...Advocacy group for physician owners of ambulatory surgery centers...

Welcome to the official site of the Society of Interventional Pain Management Surgery Centers. We hope this site is informative and useful. If you have any questions please feel free to email us.

 

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:

1. The most critical is support from patients with letters by Nov. 7, 2014.

2. 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

WO31-2417

Silver Spring, MD 20993-0002

E-mail: AADPAC@fda.hhs.gov

 

It is our understanding that several pain organizations and other societies such as ASA, PMR, etc., will also be presenting both pro and con views. In addition and most importantly, there are many patient groups such as the Arachnoiditis Association, which may be presenting in opposition to epidural injections.

 

Because of this, it is crucial to obtain as many patient letters and send them to the FDA via our 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

 

Work group passes epidural steroid injection consensus in response to FDA warning. 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 Regulations.gov web site: http://www.regulations.gov/#!documentDetail;D=FDA-2013-S-0610-0001

 

 

SIPMS BOARD
Chairman of the Board And Chief Executive Officer
Laxmaiah Manchikanti, M.D
Paducah, KY

OFFICERS
President
Standiford Helm II, MD
Laguna Hills, CA

Executive VP
Frank J.E. Falco, MD
Newark, DE

Secretary
David M. Schultz, MD
Minneapolis, MN

Treasurer
Carlos Giron, MD
Macon, GA

LIFETIME DIRECTORS
Stanley R. Dennison, JR., MD
Tampa, FL
Frank J.E. Falco, MD
Newark, DE
Allan T. Parr, MD
Covington, LA
Laxmaiah Manchikanti, MD
Paducah, KY
Vijay Singh, MD
Niagara, WI

DIRECTORS AT LARGE
Ray D'Amours, MD
Palmdale, CA
Hans C. Hansen, MD
Conover, NC
Peter S. Kosek, MD
Eugene, OR
Bradley W. Wargo, DO
Paducah, KY

Contact SIPMS