direct to consumer advertising of prescription drugs current issues l.
Download
Skip this Video
Download Presentation
Direct-to-Consumer Advertising of Prescription Drugs: Current Issues

Loading in 2 Seconds...

play fullscreen
1 / 22

Direct-to-Consumer Advertising of Prescription Drugs: Current Issues - PowerPoint PPT Presentation


  • 139 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Direct-to-Consumer Advertising of Prescription Drugs: Current Issues' - aitana


Download Now An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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
Talk Outline
  • Major influences in 2005
  • The year in DTC
  • What is next?
requirements for ads
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
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
What Events Shaped 2005?
  • Reexamination of DTC advertising
  • PhRMA DTC Guidelines
calls for limitations on dtc ads
Calls for Limitations on DTC Ads
  • Congress
  • Some companies enact voluntary delay
phrma dtc guidelines
PhRMA DTC Guidelines
  • Follow the existing regulations
  • More disease awareness
  • No broadcast reminders
  • Voluntary pre-submission to DDMAC
  • Physician education pre-DTC
where to find recent guidances
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
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