Risk Evaluation and Mitigation Strategies - Adaptation in an evolving system

Risk Evaluation and Mitigation Strategies - Adaptation in an evolving system

Summary

The Food and Drug Administration has been looking at ways to mitigate risk on certain pharmaceutical products since the 1970s. As an evolution of this process, the agency established the Risk Evaluation and Mitigation Strategies (REMS) program in 2008.

Products can be approved with a Medication Guide only REMS, a Communication Plan REMS – which incorporates a Medication Guide together with educational materials for providers or it can require Elements to Assure Safe Usage (ETASU).

There has been substantial criticism of the current REMS system from pharmaceutical companies, as well as from providers and dispensers. The FDA is moving to address some of these criticisms by trying to establish greater standardization across the system.

The report, “Risk Evaluation and Mitigation Strategies - Adaptation in an evolving system”, has been written to provide insights, analysis, and support to the pharmaceutical teams working on their company’s REMS. CBR’s report on REMS uses both primary & secondary market research to support the analysis and insights provided.

Scope

- Overview, requirements and elements of REMS
- Current opinions and strategies
- Future outlook

Reasons to buy

- Compare your company’s REM procedures with those of other pharmaceutical companies
- Analyze the most effective ways to develop REMS programs for your products
- Understand the current FDA trends on REMS and the impact they may have on your company
- Assess the strategies that can help make REMS a competitive tool
- Determine the best practice for your REMS teams
- Benefit from industry primary research to support your key decision making with regards to your REMS procedures & strategy

Executive Summary
Establishment of REMS
Early FDA risk mitigation
The establishment of REMS
Requirements of the REMS system
Elements of REMS
Current Opinions on REMS
Criticisms of the REMS system
FDA Response
Strategy
REMS planning
Risk Assessment
Cross-functional teams
Stakeholder input
The Outlook for REMS
Innovators vs. generics
Changing types of REMS
The Outlook for REMS (continued)
Moving to class-wide shared REMS
The need for formal procedures
The increasing challenge of assessments
The role of evolving technology
REMS as a strategic tool
Appendix