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FDA Responds to Public Concerns and Reconsiders REMS Elements

By Edward Li, PharmD, BCOP, Drugs and Biologics Editor

New and important developments related to Risk Evaluation and Mitigation Strategies (REMS) will ease the impact of this regulation on clinicians.  Most significantly, the U.S. Food and Drug Administration (FDA) is seeking to remove Medication Guides from the REMS process because of the substantial burden Medication Guide-only REMS impose on manufacturers, providers, and the FDA (“The Pink Sheet,” June 21, 2010).  The FDA is investigating ways to streamline this process and to reduce the workload in this area. 

The FDA is revising its policies and approaches to REMS based on public feedback; the work that NCCN has done through hosting the NCCN Oncology Summit: Recommendations for REMS Stakeholders and publishing a draft REMS White Paper (link to: http://www.nccn.org/about/news/ebulletin/2010-06-28/rems_white_paper.asp) may have contributed to this reconsideration.  For example, participants at the NCCN REMS Oncology Summit (link to: http://www.nccn.org/about/news/ebulletin/2010-05-17/rems.asp), held on May 7, 2010, expressed concern over the issues related to the Medication Guides, and an FDA representative acknowledged the limitations of Medication Guides at this meeting.  Additionally, some key discussions at the NCCN REMS Oncology Summit included:

  • A presentation of data regarding how prescribers will avoid utilizing drugs with complex REMS.
  • An emphasis regarding the need to better assess whether REMS are effective in mitigating risk.
  • Highlights concerning the need to focus on patient and provider education.


In related events, on June 28, 2010, the FDA informed manufacturers of long-acting opioids that the REMS for their products will not require provider or patient registration.  Originally, in February 2009, the FDA informed manufacturers of certain opioid products that their product would require a REMS, citing safety concerns related to the improper selection of patients treated with opioids, misuse, abuse, and overdose (intentional and accidental).  It was expected that the class-wide REMS for opioids would include elements to assure safe use (ETASU), which would require that physicians enroll in a program and that pharmacies verify prescriber training.  However, the FDA recently acknowledged concerns that pharmacies and physicians would utilize other options that did not require registration, thus decreasing access.  Additionally, public input suggested that creating a patient registry would hinder the useful prescribing of these drugs; patients may forgo treatment to avoid the stigma associated with taking an opioid. 

Therefore, the FDA narrowed its approach to opioid REMS.  The current focus is now on prescriber and patient education.  Physician education would be voluntary, and the manufacturers would provide prescribers with FDA-approved patient education materials to be used during patient counseling sessions.  Assessing the effectiveness of the REMS will also be emphasized. Manufacturers are working with the FDA to identify and collect baseline metrics in prescriber/patient knowledge, behaviors, and health outcomes so that improvement can be measured. 

As the FDA considers the future of Medication Guides and opioid REMS, clinicians should keep these events in mind:

  • The revised opioid REMS proposal was presented at a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA on July 22-23, 2010.
  • The FDA is holding a 2-day public meeting on July 27-28, 2010 to obtain input on the issues and challenges in the development and implementation of REMS.  NCCN will submit comments based on the Work Group recommendations and NCCN Trends™ data.
  • The comment period for opioid REMS ends on October 19, 2010.
  • After the comment period, the FDA will make a final decision regarding opioid REMS.
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