Registered: Aug 2009
Posted July 29th, 2010 10:32 AM IP
REMS: The FDA and Pain Medications
What are REMS and what do they have to do with people who live with pain? How can you make a difference in shaping pain policy?
This page provides links to information about REMS and how they have the potential to affect the lives of millions of people who live with pain and the health care professionals who care for them.
What are REMS and what do they have to do with people who live with pain?
REMS stands for Risk Evaluation Mitigation Strategies. One component of the 2007 Food and Drug Administration Amendments Act (FDAAA) expanded the Food and Drug Administration’s (FDA) authority to regulate medications after they are approved. As a part of this charge, FDA is working with the pharmaceutical industry and stakeholders to develop REMS for certain classes of medication, including opioid medications. If you are a person with pain, a caregiver or health care professional who treats pain, you are a stakeholder who can play a role in the development of this policy.
The American Pain Foundation (APF), along with the larger pain community, has been working diligently to ensure that FDA protects the rights of people with pain and takes a balanced approach when finalizing their recommended REMS for opioid medications.
It is well documented and widely understood that pain is undertreated or poorly treated for millions of people. The REMS process is well-intended and is meant to assure the safe use of medications. However, both consumer and provider pain organizations are concerned that the REMS process will erect new barriers to timely and appropriate pain care.
The initial design for a REMS process implied that each medication would have its own REMS requirements. In the case of medications like opioids, requiring “elements that assure safe use” could mean separate education and certification processes for each medication. This scenario would create a confusing, intimidating obstacle to prescribers – many of whom would opt out of prescribing pain medication altogether. The recent FDA REMS proposal for sustained-release and long-acting opioids is noteworthy for its emphasis on prescriber and patient education without mandating burdensome requirements or certification processes. This is good news for the pain community! We believe that prescriber and patient education is an important component to simplifying REMS requirements for all opioids.
We also recommend that the FDA extend the class of opioids covered to include short-acting opioids to eliminate any inclination to substitute short-acting for long-acting opioids.
How can you make a difference in shaping pain policy?
1) GET READY…
First, become more informed about REMS and the FDA’s recommendation about the key features of REMS for long-acting opioids.
The following links provide background information about REMS:
APF recently posted a REMS FAQ in our newsroom.
You can also read the Pain Care Forum REMS task force’s recommendations that were presented to FDA and supported by APF.
APF and advocates who live with pain testified before FDA on May 27, 2009. Read APF’s position statement on REMS below, as well as testimonies of people who live with pain.
Written Testimony: The American Pain Foundation Calls for Balanced Perspective on FDA’s Proposed Risk Evaluation Mitigation Strategy (REMS) for Opioid Therapy
Public Testimony: FDA Public Meeting on Risk Evaluation and Mitigation Strategies (REMS) for Certain Opioids, May 27, 2009
Pain advocates who live with pain courageously shared their struggles with obtaining appropriate and effective pain treatment and implored FDA to consider the voices of the millions of Americans whose lives have been restored because of opioid pain medications.
Mark Maginn, MSW, ACSW
Mary Vargas, JD
2) GET SET…
Next, be ready to act. APF will request your ACTION in support of fair and balanced REMS for pain medication in the near future.
Thanks to all who sent letters to FDA urging access to pain medications! APF appreciates the efforts of the countless advocates who have taken ACTION and submitted comments to FDA to express concerns and opinions regarding the development of REMS for certain opioid medications. Our collective efforts and voices are making a difference!
Be on the lookout for ACTION ALERTS from APF about REMS. Not receiving updates and alerts from APF? Click here to join. You will receive updates on this and other APF programs designed to protect access to pain treatment options, medication safety, and more!
**APF is not requesting any ACTION at this time – please take this time to learn more about REMS and check back for updates and ACTION ALERTS. **
It is critical that the FDA hears from organizations and individuals concerned about the availability of and access to pain medicines. Without careful consideration of the voice of people who live with pain, REMS have the potential to further limit access to important and often life-saving medications. The FDA needs to hear your voice! Please be ready to TAKE ACTION and encourage others to TAKE ACTION.
How can I follow REMS regulations and advocate for fair pain policy?
The FDA has extended the docket for comments on REMS to October 19, 2010. All submissions must reference the docket number: FDA-2009-N-0143
Comments can be submitted electronically at: http://www.regulations.gov or by mail at:
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Regulations.gov also allows you to sign up for email alerts to track dockets (FDA-2009-N-0143).
Patient Specialist/Chronic Pain Forum
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