history-of-pharmaceutical-advertising_thesis

History of Pharmaceutical Advertising: The Road to DTC
Meghan Patenaude
Senior Thesis
12/8/12

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The emergence of direct-to-consumer advertising of prescription drugs is bringing
back the original argument between patent and ethical drugs dating back to the
early 1900s. The main issues between the two revolved around regulation, safety,
and whether or not to have messages about the drug directed to physicians or the
general public. Currently, the United States and the world are struggling with how
to handle the regulation of direct-to-consumer advertising (DTC). In order to
understand the current debate over DTC, it is necessary to take a look at the
history of pharmaceutical advertising as a whole and the regulation that has
developed along with it. The controversy behind DTC revolves around the
colliding interests of regulatory bodies such as the FDA and FTC in determining
jurisdiction over restriction, the change in conversation between physician and
patient, and the branding versus non-branding issue in the ads themselves.
History of Pharmaceutical Advertising – The emergence of medicine as an industry:
In the late nineteenth century the delegates of the national medical convention in
Philadelphia formed an association known as the American Medical Association (AMA).
The goal of this association was to encourage scientific advancement, improve the health
of the public, create an ethical environment for medicine, and heighten standards for

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medical education in the US.1
It was this organization that was at the forefront of the
developing medical industry and became a resource of regulation and structure within it.
A competition emerged between patent or nostrum drugs and ethical drugs. Patent drugs
were medications that had a trademark and did not reveal their ingredients to users. New
medications called ethical drugs prioritized ethics and showed the ingredients in the drug.
The manufacturers of both ethical and patent drugs promoted their products to physicians
and pharmacists. One major difference between these two classes of pharmaceutical
products was that patent drug manufacturers also promoted directly to the public.2
The
AMA saw this as a major concern since the drugs in question did not reveal their
ingredients and could be dangerous in the hands of doctors and extremely dangerous in
the hands of the uninformed public. In 1905 the AMA formed the Council on Pharmacy
and Chemistry which began setting standards for drugs not through regulation but
persuasive limiting of promotional outlets. The widely read publications that the AMA
put out including New and Non-Official Remedies and the Journal of the American
Medical Association would not accept the advertising of drugs that did not meet their
standards. This medium in particular was an extremely crucial means for manufacturers
to reach their primary target audience, physicians.3
As these journals held the latest
medical discoveries, studies and was read by virtually every physician. These
publications were highly trusted by those in the medical field, so if a product was
1
"Historical Timeline." American Medical Association. http://www.ama-
assn.org/ama/pub/about-ama/our-people/ama-councils/council-medical-education/historical-
timeline.page
2
William G. Castagnoli. Medicine Avenue: the story of medical advertising in America..
Huntington, N.Y.: Medical Advertising Hall of Fame, 1999. 12.
3
William G. Castagnoli. Medicine Avenue. 13.

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advertised in the publication it was much more likely to be considered by the physician in
the prescription process when sitting down with patients and going about their normal
practices. These AMA standards were created specifically to de-popularize the use of
patent medicines and thereby boost the ethical standards of medicine as a profession and
industry.
To have drug advertising accepted into the AMA journals, the drugs had to pass the
AMA’s standards. Any drug that utilized false advertising, did not disclose the materials
in the drug, or advertised directly to the public were not authorized to promote their drug
in the AMA journals.4
In effect the AMA acted as a gateway for pharmaceutical
advertising and a regulatory body. In addition to limiting the ads in their journals, the
AMA also gave out seals of approval for drugs they deemed safe and trusted for use by
physicians. These two actions helped shape the basis of regulation and approval that are
used today by a different regulatory body, the FDA.
The first solely medical advertising agency was established in 1921 in Chicago by a man
named Henry C. Phibbs. This came at a time when the AMA was looking to revamp the
pharmaceutical industry and its reputation. The AMA saw a great need to focus the
industry around only ethical drugs so that medicine could become trusted by the public,
and safety would be more greatly promoted. The advertising agency was called Phibbs.
Phibbs believed this to be an exciting opportunity for the advertising industry, for he saw
that pharmaceutical offered a partnership not required by most fields of advertising. He
4
Starr, Paul. The social transformation of American medicine. New York: Basic Books, 1982.

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stated, “It is the cooperation between modern advertising and modern organized medicine
that will yield the best results for the public good.”5
This is exactly the ideal that the
AMA was striving for in trying to balance economic benefits of medicine with the
importance of the public well-being. Advertising agencies then began to see the
tremendous market for profit in this relatively untouched area of advertising for
pharmaceutical manufacturers. As an industry with little regulation in existence,
pharmaceutical became an open field for advertisers.
Once the success of the Phibbs advertising agency was established, more and more
agencies began to pick up pharmaceutical manufacturing clients and some became
specialized in pharmaceuticals alone rather than consumer goods. The 2nd
medical
advertising agency to appear was also in Chicago and was founded by a man named
William Douglas McAdams. The agency came to be known as McAdams and
concentrated its work to advertising specifically to physicians. Consumer advertising
agencies had not quite jumped on the bandwagon yet in the early 20th
century.
Pharmaceutical promotion was at its infancy at the time and was seen as unglamorous
territory with limited opportunities for creativity. In the 1950’s this all began to change.
The period after World War II marked the beginning of the boom of pharmaceutical
advertising that would come to be known as the “Golden Age.”6
During this time
research in medicine was rampant and new drugs appeared on the market. Researchers
and manufacturers introduced antibiotics, steroids, oral hypoglycemic, and
5
6
William G. Castagnoli. Medicine Avenue. 21.

