Summary of FDA Meeting

Kathleen White, RN BSN MBA
Nurse Consultant, Safety Signal Coordinator
U.S. Food and Drug Administration

RE: Physician Guidance on the Use of Off Labeled Drugs in Intrathecal Drug Delivery Systems for Chronic Pain

On April 29, 2019, the multi-society task force met with the parties of importance at the FDA to discuss issues surrounding their physician communication regarding off label intrathecal medications.

The meeting started with the introduction of physician representatives from different pain societies and  U.S. Food and Drug Administration (FDA) members, including Kathleen White and at least eight representatives. There was a neurosurgeon, and representative from the drug and device division of the FDA.

Each physician representative introduction included emphasis on access and safety. Background information on the use of compounded medications for cancer and non-cancer pain followed. We also discussed concerns with the data and the use of Medtronic’s Implantable System Performance Registry. One representative discussed the concern of opioid epidemic and use of intrathecal therapy for non-cancer pain. Our first question focused on the underlying reasons behind the FDA decision to send the physician letter. After some discussion, one of the FDA representatives mentioned internal reporting as the source of concerns of pump failure related to compounded medication. When asked to elaborate, we were told that this was reporting that could not be shared with us at the time and that this information may not be released to the public.

They asked us what our societies’ goals were for the meeting. The biggest issue was that the warning goes against what is standard of care in this country and what has been recommended by the leading experts in our field in numerous publications and which have been shared with the FDA. We pointed out that we fear that this warning could have unintended consequences, including increased malpractice exposure, and that this greatly concerns our members. In addition, we feared that this letter would be used to deny payment when off-label medications are used for legitimate reasons in a spinal drug delivery system. While we understand that was not the FDA’s intent, this may be a ramification of the safety communication that was released. The FDA officers attending the meeting suggested getting the societies, and potentially the industry, to create a registry to provide more data on safety and benefits of compounded medications for intrathecal therapy. We asked for a clarification on what is needed in this data registry, as biomedical information is not enough. We suggested a compounded medication registry and asked whether the FDA would be willing to help provide us input and advice in the development of this query. We look forward to further discussions with the FDA on compounded intrathecal medications that are currently standard of care in this country, and in that regard, we would welcome the following meeting that was suggested by FDA at the conclusion of our meeting.

In the end, our goal is the same as the FDA’s, and that is to ensure that Americans get safe, high-quality care. We hope that the FDA will reconsider its stance and release a clarification letter to this safety warning that indicates that compounded medications in intrathecal drug delivery systems are currently the standard of care in this country and are required by many patients to achieve proper therapeutic effect with these devices. We look forward to a following meeting on this subject, which could be scheduled within 2–3 months, to further discuss the creation of the above mentioned registry.