# Presentation: 455880

## 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](http://www.fda.gov/cder/warn/index.htm)_
- Contact info:  _[kathryn.aikin@fda.hhs.gov](mailto:kathryn.aikin@fda.hhs.gov)_