Food and Drug Administration Hearings on Direct to Consumer Advertising November 2, 2005

1. Food and Drug AdministrationHearings onDirect to Consumer AdvertisingNovember 2, 2005 James H. Davidson Davidson & Company of Polsinelli Shalton Welte Suelthaus LLC Executive Director The Advertising Coalition

2. American Advertising Federation American Association of Advertising Agencies Association of National Advertisers Grocery Manufacturers of America Magazine Publishers of America National Association of Broadcasters National Broadcasting Company National Cable and Telecommunications Association National Newspaper Association Newspaper Association of America Pfizer, Inc. Pharmaceutical Research and Manufacturers of America The Advertising Coalition

3. DTC Advertising • Is Protected • Commercial Speech

4. DTC advertising is protected commercial speech • DTC advertising has motivated millions of Americans to seek advice from their doctors

5. DTC advertising is protected commercial speech • DTC advertising has motivated millions of Americans to seek advice from their doctors • DTC advertising raises awareness about under diagnosed conditions and addresses public health disparities

6. DTC advertising is protected commercial speech • DTC advertising has motivated millions of Americans to seek advice from their doctors • DTC advertising raises awareness about under diagnosed conditions and addresses public health disparities • Self-Regulation will enhance quality of DTC

7. DTC Advertising is protected commercial speech • Justice Blackman: “As to the particular consumer’s interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the day’s most urgent political debate.” • Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council

8. DTC Advertising is protected commercial speech • Justice O’Connor: “ . . . if it is appropriate for the statute to rely on doctors to refrain from prescribing compounded drugs to patients who do not need them, it is not clear why it would not also be appropriate to rely on doctors to refrain from prescribing compounded drugs to patients who do not need them in a world where advertising was permitted.” • Thompson v. Western States Medical Center

9. DTC advertising has motivated millions of Americans to seek advice from their doctors • 62 million Americans say they have spoken to their doctors about an advertised medicine • Between 25 and 30 million Americans have been prompted by an ad to talk to their physician for the first time about a medical condition

10. Are too many Americans making appointments with their doctors?

11. Advertising should inform and motivate - but it need not be encyclopedic“Less is more”FDA Commissioner Mark McClellan

12. Many prompted by ads to seek help suffer from high priority conditions • Harvard, Massachusetts General Hospital and Harris Interactive: • 35 percent of 3,000 patients sought medical advice after seeing an advertisement • 25 percent of those received a new diagnosis • 43 percent of those were for high priority conditions

13. DTC Advertising Can Highlight Under Diagnosed and Under Treated Conditions • The Silent Killer • 30% or 19.5 million don’t know • 11% are not receiving therapy • 25% are receiving inadequate therapy • One out of three adults, or 65 million Americans, has high blood pressure

14. DTC Advertising Can Highlight Under Diagnosed and Under Treated Conditions • Diabetes • 6th leading cause of death in the U.S. • 21 million Americans affected – 7% of the population • 6 million of them don’t know they have diabetes

15. DTC Advertising Can Highlight Under Diagnosed and Under Treated Conditions • Depression • Nearly 40 million Americans suffer from a depressive disorder • Only 4 to 8 million Americans are in active treatment

16. DTC Advertising Can Highlight Under Diagnosed and Under Treated Conditions • From 1987 to 1997, the percent of Americans treated for depression tripled from .7% to 2.3% • Dr. Mark Olafson: increased number of “multi-million dollar marketing campaigns.”

17. DTC Advertising Can Highlight Under Diagnosed and Under Treated Conditions • Osteoporosis and Bone Health • ‘The private sector’s financial resources and ability to reach a huge market can be brought to bear on the public health issue of bone health’ • Dr. Richard Kravitz: ‘DTC apparently works . . . several studies show that DTC ads are read and acted upon.’

18. Access to Information by Under Served Communities • ‘Access to information is a critical piece in the access picture for Hispanic and other under served communities.’ • ‘New research is showing that health care disparities among black, Hispanic, and white Americans cannot be explained wholly by disparities in income and health insurance coverage among these groups . . . other factors such as lack of information play a critical role.’ • Dr. Jane Delgado, President and CEO of the National Alliance for Hispanic Health

19. National Medical Association • 90 percent of the African American physicians surveyed said that they had been asked their medical opinion because their patients had seen prescription drug ads. • Commonwealth Fund: study shows that minorities lag behind in health care quality and are more likely to have communication problems with their doctors than caucasian patients.

20. Woman’s Day • Reaches 20 million – or 1 in 5 – American women • Over 100,000 reader panel

21. Woman’s Day • Mental Health • ‘Advertisements for [product] prompted me to visit my physician to seek relief for my migraine headaches. I now take [product] and feel like I have been given my life back. I can live again instead of worrying about getting a migraine.’ • Debbie P., Age 51, Painesdale, MIchigan

22. Woman’s Day • Mental Health • ‘I suffered from severe depression and anxiety. I was trying to find something to even out my moods. I discussed many medications with my doctor. I had found an ad for [product] and spoke to him about it. It turned out to do miracles for mine and my children's well being as it continued to improve my quality of life.’ • Samantha J., Age 32, Bedford, Texas

23. Woman’s Day • Mental Health • ‘My mother was very depressed and after months of being on a prescription, she was not feeling any better. I read about [product] and talked to her about getting her prescription changed. She talked to her doctor, got the new product, and we saw a change immediately.’ • Cindy W., Age 49, Muncy, Pennsylvania

24. Woman’s Day • Osteoporosis • ‘As I was waiting for the results of my second bone density test, I remembered seeing an ad for [product] which allowed me to review the medication. Upon meeting with my doctor it was his suggested medication, and the ad enabled me to ask questions at my appointment.’ • Cindy, H., Age 55, Geneva, New York

25. Industry Self Regulation Promises to Enhance Pharmaceutical Advertising • PhRMA • Program of self regulation for prescription drug advertising • Committed to delivering messages that educate patients and consumers and encourage them to seek guidance from their health care professionals

26. Conclusion • How many of the 25 percent of new diagnoses identified in the Harvard-Harris survey would have never occurred without the prompting of an ad? • I hope we never have to weigh that risk.