Final Voyage of FDA and MPW Epidural Saga: Victory for Practicing Interventional Pain Physicians
On October 5, 2015, the Center for Drug Evaluation and Research, the U.S. Food and Drug Administration (FDA), and the Department of Health and Human Services, notified the American Society of Interventional Pain Physicians (ASIPP) of the status of the citizen's petition concerning the rejection of the 17 recommendations developed by the Multisociety Pain Workgroup (MPW). See Letter
The rejection was in response to the FDA citizen’s petition filed by ASIPP and the letter sent to the FDA from 1,040 practicing pain physicians to amend the April 23, 2014, Drug Safety Communication regarding epidural corticosteroid injections for pain urging the rejection of the 17 recommendations developed by MPW.
The letter signed by 1,040 interventional pain physicians was sent on June 26, 2014, and ASIPP filed a citizen petition on September 3, 2014. The FDA held hearings on November 24-25, 2014 on the safety of epidural steroid injections. On March 4, 2015, the FDA informed ASIPP that they were unable to reach a decision on our petition because it raised complex issues requiring extensive review and analysis by agency officials.
The FDA has now determined that they will not amend the drug safety communication; however, they will not adopt the 17 recommendations made by the MPW. This ruling by the FDA is a major victory for practicing interventional pain physicians that avoids micromanagement and the additional bureaucracy created by the MPW. The FDA also published an article in the New England Journal of Medicine which essentially alludes to the same facts as described, and in no uncertain terms, they emphasize the fact that they are not withdrawing the issued warning, but they also were not endorsing the standards from MPW, even though they facilitated the discussion.
It is sad that despite the FDA's and other agencies’ inability to identify what patients are receiving, ASA, ISIS, and other organizations on the CPT Committee blocked our CPT codes specifying the epidural approach, such as caudal or interlaminar, and the use of particulate steroids or nonparticulate steroids or other agents.
Sadly, ISIS has issued a practice advisory stating how they protected the performance of epidural steroid injections and they are standing by the 17 standards refused to be adopted by the FDA.
Consequently, the epidural saga continues even though this may be the final chapter.