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antihistamines. Advertising agencies had the duty of carrying out these messages of
technological advancement. This was also an advertiser’s dream for profit; a nearly
untouched market with little regulation and little competition from other advertising
agencies. Due to this fact, promotion was raging and drug prices began to rise along with
it. During this period numerous advertising agencies were formed such as: Frohlich,
Klemtner, McAdams, Phibbs, Sudler & Hennessey, Murray, and Breese.7
Consumer ad
agencies also began to see the opportunity in pharmaceuticals including: Doherty,
Clifford, and Steers & Shenfield. This increased competition in the promotion of
pharmaceuticals and was the defining period when pharmaceutical advertising became an
industry separate from pharmaceutical manufacturing. As the business of pharmaceutical
advertising emerged, advertisers applied new creative techniques to the market. The
creativity of Madison Avenue in New York City was quickly infiltrating the previously
boring and by-the-book journal ads originally introduced by agencies like Phibbs and
McAdams in the previous decade.
8
7
Huntington, N.Y.: Medical Advertising Hall of Fame, 1999.
8
Terramycin advertisement. William G. Castagnoli. Medicine Avenue. 27.

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Above is an ad from 1952 for Terramycin drug put out by the McAdams advertising
agency for the pharmaceutical manufacturing company Pfizer. This drug is a prescription
drug used for treating bones. The ad is very straightforward with the image depicting a
bone directly. The copy in the headline is a clever play on a common phrase, however in
this ad there is limited creativity and overall it has a more scientific feel to it. This is
representative of the 40s and early 50s when few advertising agencies were on the
pharmaceutical playing field. Also, in the small print in the advertisement there is no
safety or warning information. This is indicative of the little regulation that existed in
pharmaceutical advertising during the time since this was before the time when it was a
requirement for an ad to have such information.
Creativity was king in the mid to late 1950’s as advertisers treated the drugs as just
another product and the regulation of the pharmaceutical drugs themselves was not yet
translated into legislation involving limits on promotional materials. For advertising, and
for pharmaceutical manufacturers this was a time period of opportunity. An article in
Chemical Week states, “between 1948 and 1958, manufacturers launched 4,829 new
products, 3,686 new compounds, and 1,143 new dosage forms.9
” This exemplifies how
fast the pharmaceutical industry was growing and how large it was becoming during this
time period. It boasted the prime opportunity for profit. The federal Food and Drug
Administration (FDA) had been formed back in 1906 to protect the public from unsafe
substances, but did nothing to address advertising. Therefore, the agencies had relatively
free reign but this was short-lived.
9
Stanley Siegelman. "Pharmaceuticals; A Fast Growth Track." Chemical Week. 75th Anniversary
(1989): 2.

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10
Above is an advertisement done by the advertising agency Sudler & Hennessey in the
1950s for the pharmaceutical manufacturer Warner-Chilcott. This ad is more creative and
humorous than the previously pictured ad from the early 1950s. This advertisement does
not have a scientific feel to it as it relies heavily on creative copy mixed with engaging
imagery in the copy itself. This kind of ad was much more representative of creative
consumer advertising rather than traditional pharmaceutical. It represents the period
where more consumer advertising agencies were gaining pharmaceutical manufacturers
as clients and applying the same creativity they use in consumer to the ads created for
pharmaceutical professionals.
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10
Schering advertisement. William G. Castagnoli. Medicine Avenue: the story of medical
advertising in America.. Huntington, N.Y.: Medical Advertising Hall of Fame, 1999. 32.

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Above is an advertisement done by the advertising agency Sudler & Hennessey for the
drug Lasix in the 1960s. It is a conceptually creative ad in that it is relating the innovation
of the drug to the new technology era that was able to put a man in space. However, the
copy itself is very scientific and flat out states the benefits of prescribing this drug over
another. This shows the balance in the period between feeling the first punch of
regulation in the pharmaceutical and advertising industry and still maintaining creativity.
In the 1960s, pharmaceutical advertising faced restraints from private associations and
government. Following two major fatal medical disasters, the Sulfanilamide Syrup
Tragedy of 1938, during which approximately 100 children died as a result of an untested
ingredient, and the Thalidomide disaster of 1962, when thousands of children were born
with deformed limbs, the safety of drugs became a top priority in the United States and
abroad. An article in the New York Times states that it was the Thalidomide disaster that
“led President Kennedy to call for stronger drug laws, and Congress quickly complied,
with the thalidomide issue serving to focus attention on the issue of effectiveness as well
as on safety.12
” Since the public was now more aware of the dangers of drugs around
them, the next question to be asked was who was selling them and by what methods. The
Kefauver hearings brought the new advertising industry of pharmaceuticals to the
attention of the public for the very first time in a series of five hearings. Public sentiment
towards the pharmaceutical industry as a whole was addressed as prices for drugs began
to skyrocket and the public and government began pointing at drug manufacturers and
11
Lasix advertisement. William G. Castagnoli. Medicine Avenue: the story of medical advertising
in America.. Huntington, N.Y.: Medical Advertising Hall of Fame, 1999. 52.
12
Irvin Molotsky. "U.S. Review of Prescription Drugs Ends." New York Times, September 16,
1984, sec. 1.

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advertising agencies for driving up the cost to collect means for increased promotion. In
an article from the Washington Post on the hearings, Robert A. Derzon, the administrator
HEW’s Health Care Financing Administration, was quoted stating “research, promotion
and profit are among the most critical aspects of pricing [for prescription drugs].13
” In the
first of these hearings, Abraham Ribicoff, Secretary of the Department of Health,
Education, and Welfare, states “Annual sales of prescription drugs manufactured in this
country have jumped from $200 million in 1939 to over $2 ½ billion today. The cost is
now 20 percent of the total bill for medical care.14
” This began the argument of the four
hearings to follow about the concern over drug price for prescription drugs necessary for
life and public well-being. Estes Kefauver pointed out that much of this increased price
for drugs came from the manufacturers seeking extravagant advertising and relaying that
cost to consumers. This was a concern since the drug industry was in essence a monopoly
with no competition in prices other than generic versus brand name drugs. One of the
worries of physicians prescribing generic over brand name was they felt trade name was
more trusted, which actually costs the patient more even though the drugs perform the
same task. In order to counteract this idea, the bill proposed in these hearings before the
subcommittee on antitrust and monopoly called for a greater amount of drug inspection
powers and new licensing power to be performed by the FDA as a means of ensuring that
all drugs on the market both generic and brand-name are safe for physicians to
13
Morton Mintz. "Senate Panel Begins Year-Long Hearings On High Drug Prices." Washington
Post, July 15, 1977.
14
Drug Industry Antitrust Act. Hearings before the Subcommittee on Antitrust and Monopoly of
the Committee on the Judiciary U.S> Senate. (Washington DC, 1961), 2581. “Kefauver
Hearings”

