Update on our Response to FDA Statement on ESIs

This message is in response to the FDA statement released on April 23rd, addressing the safety and effectiveness of epidural steroid injections. 
http://www.fda.gov/Drugs/DrugSafety/ucm394280.htm 

 

The International Spine Intervention Society feels that the alert was misleading in its message regarding the safety of epidural steroid injections and contained inaccuracies regarding the effectiveness of this procedure.

 

The statement was released by the regulatory division of the FDA and not the FDA Safe Use Initiative (SUI). The FDA SUI has been working with physician experts from multiple organizations, including several ISIS leaders, over the past two years to help create a set of expert recommendations for the safe administration of epidural steroid injections. It is important to note that the release of the April 23 statement by the FDA regulatory branch was unilateral and unbeknownst to the panel of experts working with the SUI on epidural steroid injections. Following the release of this statement, the expert panel leaders on this project decided to involve the 14 societies represented on the Multi-Society Pain Workgroup (MPW) to craft a set of consensus recommendations for the safe administration of epidural steroid injections.

 

The MPW was originally formed to assist Medicare contractors in developing more consistent local coverage determinations (LCDs) through multi-society consensus recommendations. Based on its track record in generating consensus and producing multi-society recommendations on interventional pain medicine issues, the MPW was selected to develop multi-society consensus recommendations on the safe use of epidural steroid injections. The MPW process, which results in majority consensus recommendations, is entirely democratic, transparent, and collaborative with no single society having more influence than any other participating society.

 

The societies represented in the MPW are:

 

1. American Academy of Neurological Surgeons (AANS) *

2. American Academy of Pain Medicine (AAPM)

3. American Academy of Physical Medicine and Rehabilitation (AAPM&R)

4. American College of Radiology (ACR)

5. American Pain Society (APS)

6. American Society of Anesthesiologists (ASA)

7. American Society of Neuroradiology (ASNR)

8. American Society of Regional Anesthesia (ASRA)

9. American Society of Spine Radiology (ASSR)

10. Congress of Neurological Surgeons (CNS) *

11. International Spine Intervention Society

12. North American Neuromodulation Society (NANS)

13. North American Spine Society (NASS)

14. Society of Interventional Radiology (SIR)

 

* AANS/CNS receive a single vote on the MPW.

 

The American Society of Interventional Pain Physicians (ASIPP) was involved in the MPW upon its inception, but subsequently resigned from participation.

 

The intent of this effort is not to mandate policy or write standards of care regarding the performance of epidural steroid injections, but to produce a set of tenable and publishable consensus recommendations regarding the safe administration of epidural steroid injections. We are optimistic that this will be forthcoming from the MPW and the SUI team within a reasonable time frame. The MPW societies that have been integral to this process are effectively progressing in a good-faith effort to produce a positive and sound resolution to address ongoing concerns regarding the safe use of epidural steroid injections. The resulting multi-society endorsed recommendations will undoubtedly be a product held in much higher regard than anything that a single society could hurriedly produce and release, given the time-sensitive nature of this issue.

 

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