Direct-to-Consumer Advertising of Prescription Drugs:

Looking Back, Looking Forward

Kathryn J. Aikin, Ph.D.Division of Drug Marketing, Advertising

and Communications, FDA

Society for Women’s Health Research October 25, 2005

Talk Outline

Requirements for pharmaceutical ads How DTC evolved FDA survey findings What’s next?

Some Sources of Product-Specific Health Information for Patients Healthcare Provider Patient Package Insert Advertising Brief Summary Internet Other Sources

Disease Awareness

Reminder

Product Claim

Requirements for Ads

Per FDA regulations issued in late 1960’s, ads: 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

What Does this Mean?

Accurately communicate indication(s) including context for any claim Limitations on indication(s)

Relevant patient population Concomitant therapies/treatments

Likelihood of benefit(s) Communicate most important risks in a manner reasonably

comparable to benefits (presentation and language) Cannot omit important information

In plain language Ads must communicate an accurate and balanced picture of the drug product

How DTC Evolved

Up to 1980’s: consumer communications through “learned intermediary”

1980’s: saw 1st DTC ads and fallout

--1983-1985: FDA voluntary moratorium

--1985: lifted, regulations provide “sufficient safeguards to protect consumers”

1990’s: print ads proliferated mid 1990’s: broadcast ads enters mix

Does DTC advertising...

Increase demand for advertised drugs? Cause patients to pressure doctors for

advertised drugs? Cause inappropriate prescribing? Increase the price of drugs or the cost of health

care? Harm the relationship between patients and

doctors? Is DTC advertising appropriate at all?

FDA Surveys

Look more closely at impact of DTC advertising on doctor-patient relationship Two consumer surveys (1999 and 2002) One physician survey (2002)

1999 and 2002 Consumer Surveys: Methodology 1999 National probability

sample conducted by telephone interview

1,081 respondents, 960 who had visited a doctor in the last three months for a problem of their own

2002 National probability

sample conducted by telephone interview

943 respondents who had visited a doctor in the last three months for a problem of their own

Note: results not weighted and therefore not directly projectable

2002 Physician Survey: Methodology

Random Sample from American Medical Association Physician Masterfile

250 General Practitioners 250 Specialists in areas targeted by DTC

Dermatology Allergy/Pulmonology Endocrinology Psychiatry

Note: results not weighted and therefore not directly projectable

Does DTC advertising increase demand for advertised drugs? DTC not primary driver of visits to doctor DTC plays a role in generating questions for

doctor Patients still use their doctors as #1

information source when looking for more information about a drug or treatment Pharmacists, nurses also highly ranked as

sources

Does DTC advertising cause patients to pressure doctors for advertised drugs?

Some patients do expect a prescription because of a DTC ad

Asking about prescription drugs constant across time Brand-specific requests are likely to be

accommodated Patients who ask about a brand are more likely to be prescribed that

brand than patients who ask in general General Practitioners are more likely to prescribe a requested brand

than Specialists General Practitioners report feeling more pressured to prescribe

Does DTC advertising cause inappropriate prescribing? Vast majority of patients who ask about a

brand have the condition that drug treats Among physicians who did not prescribe

requested drug, most common reasons were: drug not right for patient different drug more appropriate

Does DTC advertising increase the price of drugs or the cost of healthcare? Patients rarely discuss cost of drugs with

doctor Certain groups are more likely to discuss cost:

Women Patients in poor health Patient taking one or more prescription drugs Patients without prescription drug payment plan

Does DTC advertising harm the relationship between patients and doctors?

Patients report their doctors generally respond positively to questions

Greater percentage of doctors say patient having seen a DTC ad had positive impact on interaction, as opposed to negative impact

General Practitioners report more negative beliefs about potential negative effects of DTC ads than Specialists Physicians are evenly divided in opinions about overall impact of DTC ads on

patients and practice- 1/3 positive, 1/3 no effect, 1/3 negative General Practitioners report a more negative overall impact of DTC ads on

patients and practice than Specialists

Is DTC advertising appropriate at all?

DTC ads increase awareness of possible treatments

DTC ads do not convey information about risks and benefits equally well Physicians believe patients understand benefits

much better than risks Physicians believe DTC ads confuse patients about

relative risks and benefits of drugs Patient attitudes about many aspects of DTC

advertising have become less positive over time

What is Next?

PhRMA DTC Guidelines

Follow the existing regulations More disease awareness No broadcast reminders Voluntary pre-submission to DDMAC

Upcoming FDA Public Meetings

Direct-to-Consumer Promotion of Medical Products, November 1-2, 2005 “opportunity for broad public participation and comment on

direct-to-consumer (DTC) promotion of regulated medical products”

http://www.fda.gov/cder/ddmac/dtc2005/default.htm

CDER's Current Risk Communication Strategies for Human Drugs, December 7-8, 2005 “to obtain public input on CDER’s current risk communication

tools … and obtain greater understanding of the strengths and weaknesses of CDER’s existing risk communication”

http://www.fda.gov/cder/meeting/RiskComm2005/default.htm

Where to Find Recent Guidances

Consumer-Directed Broadcast Ads: http:// www.fda.gov/cder/guidance/1804fnl.htm

“Help-Seeking” and Other Disease Awareness Communications: http://www.fda.gov/cder/guidance/6019dft.pdf

Brief Summary: Disclosing Risk Information in Consumer-Directed Print Ads: http://www.fda.gov/cder/guidance/5669dft.pdf

Other Online FDA Resources

General FDA information: http://www.fda.gov

DDMAC home page: http://www.fda.gov/cder/ddmac.htm

Untitled and Warning Letters: http://www.fda.gov/cder/warn/index.htm

Contact info: kathryn.aikin@fda.hhs.gov