Running Head: The Evolution of Pharmaceuticals

| February 25, 2017

Running Head: The Evolution of Pharmaceuticals

Drug/Device Regulations:

MPE 610


Keary Dunn

Direct to Consumer advertising and other promotional practices
(Including a discussion of industry and medical professional self-regulation)
– Assignment #3
Kim McGiboney
December 31, 2015

Running Head: The Evolution of Pharmaceuticals
Table of Contents
Introduction………………………………………………………………… 3
Historical Milestones and Evolution…………………..…………………… 3
Promotional Practices…….………………………………………………… 4
Other Promotional Practices…..…………………………………….……… 5
Legal Counsel…….………………………………………………………… 6
Global Efforts……………………………………………………….……… 6
Viewpoints…………………………………………………………………. 7
Discussion………………………………………………….……………… 9-10
References………………………………………………………………… 11-12

Running Head: The Evolution of Pharmaceuticals
Direct-to-Consumer Pharmaceutical Advertising (DTCPA) refers to concerted efforts by
pharmaceutical companies to promote their prescription products directly to the patients. This
form of advertising is done through the use of popular media such as television commercials,
radio advertisements, and printed media. In the United States of America, the advertisements are
permitted by the companies including product claims. However, in other parts of the world, this
practice is highly forbidden. For example, in Canada and the European Union, these
advertisements are not permitted. There is no room for patients to be given little information
about drugs despite growing calls from the pharmaceutical industries and lobby groups (Vitry,
There are several types of DTCPA. Firstly, the ‘product claim ad’ includes the product,
indication and safety claims. This is the most common type of DTCPA. Secondly, the ‘help
seeking ad’ includes the provision of vital information about the medical condition without the
mention of the product while encouraging patients to seek medical attention. Lastly, ‘reminder
ads’ include the product name and other information such as the strength, dosage form, and price.
However, these types of advertisements do not indicate any claims or mention to the disease state
(Vitry, 2009).
The Food and Drug Administration (FDA) was established as the federal agency
responsible for checking the quality of drugs and regulating the conduct of the pharmaceutical
companies. The DTCPA rules and regulations provide the threshold governing the conduct of the
pharmaceutical companies when promoting their products to the patients. The FDA enforces the
rules mentioned above and regulation. This means that the agency has the obligation of taking
appropriate action against the pharmaceutical companies that are not abiding to the rules and
regulations (Cox & Cox, 2010), but how has the industry evolved as it relates to advertising?
Historical Milestones and Evolution
From a historical view, there are some milestones worth mentioning. In 1912
congress passed the Sherley Amendment which prohibited false therapeutic labeling of
medicines with the intent to defraud customers. The Federal Food, Drug, and Cosmetic Act of
1938 require manufacturers to show that new drugs are safe prior to promotion. Under the
Wheeler-Lea Act, the Federal Trade Commission was authorized to manage
advertising related with products, including pharmaceutical products. Regulations

Running Head: The Evolution of Pharmaceuticals
were extended further in 1951 by the Durham-Humphrey Amendment, which established a
list drugs that required medical supervision and a licensed practitioners prescription. This
shifted advertising and marketing of drugs from the general public to healthcare
providers. Congress passed the Kefauver-Harris Amendments in 1962, which require
manufacturers to demonstrate drugs safe and efficacy prior to marketing.
Furthermore, the FDA gained the accountability and authority to regulate the
advertising of prescription drugs. Since then the distribution of prescription drugs
has remained essentially the same, the FDA and Congress have continued to polish
approaches by which drug information is communicated to consumers. In 1967,
Congress enacted the Fair Packaging and Labeling Act, which stated packages and
their labels should equipped consumers with accurate information as to the quantity of
the contents. So it was declared to be the policy of the Congress to assist consumers and
manufacturers in reaching these goals in the marketing of consumer goods. In 1970,
the FDA required the first patient package insert (PI) for a prescription drug
information. In 1982, the FDA requested a voluntary cessation on DTCPA they
recognized there had been a shift of focus from the healthcare provider to the
consumer and wanted to elevate the current state. In 1985, the FDA lifted this
moratorium, and once again DTCPA gradually increased. In 1993, the FDA requested
voluntarily submissions of marketing and advertising materials for review and
comment. As part of this change in policy, the FDA mandated a list of all side effects and
contraindications as a part of promotion.
In summary, the FDA recognizes two primary types of labeling drugs. Firstly, the
FDA has its unique required labeling that all pharmaceutical companies have to adhere to.
Secondly, the FDA approves promotional labeling that is devised to promote the drug among
the customers (, 2015).
On the other hand, the FDA feels that most consumers have insufficient knowledge about
the information described in the full PI. In some instances, the consumers may find the
information to be of limited use to them. In this regard, the aforementioned approaches are not
viewed as optimal for consumer-directed prescription drug print advertisements and promotional
labeling pieces. These reasons have given the manufacturers a leeway to avert the agency’s
wrath in case they forfeit on including information about side effects of the drugs. This means

