DIRECT TO CONSUMER PHARMACEUTICAL ADVERTISING
Saray Perez v. Wyeth Laboratories, Inc., Questions, p. 281
1. What is the Learned Intermediary Rule? In what context did it become law?
The exception to the general rule that manufacturers must warn consumers directly of dangers
When the rule first came into effect, as the case states, it made sense in the “doctor knows best”
2. Legal reasons Rule does not apply when drugs are advertised directly to consumers?
According to the majority, the premises for the LIR are undermined in the age of
direct-to-consumer drug marketing. The house-calling “Norman Rockwell” style doctor is a
Dissent? The dissent focuses on the instance of the Norplant device, finding that these
considerations do not apply. Norplant must be implanted surgically, putting the doctor in the best
3. Would a ban on DTC advertising of prescription drugs survive a Central Hudson
Challenge in the United States? Research: What happened with the FDA’s attempt to
regulate DTC ads?
Under the Central Hudson test, to prohibit direct to consumer drug advertising, the speech must
be misleading or the government has to demonstrate 1) a substantial interest in regulating the
Current information regarding the FDA and ad regulation is on their website:
4(a). Pros/cons of DTC advertising from consumer perspective?
Pros: More information about a broader array of options than might be delivered by a doctor.
Cons: Tendency to rush to the wrong judgment. Recent revelations about two popular arthritis
drugs show that consumers must remain skeptical of the DTC approach. In June 2002 it became
4(b). Who are the major stakeholders in the pharmaceutical direct-to-consumer scenario?
Does this type of marketing create “the greatest happiness for the greatest number” in
utilitarian terms? What might a deontological thinker say about DTC marketing?
Utilitarian Ethical analysis:
Pharmaceutical companies stand to benefit with the DTC technique, assuming the added costs of
advertising online, and on broadcasting and print media does not outstrip profits gleaned by
reaching consumers directly. Advertisers get more business, so DTC is an unadulterated plus for
Deontological analysis:
A deontological thinker would analyze the situation in terms of universal principles.
Additionally, a deontologist would be opposed to using people simply as a means to an end.
CHAPTER PROBLEMS
1. Research: Find out what happened when the Supreme Court decided Sorrell v. IMS
Health, Inc.:
The Supreme Court affirmed the lower Court’s decision. A Vermont statute that restricted the
use, disclosure or sale of records revealing individual doctors’ prescribing practices violated the
First Amendment.
2. Research: Has the FTC taken any action against the Sustainable Forestry Initiative
(SFI)? Which companies have deserted SFI and sought certification from the Forest
Stewardship Council?
A web search of “FTC and Sustainable Forest Initiative” leads to several websites about the SFI
and the complaint filed with the FTC including:
3. Research: What were the terms of the PepsiCo Naked Juice settlement? Do you think it
is fair? What other cases can you find charging that the label “all natural” was
misleading?
Information regarding the settlement, which PepsiCo appealed, is here:
Information about a class action lawsuit against multiple food companies:
4. Research: Has the Higg Index been rolled out? Has it made a difference to customers?
The Higg Index was rolled out in June 2012:
As of this writing it is too early to evaluate its difference to consumers.
5. What do you think about the sale of aggregate location and web-use data? Are there
ethical issues here?
6. Visit websites for organizations which are opposed to genetically modified foods, like
the Organic Consumers Association. Make a list of the kinds of concerns they express.
Then go to GMOAnswers.com. Do you feel that the biotech companies do a good job of
responding to critics?
A web search will turn up several sites, including:
7. What role should advertisers play in reflecting and supporting a more inclusive society?
(a) What would be the arguments pro and con, within a company like General Mills,
when deciding whether or not to produce an ad with an interracial child? What
ethical issues arise?
(b) Consider the pros and cons for marketers of producing gay-oriented ads for
mainstream audiences. Who are the stakeholders? What are the ethical issues? Does
it matter what kind of products or services are being sold? Are there differences
between this kind of inclusive messaging and that which embraces interracial
marriage?
8. Users of Epocrates (doctors, pharmacists, nurses, and medical students) must click
through pharmaceutical company ads before they can access information. Is this any
different than ordinary Internet users being bombarded by ads reflecting their previous
browsing history? Who are the stakeholders? What ethical issues arise?
Stakeholders include the users, pharmaceutical companies, the maker of Epocrates and
9. Is there anything ethically troubling about the “Coke Day” story? Is there a distinction
between paid advertisements in schools and corporate sponsorship of the content of
education? What happened when Mike Cameron sued for violation of his First
Amendment rights?
Opinions will vary regarding the ethical issues. Some thoughts about advertisements and
corporate sponsorship:
From Eric Schlosser, Fast Food Nation, (NY: HarperCollins, 2001):
The nation’s three major beverage manufacturers are now spending large sums to
increase the amount of soda that American children consume. …Coca Cola has
set the goal of raising consumption of its products by at least 25% a year. The
The concern about commercialization of the classroom can be related to Klein’s thesis
referencing the branding of our culture. If children and young people lose the ability to
distinguish between Coca Cola Inc. and Coke culture, they are being duped, not educated. What
Or was the corporation actually demanding much more? Consider the context of this kind of
school sponsorship:
Apparently bowing to pressure from school food-service professionals, the U.S.
Department of Agriculture and elected officials who seemed ready to debate
The top priority, according to Jeffrey Dunn, president of Coca-Cola Americas, is
to switch from the strategy of requiring exclusivity from school districts in return
“One of our guiding principles has always been to listen to educators, and we
want teachers, parents and everyone concerned about commercialism and
–Paul King, “New Coca-Cola Marketing Pours It On For Education,” 35 Nation’s
Restaurant News 13, March 26, 2000, p. 20.
A couple of additional questions to ponder: Does Coke’s announcement indicate that the
company aims to help solve the problem of obesity rampant in the U.S. youth population, as
some regulators now believe? Does knowing that Coke’s school sales represents less than 1% of
its overall business change things?
With some 340,000 to 650,000 television advertising hours being logged by the average
Ask students if they have had exposure to Channel One or other forms of advertising in school.
How did they respond to it? Do they believe that students are more likely to learn from
Regarding whether advertising is more or less ethical than exclusive contracts, ask students
whether they believe they are able to distinguish the presence of advertising and to judge for
By entering terms such as “schools,” “corporate,” and “sponsorship,” students will be able to
Here’s another glimpse at corporate sponsorship in the higher educational context:
[M]any universities restrict corporate advertising on campus. So companies look
for roundabout entry points. They jockey for exclusive soda contracts in dining
At Auburn University Murphy and her marketing classmates earned credit by
throwing a campus carnival to showcase Chevrolet cars. Her class got $2,500
The word-of-mouth buzz generated by student-run promotions is considerable.
After one event sponsored by a local Pontiac dealer at Kennesaw State University
–Cora Daniels, “If It’s Marketing Can It Also Be Educational?” Fortune, October
2, 2000, p. 274.
And another:
A 1998 study of [corporate-sponsored] teaching materials by the Consumers
Union found that 80% were biased, providing students with incomplete or slanted
information that favored the sponsors products or views. Proctor & Gamble’s
–Eric Schlosser, Fast Food Nation, (NY: HarperCollins, 2001):
According to Gary Ruskin, president a consumer watchdog group that campaigns against any
type of corporate presence on campus: “Increasingly schools are turning into cash-and-carry
operations for the advertisers and marketers of America.” See:
The school expunged the suspension from Mike Cameron’s records in support of his First
Amendment rights:
10. Research: How did the Supreme Court rule in Lexmark v. Static Controls?
As of February 2014, the case has not yet been settled: