Direct to Consumer Advertising

1
Direct to Consumer Advertising

• Tamar Mentzel
• April 30, 2003

2
Contents

• What is Direct to Consumer Advertising?
• History
• The Debate
• Clinical Issues
• Economic Issues
• Ethical Issues
• FDA regulation

3
What is Direct To Consumer Advertising (DTCA)?

• Marketing campaigns by pharmaceutical
  manufacturers directed at consumers
• Also, marketing by manufacturers of diagnostic
  products to consumers
• i.e. high-tech screening tests

4
History

• Pre-1980s Pharmaceutical manufacturers
  advertise largely to health professionals
• 1980s First print advertising designed to reach
  consumers
• 1997 FDA issues a draft guidance allowing
  electronic and broadcast advertising of
  prescription drugs
• 1999 Draft guidance finalized

5
In 1999, pharmaceuticals is included in the top 5
industries in terms of ad spending
6
The media onslaught has yielded extraordinary
results

• In 1998, Shering-Plough spent 186 million in
  DTCA and reaped 1.9 billion in sales, a
  half-billion dollar annual increase
• Formerly the allergy market was dominated by
  over-the-counter remedies
• Now 53 of allergy sufferers buy prescription
  products

7
The Debate

• Is this progress in empowering patients or just a
  way to make money?
• Does DTCA mislead consumers?
• Does the FDA adequately enforce advertising
  regulations?

8
THE CLINICAL ISSUES
9
Calls attention to untreated disorders
Pro-DTCA argument

• Studies show 47 of post-menopausal women have
  undetected low bone density or osteoporosis
• Physician visits for osteoporosis doubled

10
Pro-DTCA argument
De-stigmatizes diseases

• When doctors prescribe Zocor.
• Patients say, I know all about that. Coach Dan
  Reeves of the Atlanta Falcons takes it.

11
Pro-DTCA argument
Encourages compliance

• DTCA reminds people to take medication and to get
  their prescriptions refilled
• Patients who ask for a medicine after being
  prompted by DTCA are substantially more likely to
  continue with treatment after 6 months

12
DTCA does not educate consumers
Anti-DTCA argument

• Advertisements convey info that drugmakers want
  consumers to remember (1) brand name and (2)
  treated condition
• 70 of those shown ads said they learned little
  or nothing about the treated condition
• 59 said that they learned little or nothing
  about the advertised drug

13
Patient pressure leads to excessive or
inappropriate prescribing
Anti-DTCA argument

• Study found that 15.1 million patients asked a
  physician for an advertised drug
• 80 of the time doctors honored the request
• 50 of time it was unlikely that the physician
  would have prescribed the drug by their own
  judgment
• Patients almost feel that the physicians office
  is the drive-through window at McDonalds where
  they put in their order and you fill it.
  American College of Physicians

14
Ads omit, minimize and obscure drugs risks
Anti-DTCA argument

• 1/3 of respondents failed to notice the small
  print that summarizes risks and side effects
• Of those who saw it, only 1/3 said they usually
  read it

15
DTCA promotes unapproved drugs and approved drugs
for unapproved indications
Anti-DTCA argument

• An ad for Niaspan in Time Magazine proclaims
• What you dont know about cholesterol might
  shock you. Heart attacks happen to many people
  with normal LDL cholesterol levels.
• Niaspan is not indicated to reduce the risk of
  heart attack in patients with normal LDL levels

16
THE ECONOMIC ISSUES
17
DTCA fuel rise in prescription-drug spending
Anti-DTCA argument

• 19 increase in prescription-drug spending in
  2000 and 17 in 2001
• Half of the increase in 2000 was driven by sales
  of the 50 most heavily advertised drugs

18
DTCA fuel rise in prescription-drug spending
Anti-DTCA argument

• 1. Encourages the use of more expensive drugs
  when there are cheaper alternatives
• 2. Encourages excessive, inappropriate
  prescribing
• 3. Drug prices are absorbing the cost of
  increased spending on DTCA

19
Pro-DTCA argument
DTCA results in overall lower costs

• Rise in drug spending is because ads compel
  people to seek treatment for previously untreated
  conditions
• DTCA prompts drug compliance which is
  cost-effective relative to the costs of surgery
  and hospitalization
• Patient requests balance financial incentives
  given to physicians

20
THE ETHICAL ISSUES
21
DTCA strains doctor-patient relationship
Anti-DTCA argument

• Time spent with patients gets diverted from
  education to negotiation
• 46 of respondents said they would be
  disappointed if a doctor turned down a request
  for an advertised drug
• 15 said theyd consider switching physicians

22
Anti-DTCA argument
Patients have dangerous misperceptions about DTCA

• People believe that drug advertising is
  meticulously regulated
• 50 of people wrongly believed that drug ads are
  pre-approved by the FDA
• 43 wrongly believed that only completely safe
  drugs can be advertised

23
FDA regulation process

• Ads must be submitted to the FDA but can run
  without a go-ahead from the FDA
• FDA can send a notice of violation and demand
  withdrawal of ad
• FDA has only 30 reviewers to handle the roughly
  30,000 submissions each year
• Jan 2002, Dept of Human and Health Services
  required legal review of all proposed regulatory
  letters, slowing down the process from 2 to 11
  weeks so ads complete broadcast lifecycle before
  the letter is sent
• FDA has no power to levy fines
• FDA granting free pass to drug manufacturers,
  posing danger to public health

24
Future direction for regulation

• Rep. Tom Allen, D-Maine, proposed legislation
  that would give the FDA authority to levy up to
  10 million in fines for false or misleading drug
  advertising
• Sen. Debbie Stabenow, D-Mich, has proposed a law
  that would limit the federal tax deductions
  drugmakers can take for advertising to the amount
  they take for RD
• Some states are considering legislation that
  would eliminate tax deductions altogether for
  advertising
• Janet Rehnquist, inspector general at HHS,
  declared a new goal to issue enforcement letters
  within 15 days of legal review