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prescribe15
. The new bill also called for: the lowering of drug prices by promoting
competition in the industry between trade name and generic, making the FDA the
determiner of efficacy for all drugs on the market before they reach the phase of public
promotion, including of package inserts containing warnings of side effects of drugs
when drugs are sent to physicians, and creating inspection and licensing powers to be
carried out by the FDA.16
These hearings resulted in an expansion of the FDA’s authority
to now include the overseeing of the advertising and promotion of pharmaceuticals, in
addition to seeing to the safety and approval of drugs. The specific actions of the hearings
as well as legislation that followed will be detailed in the next section regarding
legislation and government regulation.
The passing of the Kefauver-Harris Amendments resulted in industry regulation for both
pharmaceutical manufacturers and for the first time, advertising, under the federal
umbrella of the FDA. To an industry that previously saw little to no regulation, this was a
game changer that threw off some agencies, manufacturers, and media outlets. Even the
FDA itself was fuzzy on what the regulation should consist of and how detailed it should
be as traditionally it was not the place of government to regulate communications unless
under extreme circumstances. As the New York Times points out in an article following
the passage of these amendments in 1973, one issue of these amendments is figuring out
the “FDA’s power to hold hearings that deny some drugs equivalent of license and to
refuse full hearing where manufacturer has not produced enough evidence of efficacy to
15
Drug Industry Antitrust Act. Hearings before the Subcommittee on Antitrust and Monopoly of
the Committee on the Judiciary U.S> Senate. (Washington DC, 1961), 2578. “Kefauver
Hearings”
16
Drug Industry Antitrust Act. (Washington DC, 1961), 2577-2580. “Kefauver Hearings”

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warrant such a move.17
” In other words, part of the aftermath of the amendments was
figuring out the logistics behind sorting out the drugs at market currently and evaluating
their safety. The vagueness of the regulation also confused advertisers who were now
unsure how to proceed promoting the drugs. The terms used in the Federal Food, Drugs
and Cosmetics act18
were quite subjective and stated as “brief summary”, and “fair
balance” but no real breakdown of the meaning or examples of what was right and
wrong. There was no real precedence for this kind of action. The FDA waited to see how
the advertisers would proceed and the advertisers waited for the FDA to clarify the
regulation. Two major media vehicles for pharmaceutical advertising, Medical
Economics and Modern Medicine, suspended advertisements until clarifications were
made on the FDA regulations. After all, the publications did not want to be the first to
violate the new rules.19
Given some time both manufacturers and advertising agencies
figured out a balance and way of performing their jobs within the new guidelines.
20
17
New York Times, "After the Hearings," January 9, 1973. Page 27, Column 1.
18
"U S Food and Drug Administration Home Page." U S Food and Drug Administration Home
Page. http://www.fda.gov/.
19
20
Tolectin advertisement. William G. Castagnoli. Medicine Avenue: the story of medical
advertising in America.. Huntington, N.Y.: Medical Advertising Hall of Fame, 1999. 66.

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Above is an advertisement done by the advertising agency Sudler & Hennessey in 1975
for the anti-inflammatory drug Tolectin. This ad has a more scientific feel than seen in
previous years. It shows directly in the image exactly what the drug does rather than
using a creative metaphor. This is how some agencies dealt with the new regulations on
the pharmaceutical industry; they came up with ads that were more scientific and less
conceptually creative (not in all cases but in some).
The FDA was thrown for a loop in the 1980s when Direct-to-Consumer (DTC)
advertising of prescription drugs was introduced. This form of advertising had not been
attempted since the early 20th
century when the AMA had made it clear the industry was
not going to support patent medicine. Since that time, this practice was seen as taboo and
not attempted on a large scale. The difference now was that unlike before when patent
medicines were advertising to the public, now regulations prevented manufacturers from
hiding ingredients. Now the drugs had to be thoroughly tested and put through years of
clinical trials before they could even enter the marketplace and get a single ad out. And
so now was the time to bring up the discussion of public promotion of prescription drugs
that were clinically approved by the FDA as safe. This began with the advertising
campaign of Rufen by Boots Pharmaceuticals.21
Boots decided to use the medium of
television to get directly to consumers. The airing of this ad led the FDA to declare a 2-
year moratorium on branded DTC prescription drug ads from 1983 to 1985. This was the
single advertisement that changed the pharmaceutical advertising industry forever by
introducing DTC advertising specifically for prescription drugs.
21
Liz Moench. "How 5/19 Changed the Industry Forever." Pharma VOICE 1 (2003): 46-50.

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Above are snapshots from the Rufen ad that ran on television. In the ad both the name of
the drug as well as the use was told to the consumer. It stated that it was equivalent to
Motrin since it also used ibuprofen. This was the first time that this information was
relayed to a consumer/patient rather than a physician. And the first time a major medium
of the time (television) had been used to carry out this message from the brand to the
patient directly with no doctor as the middleman. Immediately people could connect a
brand name with an ailment that they wanted to be rid of, and this answered the question
in their minds of how to do it and what to take. The name became top-of-mind.
This new strategy for advertising such a highly regulated product both in content and
promotional messaging illustrates the clash between three legal avenues: the laws
regarding the safety and materials of prescription pharmaceutical products, the
jurisdiction of the FDA in approving the safety of drugs and the truthfulness of
promotional materials involving drugs, and the jurisdiction of the FTC in protecting
consumers from false or misleading advertisements. Direct-to-consumer advertising of
prescription drugs is extremely unique in that the product is not being advertised to
physicians, the audience with the authority to prescribe it. In DTC advertising of
prescription drugs the advertisers target consumers, who then discuss the drug with their
doctors. In other words, the consumer does not have direct access to the product or have
direct purchasing power. Instead, the purpose of DTC is to encourage a conversation to

