Transcript Document 7299149

Lotronex® (alosetron HCl) Tablets
Introduction
Victor F. C. Raczkowski, M.D.
Director, Division of Gastrointestinal and
Coagulation Drug Products
April 23, 2002
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Center for Drug Evaluation and Research
(CDER)
• A CDER priority:
– Assure that safe and effective drugs are
available to the American Public
• Basis of regulatory decisions:
– Laws and regulations
– Scientific evidence
– Judgement
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Need for Joint Advisory Committee
• Public debate over Lotronex
– Safety of Lotronex
– Access to Lotronex
• New data about Lotronex
– Clinical-trial data
– Post-marketing data
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Issues for this Joint Advisory Committee
• Can conditions be described for which
benefits of Lotronex exceed the risks?
– Describe patients
– Describe physicians
• Does the GSK risk-management plan
adequately ensure appropriate use of
Lotronex?
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Issues (continued)
• How is the success of the plan best
monitored or audited:
– At the level of the patient?
– At the level of the physician?
– At the level of the pharmacist?
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Issues (continued)
• Describe criteria for success of the plan:
– Process controls
– Evaluation of outcomes
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FDA Presentations
• Clinical-Trial Experience
Thomas Permutt, Ph.D.
• Post-Marketing Experience
Ann Corken Mackey, M.P.H.
• Risk-Benefit Issues
Victor F. C. Raczkowski, M.D.
• Risk-Management Program Toni Piazza-Hepp, Pharm. D.
• Summary and Conclusions
Victor F. C. Raczkowski, M.D.
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