Direct‐to‐Consumer Drug Advertisements and the Informed Patient: A Legal, Ethical, and Content Analysis

Date01 December 2013
Published date01 December 2013
Direct-to-Consumer Drug
Advertisements and the Informed
Patient: A Legal, Ethical, and
Content Analysis
Joshua E. Perry,* Anthony D. Cox,** and Dena Cox***
The ultimate goal of most advertising is to increase product sales.1
However, much advertising does not exert an immediate impact on
*Assistant Professor of Business Law and Ethics, Life Sciences Research Fellow and Jesse Fine
Fellow in Practical Ethics, Kelley School of Business, Indiana University.Preliminary drafts of
this article were presented at the 2012 Huber Hurst Seminar, hosted by the Warrington
College of Business Administration’s Department of Management at the University of
Florida, and the 2012 Tri-State Academy of Legal Studies in Business Conference, hosted by
Central Michigan University. The authors are grateful for constructive feedback provided at
these meetings by Virginia Maurer, Robert Thomas, Robert Emerson, Dan Cahoy, David
Orozco, Amy Sepinwall, Karie Davis-Nozemack, Alex Reed, Mystica Alexander, Stuart
Pardau, and Ken Sanney. Additionally, our Kelley School colleagues in the Department of
Business Law and Ethics provided helpful comments to a preliminary draft presented during
a fall 2012 faculty research presentation. Finally,this article was strengthened in a number of
ways by the adroit editorial efforts of Robert Sprague. The authors are indebted to these
many generous colleagues.
**Professor of Marketing, Chancellor’s Faculty Fellow and Life Sciences Research Fellow,
Kelley School of Business, Indiana University.
***Professor of Consumer Research, Health Behavior Research Fellow and Life Sciences
Research Fellow, Kelley School of Business, Indiana University.
1C.L. TYAGI &ARUNKUMAR,ADVERTISING MANAGEMENT 278 (2004) (“It would not be out of place
to stress that the main purpose of advertising is to increase sales.”). All advertising is intended
to sell a product. In fact, successful marketing campaigns are often aimed at convincing
consumers that their lives will be improved if they buy what is being sold. Generally speaking,
informing the end-use consumer about product details is, from the perspective of the
manufacturer,only necessary to the e xtent this information can be used to trigger a desire on
the part of the consumer to purchase the product. DAVID OGILVY,OGILVY ON ADVERTISING 24
American Business Law Journal
Volume 50, Issue 4, 729–778, Winter 2013
© 2013 The Authors
American Business Law Journal © 2013 Academy of Legal Studies in Business
consumer purchase behavior, but rather elicits intermediate consumer
responses such as increased brand awareness, interest, and information
In the case of direct-to-consumer (DTC) advertising of prescription
drugs, the link between advertising exposure and purchase is often espe-
cially circuitous, in part because consumers cannot simply go out and
freely purchase the advertised product. Instead, consumers must first
consult with a health-care provider,3who then decides whether to pre-
scribe the advertised product, an alternative treatment, or nothing at all.
Thus, DTC advertising seeks to educate and ultimately motivate consum-
ers to initiate discussions with their physicians, with the hope that some of
these discussions will lead to the purchase of the advertised product.4
(1985) (quoting legendary advertising executive Rosser Reeves: “Let’s say you are a
manufacturer....[W]hat do you want out of me? Fine writing? Do you want masterpieces?
Do you want glowing things that can be framed by copywriters? Or do you want to see the
goddamned sales curve stop moving down and start moving up?”). Of course, the law also mandates
that adequate warnings accompany products and proper instructions for use be included so
that the foreseeable, end-use consumer can avoid harm and make a fully informed decision
regarding purchase and use. In fact, products liability law generally considers a product to be
defective if “the foreseeable risks of harm posed by the product could have been reduced or
avoided by the provision of reasonable instructions or warnings by the seller or other
distributor.” RESTATEMENT (THIRD)OF TORTS:PRODUCTS LIABILITY § 2(c) (1998); cf. infra note 58
(discussing RESTATEMENT(SECOND)OF TORTS § 402(A) cmt. k (1965) (noting that an unavoidably
unsafe product, such as a drug, can be rendered not defective by proper directions and
warnings)); see also Karl A. Boedecker et al., Excessive Consumption: Marketing and Legal Per-
M.BUS. L.J. 301, 324 (1999) (noting that for products that are unavoidably
unsafe, including pharmaceuticals, warnings must be adequate in terms of both semantics
and physical presentation).
