June 30, 2009

FDA Docket: Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting | FDA-2009-N-0143 | FDA-2009-N-0143-0002

Document: Demonstration and Interim Analysis of Long-Acting Opioids REMS Design Process using RxFMEA - June 30 2009.pdf

Public Submission: ParagonRx - Comment | FDA-2009-N-0143-0955.1

Cover Letter:

June 30, 2009

FDA sent letters to manufacturers of certain opioid drug products on February 6, 2009 indicating that these products will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits continue to outweigh their risks.  At an industry meeting on March 3, 2009, FDA informed opioid manufacturers that they are expected to cooperate in developing a class-wide REMS.

As President and CEO of ParagonRx, I was pleased to participate in several recent Long-Acting Opioid REMS planning meetings, including the FDA Public Meetings on March 3 and May 28, 2009.  Those meetings clearly demonstrated the widely divergent opinions, beliefs, and interests associated with this topic.  It will be exceedingly difficult to integrate such input into a REMS using an ad hoc design process.  Our interest in the work accompanying this letter was to demonstrate how a science-based process could effectively organize diverse input into a highly targeted REMS design process.

ParagonRx, founded in 2001, is a healthcare consulting leader in pharmaceutical product risk assessment, REMS design, program implementation readiness, and REMS assessment. Our team of dedicated professionals has over 100 years of combined experience in pharmaceuticals, care management, adult education, clinical research, medicine, and other disciplines including engineering, pharmacovigilance, healthcare, pharmacy, training, project management, and health informatics.  Our culture of proactivity, focus, responsiveness, delivery, and value creation is unrivaled.  We combine insights into what is doable in clinical practice with what regulators expect and what companies can implement to find the balance that is so critical for REMS success.

ParagonRx has developed a proprietary approach to risk management using an adaptation of failure modes and effect analysis (FMEA), called RxFMEA®.  It is a rigorous assessment to identify key causes of suboptimal outcomes and to prioritize those behaviors that are most important to address. Through this process, we identify and target interventions that directly mitigate the most frequent risks that are amenable to intervention.

We are currently applying RxFMEA® to the medication use process for long-acting opioids.  In the following slides, we present findings of our interim analysis and demonstrate how RxFMEA® can be successfully applied to designing a robust class REMS program for long-acting opioids.

Sincerely,

Jeffrey E. Fetterman
President and C.E.O.

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