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take place between the physician and patient about the product in question. It also acts as
a persuasion tactic. This is a roundabout way of advertising that is highly controversial.
The three sides of regulation must be explained in order to understand the complex issue
of DTC prescription pharmaceutical advertising.
Federal Regulation - FTC:
In the 20th
century advertising went through many stages of regulation as the industry
scrambled and struggled with the issue of public trust and social responsibility. For a long
period of time the government struggled over how, when, and where it should be
involved in advertising regulation. The trick was to balance the social responsibility with
the first Amendment right to freedom of speech.
In 1914, during the Presidency of Woodrow Wilson, Congress created the Federal Trade
Commission (FTC). The intent was to solve problems in business relations and
monopolies. Wilson saw the FTC as establishing guiding principles in the business world
and providing information. The nation, he argued, “demands such a commission only as
an indispensable instrument of information and publicity, as a clearing house of the facts
by which both the public mind and the managers of great business undertakings should be
guided.”22
Later the FTC’s powers grew from being the overseer of trade and business to
banning unfair practices of promotion that are “exploitative or inequitable… morally
22
Dean Keith Fueroghne. Law & Advertising: current legal issues for agencies, advertisers, and
attorneys. Chicago, IL: Copy Workshop, 1995.

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objectionable, [or] seriously detrimental to consumers or others.”23
This idea of
protecting consumers against advertisers was recognized in 1938 with the Wheeler-Lea
Amendments prohibiting deceptive acts in commerce. Interestingly, this act also
addressed the advertising of drugs. In April of 1938, President Roosevelt gave the FTC
its own building. He remarked “May this permanent home of the Federal Trade
Commission stand for all time as a symbol of the purpose of the government to insist on a
greater application of the golden rule to conduct the corporation and business enterprises
in their relationship to the public body.”24
From then on the FTC continued to gain more power in determining the line of deception
and when advertisers crossed it. In 1957 the FTC developed a system for monitoring
television advertising. This was its first real attempt to be proactive in this new form of
media. Previously, the FTC would just review scripts before the commercials went on the
air, however much unauthorized speech as well as deceiving visuals were being used in
the ads without their prior knowledge. Now the FTC had a monitoring program and asked
consumers to join in by reporting ads to them that they felt were misleading or false. In
the very first year of monitoring broadcast messaging, six complaints were filed, all
against drug and cosmetic products. One of these products was Rolaids25
(company
misrepresented the neutralizing aspect of the product and that doctors recommended it).
The advertisement was a 1957 radio spot that featured two men in a bar together and one
23
Dean Keith Fueroghne. Law & Advertising. 1995.
24
Franklin Delano Roosevelt. "Opening of the FTC building in DC." Speech, opening of the 600
Pennsylvania Avenue Office of the FTC from United States Government, Washington DC, April
21, 1938.
25
"Federal Trade Commission: A History." Federal Trade Commission.
http://www.ftc.gov/ftc/history/ftchistory.shtm

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of the men picking up a woman there, going home with her and her cooking for him. The
man said he had to pop a Rolaids to settle his stomach and that it worked in only ten
seconds. The FTC received complaints on this ad because most obviously the product
could not work in that short amount of time so it was being falsely represented.26
The FTC Improvement Act of 1975 modified the phrasing of the original FTC Act by re-
writing a key phrase to read “in or affecting commerce” rather than “in commerce” which
it was previously. This law shows the versatility of the Commission in that it has
expanded from regulating business-to-business commerce to regulating industries
affecting commerce, which includes advertising and promotions. Congress authorized the
Commission to seek preliminary injunctions and permanent injunctions. In 1979 the FTC
confronted the medical industry when it charged the AMA (American Medical
Association) with limiting consumer access to the true price of medical services. The
FTC also found a ban on pharmaceutical advertising which deprived consumers from
knowing the availability of healthcare services. The FTC ordered the AMA to revoke any
existing guidelines restricting the advertising of doctors and contractual relations which
was upheld by the Supreme Court.27
Also, civil penalties were created for violations of
the FTC regulation. The 1994 FTC Act Amendments gave a definition to unfair acts or
practices stating “likely to cause substantial injury to consumers.”28
In 1995 the FTC
launched its website as a means of documenting the history, progress, and current actions
26
Harris, Godfrey. The hottest ideas in word of mouth advertising. Cirencester: Management
Books 2000, 2006. Page 243.
27
28
1994 FT Act Amendments. "Federal Trade Commission: A History." Federal Trade
Commission. http://www.ftc.gov/ftc/history/ftchistory.shtm

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of the commission. The FTC continued on the web platform as they turned to Internet
safety and privacy issues, especially attempting to crackdown on advertising with the
popularization of new media among advertisers. Much like its move to television
regulation, the FTC’s move towards Internet was chasing the movement of advertisers. In
2010, the FTC created a presence in social media including Twitter and Facebook,
showing the necessity for versatility in an institution that must chase consumer trends and
the continually evolving technological society of consumers.
The FTC moved into the realm of pharmaceuticals once again in 2010 to end the “pay-
for-delay” deals that kept generic drugs off the market and out of the hands of consumers.
In these deals, a brand-name drug manufacturer paid off its generic drug competitor to
delay the generic drugs entrance into the market.29
The FDA attempted to address this
issue years earlier in an act of legislation to be discussed in the following section. It is
important to note that there is much overlap between these two government agencies in
the pharmaceutical industry as the three sections of law discussed previously must come
together in this specific niche pharmaceutical market.
As two regulatory bodies with authority over the same industry, the FDA and FTC have
specific niches they act upon when dealing with the advertising of food and drugs. The
FDA has primary jurisdiction over the labeling of the actual products while the FTC has
primary jurisdiction over the truth in the promotion of the drug. However, when it comes
29