2Cf. Robert J. Lavidge & Gary A. Steiner, A Model for Predictive Measurements of Advertising
ARKETING 59, 62 (1961) (discussing measurements of advertising effective-
ness through the steps of the “purchase flight,” including brand awareness).
3While the prescribing health-care provider will often be a physician, others with the power
to prescribe include physician’s assistants, nurse practitioners, and dentists.
4Hank McKinnell, former Chairman of the Board and CEO of Pfizer, Inc. argues,
DTC advertising can be a powerful public good—making people familiar with various
therapies and promoting the primacy of the doctor-patient relationship. Good DTC
communication should encourage people to talk with their physicians about their
medical conditions. DTC advertising should help demystify sensitive medical problems
and encourage people to seek treatment even for conditions stigmatized by society. For
all these reasons, I prefer to describe our efforts as DTC education.
179–80 (2005); see Elyse Krezmien et al., The Role of Direct-to Consumer Pharmaceutical Adver-
tisements and Individual Differencesin Getting People to Talkto Physicians,16J.H
730 Vol. 50 / American Business Law Journal
Some DTC advertisements are intended to build “selective
demand”—in others words, consumer preference for a specific drug
brand. However, DTC advertisements often work by building “primary
demand” for an entire product category. An entire advertising campaign
might be built around the goal of increasing consumers’ recognition that
they might suffer from a medical condition—for example, social anxiety
disorder or low testosterone—or increasing consumers’ awareness that
there are treatments available for their condition. In fact, some DTC
advertisements—known as “help-seeking ads”—do not mention a brand
name at all, but merely prompt consumers to “ask their doctor” about
new—unnamed—treatments for the malady in question. Such “help-
seeking” advertisements, unlike branded DTC advertisements touting par-
ticular products, are not regulated by the Food and Drug Administration
(FDA).5Regardless of the advertising format, “[d]irect-to-consumer adver-
tising leads to more drug information for patients.”6The challenge, as
Marshall Chin notes, is ensuring that patients encounter accurate and
833 (2011) (discussing measurements of effective health messages which lead to the desired
outcome of the patient discussing the product with her doctor). As Marcia Angell, former
editor of the New England Journal of Medicine, notes, “[t]here is overwhelming evidence that
the ads work. People go to their doctors and ask for the new drugs, and very often get them.”
-Report.pdf; Meredith B. Rosenthal et al., Promotion of Prescription Drugs to Consumers, 346
NEW ENG.J.MED.498 (2002); Robert Pear, Investigators Find Repeated Deception in Ads for Drugs,
N.Y. TIMES, Dec. 4, 2002, at A22; Vanessa Fuhrmans & Gautam Naik, In Europe, Prescription-
Drug Ads Are Banned—And Health Costs Lower,W
ALL ST. J., Mar. 15, 2002, at B1).
5Denis G. Arnold, The Ethics of Direct-to-Consumer Pharmaceutical Advertising,in ETHICS AND THE
BUSINESS OF BIOMEDICINE 131, 133 (Denis G. Arnold ed., 2009); see also John E. Calfee, Public
Policy Issues in Direct-to-Consumer Advertising of PrescriptionDrugs,21J.P
174, 174 (2002) (“ ‘Help-seeking’ advertisements could discuss that a treatment existed for a
condition, but they could neither mention a drug by name nor make suggestions and
representations about drug treatments.”).
6Marshall H. Chin, The Patient’s Role in Choice of Medications: Direct-to-Consumer Advertising and
Patient Decision Aids,5YALE J. HEALTH POLYL. & ETHICS 771, 775 (2005). However,“[c]urrent
regulatory and enforcement practices have been insufficient to prevent the dissemination of
some inaccurate or misleading advertisement.” Id. at 771. One benefit of DTC is increased
awareness among the lay public of new treatments. See Before the Subcomm. on Consumer Affairs,
Foreign Commerce, and Tourism, Senate Comm. on Sci. & Transp. (2001) (statement of Nancy M.
Ostrove, Ph.D., Deputy Director, Division of Drug Marketing, Advertising & Communica-
tions, Department of Health & Human Services), available at
t010724.html (discussing potential benefits of DTC advertising).
2013 / DTC Drug Ads and the Informed Patient 731

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