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
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.htmContact info: [email protected]
