Regulating ConsumerDirected Rx Drug Promotion调节消费者定向RX药品促销.ppt

An Overview of Direct-to-Consumer Prescription Drug Promotion
Nancy M. Ostrove, .
Risk Communication Advisory Commations systems)
Different types of advertisements have different regulatory implications
Help-Seeking Advertisements
“See your doctor,” disease oriented
Not drug ads
If done properly, FDA does not regulate
regulated by Federal Trade Commission
Reminder Advertisements
Regulations specifically exempt from disclosure requirements
Focus on name(s) of product
designed to remind knowledgeable persons of existence of product
No representations beyond dosage form and packaging, price information
Not permitted for drugs with boxed warnings
Reminder
Product Claim Advertisements
Communicate benefits and risks
Require
name(s) and amount of product in each unit
approved use (indication)
optionally, other substantiated claims
Risk disclosure
requirements vary for print vs broadcast
Part of a product claim ad*
* “brief summary” not shown
Ad Content Requirements
Can’t be false or misleading
claimed uses must be consistent with drug labeling
claims must be substantiated
Must present “fair balance” between benefits and risk information
Can’t omit “material” facts
Plain language meaning: Ads must communicate an accurate and balanced picture of the product
Risk Disclosure Depends on Whether Ad or Labeling
Regulatory distinctions have implications
Advertisements vs. Labeling
“brief summary” vs. full package insert
Print vs. Broadcast ads
generally, print ads require all product risks
but, 2004 draft guidance offers alternatives
Risk Disclosure Draft Guidance
Encourages using
approved patient “package inserts” or Medication Guides (both labeling written for patients) or
translation of new “highlights” section of physician labeling into consumer-friendly language
Example: Use of Medication Guide*
*Type of approved patient labeling
What About Broadcast Ads?
Defined as ads in television, radio, an