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Direct-to-Consumer Advertising of Prescription Drugs: Current Issues

Direct-to-Consumer Advertising of Prescription Drugs: Current Issues. Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and Communications, FDA Marketing Pharmaceuticals in a Time of Change February 23, 2006. Talk Outline. Major influences in 2005 The year in DTC

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Direct-to-Consumer Advertising of Prescription Drugs: Current Issues

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  1. Direct-to-Consumer Advertising of Prescription Drugs:Current Issues Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and Communications, FDA Marketing Pharmaceuticals in a Time of Change February 23, 2006

  2. Talk Outline • Major influences in 2005 • The year in DTC • What is next?

  3. 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

  4. 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

  5. What Events Shaped 2005? • Reexamination of DTC advertising • PhRMA DTC Guidelines

  6. Calls for Limitations on DTC Ads • Congress • Some companies enact voluntary delay

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

  8. 2005 Ads

  9. The Doctor

  10. The Actor

  11. The Conversation

  12. Comparable Presentation of Risk and Benefit Information

  13. What is Next?

  14. Disease Awareness Advertising

  15. 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

  16. 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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