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  1. Direct-to-Consumer Advertising of Prescription Drugs:The Year in Review Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and Communications, FDA DTC National April 27, 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 (or Celebrity)

  11. The Conversation

  12. What is Next?

  13. Disease Awareness Advertising

  14. 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

  15. 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