RE: Physician Guidance on the Use of Off Labeled Drugs in Intrathecal Drug Delivery Systems for
Chronic Pain
Dear Dr. Gottlieb and Ms. White:
Recently the United States Food and Drug Administration (FDA) released a safety communication
cautioning about the use of off-label drugs in intrathecal drug delivery systems (IDDS), or targeted drug
delivery (TDD), for the treatment of chronic pain and spasticity. This action, intended to improve safety,
has had and will have a detrimental impact on many patients and on the practice of medicine in the
United States. This is particularly significant in that the great majority of patients implanted with IDDS
are treated with off-label drugs or drug combinations making this the current standard of care in the
United States.
The FDA is well aware that the general use of off-label medications has been an ongoing practice
standard for many years, and has been a critical part of treating many medical conditions. Any
communication which impedes the ability of physicians to successfully use intrathecal therapies in
clinical practice could also have the unintended consequence of reversing the progress that has been
made toward decreasing the use of high dose oral opioid medications. While we agree with the FDA’s
goal of improving safety and reducing risks, we also believe clarification is needed to protect patient
safety and therapy access.
We do agree with the FDA that the use of labeled drugs should be considered as the first choice for use
in these devices, and in the United States this would include Prialt (ziconotide), Infumorph (preservative
free morphine sulfate)and baclofen. In the vast majority of patients, however, off-label medications
are currently being used. Reasons for these current and historical practice standards are
multidimensional but include those patients who failed on-label medications because of side effects or
have had a poor response to treatment with lack of efficacy at reasonable dosing, while others cite a
lack of commercially available concentrations and national drug availability.
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