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to prescription drugs and advertising, the FDA has full jurisdiction over the messages and
labeling.
Federal Regulation – FDA:
As discussed earlier, the FDA was formed in 1906 under the Food and Drug Act. This
act, signed into law under President Theodore Roosevelt, was meant to insure the safety
of food and drug products crossing state lines and was passed in response to Upton
Sinclair’s novel The Jungle, which called attention to the unsanitary conditions of the
meat-packing industry. The act instituted the concept of labeling. However this act
mainly focused on the safety and labeling of food rather than drugs, as food at the time
seemed more apt to cause immediate public health concerns. After 1912, the FDA turned
its attention to drugs. Seizures of misbranded and mislabeled drugs from the market
increased in the early 20th
century.
In 1938, following the Sulfanilamide disaster of 1937, President Franklin Roosevelt
signed the Food, Drug, and Cosmetic Act into law. In this case, a drug manufacturer in
Tennessee marketed a therapeutic drug called Sulfanilamide to be used on children to
treat streptococcal infections30
. This new solvent had not been tested and turned out to be
fatal. Over 100 children died as a result. This called the nation’s attention to the need to
insure the safety of drugs and regulate the way that they are promoted. The new law
required drugs be labeled with directions for safety use, mandated pre-market approval of
30
Ronald Hamowy. "Medical Disasters and the Growth of the FDA." Independent Policy Report
1 (2010): 1-10.

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all new drugs, prohibited false therapeutic claims for drugs, and authorized factory
inspections.31
As mentioned in the earlier section concerning the FTC history, in 1938 the
Wheeler-Lea Act was passed by President Franklin Roosevelt and also addressed
deception in food and drug advertising. This shows that during this time period, there was
a scramble by government to address this issue. The government just wasn’t sure exactly
what department should have primary regulation jurisdiction just yet. Having the two acts
pass at the same time just illustrates how expansive of an issue this was in American
society as the public watched massive amounts of deaths around the globe from the use
of un-safe drugs.
It was not until 1962 when the Kefauver-Harris Amendments were enacted that the
power to regulate prescription drug advertising was specifically placed under the
umbrella of the FDA. Previously, the FTC had regulatory jurisdiction over all
advertising. Now the power was being placed in the hands of the same agency that
ensured the product safety of the prescription drugs being advertised. This action shows
how influential the pharmaceutical advertising industry was becoming, since it called for
its very own regulatory body separate from all other forms of advertising. Today the
power to regulate prescription drug advertising falls under the jurisdiction of the FDA in
most cases while the power to regulate the advertising of over-the-counter drugs presides
with the FTC.
31

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In 1983, the FDA passes the Orphan Drug Act32
to help boost pharmaceutical research
and development by providing incentives for manufacturers to create new drugs. Part of
this incentive is giving a 6 month extension to the amount of time the new drug has
marketing exclusivity, meaning no generic drug can come into the market and advertise
at the same time. This would increase immediate profits for the drug manufacturers
helping them curb the cost of the lengthy clinical trials before gaining FDA approval.
Otherwise, the incentive to create something new would be completely crushed and every
company would just wait until a new drug came out, copy the formula, and make a
generic version which they could then sell without having to earn back money from
lengthy and expensive clinical safety trials. All in all this new legislation was meant to
push progress through market incentives. After all, the medical industry at its roots is a
business involving money as the core. Interestingly enough, this idea sounds similar to a
move made by the FTC in its “pay-for-delay” deals in 2010. The kind of delay the FDA
was approving remained ethical but it was when manufacturers tried to go beyond the
specified marketplace advertising delay date where it became an issue of the public and
thus moved to the realm of the FTC.
In the 1960’s the FDA moved towards a crusade in addressing the substances in additives
in foods. This also led to assessing misbranding of dietary supplements and vitamins.
However, in 1976, public concern over the far-reaching authority of the FDA became
prevalent and Congress prohibited the FDA from “controlling the potency of dietary
32
John P. Swann, and Ph.D.. "FDA's Origin." U S Food and Drug Administration Home Page.
http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm.

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supplements.”33
The line between public safety and hunger for power and regulation was
beginning to be drawn by the public and government.
In the 1980s, companies began using DTC, which called for action from the FDA. The
problem was the FDA was not sure about the effect of advertising prescription drugs
directly to consumers. In order to figure out the pros, cons, and possible dangers the FDA
asked Congress to place a 2-year moratorium on the use of branded prescription drug
advertisements. Unbranded campaigns, meaning those campaigns that did not mention
the name of the drug specifically or did not attach the name of the drug to a specific
ailment, could still be used. These unbranded campaigns were basically awareness
campaigns about a disease and then stated at the end of the advertisement that there was a
drug available to help treat the symptoms. One example of this is the Zantac campaign
which was a disease awareness campaign for ulcers. The ads did not mention Zantac, but
rather encouraged the patient to go see their doctor if they were suffering from ulcer
symptoms.34
However, the ad did not state the name of the drug.
35
33
http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm
34
Pathak, Dev S., Alan Escovitz, and Suzan Kucukarslan. Promotion of pharmaceuticals: issues,
trends, options. New York: Pharmaceuticals Products Press, 1992.
35
Allegra commercial. 1977. http://www.youtube.com/watch?v=b8l1x0o5mAQ.

23
An ad for Allegra (pictured above) is another example of a DTC ad that did not mention
the ailment the drug was meant to help alleviate. Rather this ad pictured a woman wind
surfing through wheat field. The ad simple stated that Allegra could give you a calming
“ahhhh” moment. But nothing about what the drug was meant for. People just knew that
for some reason, Allegra made you feel good.
The FDA thought this was a fair and safe means for the advertisers to promote a drug
without directly advertising a drug. Rather the advertisers were spreading awareness
about a specific disease or condition and telling patients that if they suffer from the
symptoms or disease described they should go see their doctors and ask for a treatment to
help. Or, advertisers were simply getting the name of a drug out there but not stating what
it was for. Ultimately the FDA saw this as an acceptable means to encourage a
conversation to take place between a patient and a physician. “Those who question
promotional activities need to recognize that they have value, are here to stay, and will
continue to be a major source of information about prescription drugs” said FDA
Commissioner Dr. Kessler in regards to DTC promotional methods.36
The effects of
DTC advertising were soon clear. If branded, then patients could go to doctors and
demand a medication that the doctor did not know or did not trust, which would put the
physician in a difficult position. Those against the idea of DTC advertising believe that it
puts expert control into the hands of un-educated patients rather than in the hands of
capable well-educated doctors. In her book Direct-to-Consumer Advertising of
Prescription Products, Bambi Thompson states “the conversation between patients and
36
Dev S. Pathak, Alan Escovitz, and Suzan Kucukarslan. Promotion of pharmaceuticals: issues,
trends, options. New York: Pharmaceuticals Products Press, 1992.

