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Noora Alali
Oshba Alsuwaidi
Amanda Ha
Patricia Cucinotta
Marion Petryk
Cindy Tam
Maria Tatarsky

Overview
What is DTCA?
Goals of DTCA
History of DTCA
Different types of DTC Advertisements
Pros and Cons
DTCA’s role in drug spending and prescribing
Laws in the U.S.
DTCA in other countries
New Zealand
India
Future of DTC

What is Direct-to-Consumer
Advertising?
Also known as DTCA
Pharmaceutical company’s promotion of prescription
drugs
Aimed at a general audience (consumers)
Appear on TV and radio, in magazines and newspapers,
and also online

Goals of DTCA
Inform consumers about different diseases
Inform consumers about different treatment options
Encourages patients to visit their primary care physicians
Make doctors and patients better partners

History of DTCA
1950s - early 1980s
Pharmaceutical ads directed to medical personnel and
absent from mass media
First DTC television ad for Boots Pharmaceuticals’ Rufen
(ibuprofen) aired in early 1980s
Advent of Merck and Dohme’s advertising campaign for
Pneumovax, pneumonia vaccine
Pharmaceutical companies recognized that doctor-patient
relationships changed with the rise of consumer and
patients’ rights movement

History of DTCA
1983 – 1985
DTCA suspended so FDA could create a more explicit
policy
1997
FDA relaxed rules so that drug companies use drug’s
brand name and describe benefits in the same ad
Before 1997, drug companies can only use drug’s
name but cannot disclose what it was intended to
treat

Types of DTCA
Product Claim

Help-seeking

Reminder

Product Claim Advertisements
Most common form
Includes brand name & medical condition
Describe risks and benefits
Must contain safety & efficacy information
Must comply with fair-balance rule
Paxil Product Claim Commercial

Help-Seeking Advertisements
• A.K.A. disease-awareness communications
• Talks about disease or medical condition
• Does not discuss name of drug
• Creates awareness of health conditions among
consumers
• No requirement for risk information
• Encourages physician consultations
• Vaccine Help-Seeking Commercial

Reminder Advertisements
Talks about brand, dosage form, and cost
information
Does not include medical condition
Does not make claims about the product
Reinforces brand name and brand loyalty

Pros of DTCA
Informs consumers about new treatments
Meets increasing demand for medical information
Encourages people to seek medical attention for
conditions or symptoms that might otherwise go
untreated
Patients are not ashamed of their diseases.
Patients are more proactive in their personal health.

Meets increasing demand for
medical information

Encourages people to seek
medical attention

Cons of DTCA
Patients may misunderstand ads and request a
prescription for an illness they may not have
Patients start to self- diagnose and think they need
treatment when they don’t.
Physicians can feel pressured to prescribe a particular
medication.

DTCA Role in Costs
Research and Development (R&D) costs and promotion
costs are rising.

DTC costs are barely changing.

R&D is still the main point of spending of pharmaceutical
companies.

DTCA Role
in Costs
Does not increase
spending

DTCA
Role in
Costs
Does not
increase
spending

Who Regulates DTCA?
The FDA regulates the advertising of prescription drugs
under the Federal Food, Drug, and Cosmetic Act (FFDCA)

The Division of Drug, Marketing, Advertising, and
Communications (DDMAC) within the FDA's Center for
Drug Evaluation and Research (CDER) is responsible for
implementing the regulations governing DTC advertising

FDA Regulations
Section 502(n) of the FFDCA requires that an

advertisement include "the established name, the brand
name (if any), the formula showing quantitatively each
ingredient, and information in brief summary which
discusses side effects, contraindications, and
effectiveness."

FDA Regulations
Prescription drug advertising regulations in the Code of
Federal Regulations, Title 21, part 202 (21 CFR part 202)
specify that prescription drug advertisements must not
be false or misleading,

must not omit material facts, and

must present a fair balance between effectiveness and

risk information.

FDA Regulations
If the FDA identifies a violation of laws or regulations in a
DTC advertisement, the agency may issue a regulatory
letter asking the drug company to take specific actions.
Untitled letters address violations, such as overstating
the effectiveness of the drug.
Warning letters target pharmaceutical companies that
engage in continued violations of the act or address
companies engaged in serious violations that affect
consumer safety or health.

FDA Educational Program

FDA's educational outreach program is designed to
educate healthcare providers about the role they can
play in helping the agency make sure that prescription
drug advertising and promotion is truthful and not
misleading.

The "Bad Ad" Program is administered by DDMAC

PhRMA Regulations
The pharmaceutical industry attempts to self-regulate
through a 15-point code of conduct issued by its trade
association, Pharmaceutical Research and Manufacturers
of America (PhRMA)
Example:
All such advertising should be "accurate and not
misleading, should make claims only when supported
by substantial evidence, should reflect balance
between risks and benefits, and should be consistent
with FDA-approved labeling."

DEA Issues With DTCA
U.S. Drug Enforcement Administration (DEA) is

concerned about the issues of direct to consumer
advertising of controlled substance products and the
promotion of such products to the medical community
and may be contrary to the public interest.

