Abstract to educate patients about the diseases


Direct to Consumer Prescription Advertising (DTCPA) in other
words is marketing of Food and Drug Administration (FDA) approved prescription drugs.

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This type of advertisement is legal only in United States of America (USA) and
New Zealand. The primary aim of DTCPA is to educate patients about the diseases
and new types of treatments that are available in the market. In the USA, FDA has
been regulating the DTCPA since 1962 to prevent false or misleading claims. There
are currently various types of DTC Drug Advertisements, such as “help seeking
ads” which only educate people of certain diseases but doesn’t mention a
product name. The “reminder ads” provide the drug name, dose and price but not
its use. The “product claim ads” provide the drug name and its benefits and
risks showing fair balance. This paper will provide policymakers an insight
into health issue of advertising prescription drugs and provide recommendations
to make effective policy on DTCPA.


words: Direct to Consumer Prescription Advertisements (DTCPA),
Food and Drug Administration (FDA)












The role of DTCPA is to increase patient
awareness of the disease and its treatment options but instead it is affecting
the patient physician relationship and making people overuse prescription
drugs. Physicians believe that drug companies use DTCPA to only convey the
short term benefits of their drugs and leave the patients in dark regarding the
possible risks. Most of the physicians believe that DTC ads cause patients to
think that the new drug that is advertised on televisions, newspaper or
magazine works better than the ongoing regimen the patients are on. The outline
and execution of DTCA has been seen as deceiving, influencing adversely the
relation amongst patient and physician. DTCA has been blamed for lacking
instructive esteem, deceiving patients into imagining that they have conditions
that can be cured with the publicized medications. Many physicians feel
pressurized and frustrated to prescribe a drug that a patient mention during
his or her visit to a healthcare provider. When any advertisement claims that a
drug being effective, people do not make the necessary efforts to know the rest
of the information inside the message which also contains the risk and side
effects of the drug. Information about the risks are often displayed in smaller
prints or as a part of an undifferentiated text or audio. If a patient’s
request for an advertised drug is inappropriate and the physician is unable to
correct the patient’s perception, then he/she is indirectly forced to give an
unnecessary prescription. Denial
of a prescription request can decrease the patient satisfaction and increases
physician switching. Accordingly, physician may need to spend a greater amount
of time during the clinical visit tending to mistaken assumptions of medication
and treatment alternatives.


In early 1900’s there were no specific
regulations on obtaining drug or how it is marketed. In 1906, Pure Food and
Drug act was established which regulated drug labelling before it is introduced
in market (North, 1906). After the Sherley
amendment act in 1912, false therapeutics claims on drugs was prohibited. In
1914 Federal Trade Commission (FTC) first regulated the interstate advertising
of drugs (Greene, 2010). FTC exempted the
journal advertising to physicians considering their unique expertise. After the
Thalidomide incident in 1937 which lead to the deaths of 105 people (Ballentine, 1981), Food Drug and Cosmetic Act
(FDCA) was passed. This act eliminated Sherley amendment act and put forth new
regulations that a drug has to be proved to be safe before it is marketed (Donohue,

In 1951 Durham-Humphrey amendment stated that a drug is categorized under
prescription drug if it is taken under the supervision of a licensed physician.

FDA was given the statutory authority in 1962 to regulate prescription drug
labelling and advertising by the Congress (Donohue, 2006). In 1969, FDA came
up with the following regulations regarding the DTCPA 1) The ads must not be
false or misleading. 2) The ads should provide both the benefits and the risks
of the drug calling it a “fair balance”. 3) The ads should provide facts
regarding the advertised uses of the drug. 4) The ads should provide a “brief
summary” of the risk provided on the product’s labelling (Greene, 2010). In 1985, FDA
claimed regulatory jurisdiction over DTCPA stating that “fair balance” and
“brief summary” is enough to protect American citizens against false claims of
the drugs. In 1995, FDA held a hearing to ease broadcasting of DTCPA
regulations. In 1997, FDA allowed broadcast DTC product claim ads to include a
“major statement” and “adequate provision” which would go with the requirement
of “fair balance” rather than lengthy “brief summary”. In 2004 FDA changed
regulations on DTCPA allowing drug companies to present information about major
health risks in an easily understandable manner for consumers.


Up until 1986, Physicians kept track of all
the medications available in the market and prescribed best treatment option
for the patient. This changed when Hoescht AG aired their first DTCPA about
Seldane (Anti-histamine). After this advertisement, annual sales jumped from
$34 million to $800 million (Spiegel, 2009). In 2016, the pharmaceutical
industry spent $6.7 billion pitching its products and messages to
Americans, a 62% increase from 2012, according to the leading market research
firm Kantar Media. That much resources purchases a considerable measure of
broadcast appointment — so it’s no big surprise that doctors fuss that drug
promotions can make unseemly desires in customers or influence specialists to
feel constrained to compose medicines out of concern their patients will go
somewhere else. According to Nielsen, a market research firm, the spending on
pharmaceutical advertising has been increased in the last decade. In US, the
advertising expenses were $2.47 billion in 2000, which increased to an
estimated $5.2 billion in 2015 and to $6.7 billion in 2016 (Statista, 2017). This clearly shows that DTCPA
has significantly influenced the treatment options.


According to the Altarum Institute Centre
for Sustainable Health Spending, there has been a substantial rise of 4.7% on
branded and generic prescription drugs in 2015. The American Medical
Association (AMA) as well as the clinicians have collectively voted in support
of a ban on Direct to Consumer Pharmaceutical Advertisements (DTCPA) citing
concerns regarding the patient-physician relationship due to the same. In 2016,
the American College of Physicians (ACP) stated how Pharmaceutical companies
are spending more on marketing and administration rather than on Research and
Development. In 2017 ADC Review, they even mentioned how DTCPA undermines the
physician patient relationship.

However, the Pharmaceutical Companies, and
the Marketing Agencies have actively opposed to these efforts to ban on DTCPA,
making it a source for them to mint money. The PhRMA have even stated how DTC
advertising increases patient awareness on new treatment options and encourages
them to engage with their physicians for proper understanding of the disease.



medical providers should maintain complete information on the new drugs ahead
of a time for most heavily advertised drugs. By having this information,
physicians can explain the benefits and risks of a drug precisely to the
patient, saving appointment time.

of the many ways to bring a regulation on DTCPA could be by delaying or a
temporary ban on advertising new products. Banning ads for temporary period to
see if any serious problems arise could serve the public interest. Another way to
curb this problem is to ban product Specific Advertisements. Rather than highlighting
the benefits, risks and costs of a specific drug, DTCPA can be replaced with
informational ads which will educate the consumers and at the same time would be
safer, more effective and economical.

Clearly pharmaceutical companies have right
of free speech. However, advertisements should avoid exaggeration of after benefits
of the drug. Over emphasizing the drug benefits should lead to disciplinary
action from FDA. Instead of advertising the distracting messages,
the FDA can implement regulations which include the quantitative data in DTCPA.

Consumers should receive unbiased information that does not necessarily
jeopardize their health or increase costs. Thus making it more clear regarding
the benefits and risks of a drug rather than just showing the exaggerated
perceptions of drug benefits.