FDA Committee Rejects Reasonable Opioid REMS Plan

Karen Lee Richards Health Guide
  • Earlier this month I told you about the FDA's proposed new Opioid REMS (Risk Evaluation and Mitigation Strategies), which were surprisingly sensible.  I was impressed that they had actually listened to the concerns of chronic pain patients and the physicians who treat them.  The proposed REMS provided for additional education on the safe prescribing and use of extended-release opioids without making it even more difficult for legitimate pain patients to get the medications they need. 

    The FDA presented their proposed REMS to a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on July 22-23.  Sadly, the 35-member committee overwhelmingly rejected the proposal by a vote of 25 to 10, saying the plan lacked the teeth to stem the "public health crisis" of opioid addiction, overdose, and death. 

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    Some of the problems the committee had with the proposed REMS included:

    • The panel felt it would not be appropriate for drugmakers to develop the educational training, telling doctors how to prescribe the drugs.  They seemed to think it would be better for the FDA to create the training program.

    • Many felt that special training should be required before a physician could register with the DEA to prescribe opioids. 

    • Panel members felt the proposal should cover immediate-release as well as extended-release opioids. 

    Many of the committee members endorsed a statement calling for Congress to pass a law to urge other government agencies — including the Drug Enforcement Agency (DEA) — to work together to stem the problem of prescription drug abuse. 

    The FDA is not required to accept the recommendations of its Advisory Committees, but the fact that these REMS were turned down by a 71% majority is bound to have an impact on the FDA's final decision. 

    In My Opinion...

    The decision of this Advisory Committee was a huge disappointment and a major setback.  I was so pleased when I first read the FDA's proposal because they had obviously listened to the concerns of all involved – pain patients, physicians, and people whose lives had been touched by drug abuse.  I felt the REMS they developed were sensible and wouldn't put an undue burden on chronic pain patients.  Unfortunately that reasonable plan is now in jeopardy.

    There are a few things about this Advisory Committee that really disburb me:

    • An additional 24 members were temporarily added to this committee for this meeting, only nine of which are directly involved with pain management.

    • A majority of the committee members are not directly involved in pain care or anesthesiology clinical practice.

    • There was only one member representing patient's interests.

    One Committee member, Roland Gray, MD, made an interesting observation.  He noted that one reason opioid use is so prevalent is because of unscrupulous doctors who are quick to dole out these drugs.  Gray said, "They don't need a course in writing prescriptions, they need a course in ethics. If they don't have a conscience, we can't give them that." 

  • I tend to agree with Dr. Gray.  The government can only go so far.  Even if tighter restrictions are enacted, unethical doctors will simply take the required training and go on prescribing as they always have.  You can't legislate morality. 

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    I could be wrong, but I have trouble believing there are really that many unscrupulous doctors out there who are handing out opioid prescriptions like candy.  Most seem to be afraid of even prescribing needed opioids for fear of losing their practices and careers.  It seems more likely that a few really compassionate doctors, who genuinely want to help their pain patients, are taken advantage of by drug abusers who have learned how to fake pain in order to get drugs.   

    Speak Up While You Can

    The FDA is still accepting comments until October 19, 2010.  If you disagree with the Advisory Committee's recommendations, I would encourage you to go to “Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs” at regulations.gov, click on “Submit Comment” near the top of the page and share your thoughts and opinions.  The FDA listened to us before; let's hope they'll listen to us again.



    Leavitt SB. FDA Committee Nixes Sensible Opioid-REMS Plan. Pain-Topics.org News/Research Updates. July 24, 2010.

    Walker EP.  FDA Panel Wants Tougher Restrictions on Opioids. MedPage Today. July 23, 2010.


Published On: July 30, 2010