Schedule II Controlled Substance
Consumer Advertisements

Internet Issues With DTCA
FDA sent out warning letters in March 2009 to 14
pharmaceutical companies about online advertisements
that violated regulations
Omission of risk information
Minimization of risk information
Inadequate communication of indication
Overstatement of efficacy
Failure to use established brand names

DTCA in New Zealand
DTC was permitted in New Zealand under conditions set
by the Medicines Act (1981) and Medicines Regulations
(1984).
The new type of advertising wasn’t used until late 1980’s,
specifically 1989 when then SmithKline and French ran a
two-page advertisement in a magazine promoting a
Hepatitis B vaccine.
In the same year Edinburgh Pharmaceuticals advertised
Ventolin.
None of these advertisements actually complied with the
legislative requirements.

DTCA in New Zealand
Merck Sharp and Dohme’s Proscar (finasteride), a
treatment for benign prostatic hypertrophy, was the first
television aired DTC advertisement in New Zealand.
Doctors who may not receive details for drugs before the
launch of advertising campaigns that generate consumer
inquiries cause potential harm.
Sets up a complex relationship with patients

New Zealand: Medsafe
Medsafe is the New Zealand Medicines and Medical
Devices Safety Authority. It is a business unit of the
Ministry of Health and is the authority responsible for the
regulation of therapeutic products in New Zealand.
Mission: To enhance the health of New Zealanders
by regulating medicines and medical devices
to maximize safety and benefit.
Medsafe is accountable to the Ministry of Health, and
through the Ministry to the Minister of Health.

www.medsafe.govt.nz/

Medsafe regulates products used for a therapeutic
purpose. They include:

Medicines
Related products
Herbal remedies
Medical devices
Controlled drugs used as medicines

Pre-marketing approval must be obtained for new
and changed medicines. New medicines cannot be
marketed in New Zealand without the consent of the
Minister of Health. Medicines to which changes have
been made cannot be marketed without the consent
of the Director-General of Health. Data that
satisfactorily establish the quality, safety and efficacy
of the product, for the purposes for which it is to be
used, must be submitted for evaluation before
consent can be granted.

New Zealand: DTCA Review
In 1994 a review of the Medicines Act proposed that DTC
be banned, but the Ministry of Health was favoring
industry self-regulation to “shift a degree of
responsibility, and therefore, cost, to the industry to act
as watchdogs” (MOH 1995).
DTCA came under fire once again in 200o by minister of
health, Anette King, influenced by Pharmac stating that
DTC advertising was increasing the countries drug bill
because of self regulation. This was overturned by the
MOH arguing that banning DTC would be a a violation of
the New Zealand bill of rights act of 1990.

New Zealand: DTCA Review
In 2006 Annette King the health minister of New
Zealand’s Ministry of Health said that on the advice of
various consumer/physician groups she was going to ban
DTCA.
One reason being Professor Toop’s report: stating that
“drug advertisements can endanger rather than
empower consumers by minimizing risk information and
maximizing benefits” and “could contribute to increased
or inappropriate drug consumption”.
The New Zealand cabinet overturned her decision.

New Zealand: DTCA in 2009
A comparison between the United States and New
Zealand showed that despite differences in the process of
regulation and the conditions and mechanisms through
which DTC advertising came to be legal in the two
countries, the resulting character and effects of the
advertising were remarkably similar.
Advertisements in both contexts turned out to be
misleading, unbalanced with regard to risks and benefits,
make appeals to emotions, and focus on lifestyle
problems over serious conditions.

DTCA in India
Ministry of Health and Family Welfare (= U.S. FDA)
Central Drugs Standard Control Organization
(= U.S. CDER)
 Laying down standards of drugs, cosmetics,
diagnostics and devices
 Laying down regulatory measures, amendments to
Acts and Rules
 To regulate market authorization of new drugs

DTCA in India
D&C Act of 1940
Schedule H: List of drugs which are to be sold by
retail against the prescription of Registered
Medical Practitioner and which shall be labeled
with words “Schedule H Drug - Warning: to be sold
by retail on the prescription of a Registered
Medical Practitioner only.”

DTCA in India
The Drugs and Magic Remedies
(Objectionable Advertisement)
Act, 1954
Control advertisements
regarding drugs
Prohibits advertising of
remedies alleged to possess
magic qualities
Prohibits advertising of Rx
drugs defined as Schedule H
and Schedule X Drugs

DTCA in India
Definition of a “drug” in India:
A medicine with active ingredients for internal or
external use.
Any molecules or substances used for diagnosis,
cure, mitigation, treatment or prevention of disease.
Others, like food, that intended to affect the human
body or animals in any way.
Any substances that aimed to be used as a
component for medicine.

DTCA in India
Definition of a “magic remedy” in
India:
Includes talisman and any other
charms that possess powers intended
to be used for diagnosis, cure,
mitigation, treatment or prevention of
any disease in human beings or
animals.

