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Session 2: Prescription Opioid Abuse Epidemic: Regulatory Actions and Quantitative Evaluation
Session Chair(s)
William Wang, PhD
President
Merck & Co, Inc, United States
The prescription opioid abuse epidemic has grown in scope and has become a major public health concern. The FDA has developed an action plan to address this epidemic. The plan includes new professional labeling, postmarketing studies to measure and understand abuse, promotion of abuse deterrent formulations, and Risk Evaluation and Mitigation Strategies. This session provides an overview of the prescription opioid epidemic and future FDA actions. It then considers the unique challenges to evaluate the actions including the use of novel data sources and quantitative methods.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the unique challenges to measuring and understanding the prescription opioid epidemic
- Explain the use of novel data sources and quantitative methods
Speaker(s)
Session Co-Chair
Mark Levenson, PhD
FDA, United States
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
Overview of the Prescription Opioid Epidemic and the FDA Activities to Address It
Judy Anne Staffa, PhD, RPh
FDA , United States
Associate Director for Public Health Initiatives, OSE, CDER
Estimating Prescription Opioid Abuse and Assessing Causality: Statistical Challenges
Kunthel By
FDA, United States
Biostatistician
Epidemiologist Perspective on the Prescription Opioid Abuse Epidemic
Scott Novak, PhD
Battelle Memorial Institute , United States
Director of Prescription Drug Research