MORE FDA overreach

Discussion in 'Pain Medicine' started by Yo GabbaPentin, 10.30.14.

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  1. Yo GabbaPentin

    Yo GabbaPentin 5+ Year Member

    Attending Physician
    I'm surprised that no one has brought this up yet... All info is from the main ASIPP webpage.

    FDA Meeting on Epidural Corticosteroid Injections - How to Get Involved

    On November 24-25, 2014 the FDA Anesthetic and Analgesic Drug Products Advisory Committee Meeting will hold a meeting to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. The outcome of this meeting will determine future regulatory options, including but not limited to changes to the product labeling. This FDA hearing could be the greatest threat to IPM than anything we have faced in the past.

    You can get involved in two ways:

    • The most critical is support from patients with letters by Nov. 7, 2014.
    • Attend the FDA meeting on November 24
    ASIPP is attempting to secure time to present our views; however, we will not know the time allocated to us until October 31st. If you would like to submit your own request to speak, you may do so by October 30th. Request may be submitted via e-mail to:

    Stephanie L. Begansky, PharmD

    Center for Drug Evaluation and Research

    Food and Drug Administration

    10903 New Hampshire Avenue


    Silver Spring, MD 20993-0002

    E-mail: Capwiz link

    Time is of the essence. The comments must be sent by November 7th so you should start today and continue sending through November 7.

    How to Get Patients Letters Signed and Submitted

    1. Print off the sample Patient Letter.
    2. Ask the patients to sign the letter as they check in. You can also include the patients' driver.
    3. Assign staff to enter the patients' letters using the Capwiz letter link:
    4. If the patient does not provide an email address, you can use your practice's email.
    5. All letters should be entered daily and any letters signed on Nov. 7 must be entered by COB that day.

    Let us know if you have any questions and we will assist you.

    Time is of the essence. The comments must be sent by November 7th so you should start today and continue sending through November 7.

    The following information has been published thus far on epidural injections, FDA warning of epidural injections and other developments:

    ASIPP's FDA Citizen Petition requesting the Commissioner to withdraw the present Safety Warning.

    Fact Sheet on FDA Epidural Steroid Warning, Safe Use Initiative, and the MPW Approval of 17 Regulations to be Instituted by the FDA

    Health Policy Opinion: Epidural Steroid Injections Safety Recommendations by the Multi-Society Pain Workgroup (MPW): More Regulations Without Evidence or Clarification Click HERE TO READ

    Health Policy Review: Epidural Steroid Warning Controversy Still Dogging FDA Click HERE TO READ

    Letter to the Editor: The Food and Drug Administration’s Recent Action on April 23, 2014 Failed to Appropriately Address Safety Concerns about Epidural Steroid Use Click HERE TO READ

    Healio Spine Surgery, August 1, 2014

    Recommendations for safe use of epidural steroid injections presented at the ASA 2013 annual meeting as part of FDA's Safe Use Initiative

    American Society of Anesthesiologists. ASA Formally responding to FDA warning on injection of corticosteroids into epidural space, July 14, 2014.

    International Spine Intervention Society. Update on ISIS Response to FDA Statement on ESIs.

    The open public portion of the meeting will take place on Monday, November 24 from 8:00 a.m. to 5:00 p.m. If you would like to attend you would need to arrive on Sunday and could leave Monday afternoon and there are numerous hotels available in the area. The meeting location is:

    FDA White Oak Campus

    Building 31

    The Great Room (Rm. 1503)

    White Oak Conference Center

    10903 New Hampshire Avenue

    Silver Spring, Maryland

    It is crucial that we have good representation at the meeting. If you are planning to attend please let us know.

    Physicians may submit comments to the FDA on the web site:!documentDetail;D=FDA-2013-S-0610-0001
    oreosandsake likes this.
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  3. nvrsumr

    nvrsumr Member 10+ Year Member

    Attending Physician
    I agree this could be the big one.... EBM only counts when it limits procedures.
    NOSfan likes this.

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