24
physicians that DTC advertising encourages can be viewed as a one-way transmission
from the pharmaceutical companies to consumers.37
” This is due to the fact that
consumers cannot ask questions, they are simply being told about the drugs. Critics argue
that it damages the credibility of the physician and forces them to choose between a
satisfied patient and a healthy patient.
During the 2-year moratorium the FDA conducted three primary studies to find out more
about DTC advertising of prescription drug products. To do this, the FDA considered the
perspectives of both involved parties i.e. the consumer and the physician. The results
were as follows:
What Information was Recalled from TV Ads for Pharmaceutical Products
Benefits 90%
Risks/side effects 90%
Who should not take 89%
How to get more information 86%
Who should take 74%
Questions for doctor 71%
Directions for use 35%
Over-dosage 12%
37
Bambi Thompson. Direct-to-consumer advertising of prescription products ethical strategies
that make good business sense. 2008. Page 6.

25
*source: Rados, 200438
Physician Views of Beneficial Effects of DTC Advertising on Consumers
Better discussion with patient 53%
Patient more aware of treatments 42%
Informs/educates 10%
Patient more likely to take prescribed drug 10%
Patient more likely to consider Rx drug 9%
New condition discovered 6%
Patient sought treatment for serious
condition
2%
*source: Rados, 2004
Through this study it was found that DTC advertising of prescription drugs was in fact
acting as an educational tool for consumers. They reasoned that the concern for doctors
was not significant and it was important for a patient to understand and become aware of
drugs and possible solutions to their health issues. Ultimately the prescription power and
final decision would still be left in the hands of the physician. The FDA therefore decided
that it should be allowed for manufacturers to take this route in their advertising, as it was
beneficial to society. The only new restrictions the FDA put on DTC was a requirement
of fair balance between the risk factors and benefits of the drug and brief summary of
risks and warnings in the advertisements. However, there is no further regulation
38
Carol Rados. "Truth in Advertising: Rx Drug Ads Come of Age." FDA Consumer, July 1,
2004.

26
regarding DTC specifically. In the 1997 FDA Modernization Act39
, the FDA even
loosened the brief summary requirements for broadcast DTC ads so that advertisers could
instead showcase a toll free number, refer a consumer to a website, or provide the name
of a magazine that had an ad where the consumer could fins more information. This
allowed for broadcast messaging to be used at a greater scale with less regulation.
Originally The FDA’s division of Drug Marketing, Advertising, and Communications
(DDMAC) oversaw DTC advertising alongside prescription drug advertising directed at
Health-Care-Professionals (HCP). The mission of this division was simply to ensure the
truthfulness and accuracy of the prescription drug advertisements. However, it is not a
requirement for advertisers to submit the DTC advertising to the FDA prior to public
release, this action is only voluntary. Rather, the ads must be submitted at the time of
release (the same time it is being released to the public). If DDMAC finds after reviewing
the ads that the manufacturer has violated the guidelines, it can issue warning letters to
the manufacturer and ask them to cease and desist their advertising. In 2007 the FDA was
given power under the Food and Drug Administration Amendments Act to impose civil
penalties on any company that shows misleading or untruthful prescription drug ads.
In 2011, the FDA announced the formation of the Office of Prescription Drug Promotion
(OPDP) to replace DDMAC. OPDP is a branch of the FDA that has the primary
responsibility of reviewing prescription drug advertising, promotions and labels. The
mission of OPDP is:
39
that make good business sense. 2008.

27
To protect the public health by assuring prescription drug information is truthful,
balanced and accurately communicated. This is accomplished through a
comprehensive surveillance, enforcement and education program, and by fostering
better communication of labeling and promotional information to both healthcare
professionals and consumers.40
This was a move by the FDA to help in the regulation of Direct-to-Consumer advertising.
Previously, there was no separate branch of the office that had the specified jurisdiction
in this audience for prescription drug promotion. DDMAC included DTC under their
umbrella, but with the increased use of DTC by advertisers, the FDA realized they had to
adjust their regulatory body and have a team that specialized in this growing area of
promotion specifically.41
This is in part a result of structural adjustments within the
healthcare market as a whole.
The introduction of managed markets into the healthcare system threatened the use of
brand name drugs. The goal of managed markets is to curb the cost of healthcare for
individuals. Due to this fact, brand name drugs are less likely to be favored because they
are more expensive and managed care markets would rather go after cheaper generic
drugs. Direct to Consumer Advertising became a way of coping with this new difficulty.
Previously, targeting the physician showed successful results, but with managed care
markets, the decision left the hands of the physician and thus, so did much of the
advertising messages. Consumers were seen as a new avenue for promotion as a
40
41
"DDMAC loses a letter but gains a new name and more prominence - Lexology " Lexology .
http://www.lexology.com/library/detail.aspx?g=6b134a50-1911-4701-901b-caca9e83214c.

