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Direct to Consumer Advertising

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Title: 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  • 1997 FDA issues a draft guidance allowing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  • 1999 Draft guidance finalized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
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