Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)

Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)

FDA Reviews Docket Submissions and Comments from Stakeholder and Public Meetings (Update - November 2009)

FDA is reviewing public and stakeholder input related to the development of a Risk Evaluation and Mitigation Strategy (REMS) for certain opioid drug products. On May 4 and 5, 2009, FDA held two days of meetings with stakeholders from the healthcare provider, pharmacy, and patient communities. These meetings were followed by a larger public meeting on May 27 and 28, 2009, during which more than 100 people provided comments on their experiences with opioid drugs along with suggestions for a REMS for long-acting and extended-release opioid products. In addition, FDA opened a public docket to enable stakeholders and the public to provide written comments related to the opioid REMS. FDA received more than 2,000 submissions before the docket closed on June 30, 2009.

FDA formed an Opioid REMS Steering Committee, a multidisciplinary team from throughout the Center for Drug Evaluation and Research to carefully review and consider all the input we have received. This work is divided among eight workgroups that will focus on the following key areas: scope, prescriber education, pharmacist education, patient education, pharmacy systems, patient access to pain medication, metrics and public communication.

FDA recently announced the re-opening of the opioid REMS comment period through October 19, 2010 (Federal Register notice (PDF - 48KB)). FDA has continued to receive information and submissions that will be made available to all stakeholders. We have received inquiries regarding this decision to reopen the comment period and how it relates to the planned timeline for development and implementation of an opioid REMS. This additional comment period is not tied to or indicative of any timeline for a REMS decision or implementation. FDA continues to carefully review and consider all public and stakeholder input.

Stakeholders may be contacted if more information is needed to assist FDA in this effort. FDA has received requests from stakeholders and others to meet with members of the Opioid REMS Steering Committee. The Steering Committee cannot grant all the requests it has received and will carefully evaluate meeting requests from individuals and groups of stakeholders as we continue to review the input and develop a proposed REMS. In considering meeting requests, the Steering Committee will be mindful of the need to maintain an efficient, transparent, and fair process.

On December 4, 2009, FDA will hold a public meeting with sponsors of certain opioid drug products regarding the opioid REMS. FDA has encouraged affected sponsors to work collectively to develop a proposed REMS. The purpose of this meeting is to hear from sponsors about the status of the development of a proposed REMS and their views regarding the specific features of the REMS. For more information on this meeting, please see the notice in the Federal Register (PDF - 45KB).

Once our internal analyses and deliberations are complete, the workgroups will provide recommendations for the REMS to the Steering Committee, and FDA plans to provide an additional opportunity for public input before finalizing the elements of the REMS.

Contact: OpioidREMS@fda.hhs.gov

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