PHAR 509: Final Exam
Direct to consumer Advertising (DTC)
ads made by pharmaceutical companies directed towards the general public with the
aim to promote prescription products directly to patients
How do companies communicate?
television, magazines, newspapers, radio and internet. these communications often
feature a celebrity spokesperson, actors, or computer generated characters generally
portraying happy and satisfied patients
Types of DTC Advertising
help-seeking
reminder
product claim
Help seeking DTC
describes the disease state and encourages patients to contact their providers
requirements: no product of claims being made so fair balance does not apply. brief
summary, major statement, or providing sources or prescribing info not required
Reminder DTC
states product name but does not mention indication or make any claims
requirements: no claims made so fair balance doesn't apply, brief summary, major
statement, or providing sources of prescribing info not required. cannot be used for
drugs with serious adverse effects
Product claim DTC
names drug and condition and includes efficacy and safety claims
requirements: must fair balance of risks and benefits. for print ads all risks must be
included in a brief summary. for broadcast ads most important risks must be included in
major statement and must provide sources of prescribing info
FDA role in DTC advertising regulation
division of drug marketing, advertising, and communications ensures that all
prescription drug advertising is truthful, balanced and accurately communicated. "fair
balance"- 1997
Evolution of DTC regulations: 1938
FDCA gave FDA authority to approve pharmaceutical marketing
Evolution of DTC regulations: 1969
FDA issued regulations:
1. not false or misleading
2. fair balance
3. include facts of product's advertised uses
4. include brief summary of risks
Evolution of DTC regulations: 1983
FDA issues voluntary suspension on DTC advertising
Evolution of DTC regulations: 1985
, FDA lifted suspension- standards of fair balance and brief summary that had been
established are sufficient to protect consumers
Evolution of DTC regulations: 1995
FDA held hearings on easing regulations on TV ads
Evolution of DTC regulations: 1997
FDA relaxed regulation on TV ads- product claim ads to include major risks and provide
info on where to find prescribing info
Evolution of DTC regulations: 2004
FDA eliminates the need to reprint complete prescribing info in print product claim ads-
only need to present major risks
Who does most advertising target?
most advertising remains directed at prescribers and other health care professionals
DTC advertising average annual spending is now how much?
over $6 billion annually (past 2015)
Leading drug classes with DTC ads (2005)
statins- $16,000 million sales vs $292 million advertisement
PPIs- $12,900 miilion vs $301 million advertisement
SSRIs or SNRIs- $12,500 million vs $122 million advertisement
Leading drugs with DTC ads (2005)
Nexium- $224 million
Lunesta- $214 million
Vytorin- $155 million
How does advertising pay off?
- Medications ranking high in sales are heavily advertised.
- a 10% increase in advertising= 1% increase in sales of drugs in the class
- Every additional $1 spent on advertising= $4.20 in additional sales
- DTC is an important but not primary driver in prescription drug spending
Who are among the the most targeted?
Women's magazines
More view Rx drug ads as positive than negative (T/F)
True
Effects of DTC on patient adherence
Little to none
Effects of DTC on physician prescribing behavior
there seems to be a potential correlation
Latest Developments for DTC ads- 2017
- actions to stop DTC advertising (legislation and professional orgs)
- measure effect of DTC on prescribing
- improving the message delivered in DTC ads (changing content- less is more, improve
stress in format)
Pros of DTC advertising
- informs, educates and empowers patients
- encourages patients to contact their healthcare provider
- promotes dialogue between patients and healthcare provider
- encourages patient compliance
Direct to consumer Advertising (DTC)
ads made by pharmaceutical companies directed towards the general public with the
aim to promote prescription products directly to patients
How do companies communicate?
television, magazines, newspapers, radio and internet. these communications often
feature a celebrity spokesperson, actors, or computer generated characters generally
portraying happy and satisfied patients
Types of DTC Advertising
help-seeking
reminder
product claim
Help seeking DTC
describes the disease state and encourages patients to contact their providers
requirements: no product of claims being made so fair balance does not apply. brief
summary, major statement, or providing sources or prescribing info not required
Reminder DTC
states product name but does not mention indication or make any claims
requirements: no claims made so fair balance doesn't apply, brief summary, major
statement, or providing sources of prescribing info not required. cannot be used for
drugs with serious adverse effects
Product claim DTC
names drug and condition and includes efficacy and safety claims
requirements: must fair balance of risks and benefits. for print ads all risks must be
included in a brief summary. for broadcast ads most important risks must be included in
major statement and must provide sources of prescribing info
FDA role in DTC advertising regulation
division of drug marketing, advertising, and communications ensures that all
prescription drug advertising is truthful, balanced and accurately communicated. "fair
balance"- 1997
Evolution of DTC regulations: 1938
FDCA gave FDA authority to approve pharmaceutical marketing
Evolution of DTC regulations: 1969
FDA issued regulations:
1. not false or misleading
2. fair balance
3. include facts of product's advertised uses
4. include brief summary of risks
Evolution of DTC regulations: 1983
FDA issues voluntary suspension on DTC advertising
Evolution of DTC regulations: 1985
, FDA lifted suspension- standards of fair balance and brief summary that had been
established are sufficient to protect consumers
Evolution of DTC regulations: 1995
FDA held hearings on easing regulations on TV ads
Evolution of DTC regulations: 1997
FDA relaxed regulation on TV ads- product claim ads to include major risks and provide
info on where to find prescribing info
Evolution of DTC regulations: 2004
FDA eliminates the need to reprint complete prescribing info in print product claim ads-
only need to present major risks
Who does most advertising target?
most advertising remains directed at prescribers and other health care professionals
DTC advertising average annual spending is now how much?
over $6 billion annually (past 2015)
Leading drug classes with DTC ads (2005)
statins- $16,000 million sales vs $292 million advertisement
PPIs- $12,900 miilion vs $301 million advertisement
SSRIs or SNRIs- $12,500 million vs $122 million advertisement
Leading drugs with DTC ads (2005)
Nexium- $224 million
Lunesta- $214 million
Vytorin- $155 million
How does advertising pay off?
- Medications ranking high in sales are heavily advertised.
- a 10% increase in advertising= 1% increase in sales of drugs in the class
- Every additional $1 spent on advertising= $4.20 in additional sales
- DTC is an important but not primary driver in prescription drug spending
Who are among the the most targeted?
Women's magazines
More view Rx drug ads as positive than negative (T/F)
True
Effects of DTC on patient adherence
Little to none
Effects of DTC on physician prescribing behavior
there seems to be a potential correlation
Latest Developments for DTC ads- 2017
- actions to stop DTC advertising (legislation and professional orgs)
- measure effect of DTC on prescribing
- improving the message delivered in DTC ads (changing content- less is more, improve
stress in format)
Pros of DTC advertising
- informs, educates and empowers patients
- encourages patients to contact their healthcare provider
- promotes dialogue between patients and healthcare provider
- encourages patient compliance
