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					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
Talk Outline

 Major influences in 2005
 The year in DTC
 What is next?
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
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
What Events Shaped 2005?


 Reexamination of DTC advertising


 PhRMA DTC Guidelines
Calls for Limitations on DTC Ads
 Congress


 Some companies enact voluntary delay
PhRMA DTC Guidelines
 Follow the existing regulations

 More disease awareness

 No broadcast reminders

 Voluntary pre-submission to DDMAC

 Physician education pre-DTC
2005 Ads
The Doctor
The Actor (or Celebrity)
The Conversation
What is Next?
Disease Awareness Advertising
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
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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