28
persuading party in the decision for care and treatment. The goal became to increase the
demand for prescription drug products amongst patients themselves. This is why even
today DTC advertising of prescription drug products is looked at with a cold eye. It is
viewed by some as a method of manipulating the public.
Internal Advertising Regulatory System – The unseen rulebook
In addition to FTC and FDA regulation, advertising also has an internal regulatory system
through a multitude of small agencies. These organizations put out voluntary guidelines
for the advertising industry as a means of protecting and promoting the ethicality and
moral means of an industry often put under the bus by society. It is also a way for the
industry to take the reigns in regulation rather than submitting to the government and
such public institutions. Just like every other regulatory body, the ultimate goal of these
organizations is to ensure the safety and truthfulness in advertising messages, thereby
protecting consumers from being misled. Some of these organizations include: National
Advertising Review Council and the American Association of Advertising Agencies
(AAAA).
In pharmaceutical advertising some guidelines have been created by institutions such as
the Pharmaceutical Research and Manufacturers of America (PhRMA). This organization
“represents the country’s leading pharmaceutical industry research and biotechnology
companies, which are devoted to inventing medicines that allow patients to live longer,

29
healthier, more productive lives.”42
Part of the mission of this association is to advocate
for policies in government to encourage the discovery of new medications to help the
public and to encourage the medical industry to communicate with the public in a way
that educates. This is also an internal means put in place to be sure that mistakes or
misleading messages made within the industry is caught by the industry itself before
caught by a regulatory body that would put out bad press for the company at fault and
shed a bad light on the pharmaceutical industry as a whole. PhRMA has recognized an
opportunity for improvement in this communication to the public in the realm of DTC
advertising of prescription drugs. To help push this progress PhRMA has come out with a
set of voluntary DTC guidelines for pharmaceutical companies to accurately portray
information to the public in advertising prescription drugs. One issue immediately
apparent in this set of guidelines, last updated in 2008, is that it only mentions print and
television broadcast DTC. It completely leaves out Internet and social media, which are
two areas of DTC that have grown tremendously in the past 5 years. The FDA currently
only provides guidelines for DTC under one umbrella as requiring ads to be:
1. Accurate and truthful
2. Make claims only when supported by substantial clinical evidence
3. Have a fair balance between product risks and benefits
4. Have all promotions only acknowledge uses approved by FDA approved label43
Clearly, there is currently a gap between the actions of advertisers and the regulation of
industry and government. Now with the internet being utilized through websites, banner
42
"Direct to Consumer Advertising | PhRMA." PhRMA.
http://www.phrma.org/about/principles-guidelines/direct-consumer-advertising.
43
"Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines."
PhRMA Guide 1 (2008): 1-14.

30
ads, and interactive tutorials, it comes down to the First Amendment issue of free speech
and where to draw the line. The Internet is a unique medium in that it is the ultimate
freedom of information. The big issue being faced and why the regulatory efforts have
come to a relative halt is if this is a position people want the government and other
regulatory bodies to censor and regulate.
Direct-to-Consumer:
The advertising of prescription drugs directly to consumers is the area in which all of the
regulatory bodies and history of law collide. The FTC with its jurisdiction over consumer
safety, the FDA in its jurisdiction over pharmaceutical messages and promotions as well
as drug safety, and the internal voluntary industry guidelines. DTC advertising of
prescription drugs is unique in Pharmaceutical advertising in that it is only legal in two
countries in the world: the United States and New Zealand. Despite this, it is one of the
fastest growing and most lucrative advertising markets. As previously discussed, DTC is
a rather controversial issue. Those for it argue for the educational and awareness value in
providing information to make patients informed about their health and options for
treatment. Also, DTC can encourage an informed discussion to take place between the
patient and the physician when it comes to prescription drug treatments. In this way, DTC
is an extremely valuable resource for both the public and physicians. Critics of DTC
claim that it puts a great deal of power in the hands of the consumer rather than in the
physician who is the one who needs to actually write the prescription and feel

31
comfortable with using the product.44
Pressure becomes the battle-point when patients
come in with their heart set on a brand that the physician may not know much about and
not feel comfortable prescribing. In simple terms, it puts the physician in a difficult
position that could pressure him/her to make a dangerous uninformed decision in treating
their patient.
Originally, when DTC emerged in the 1980’s TV and print was where the ads thrived.
However, with the increased use and development of the Internet, advertisers have moved
to a new medium, which allows for a more targeted user experience rather than a
screaming ad; Internet.
This becomes especially true in the field of social media where users seek the information
rather than advertisers promoting through widespread broadcasts. DTC in general became
an issue in the field of regulation as discussed earlier. Eventually the FDA took the reigns
over jurisdiction of this regulation. However, the principles brought forth by the FDA to
be followed were vague. Internal associations such as PhRMA then created guidelines for
the industry that they believed would help to continue the goal of education in advertising
rather than simply product selling.45
However, both of these attempts have left the
Internet and new technologies untouched. One could argue that the Internet
advertisements of DTC could fall under the umbrella of FTC jurisdiction as they are the
most advanced as far as regarding new technologies in their regulation concerns.
44
that make good business sense. 2008.

32
46
Above is the website of a prescription sleep-aid drug called Lunesta. The website features
details about the drug, people speaking about the drug, and even how to save money
getting the drug when it is prescribed to you by a physician. At the bottom of the page the
website reads, “This site is intended for U.S. residents 18 years or older.” However, it can
be accessed by anyone of any age and from many countries, even if it is only intended for
one. This is where controversy comes into play with Internet and DTC advertising.
The turn of DTC to the Internet creates a breach of market. Unlike print and broadcast
that can be contained to a certain area, the Internet is everywhere. Social media sites as
well as any other site is accessible from almost everywhere in the world (of course some
nations do actively censor this medium). Even though DTC of prescription drugs is only
legal in two nations, the ads in this medium are accessible around the globe. Prescription
drug websites try to compensate for this act to avoid legal issues by stating at the bottom
of their website that “this site is intended for US residents only” however, this does not
46
"Official Site Lunesta." Official Site Lunesta. http://www.lunesta.com/

