REMS Assessment Paradigm To Be RE-AIMed By FDA; “Pressure-Testing” Needed
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.
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Whose Burden Is It Anyway? REMS’ Health Care Impact Belongs To FDA, PhRMA Says
Industry group contends that FDA should assess whether a REMS places an undue burden on the health care industry – because asking companies to do that evaluation would be an additional burden on the health care system.
FDA Plans To Improve REMS Effectiveness With Guidance On Goals And Metrics
The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.
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.