Running Head: The Evolution of Pharmaceuticals
that even if the manufacturers include the required information, there is no cause for alarm on the
part of the FDA for failing to adopt the full requirements of the PI (, 2015).
However, the agency faces challenges in administering its powers as a regulatory body.
There are increased cases of decline in the number of regulatory warning letters that are issued to
the companies. —-What does this mean? Additionally, the number of staff at the agency that is
mandated with reviewing the advertisements has remained the same over the years. This limits
the time available to carefully analyze the advertisements. Finally, the agency has been poorly
funded resulting in slow reviews of the pharmaceutical advertisements (Vitry, 2009).
Promotional Practices
Talk more specifically to TV advertisement regulations….maybe how many a year, how does it
compare over the years. Bad drug ads etc.
Other Promotional Practices
In addition to the traditional 30-60 second commercial advertisements, all pharmaceutical
companies have taken strategic steps to integrate the use of Internet and its related technologies
to disseminate information about their drugs and devices. These platforms include the use of live
podcasts, online communities, social networks, micro blogs and blogs. This information is
usually created by third-parties. The companies have opted to use these advanced platforms as
they provide efficiency and effectiveness that is much desired by the techno savvy customers.
These Internet and social media platforms are opted for as they allow for real-time and
continuous communications and interactions between the pharmaceutical companies and the
customers (, 2015).
These websites allow the customers to access user-generated content (UGC) regarding
the drugs and device. Moreover, the platforms facilitate the transmission of information that
allows the patients to share experiences about the drugs. On the contrary, the FDA acknowledges
that the user-generated content (UGC) might not be accurate as intended. On other occasions this
information poses danger to the patients as it is easily edited. The FDA defines this type of data
as misinformation that is intended to benefit or harm the public health status. In this context, the
FDA requires that the pharmaceutical companies to correct the misinformation about their drugs
and devices. This is intended to benefit the level of the public health (, 2015).
The FDA does not intend to object any forms of voluntary correction of misinformation
by the pharmaceutical companies. The agency requires that the firms engage in this activity in a

Running Head: The Evolution of Pharmaceuticals
truthful and non-misleading manner. This means that the pharmaceutical companies have the
option of responding to the misinformation provided on the Internet and social media sites.
However, the FDA reserves the right to object the corrected misinformation if it does not oblige
to the provisions laid out regarding labeling and advertising (, 2015).
The medical journals play a vital role in industry and medical professional selfregulation. These publications have been used as the main media in which the healthcare
professions and pharmaceutical industry release codes that govern their interactions. The codes
on self-regulation have been revised over time and the trends published in the professional
journals. The public outcries about self-regulation in terms of the industry and the profession
have been released in these journals. The relationship between health professions and the
industry is under scrutiny due to the articles that are written in these publications. Any forms of
misconduct and unethical behavior by the medical practitioners and the pharmaceutical
companies are brought to the limelight (Agrawal, 2001).
Legal Counsel
There are cases arising from the healthcare industry that concerns misconduct of the
physicians and the pharmaceutical companies. These two industry players have been accused of
being too harsh in their decisions regarding the patients. There are cases in which doctors have
exercised negligence that has led to patients suffering. The patients have a legal right to
undertake the suffering to lawful decision makers within the country. Sometimes the medicines
prescribed by the doctors are ineffective due to the aforementioned promotional misconduct by
the manufacturers (Avorn, 2003).
Since the Perez v. Wyeth trial escaladed to the Supreme Court, in August 1999, there
has been added accountability by the manufactures. The Supreme Court of New Jersey
issued the first high-level court opinion to recognize a DTCPA exception to the learned
intermediary rule. Based on the case, although the manufacturer had satisfied the duty
of providing medical professionals with full warnings, in the first place the court
held that the protection that usually offered by the learned intermediary doctrine was not
automatically available since the manufacturer, in this case, had engaged in DTCPA
(Piranian, 2000).
Global Efforts

