Direct-to-Consumer Prescription Drug Promotion

Nancy M. Ostrove, Ph.D.Division of Drug Marketing,

Advertising, and Communications Food and Drug Administration

Overview

What we know– law– history– stakeholder concerns– enforcement problem areas– consumer/patient perceptions

What we don’t know– broad effects on the public health

Background Facts

No laws or regulations ever prohibited promoting prescription drugs to consumers

Law requires advertisements to include “information in brief summary” about product’s risks and benefits

Law generally prohibits preclearance

Types of Advertisements - 1

Help-seeking (“See your doctor,” disease oriented)– these are not drug ads

Types of Advertisements - 2 Reminder

– regulations specifically exempt from disclosure requirements

– include name of product, but no representations beyond dosage form and packaging, price information

– designed to remind knowledgeable persons of existence of product

Types of Advertisements - 3

Product-claim -- includes– name and quantitative information

– product use (indication)

– optionally, other substantiated claims

– risk disclosure (requirements vary as a function of whether print or broadcast)

Law Focuses on Content of Ads Can’t be false or misleading Must present “fair balance” between

benefits and risk information Can’t omit “material” facts

Plain language meaning: Ads must communicate an accurate and balanced picture of the product

If the law allowed ads to be directed to consumers, why

didn’t we see them until relatively recently?

Things Changed Consumer empowerment

– desire for involvement in own care– active information seeking

Aging baby-boomer population

– selves, children, parents Managed Care Increasing focus on First Amendment

Evolution of DTC

Up to 1980s -- “learned intermediary” only 1983 - 1985 -- voluntary moratorium 1985 - regulations provide “sufficient

safeguards to protect consumers” 1990s - steady increases in print promotion mid 1990s - broadcast increasingly enters

mix

Broadcast Environment

Static -- sponsor uncertainty regarding requirement for “brief summary”

“Adequate provision” for providing labeling always allowed

– FDA never gave guidance on “how to” Major risks required to be disclosed

regardless of mechanism

Result was a confusing broadcast environment --

more and more uninformative “reminder” advertisements

“Adequate Provision” Guidance

How to reach diverse group of consumers? Sponsors had some suggestions 1997 draft gave possible approach, finalized

in 1999– reference to health care provider– print ads/brochures– telephone contact number– internet site

Perspectives

Stakeholder Perspectives - 1

DTC is good -- FDA should not over-regulate– PhRMA, individual pharmaceutical

sponsors– ad agencies and associations– communications groups– media providers (print, TV, radio, internet)– Federal Trade Commission (FTC)

Stakeholder Perspectives - 2

Mixed bag -- DTC may have some benefits but FDA should strictly regulate– some consumer/patient groups (e.g.,

National Consumers League)

– some health care professional associations (AMA, ACP/ASIM, APhA)

generally want FDA to preapprove promotional materials

Stakeholder Perspectives - 3

DTC is bad -- should be stopped– some consumer groups (e.g., Public

Citizen, Center for Medical Consumers, National Women’s Health Network)

– managed care (AMCP)– historically, generic manufacturers– Drug Enforcement Administration (DEA)

Focus of Arguments

Patient-physician interaction/relationship Prescribing behavior Patient knowledge about drugs Product costs

Current Situation

Close surveillance and quick enforcement Encourage compliance -- cooperate with

voluntary requests for pre-review and comment

Assessing impact

Enforcement Product efficacy claims

– broadening indication, patient population– overstating or guaranteeing efficacy– implying use without disclosing risk

Disclosure of product risks– content– presentation (minimization; fair balance)

“Adequate provision” mechanism

What is DTC’s Impact?

Little research until relatively recently– cost concerns (correlational analyses)

– effects on physician/patient relationship (self-report surveys)

FDA, Prevention, TIME Inc., NCL, AARP

– effects on patients’ knowledge about drugs (experimental designs, surveys)

– effects on prescribing behavior (?)

FDA’s Research

Patient/Physician interaction– is DTC influencing patient behavior?

2000 - national survey of patients’ behaviors and attitudes– www.fda.gov/cder/ddmac/research.htm

Methodology National probability sample

– focus on patients visiting doctor in last 3 months about a problem of their own

Telephone interview (n=1,081) Final sample

– 960 who had seen doctor in last 3 months

– 121 who had not

Demographics

More females than males; especially among those who had seen a doctor– 65% vs. 55%

Similar ethnicity and overall education among those who had and had not seen a doctor

Self-Reported Health

0 10 20 30 40

Excellent

Very Good

Good

Fair

Poor

Seen MD in last 3 months Not seen MD in Last 3 Months

Do Respondents Recall Seeing Advertisements?

