National Survey on Consumer Reaction to DTC Advertising of Prescription Medicines: Comments from DDMAC

1. National Survey on Consumer Reaction to DTC Advertising of Prescription Medicines: Comments from DDMAC Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and Communications, FDA Prevention Magazine/Men’s Health/Women’s Health 9th Annual LuncheonMay 11, 2006

2. Comments from DDMAC • Slides #3 through #5, #7 through #8 and #10 taken from 9th Annual Prevention/Men’s Health/Women’s Health Survey on Consumer Reaction to DTC Advertising of Prescription Medicines

3. Asking the Doctor “FOR” Advertised Medicines(Base: Consumers who have asked about advertised medicines) Source: Prevention/Men’s Health/Women’s Health DTC Studies

4. Talked with a Doctor about Specific Medicine Seen or Heard Advertised Source: Prevention/Men’s Health/Women’s Health DTC Studies

5. Awareness for Branded and Unbranded DTC Ads + 7 Points % who say they have seen ads for specific medicines that you can only get with a prescription % who say they have seen ads that talk about a medical condition but don’t mention a specific medicine or treatment Source: Prevention/Men’s Health/Women’s Health DTC Studies

6. PhRMA DTC Guidelines • Follow the existing regulations • More disease awareness • No broadcast reminders • Voluntary submission requesting comments from DDMAC • Physician education pre-DTC

7. Consumer View:Doctor Ads – Believability for Effectiveness & Safety 60% have seen the Doctor ads 69% say they make no difference in believing the medicine is effective 20% say they are more likely to believe % who say they are more/less likely to believe a medicine is effective seeing an ad with a doctor Source: Prevention/Men’s Health/Women’s Health DTC Studies

8. Consumer View:Celebrities Ads – Believability for Effectiveness & Safety % who say they are more/less likely to believe a medicine is effective seeing an ad with a celebrity 62% have seen the Celebrity ads 77% say they make no difference in believing the medicine is effective 6% say they are more likely to believe Source: Prevention/Men’s Health/Women’s Health DTC Studies

9. It depends on the celebrity… - 38% + 37%

10. Percent of Consumers Who Read the Brief Summary “Thoroughly” (Base: Consumers who were aware of brief summary in print advertisement) Source: Prevention/Men’s Health/Women’s Health DTC Studies

11. The more things change… “ It says ‘crunchy frog’ " “ Well, the superintendent thought it was an almond whirl. People won't expect there to be a frog in there. They're bound to think it's some form of mock frog.” “ Mock frog? We use no artificial preservatives or additives of any kind.” “ Nevertheless, I must warn you that in future you should delete the words ‘crunchy frog’ and replace them with the legend ‘crunchy, raw, unboned, real dead frog’ if you want to avoid prosecution.” “ What about our sales?” “ I'm not interested in your sales. I have to protect the general public.” Copyright 1969 Python (Monty) pictures and BBC

12. 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

13. 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