Drug Safety and Risk Management Advisory Committee

1
Drug Safety and Risk Management Advisory Committee

• Paul J. Seligman, MD, MPH
• Acting Director
• Office of Drug Safety
• July 17, 2002

2
Consumer Medication Information

• Communication with consumer vital
• Achieve greatest benefit of drug therapy
• Maximize safe use of drugs
• FDA regulates
• Medication Guides
• Patient Package Inserts (OCP, estrogens/HRT)
• Direct-to-consumer advertising

3
Background

• Understand the history of consumer drug
  information issue
• Review progress in meeting Year 2000 2006
  goals
• 75 useful information in 2000
• 95 useful information in 2006
• Describe how information from the FDA-approved
  label is conveyed to consumers
• Ensure the communication with consumers based on
  evidence and scientific principles

4
Scope of Meeting

• Focus on how to improve consumer information
• Provide best advice to FDA on ways to meet 2006
  goal
• Discussion of next steps

5
Goals

• What additional analyses of the current data
  would be useful?
• What additional research needs to be conducted to
  ensure that best evidence is used to improve
  patient medication information?
• What actions would improve consumer medication
  information to meet 2006 goal?