• FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)
  • January 19, 2015 | Authors: Frederick R. Ball; Emily N. Winfield
  • Law Firms: Duane Morris LLP - Boston Office ; Duane Morris LLP - Chicago Office
  • The U.S. Food and Drug Administration (FDA) recently published a report titled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA's Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization.

    The report briefly reviews the background and context for REMS, as well as FDA management initiatives for REMS administration and program improvement; summarizes key perspectives expressed by stakeholders; and presents the design and proposed work plans of projects in four designated priority areas.

    As part of the agency's PDUFA commitments, the FDA was directed to "identify at least one priority project and corresponding work plan in each of the following areas": (1) providing benefit/risk information to patients, (2) prescriber education, (3) pharmacy systems and (4) practice settings. In response, FDA has identified the following four priority projects, which are each summarized in the report:

    • Project 1: Patient Benefit/Risk Information Under REMS: Providing Patient Benefit/Risk Information by Improving Tools for Prescriber-to-Patient Counseling
    • Project 2: Prescriber Education Under REMS: Prescriber Education—REMS and Continuing Education (CE) for Health Care Providers
    • Project 3: Pharmacy Systems Under REMS: Standardizing REMS Information for Inclusion into Pharmacy Systems Using Structured Product Labeling (SPL)
    • Project 4: Practice Settings Under REMS: Providing a Central Source of REMS Information for Practice Settings

    The selection and development of these projects were in response to advice FDA received from stakeholders regarding significant areas of opportunity to improve REMS evaluation and standardization. These recommendations are the culmination of a variety of outreach efforts conducted over several years, including roundtables; focus groups; webinars; symposia; and an FDA-hosted public meeting in the summer of 2013, at which more than 30 stakeholder organizations offered perspectives and suggestions.