IAPCD

FDA Approves Shared System REMS for TIRF Products

FDA Opens a Register for Comments on the Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy

• Register for comments by Dec 7, 2011
• Draft Blueprint

Developing a Risk Evaluation and Mitigation Strategy (REMS) for Extended Release Opioids - Milestones and Materials from the Food and Drug Association (FDA) Initiative

Preliminary Responses to Industry Questions About Opioid REMS

FDA is providing preliminary responses to the following questions, discussed at an FDA-Industry Working Group (IWG) Face-to-Face Meeting on May 16, 2011.

Update on Implementation of Opioids REMS

On May 16, 2011, the FDA met with members of the Industry Working Group (IWG) and other sponsors of Long Acting and Extended Release opioid drugs. The purpose of the meeting was to discuss the next steps in implementing A Risk Evaluation and Mitigation Strategy (REMS) for these products through a single shared system. Topics discussed included:

• 1) prescriber training
• 2) Medication Guides
• 3) REMS assessment plan
• 4) administrative requirements

The meeting was productive and resulted in greater clarity for how drug sponsors will proceed with the opioids REMS implementation.
The minutes of this meeting.

On April 19, 2011 the Office of National Drug Control Policy (ONDCP) released the Obama Administration’s Epidemic: Responding to America’s Prescription Drug Abuse Crisis- a comprehensive action plan to address the national prescription drug abuse epidemic.
In support of the action plan, the FDA announced the elements of a Risk Evaluation and Mitigation Strategy (REMS) that will require all manufacturers of long-acting and extended-release opioids to ensure that training is provided to prescribers of these medications and to develop information that prescribers can use when counseling patients about the risks and benefits of opioid use.
Read the FDA Questions and Answers on REMS

As a member of the global community of professionals involved in managing care at the interface of pain and dependency, you understand that our institutions and organizations are dealing with significant challenges on numerous fronts.

Access to medications that alleviate painful suffering used to be the focus mainly in emerging countries, but that is no longer the case. Now, in the industrialized nations, the rising incidence and prevalence of opioid diversion, misuse, abuse, and addiction has triggered regulatory interventions that may result in diminished access to pain management therapies for patients in need.

The only resolution to this cyclical conundrum is for those who once collaborated to win the right to fundamental pain management to come together again to advocate, with equal passion, the mitigation of unwanted risk in the context of chronic pain treatment.

On behalf of IAPCD members, our administrative supporters, MediCom Worldwide and Corona Productions have been working diligently to monitor the development of risk management regulations related to extended release opioids. One result of their activities is this new resource. Here you can access:

• Scientific and clinical slide presentations complete with data
• Tutorial webinar about what REMS is all about
• Notices of upcoming activities
• Webcasts of meetings between FDA and industry
• Links that allow practitioners to contribute their data and perspectives directly to the FDA as the new regulations are being formulated.

IAPCD is also represented on a stakeholder group, The Pain Care Forum, that closely monitors and comments on the activities as they are evolving. Members also can access materials of interest from that group.

• Background on Opioid REMS
• FDA Consumer Update: FDA Acts to Reduce Harm from Opioid Drugs