1. 1 Meredith Rosenthal, Ph.D. May 10, 2007 Direct-to-Consumer Advertising of Prescription Drugs

2. 2 Outline A brief history Spending on DTCA FDA oversight Evidence on impact of DTCA Policy implications

3. 3 A Brief History of DTCA in the U.S. In the beginning, there was nothing but consumer promotion (snake-oil salesmen) Durham Humphrey Amendments of 1951 required certain drugs to be available only by prescription By 1960, 90% of marketing spending targeted physicians 1969 regulations for promotion to physicians required “brief summary” of product label be transmitted 1980s saw first broadcast consumer ads 1983 FDA asked for voluntary moratorium on consumer advertising 1985 moratorium lifted, 1969 regulations applied to DTCA Early 1990s industry began reminder, help-seeking ads FDA held hearings on DTCA; August 1997 released draft guidelines allowing alternative to “brief summary” in broadcast ads – toll-free phone number; print ads; website; “ask your physician/pharmacist”

4. 4 DTCA of Prescription Drugs in 2005 Dollars, 1994-2005

5. 5 FDA Oversight of DTCA Manufacturers must submit ads for review but are not required to obtain pre-approval In 2002, DHHS began requiring legal review of all draft regulatory letters including DTCA warnings Staff for review of ads numbers only four In 2004, only about 1/3 of ads were reviewed before airing according to FDA

6. 6 FDA Warning Letters to Manufacturers: All Promotion and DTCA

7. 7 What do we know about impact? Consumers clearly act on advertising DTCA increases sales of both advertised drugs and competitors Something intervenes with direct translation of interest in a drug to a purchase – formularies, physician opinions about what to prescribe Emerging evidence on appropriateness, cost- effectiveness of use driven by DTCA suggests both good and bad

8. 8 Make physicians better agents Pursue concerns about marketing to physicians by pharmaceutical companies counter-detailing Reinforce FDA oversight Use coverage, cost sharing to reduce excessive exuberance over advertised drugs Role for AGs? What Are the Policy Issues?