1. 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

2. Talk Outline Requirements for pharmaceutical ads How DTC evolved FDA survey findings What’s next?

3. 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

4. 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

5. 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

6. 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

7. 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?

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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. What is Next?

18. PhRMA DTC Guidelines Follow the existing regulations More disease awareness No broadcast reminders Voluntary pre-submission to DDMAC

19. 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

20. 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

21. 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.govkathryn.aikin@fda.hhs.gov