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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, FDADTC NationalApril 27, 2006
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Talk Outline
Major influences in 2005 The year in DTC What is next?
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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
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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
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What Events Shaped 2005?
Reexamination of DTC advertising
PhRMA DTC Guidelines
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Calls for Limitations on DTC Ads
Congress
Some companies enact voluntary delay
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PhRMA DTC Guidelines Follow the existing regulations
More disease awareness
No broadcast reminders
Voluntary pre-submission to DDMAC
Physician education pre-DTC
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2005 Ads
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The Doctor
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The Actor (or Celebrity)
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The Conversation
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What is Next?
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Disease Awareness Advertising
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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
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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.htmContact info: [email protected]