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Articles of Interest

REMS Integration Initiative Aims to Standardize REMS and Encourage Better Integration into the Health Care System

By Terry Toigo, Office of the Center Director

The Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized FDA to require a Risk Evaluation and Mitigation Strategy (REMS) if it is determined — either during initial product review or at any point in the postmarketing period — that specific safety measures are needed to ensure that a drug’s benefits outweigh its risks. REMS serve to inform and educate patients and health care providers about the serious risks of a drug, and offer tools and strategies to mitigate those risks.

Elements to Assure Safe Use

A REMS may be approved with elements to assure safe use (ETASU) to mitigate a specific and serious risk listed in the labeling of the drug.  Depending on the risk, ETASU might include one or more of the following:

  • Health care providers who prescribe the drug have particular training or experience, or are specially certified.
  • Pharmacies, practitioners, or health care settings that dispense the drug are specially certified.
  • The drug may be dispensed only to patients in certain health care settings (such as in hospitals or infusion centers).
  • The drug is dispensed to patients with evidence or other documentation of safe-use conditions (for example, liver enzyme tests, pregnancy tests).
  • Each patient using the drug may be subject to certain monitoring, or each patient using the drug must be enrolled in a registry.
Risk Evaluation and Mitigation Strategy meeting
Terry Toigo, CDER’s associate director for drug safety operations, opens day two of the "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies" public meeting on July 26.

Improving FDA’s Implementation of REMS Authorities

FDA created the REMS Integration Initiative in 2011. The initiative is designed to review and improve the Agency’s implementation of REMS authorities. The goals are to:

  • Develop guidance on how to apply statutory criteria to determine when a REMS is required
  •  Improve standardization and assessment of REMS
  • Improve the integration of REMS into the existing and evolving health care system

Under the umbrella of the REMS Integration Initiative, the REMS Integration Steering Committee (RISC) was established to provide a formal structure for governing various Center activities needed to improve the application of REMS in managing drug safety.

The RISC oversees the activities of three REMS workgroups: the Policy Workgroup, the Design and Standardization Workgroup, and the Evaluation Workgroup. RISC deliverables include fulfillment of commitments FDA made under the Prescription Drug User Fee Act (PDUFA V).

Obtaining Feedback from Stakeholders

A key component of the REMS Integration Initiative is stakeholder outreach to better understand how existing REMS programs are working and identify opportunities for improvement. Over the last three years, CDER has actively solicited and incorporated stakeholder input through a series of public meetings. 

In July 2010, FDA held a public meeting to obtain input on issues and challenges associated with the development, implementation, and assessment of REMS.  In June 2012, FDA held a public workshop to solicit feedback on survey methodologies and instruments for use in evaluating patients’ and health care providers’ knowledge about the risks of drugs marketed with approved REMS.  

 Risk Evaluation and Mitigation Strategy meeting
Marie Link, Pharm.D., REMS Logic, LLC, presents at the REMS public meeting.

Since 2011, FDA has held annual meetings with the Drug Safety and Risk Management Advisory Committee to evaluate REMS with ETASU for specific drugs.  Feedback from these meetings has generally emphasized a need for greater standardization of REMS and more robust assessments. FDA also regularly discusses both pre- and post-approval REMS with ETASUs with various FDA advisory committees when discussing specific product applications.

At several meetings in the last few years, CDER discussed REMS with its Drug Safety Oversight Board to obtain feedback about how well REMS programs were working for federal partners, and where they saw opportunities for standardization and better integration into their systems.

Most recently, on July 25 and 26, FDA held a public meeting on standardizing and evaluating REMS. We received valuable stakeholder input across a variety of concerns and potential challenges. The meeting served as a forum for FDA to hear from a broad spectrum of stakeholders, including advocacy communities, industry, and professional societies. 

FDA also invited stakeholders to suggest potential projects that will help to both standardize and better integrate REMS into the health care delivery system.  (See http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm351029.htm for complete details, including FDA slide presentations and background materials.)

Terry Toigo is the associate director for drug safety operations in CDER.

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