presence of various promotional offers 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.

(2) See for example, deGroot, I.M., G. Antonides, D. Read, et al., “The Effects of Direct Experience on Consumer Product Evaluation,”Journal of Socio-Economics, 38(3), 509-519, 2009; DelVecchio, D., D.H. Henard, and T.H. Freling, “The Effect of Sales Promotion on Post-Promotion Brand Preference: A Meta-Analysis,”Journal of Retailing, 82(3), 203-213, 2006; Mico, C.C. and T.G. Chowdhury, “The Effect of Message's Regulatory Focus and Product Type on Persuasion,”Journal of Marketing Theory and Practice, 18(2), 181-190, 2010.

(3) LeClerc, F. and J.D.C. Little, “Can Advertising Copy Make FSI Coupons More Effective?,”Journal of Marketing Research, 34(4), 473-484, 1997.

(4) Wolk, A. and C. Ebling, “Multi-Channel Price Differentiation: An Empirical Investigation of Existence and Causes,”International Journal of Research in Marketing, 27(2), 142-150, 2010.

(5) Johar, G.V. and C.J. Simmons, “The Use of Concurrent Disclosures to Correct Invalid Inferences,”Journal of Consumer Research, 26(4), 307, 2000.

(6) Chaiken, S., A. Liberman, and A. Eagly, “Heuristic and Systematic Proocessing Within and Beyond the Persuasion Context,” 1989; In J.S. Uleman and J.A. Bargh (Eds.), Unintended Thought (chapter 7, p. 212-252), Guilford Press: New York; Bettman J.R., M.F. Luce, and J.W. Payne, “Constructive Consumer Choice Processes,”Journal of Consumer Research, 25(3), 187-217, 1998.

(7) Alba, J.W. and H. Marmorstein, “The Effects of Frequency Knowledge on Consumer Decision Making,”Journal of Consumer Research, 14(1), 14-25, 1987; Inman, J.J., L. McAlister, and W.D. Hoyer, “Promotion Signal: Proxy for a Price Cut?,”Journal of Consumer Research, 17(1), 74-81, 1990.

(8) FTC (Federal Trade Commission) (1983), Federal Trade Commission policy statement on deception, appended to Cliffdale Associates, Inc., 103 F.T.C. 110 (1984), Available at http://www.ftc.gov/bcp/policystmt/ad-decept.htm, Last accessed September 8, 2010; Hoy, M.G and M.O. Lwin, “An International Perspective of Online Disclosure Information: A Comparison of Banner Ad Disclosures from United States, United Kingdom and Singapore Websites,”Journal of Consumer Policy, 31, 327-347, 2008.

(9) See, for example, France, K.R. and P.F. Bone, “Policy Makers' Paradigms and Evidence FromConsumer Interpretations of Dietary Supplement Labels,”Journal of Consumer Affairs, 39(1), 27-51, 2005; Mason, M.J., D.L. Scammon, and X. Fang, “The Impact of Warnings, Disclaimers and Product Experience on Consumers' Perceptions of Dietary Supplements,”Journal of Consumer Affairs, 41(1) 74-99, 2007.

(10) Garretson, J.A. and S. Burton, “Highly Coupon and Sale Prone Consumers: Benefits Beyond Price Savings,”Journal of Advertising Research, 43, 162-172, 2003.

(11) Bhutada, N.S., C.L. Cook, and M. Perri, “Consumer Responses to Cupons in Direct-to-Consumer Advertising of Prescription Drugs,”Health Marketing Quarterly, 26, 333-346, 2009.

(12) Because FDA does not have the authority to regulate prescription drug pricing we will not examine prescription drug prices.

(13) Prescription drug full product advertisements contain information about both benefits and risks, whereas prescription drug reminder advertisements do not contain this information. OTC drug advertisements contain benefit information but not risk information, thus making it a good choice for an experimental comparison.

 
 
Comment Period Closed
Nov 22 2010, at 11:59 PM ET
ID: FDA-2010-N-0465-0001
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Date Posted: Sep 22, 2010
Federal Register Number: 2010-23632
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Comments

6
Comments Received*
Please find attached PhRMA's comments regarding: Docket No. FDA-2010-N-0465, Agency Information Collection Activities; Proposed Collection; Comment Request...
Attached are McKesson Corporation's comments to the FDA on Direct-to-Consumer Prescription Drug Advertisements.
See attached file(s). Thank you for the opportunity to provide these comments.

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* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.

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