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Scott Gottlieb, MD
Commissioner
US Food and Drug Administration

Kathleen White, RN, BSN, MBA
Nurse Consultant, Safety Signal Coordinator
US Food and Drug Administration

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.

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