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REMS Assessments Could Measure Behavior, Not Just Knowledge, Industry Tells FDA

 
• By Cathy Dombrowski

Lilly suggests a hierarchy of metrics at an agency workshop: At the lower end, surveys could elicit respondents’ knowledge about a drug’s risk, but also seek information about their behavior and the impact of the REMS on access to the medication; for riskier drugs, secondary data could be utilized to assess behavior; for the riskiest drugs, the effect of behavior on outcomes could be assessed.

Assessments for Risk Evaluation and Mitigation Strategies should use tiered metrics based on a drug’s risk, industry suggested to FDA during a recent workshop.

Several participants in the workshop panels suggested the assessments should go beyond knowledge and look at behavior as well. Kenneth Hornbuckle, a senior advisor at Eli Lilly & Co.,...

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