Q: One of my MS patients just asked me what would happen if a drug he is using got pulled from the market. He is now stabilized after some rocky periods and is fearful that this could be lost to him. Could I get an informed consent from him and keep using such a drug if it was obtainable from a location where it was still accessible? Would a situation such as he is worried about come under a “compassion” exception?
A: The compassion exception that you are referring to is the FDA’s Individual Patient IND (Investigational New Drug) exception which allows a physician to get permission to use a promising new drug before it gets full approval. It would not apply to a previously available drug that has been pulled because problems developed.
That would only leave the other option, but that option is actually not possible. You cannot get a legally valid consent – no matter how anxious the patient is to continue – for a treatment that has been declared unsafe. It would be inherently violative of your fiduciary duty of care in a manner that you cannot delegate to the patient and the patient’s assent to receive an unsafe drug would be viewed as intrinsically unreasonable. By either criterion the consent would fail to pass legal muster.
