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Pain Arthritis Advisory Committee July 29, 2002 (afternoon session)

Pain Arthritis Advisory Committee July 29, 2002 (afternoon session). James Witter MD, PhD Division of Analgesics, Anti-Inflammatory & Ophthalmologic Drug Products HFD-550. Safety, Tolerance & Tolerability. pleasure. pain. NSAIDs. Opioids. The Perfect Drug:. Totally safe

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Pain Arthritis Advisory Committee July 29, 2002 (afternoon session)

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  1. PainArthritis Advisory CommitteeJuly 29, 2002 (afternoon session) James Witter MD, PhD Division of Analgesics, Anti-Inflammatory & Ophthalmologic Drug Products HFD-550

  2. Safety, Tolerance & Tolerability pleasure pain NSAIDs Opioids

  3. The Perfect Drug: • Totally safe • how safe is safe? • who should decide? • Totally effective • Unfortunately, there is no such drug

  4. Safety Assessment: • Before NDA approval: • preclinical • phase 1-3 studies • NDA Approval • if safe and effective • After NDA approval • MedWatch • adverse event reporting system (AERS)

  5. Safety Assessment: • Adverse events (before and after approval) • patient reported • investigator reported • Patient global • intended to catch the “something isn’t quite right experience” with an analgesic

  6. Drug Safety = Drug Information

  7. Post-NDA tools: CDER External Databases: Utilization Passive surveillance(AERS) Background rates Active Surveillance

  8. Risk Management (RM) Tools: Routine • Product labeling changes to: • Add adverse events • Add to contraindications, precautions, warnings (including BBW) • Recommend monitoring (“directive monitoring”) • Change indication to make second line

  9. RM Tools: Less Common • Provide patient with information by: • Medication Guides • Dear Doctor Letters (DDL) • FDA public announcements • Patient registries: (voluntary or mandatory) • Product withdrawal

  10. Post-Marketing: Lessons Learned • Labeling changes • Largely ineffective for widely used drugs, complex messages • “Failures”due to persistent adverse events or studies showing contraindications have been ignored have led to market withdrawal (i.e. Duract) • Patient registries • Useful for estimating the denominator in long-term safety but don’t manage risk per se

  11. July 29, 2002afternoon speakers • Nathaniel Katz, M.D. (Harvard) • Laura Lu, Ph.D. (FDA)

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