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Direct-to-Consumer Advertising of Prescription Drugs: Looking Back, Looking Forward

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

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Direct-to-Consumer Advertising of Prescription Drugs: Looking Back, Looking Forward

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  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 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 1999 and 2002 Consumer Surveys: Methodology 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.gov

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