India: Drugs and Magic Remedy Act
The Act prohibits the advertising of following:
the procurement of miscarriage in women or prevention of
conception in women
the maintenance or improvement of the capacity of the human
being for sexual pleasure
the correction of menstrual disorders in women
the diagnosis, cure, mitigation, treatment or prevention of any
venereal disease
to directly or indirectly give a false impression regarding the
true character of a drug or make false claim for it or to convey
any false or misleading information in any material particular
about it

India: Drugs and Magic Remedy Act
 This Act doesn’t prohibit the following ways of advertising:
 any signboard or notice displayed by a registered medical
practitioner including the treatment for any of the disease
 any treaties or book dealing with any of the matters from
a bonafide scientific standpoint
 any advertisement related to any drug sent confidentially
to any registered medical practitioners or to chemists for
distribution among registered medical practitioners or to a
hospital or laboratory
 Government advertisements

DTCA in India
 There is no law that directly says not to advertise drugs
that are not Schedule X or H (OTC Drugs)
 OTC drugs seen on TV ads in India:
 Digestives, Antacids, Antiflatulents, Cold rubs and
analgesic balms/creams, Vitamins/tonics/health
supplements, Medicated skin treatment,
Analgesic/cold tablets, Antiseptic creams/liquids,
Glucose powders

India: DTCA in 2009
Under new rules, medical practitioners in India cannot
accept any gifts or favors from drug companies.
 The new rule went into effect on December 10 th 2009.
It also bars doctors and their associates from endorsing
healthcare products or accepting research grants from
the industry without official clearance from authorities.
A medical practitioner may participate in research
projects funded by pharmaceutical and allied healthcare
industries if the project is proper and ethical.

India: DTCA in 2009
Pharmaceutical
companies are allowed
to publish in medical
journals and send drug
reps to offices and
hospitals.

Future of DTCA
FDA:
Increase the likelihood of effective self-regulation
through strong, well-funded, and aggressive oversight.
Should take the lead in providing accurate, unbiased
information to consumers

Future of DTCA
Industry :
Be honest and accurate with customers.
Price comparisons, detailed explanations of benefits and
risks, and discussions of costs are encouraged
Drug industry should realize responsible self regulation and
self-policing
Promotions provide just as much attention to side effects
as they do to treatment effects
Advertisements be less “drug-centric” and more
“disease/medical condition–centric”

Future of DTCA
Medical community:
Respond vigorously to DTC advertising
The public health community needs to create mechanisms
for providing consumers with objective, independent
information about available drug therapies
Medical community needs to develop a systematic,
ongoing media literacy campaign to inform consumers of
the promotional nature of DTC advertising

What Do You Think About the
Future of DTCA?
Will DTC spending increase or decrease in the next
decade?
Should all or some forms of DTCA be banned in the U.S.?
Should there be a moratorium on DTCA? Should it be
mandatory or voluntary?
Should the business-tax deduction for DTC spending be
taken away by legislation?
Is there adequate risk information presented in DTCA?
Should there be more? Less?
Should there be more explicit guidelines with DTCA on
the internet?

Thank you for your time…

QUESTIONS?

Sources
 http://www.sourcewatch.org/index.php?title=Direct-to-consumer_advertising
 http://www.kff.org/rxdrugs/6084-index.cfm
 http://www.huffingtonpost.com/d-brad-wright/the-risks-and-benefits-of_b_412941.html
 http://www.phrma.org/direct_to_consumer_advertising
 http://www.who.int/bulletin/volumes/87/8/09-040809/en/index.html
 http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107170.htm
 http://www.csa.com/discoveryguides/direct/review3.php
 http://creationinteractive.com/articles/fda-warns-pharmaceuticals-about-google-
advertising/
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Enforceme
ntActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCo
mpanies/UCM055773#More
 http://www.justice.gov/dea/pubs/cngrtest/ct121101.html

Sources
 Peter R Mansfield, Barbara Mintzes, Dee Richards and Les Toop Direct to
consumer advertising. Off of Bmj.com
 http://www.commercialalert.org/news/archive/2005/09/new-zealand-to-ban-dt
 http://www.kff.org/rxdrugs/6084-index.cfm
 https://www.cia.gov/library/publications/the-world-factbook/geos/nz.html#top
 www.globalbusinessinsights.com/content/rbhc0031m.pdf
 Sandra, Coney: Direct-to-Consumer Advertising of Prescription
Pharmaceuticals: A Consumer Perspective from New Zealand
 OECD Health Policy Studies: Pharmaceutical Pricing Policies in a Global
Market. OECD 2008.

Sources
 http://cdsco.nic.in/html/law.htm
 http://www.indiaoppi.com/guidelines.asp
 http://goidirectory.nic.in/health.htm
 http://www.mohfw.nic.in/
 http://www.indexmundi.com/india/demographics_profile.html
 http://dspace.iimk.ac.in/bitstream/2259/347/1/397-402.pdf
 http://www.tribuneindia.com/2007/20070204/spectrum/rights.htm
 http://www.womens-health.org.nz/index.php?page=dtca-unwelcome
 http://www.anztpa.org/index.htm
 http://www.nzma.org.nz/journal/121-1276/3126/

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