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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:
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: 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 Regulations.gov web site:http://www.regulations.gov/#!documentDetail;D=FDA-2013-S-0610-0001
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
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: 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 Regulations.gov web site:http://www.regulations.gov/#!documentDetail;D=FDA-2013-S-0610-0001