Running Head: The Evolution of Pharmaceuticals
Advertising ethics can be defined as the moral beliefs that help an individual determine
what is right or wrong. In general work ethics, it would be wrong if one individual makes
decisions based on their perception in a bid to gain at the expense of other stakeholders. An
organization incorporating a self-regulating mechanism that monitors, guides and ensures
compliance of the law is one that has been built on ethical and social grounds in relation to the
business model of philosophy (Daft, 2011).
Even though the pharmaceutical industry has made a tremendous progress in terms of
research and the development of drugs that can treat malignant diseases like cancer, tension has
emanated between the consumers and the company. Many feel that the pharmaceutical
companies are not doing their social responsibility as expected. As a result of creating awareness
and improving the global standards, there was need for the regulatory boards concerned with the
pharmaceutical companies to come together and standardize the safety regulations and quality
associated with consumers so as to provide safe and quality products efficiently. Different
nations came together under their various health care organizations to form standardized health
care measures especially in addressing pharmaceutical companies and their role in production of
drugs. The International Conference on Harmonization, ICH was a body created by several
nations in order to represent the regulatory organizations and industries that deal with carrying
out research (Castner, Hayes & Shankle, 2007).
The pharmaceutical companies while addressing the emerging global issues are trying to
attempt their participation in the business industry by coming up with standards that ensure the
safety of the product. Majority of these organizations are addressing incumbent social norms
towards attaining a sustainable society. This boosts their trust among the society further in
addition to being successful companies in the past (Castner, Hayes & Shankle, 2007).
The Sunshine Act
The Sunshine Act is all about Physician Financial Transparency Reports. This document
outlines the regulations and policies that govern the relationship between pharmaceutical
companies and medical practitioners regarding payments. This Act requires the biological,
manufacturers of drugs, and the medical devices to report all forms of payments and items of
value that physicians and teaching hospitals receive from them. The process of implementing the
Sunshine Act has been bestowed upon the Centers for Medicare and Medicaid Services (CMS).

Running Head: The Evolution of Pharmaceuticals
This commission has called this implementation process the Open Payments Program (Agrawal,
Brennan & Budetti, 2013).
This Act requires the biological, manufacturers of drugs, and the medical devices to
submit annual data to the center. These data should be concerned with payments and other forms
of transfers of value that have been given to physicians and teaching hospitals. This allows for all
forms of payments that have been made for promotional purposes are published. The concerned
individuals and institutions have the right to review their Open Payments data. This allows them
to dispute any forms of errors that might have been made during the submission of the data. Even
if the period of review has elapsed, they are allowed to clear their names of any wrongful doing
(Agrawal, Brennan & Budetti, 2013).
In this context, there are two opposing sides. One calls for the ban of DTCPA, and the
other justifies the importance of these practices. There are arguments that have been opposing the
drug advertisements since their inception. Firstly, the adverts have been blamed for increasing
costs for the patients since they are not effective in treating the ailments. Secondly, there are
increasing claims that the advertisements are not rigorously regulated by the Food and Drugs
Administration. Thirdly, it is believed that the advertisements lead to partially-informed patients
who waste valuable appointment time derailing conversations with healthcare providers. This
can lead to the forth argument which addresses the consistent strain on the patient-healthcare
provider relationships as a result of DTCPA. The bottom-line is that the advertisements may
mislead the patients and result in inappropriate prescriptions. Similarly, DTCPA have been
blamed for manufacturing diseases as they encourage over-utilization of drugs and over
emphasize benefits. Moreover, newly approved products can be promoted before post-marketing
experience has been established. (Vitry, 2009).
On the other hand, there are strongly constructed arguments that call for the continued
use of DTCPA. Firstly, it is argued that the adverts encourage product competition and lower
prices among the manufacturers. They also result in early pharmacological management that
saves on the expenses that could have been used during surgeries or later stage treatment.
Secondly, the advertisements help to avert stigmas that are related to diseases such as depression
and erectile dysfunction. This helps to raise the awareness levels among the members of the
public about the diseases. Thirdly, the adverts help to reduce under diagnosis and under treatment