33
stop others from seeing it. In addition to a national issue, DTC has become a global issue
as far as regulation. Other ways that advertisers are utilizing new technologies is the
world of apps where the companies sponsor or create specific apps to be used by the
consumer. Once again, these are not limited to the United States. According to a 2011
article in the Journal of American Medicine, companies are currently spending
approximately $1 billion in DTC Internet marketing alone.47
DTC was controversial
when it was just limited to print and television. Now, as the market for this advertising
grows with Internet, social media, apps and other new technologies it has become a
global concern. On the positive side one could argue that there will be widespread
information at the fingertips of every consumer at any time they want. However, on the
negative side, since there is currently little to no regulatory standards in these new media
outlets, the promotional messages may not be truthful, accurate, or balancing information
as they would normally be required to do. This in turn could put patients at risk if they
are wrongly informed. The act of DTC advertising of prescription drugs moving to these
new worldwide forms of media has crossed the line from a national issue to a global issue
that is currently struggling to be dealt with.
Conclusion:
The history of pharmaceutical advertising was shaped by trials and tribulations,
innovations and failures, successes and devastating instances. With every new and
improved wonder drug there was another on the market that caused some fatal disasters.
47
Bryan A. Liang, and Timothy Mackey. "Direct-to-Consumer Advertising With Interactive
Internet Media Global Regulation and Public Health Issues." JAMA 305, no. 8 (2011): 824-825.

34
The increase in biological and chemical innovations marked the beginning of a medical
industry. Along with this industry came another to promote it, that of pharmaceutical
advertising. This emerged at a time when the trust of the medicinal community was being
put to the test with the war of ethical drugs, in which the materials were known and
messages were given to medical professionals, against patent drugs, which did not
disclose the materials used to produce it and used promotions directly to the public with
no regulation for safety or on misleading messages. The challenge in the 20th
century was
to balance the safety of the public with the economic prosperity of drug manufacturers to
produce the demanded products, particularly with prescription drugs. Primarily during
this time promotions were directed to physicians as a means of educating them on what to
prescribe their patients and moving away from the un-trusted patent drugs of the past.
Creativity evolved as a result of the growing stake of government in the industry, shown
especially in the transition from the 1950s where little regulation was present and a
creative boom existed to the 1970s. Each time when there was a transition from one
popular media outlet to another, regulation was increased and structure of ads changed.
This is seen by the movement towards television advertising and important to consider
with the current transition to new media including Internet.
Direct-to-consumer advertising emerged with a change in the structure of the payer-buyer
market in healthcare. This new structure included a new avenue called managed markets.
This challenged the branded prescription drug market by putting them in direct
competition with their generic likenesses to be included in the managed market
formularies of approved drugs that doctors could prescribe. The DTC outlet for

35
promotions was meant to increase the demand for branded prescription drugs. However,
this new strategy of advertising was bringing back the negative patent drug connotations
of the past when the industry was not safe, regulated, or even trusted. One key difference
that has allowed for the success of DTC is the institution of regulation on the
pharmaceutical products themselves so that safety was not as questioned as back in the
days of the patent drugs. As this new outlet began to be utilized in the 1980’s, regulatory
bodies were unsure as to how to proceed and regulate the new communication so that it
would be in the best interest of public health and safety. DTC created a clash between
FDA, FTC, and internal regulatory agencies as it encroached on all of their jurisdictional
bases. Since DTC advertised prescription drugs it partially fell under FDA jurisdiction.
Since the advertising was directed towards the public, it fell under FTC’s responsibility
of consumer protection, and agencies within the industry such as PhRMA attempted to
make ends meet through voluntary guidelines. Eventually the FDA took control of
concerns involving the advertising of prescription drugs while the FTC concerned itself
with the advertising of over-the-counter drugs. However, as DTC began utilizing new
media techniques, no regulatory body has specifically claimed jurisdiction.
It is clear that the benefits associated with DTC advertising cannot be ignored. The value
this promotions technique holds in a society where people go out everyday searching for
answers through the technologies that have become their everyday accessories is
immense. DTC acts as an answer and resource for people searching for help. It is
important for it to be present, especially in new media. However the issue is in
maintaining this benefit so that it is a trusted, accurate and truthful means for consumers

36
to gain information that could ultimately improve their own health or at least spread
awareness about possible medical conditions they may be suffering from. It is clear
through looking at the history that a new agency or at least agency branch needs to be
created to not discourage this useful media avenue, but encourage its use through the
most accurate and educational way so that it is beneficial to the consumer and trusted by
the public and not just gaining revenue for the pharmaceutical companies and the
advertisers. This is the challenge for not only the United States, but also the world.
Opinion – A personal recommendation:
After researching the regulatory guidelines and tendencies of the bodies involved with
advertising and promotional messaging I have a few brief recommendations on how to
deal with the global issue of direct-to-consumer advertising of prescription drugs.
Step1: Direct-to-Consumer advertising began at the national level, so it must first be
dealt with at the national level.
I propose that the FDA, specifically OPDP needs to create a section within its pre-
existing direct-to-consumer advertising approval branch that focuses on digital media.
This group would be in charge of reviewing and ensuring the accuracy of the content
present in the digital world such as: Internet, banner ads, websites, apps, and social
media. The world already knows pharmaceutical promotion is present in these areas,
therefore they must also be looked at through an accuracy lens. This branch needs to

37
develop guidelines specific to these new media outlets in accounting for “fair balance”
and “brief summary” and the limitations of the new media to show both. Basically, a new
way of showing these two criteria needs to be established and understood both from a
regulatory standpoint and an industry standpoint so that the limitations are clear to both
parties straight off.
This digital group must also be responsible for exploring new technological innovations
and opportunities where DTC could form and be used. By having a proactive body, the
regulatory initiatives will be more timely and there will be less gray area for promoters
and regulators.
Step 2: It is no secret that DTC has become international whether legal or not. It’s time to
address this on a global scale.
The International Chamber of Commerce is the body that releases guidelines for
advertising worldwide. In order to address DTC I believe the ICC should revamp their
guidelines to include DTC within them. The limits could be as loose or stringent as seen
appropriate, but I believe that a discussion needs to happen between the ICC and the
United Nations in order to pin down exactly what the world’s concerns are. Only then can
guidelines be put out to address this communication. The key is the conversation.

38
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