Asked whether they had seen an advertisement for a prescription drug in last 3 months– 72% of those who had seen a doctor– 69% of those who had not seen a doctor

Not inconsistent with 1999 Prevention survey– 81% had seen an ad (no time limit)

Where Was Advertisement Seen or Heard?

(Multiple responses accepted)

n = 688

0 20 40 60 80 100

Internet

In the Mail

Radio

Newspaper

Magazine

Television 94%

66%

29%

28%

17%

9%

What Information is Recalled from TV Ads?

10%

63%

64%

76%

81%

82%

87%

0 20 40 60 80 100

Overdosage

Questions for doctor

Directions for use

Who should take

Who should not take

Risks/Side effects

Benefits

n=688

Information Seeking in Response to an Ad

0

10

20

30

40

50

60

Seen MD in Last 3Months

Not Seen MD in Last 3Months

Has an ad for a prescription drug ever caused you to look for more information, for example, about the drug or about your health?

51%

41%

Sources of Information Cited Mostly from health care professionals:

– own doctor (81%), pharmacist (52%), nurse (33%)

Reference book (36%) Friend, neighbor, or relative (30%) Toll-free number, internet (both 18%) Other print sources (magazine - 14%,

newspaper - 7%)

How Many Read the Brief Summary?

30%

26%

14%

11%

15%

3%

It was there?

None

A Little

About Half

Almost All

All

n=688

What if Especially Interested in the Product?

4%3%

8%

73%

12%

None

A Little

About Half

Almost All

All

n=688

Patient/Physician Interaction?

Patients report seeing their doctors for the traditional reasons– time for checkup (53%)– feeling ill (42%)– had symptoms (41%)

DTC not directly causing large numbers of visits

– read/saw something (2%)

DTC Encouraging Discussion?27%

8%

0

5

10

15

20

25

30

Seen MD in Last 3Months

Not Seen MD in Last 3Months

Has an ad ever caused you to ask a doctor about a medical condition or illness you hadn’t previously talked about?

Awareness Influences Asking

35%

16%

25%

6%

0

5

10

15

20

25

30

35

40

Seen an Ad Not Seen an Ad

Asked about a drugto treat condition

Asked about aspecific brand

How Did Doctor React?

0 20 40 60 80 100

Angry or upset

Reacted like ordinarypart of visit

Discussed drug

Welcomed question

Which of these possible reactions did your doctor have when you asked about the drug? n = 220

81%

79%

71%

4%

Feelings About Doctor’s Reaction

37%

48%

3%5%

2%

Very Unsatisfied

Unsatisfied

Neither Satisfied norUnsatisfiedSatisfied

Very Satisfied

n=220

What Did Doctor Do?

0 10 20 30 40 50

Other

Recommend OTC

Recommend no drug

Behavior/lifestyle chg

Recommend diff Rx

Gave Rx asked about

Did your doctor do one or more of the following? n = 220

50%

15%

14%

12%

29%

32%

Reason(s) Given for Not Prescribing Drug

For 59% who didn’t get requested drug prescribed, the doctor said why (n=65)– not right for patient

48%– wanted patient to take different drug 35%– side effects patient didn’t know 29%– patient didn’t have condition 23%– patient didn’t need prescription drug 20%– patient could use OTC drug 12%– less expensive drug available 8%

Trend Data

Annual national telephone surveys by Prevention magazine since 1997

No change in percentage of patients asking about a specific prescription medicine as function of DTC promotion– despite large increases in funding of DTC

promotion and in television advertising

DTC-Related Attitudes - 1(among patients)

Prescription drug advertisements:– help make me aware of new drugs

86%– give enough information for me to decide

whether I should discuss with MD 70%– help me have better discussions with my

MD about my health 62% Ads make it seem like a MD is not needed

to decide if drug is right for me 24%

DTC-Related Attitudes - 2(among patients)

Prescription drug advertisements:– help me make better decisions about my

health 47%

– make the drugs seem better than they really are 58%

– do not give enough information about:possible benefits and positive effects 49%possible risks and negative effects 59%

Summary Patients visiting doctors for traditional

reasons– time for checkup, symptoms, feeling ill– DTC not causing large numbers of visits

DTC appears to work– awareness associated with discussing

prescription medicine/specific brand with doctor

– prompts information-seeking and asking about conditions not previously discussed

Summary

Patients think doctors reacting well to discussion about specific products

Patients think doctors denying products where appropriate; many doctors providing reasons for denial

Patients see benefits as well as risks associated with DTC advertisements

Limitations of Existing Research

Survey data self-report -- subject to recall and other biases

Correlational data subject to causality problem

Experimental studies to date focused on narrow issues of knowledge of particular products -- used small samples

Meaning of content analyses?

Remaining Questions

Regarding public health: Is DTC causing health care professionals to prescribe inappropriately?

Regarding regulation: How can DTC ads best communicate drugs’ relative benefits and risks