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