DIRECT-TO-CONSUMER ADVERTISING:

A TOOL OF EMPOWERMENT OR A GREEDY MANIPULATION?

POLAR OPPOSITES

“DTCA is an excellent way to

meet the growing demand for
medical information,
empowering consumers by
educating them about health
conditions and possible
treatments”
Direct to consumer
advertisements should be
overtly recognized for what
they are – “an unabashed
attempt to get someone to
buy something”
 WHAT IS DIRECT TO CONSUMER ADVERTISING?

Direct-to-consumer advertising (DTCA) is the promotion directly

to potential patients of prescription drugs through newspaper,
magazine, television and internet marketing.

Drug companies also produce a range of other materials that are

available in medical offices or designed to be given to patients by
medical professionals or via patient groups.

DTCA advertising is just one strand in the marketing and public

relations efforts of drug companies to promote brand-name
prescription drugs.
 DRUG ADVERTISEMENTS

WHAT DO FDA REGULATIONS SAY-

 Must not be false or misleading

 Must present “fair balance” between benefits and risk information
 Must disclose “material” facts in light of claims made about product

Accurately communicate indication(s) including context for any claim-

 Limitations on indications
• Relevant patient population
• Concomitant therapies/treatments
 Likelihood of benefits

Ads must communicate an accurate and balanced picture of the

drug product
DTCA: SHARE OF DIFFERENT MEDIA

Source: IMS Health, Competitive Media Reporting, 2000

PROMOTIONAL SPENDING ON RX DRUGS

Source: IMS Health, Competitive Media Reporting, 2000

WEB BASED ADVERTISING

Fungus
responsible for
nail infections
 TYPES OF DTC ADVERTISEMENTS

TYPE OF AD REQUIREMENT
PRODUCT CLAIM AD- Product claims are made, so “fair balance” does
apply and risks are required to be included in a
Names a drug and the indication(s); makes claims “brief summary.”
regarding safety and efficacy or (for broadcast ads only)
Risks must be included in “major statement,” and
“adequate provision” for access to a “brief
summary” is required.

REMINDER AD- No product claims are made, so “fair balance”

doesn’t apply and mention of risks in “brief
Names a drug, dosage form, and possibly cost, but summary,” “major statement,” or “adequate
not its uses provision” is not required. However, the FDA does
not allow this type of ad for drugs with serious
risks (i.e., a boxed warning).

HELP-SEEKING AD- No product is mentioned, nor are any claims

made, so “fair balance” doesn’t apply; inclusion of
Describes a disease or condition but doesn’t risks in “brief summary,” “major statement,” or
mention a specific drug that treats it “adequate provision” is not required
 Disease Specific
Ad which
creates
awareness for
undiagnosed
conditions
IMPACT OF DTC
 HISTORY OF REGULATIONS FOR DTCA
1938
The FDA was given the authority to approve
pharmaceutical products for marketing in the U.S. as a
result of the Federal Food, Drug, and Cosmetic Act, passed
in 1938.

1950s- Early 1980s

-Pharmaceutical ads directed to medical personnel and
absent from mass media
- Later pharmaceutical companies recognized that doctor-
patient relationships changed with rise of customer and
patients rights movement

1983-1985
- DTCA suspended so FDA could create more explicit policy
- Drug companies did not fully resume advertising until 1990
Since then, spending has increased exponentially

1997
FDA relaxed rules so that drug companies could use brand
name and describe benefits in the same ad
Before 1997, drug companies could only use drug’s name
but couldn’t disclose what it was intended to treat
WHY ARE WE SO CONCERNED?
GROWTH IN PHARMACEUTICAL R & D SPENDING V/S PROMOTIONAL DOLLARS-
1999-2003
TOP DTCA BUDGETS IN 2000

Source: US NIHCM Report 2001

RESULTS FROM SURVEY OF
HEALTH CARE PROVIDERS
DOES DTCA REALLY WORK?
DOES DTCA MEET INCREASING DEMAND FOR MEDICAL INFORMATION?
PROS OF DTCA

 Informs,educates,empowers patients
 Encourages patients to contact
physician/clinician
 Promotes dialogue and strengthens
relationship with health care provider
 Encourages patient compliance
 Reduces underdiagnosis and
undertreatment
 Removes stigma associated with
certain diseases
 Encourages product competition and
lowers prices
 Earlier management of more serious
conditions
CONS OF DTCA

 Misinforms patients
 Overemphasis on drug benefits
 Promotes new drugs before safety
profiles are fully known
 It flourishes “Infomercials” &
“Edutainment” which leads to
“Commodification of healthcare”
 Wastes appointment time APPEAL TERMS
 Not rigorously regulated Effectiveness Prolongs life, prevents
death, powerful, proven,
 Increase cost of therapy without works
improving quality of life
Social-Psychological Normal, happiness, hope,
 Change of “E” from Enhancements appearance, regular,
flexible
Educational Emotional.
Ease of Use Convenient, gentle, saves
The great majority of advertisements money, quickly
target human emotions and
Safety Naturally, non-habit-
vulnerability forming, reversible, safe
MISLEADING ADS

Age related
forgetfulness

Alzheimer's Disease
PRESENT SCENARIO IN INDIA

Drugs are broadly classified as ethical and OTC

Regulatory laws do not allow mass advertising for the
former
OTC drugs are products that can be dispensed even
without prescription
CHALLENGES FOR DTCA IN INDIA

Inception of a law is a tedious task

Large population: illiterate
Poor enforcement of law
No patient counseling in India
No effective pharmacovigilance system in India
 OPPORTUNITIES FOR DTCA IN INDIA

Awareness regarding healthcare could be increased

with DTCA
Increase in the literacy rate
Advertising can help informed public get a better
diagnosis in a lesser time frame