Drugs

2 New REMS Draft Guidances Out

FDA has issued two draft guidances to help improve the agency’s ability to ensure that risk mitigation programs that are put in place for certain drugs and biologics as a requirement of their approval are working.

The first guidance, REMS Assessment: Planning and Reporting, describes how to develop a risk evaluation and mitigation strategy (REMS) assessment plan, specifically how the REMS program goals, objectives, and REMS design may affect the selection of metrics and data sources, which will be used to assess whether the program is meeting its risk mitigation goals. The document also discusses considerations for assessing the impact of REMS on patient access to the drug and its burden to the healthcare delivery system. Finally, it provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report.

The guidance does not address the design or development of REMS; methods for designing, conducting, and reporting surveys; pharmacoepidemiologic safety studies; or other studies when used as a component of a REMS assessment.

Included in the document are an Introduction; Background; REMS Assessment Knowledge Surveys: Design, Conduct, and Data Analysis; Statistical Considerations When Analyzing and Presenting Results; Summary of Important Points; and References.

The second guidance, Survey Methodologies to Assess REMS Goals That Relate to Knowledge, gives information to industry on conducting REMS assessment surveys, used to evaluate respondent knowledge of REMS-related information. The document discusses general principles and recommendations relating to conducting REMS assessment surveys, including study design, survey instrument development, survey data collection and processing, and data analysis.

Its contents include Introduction, Background, REMS Assessment—Overview, Developing the REMS Assessment Plan, Considerations for Measuring Barriers to Patient Access and Burden on the Healthcare Delivery System, REMS Assessment Submissions, and two appendices.

In a statement announcing release of the drafts, FDA commissioner Scott Gottlieb says they “provide a framework for companies to develop a REMS assessment plan at the same time that the REMS program is being developed in order to improve the quality of the information used to assess the effectiveness of a REMS program, and provide post-market evidence that the REMS is meeting its risk mitigation goals.”

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