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The CPDD Special Conference on Risk Management and Post Marketing Surveillance of CNS Drugs: Implications for opioid REMS
Meeting:The College on Problems of Drug Dependence 72nd Annual Meeting
Date:June 14, 2010
Aims: Controlled Substance Act (CSA) scheduling is a regulatory approach to enable access to medications while providing safeguards to minimize abuse and diversion to patients and non patients. For CNS drugs, including those used to treatment drug dependence, risk management must consider abuse liability and CSA among other factors in developing appropriate risk management. CPDD sponsored a special conference to address the regulatory policy and research needs pertaining to risk management in the fall of 2008 with the proceedings published in Drug and Alcohol Dependence (Vol. 105, Suppl. 1, 2009). Approximately 100 researchers, regulators, pharmaceutical developers, and research institution representatives discussed issues, shared perspectives, and informed the development of recommendations for research and regulation by an Expert Panel representing diverse stakeholders. In 2009, the FDA announced that many extended release and long acting opioids would require a new form of risk management termed Risk Evaluation and Mitigation Strategy (REMS). This presentation will present the implications, conclusions and recommendations of the special conference for the development of risk management in general and the opioid REMS in particular.
Conclusions: The process of REMS development for these opioids has been slow, as the FDA along with the diverse stakeholders representing patients, healthcare providers, pharmaceutical distributors, and researchers have come to appreciate the complexity of the problem and the fact that some "solutions" might cause new problems without addressing those of concern. Consistent with the Expert Panel report, however, there is a science foundation for going forward with REMS implementation including specialized post marketing surveillance to provide rapid detection of potential unintended consequences and to guide interventions.
Conclusions: The process of REMS development for these opioids has been slow, as the FDA along with the diverse stakeholders representing patients, healthcare providers, pharmaceutical distributors, and researchers have come to appreciate the complexity of the problem and the fact that some "solutions" might cause new problems without addressing those of concern. Consistent with the Expert Panel report, however, there is a science foundation for going forward with REMS implementation including specialized post marketing surveillance to provide rapid detection of potential unintended consequences and to guide interventions.