As we advise clients about REMS design and implementation, the most frequent concern we encounter is related to REMS assessment. A look at the math reveals why this is so. Over 63 REMS have been approved since FDAAA statutes for REMS became effective in March 2008. Of those, more than 90% are comprised of Medication Guides and/or Communication Plans, plus an assessment. Most clients find the process of developing and distributing Medication Guides and Communications Plans to be familiar ground. But the prospect of creating an instrument that assesses the effectiveness of those communications is far more concerning. Frequent questions include:
- What is the appropriate sample size?
- How are stakeholders recruited?
- What is the appropriate format of the questionnaire?
- What does FDA expect to be included in the protocol?
- How is the instrument fielded?
- Are assessment thresholds necessary? If so, how should they be established?
There is emerging guidance from FDA on these topics. Draft guidance was issued by FDA in September 2009, Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS. This draft guidance provides some insights about information needed for assessment reports. But much remains undefined.
ParagonRx is offering a complimentary webinar on Wednesday, January 13, 2010 at 12:00 noon EST on the topic, Cracking the Code on REMS Assessments: Opportunities for Improvement and Redesign, which promises to address many of the frequently asked questions that remain unaddressed by guidance. This webinar is part of our continuing monthly series of REMS webinars entitled, Wednesday FoREMS, scheduled mid-day (EST), mid-week, on the 2nd Wednesday of every month. Each month we will address a new topic based on the trends we identify within the world of REMS and risk management in our industry. For more information and webinar registration, click here.