FDA guidance details how to develop REMS assessment plans

When designing REMS programs, drug companies should simultaneously develop a plan for assessing the program's effectiveness in meeting its risk mitigation goals, according to new draft guidance FDA released Thursday. The guidance marks the first time FDA has issued a framework for companies to develop REMS assessment plans.

The draft guidance recommends that assessment plans incorporate both process indicators -- such as the number of patients or healthcare providers who are enrolled or certified in the REMS -- and outcome measures. Companies should consider how the REMS program goals and design may affect the types of metrics and data sources that could be used to assess whether the program is meeting its risk mitigation goals. Examples of metrics and data sources to evaluate REMS performance include drug utilization data, surveys of stakeholders, postmarket adverse event data, observational or epidemiological data, as well as stakeholder input...