Patients cannot apply for expanded access themselves. They must have a licensed physician willing to act on their behalf. Physicians must first contact the pharmaceutical company or EAP partner and request access to the drug. Without company consent to use the drug, the expanded access process cannot proceed.
In certain countries, like the US, once the drug company has agreed to provide the drug, the patient’s physician must then apply to the appropriate local regulatory agency (e.g. the FDA) on the patient’s behalf. Physicians will also have to submit an expanded access request and informed consent document to an Institutional Review Board (IRB) or Ethics Committee.