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: kathryn.aikin@fda.hhs.gov