Running Head: The Evolution of Pharmaceuticals
of conditions. The perceptions of patients about medical conditions improve since they are able
to seek medical attention. Fourthly, it is argued that the DTCPA facilitate the promotion of
dialogue with healthcare provides, as they encourage the patients to stay in constant and regular
contact with their clinicians. Finally, the advertisements are praised for informing, educating and
empowering patients (Cox & Cox, 2010).
On a good note, the two opposing sides come together and agree that measures need to be
instituted to bring forth maximum benefits while averting the risks that patients could suffer.
Among the measures advocated for include providing drug cost information, improving patient
comprehension about the drugs, including quantitative information, establishing regulations for
online advertising, requiring pre-clearance by the agency, banning product-specific adverts, and
delaying advertising of new products (Vitry, 2009).
I strongly believe stricter FDA regulations should be implemented. Commercial
advertisements are a one contributing factor to the industry’s negative image. As a
pharmaceutical representative with over 10 years of experience, I can attest to the impact of these
DTCPA. When all things were held constant (same territory, same targets, same partners, etc.), a
simple market share report could tell you when a DTCA campaign was running without even
turning on the TV. Pharmaceutical companies have mastered the art of marketing and have no
problem with spending substantial amounts of money finding these efforts. TV networks have
learned how to capitalize profits by offering manufacturers a menu of options, certain times of
the day, at specific points in the program, and/or during specific programs. Companies can even
compete against each, if they are willing to pay for the slot behind a competitors’ commercial.
The problem is unaware consumers are victimized as marketers work to tug on their
emotional instinct with very little regard to the clinical evidence. Patient awareness is a great
thing, and I believe pharmaceutical companies should be able to raise disease state awareness
and share clinical evidence but there should be more interest in ‘help seeking ads’. Less
corporate effort should go into hiring the best marketing agency to help executives decide on the
promoting tactics. For example, as a corporate executive of a large pharmaceutical company, I
found myself in a brand meeting discussion that was unsettling. It was a one-hour meeting with
10 core brand members focused on deciding between using a grizzly bear versus an elephant as

Running Head: The Evolution of Pharmaceuticals
the main character in a commercial. The FDA should mandate a few things. First they should
sterilize the advertisements to remove analogies, actors/celebrities, and colorful settings.
Additionally, it would be useful to regulate the communication of clinical benefits in all
advertisements to include more economical outcomes or more specific reporting guidelines. For
example, making it a requirement the companies report numbers needed to treat versus relative
risk reduction. Take Drug X, marketing against the Gold Standard warfarin for the reduction of
stroke in NVAF patients. The 35% RRR seems appealing but is it? You will never see a company
talking about the absolute risk reduction of 1.08% compared to usual care or the fact that 92
patients need to be treated to avoid one additional event compared to the Gold Standard
treatment. The typical physician is not likely to prevent more than 15 strokes a year even if
he/she were to prescribe the $315 medication over the $4, but to be fair we should consider the
monitoring cost of warfarin as well.
I believe solutions can come out of regulating the marketing messages to be more
transparent in the clinical outcomes and to steer pharma in the direction of clinical evidence
versus sleek marketing pitches. In summary, I think they are in a better position to achieve more
in creating awareness and improving global standards.

Running Head: The Evolution of Pharmaceuticals
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Running Head: The Evolution of Pharmaceuticals

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