Drug Safety and Risk Management Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Holiday Inn, The Ballrooms, 2 Montgomery Ave., Gaithersburg, MD

Consumer Medication Information

Agenda for July 17, 2002

8:00 Call to Order, Introductions: Peter A. Gross, M.D., Chair

Meeting Statement: Thomas H. Perez, R.Ph., M.P.H., Executive Secretary

Welcome & Charge to Committee Paul Seligman, M.D., M.P.H., Director,
Office of Pharmacoepidemiology and Statistical Science

8:30 Background and History of Patient Information Efforts
Tom McGinnis, R.Ph., Director of Pharmacy Affairs, Office of the Commissioner

8:50 Information Development And Flow From Developer To Consumer
John Coster, Ph.D., R.Ph., National Association of Chain Drug Stores

Sharlea Leatherwood, R.Ph., National Community Pharmacist Association

9:20 Clarifying Questions to Previous Speakers

9:30 Report of Evaluation of Written Patient Information Penetration and Usefulness - part I
Bonnie L. Svarstad, Ph.D., University of Wisconsin-Madison School of Pharmacy

10:30 Break

10:45 Report of Evaluation of Written Patient Information Penetration and Usefulness - part II
Bonnie L. Svarstad, Ph.D., University of Wisconsin-Madison School of Pharmacy

11:45 Clarifying Questions to Dr. Bonnie L. Svarstad

12:00 Lunch

1:00 Open Public Hearing

2:00 Consumer Comprehension of Educational Materials: Key Cognitive Principles
Ruth S. Day, Ph.D., Duke University

2:15 Committee Questions to Presenters

3:15 Break

3:30 Committee consideration of questions

5:00 Adjourn