REMS Assessments Could Measure Behavior, Not Just Knowledge, Industry Tells FDA
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.
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The agency plans to use the RE-AIM model, which looks at an intervention’s reach, effectiveness, adoption, implementation and maintenance, as the basis for guidance on evaluating whether a REMS protects patient safety without being unnecessarily restrictive and burdensome on patient access.
Early discussions based on the framework could engender more efficient drug reviews and aid industry in decisions on clinical programs, BIO and PhRMA note in comments to the agency.
The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.