FDA Releases REMS Report

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FDA report details risk mitigation projects.

FDA has released a report describing stakeholder feedback it received in fiscal year (FY) 2013 regarding risk evaluation and mitigation strategies (REMS). The report was prepared as part of FDA’s commitment to measure the effectiveness of REMS, to continue to develop techniques to standardize REMS, and to integrate REMS into the existing and evolving healthcare system.

As part of the Prescription Drug User Fee Act (PDUFA V), FDA agreed to hold public meetings with a variety of relevant stakeholders (including pharmaceutical industry players, federal healthcare providers, patient groups, and other healthcare system partners) by the end of FY 2013 to explore greater standardization of REMS, where appropriate, to reduce the burden of REMS implementation. In addition, FDA agreed to issue a public report of its findings and to identify at least one priority project in the areas of patient benefit-risk information, prescriber education, pharmacy systems, and practice settings.

In the report, FDA details its proposals for the following projects:


  • Patient Benefit/Risk Information under REMS: Providing Patient Benefit/Risk Information by Improving Tools for Prescriber-to-Patient Counseling

  • Prescriber Education under REMS: Prescriber Education—REMS and Continuing Education (CE) for Health Care Providers

  • Pharmacy Systems under REMS: Standardizing REMS Information for Inclusion into Pharmacy Systems Using Structured Product Labeling (SPL)

  • Practice Settings under REMS: Providing a Central Source of REMS Information for Practice Settings.

The report includes suggestions and recommendations FDA has received from stakeholders through public meetings, Advisory Committee meetings, an expert panel workshop, and comments received electronically. The feedback the agency received was used to select the four priority projects within the areas specified by the PDUFA V.

Source: FDA