Action Alert: FDA Opens Discussion on Chronic Opioid Therapy

Karen Lee Richards Health Guide January 31, 2013
  • The FDA has announced a public hearing and has requested comments on the subject of the use of opioid drugs in the treatment of chronic pain.

     

    The public hearing will be held on February 7 and 8, 2013 from 9 a.m. to 4 p.m. in Bethesda, Maryland. There will be a live Web cast of the hearing. Information on how to view the live Web cast will be located at: http://www.fda.gov/Drugs/NewsEvents/ucm326450.htm.

     

    In addition to the public hearing, the FDA is requesting electronic or written comments on the subject. Comments will be accepted until April 8, 2013.

     

    This is our chance to have our voices heard by the people who are making the decisions!

     

    Some of the issues they will be considering include:

    • Should opioids only be prescribed for “severe” pain?

    • Should there be a maximum daily dose allowed for opioids?

    • Should there be a limit on the number of days or months a patient can be prescribed a particular opioid?

    • Should opioid dosage vary depending on the disease or cause of pain?

    At least one group – Physicians for Responsible Opioid Prescribing – is advocating things like:

    • Limiting opioids to a maximum daily dose equivalent of 100 mg of morphine for non-cancer pain.

    • Not allowing opioids to be prescribed for more than 90 days of continuous daily use.

    Restrictions like these would be devastating for chronic pain patients. It is essential that we let the FDA know how such severe restrictions on opioid prescribing would impact our lives.

     

    I urge you to make your comments succinct and use logical, well-reasoned arguments. And of course, please keep your remarks civil. While we definitely need to express how much harm additional restrictions will cause us, ranting and raving about it will only reduce our credibility.

     

    The FDA notice stresses that they are particularly interested in scientific evidence “such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain.” Therefore, through the month of February, I will try to gather and share this type of data with you so you can include any of it you like in your comments to the FDA.

     

    You can submit your comments or read other comments already submitted at regulations.gov. (To read the full announcement, click on the blue “Impact of Approved Drug Labeling on Chronic Opioid Therapy: Public Hearings Request for Comments.”)

     

    Let's work together to make sure the FDA understands the far-reaching effects and unintended consequences further opioid restrictions would have on chronic pain patients.