Expanded Access/Compassionate Use/Right to Try
There are potential ways for a patient with a serious, life-threatening disease or condition to try an investigational drug for treatment outside of clinical trial when there are no comparable or satisfactory therapies available.
When seeking expanded access to an investigational medical product, it is critical that you and your doctor consider all possible risks.
However, there are times when it is not possible for a patient to be a part of a clinical trial due to no ongoing trials, lack of access to a clinical trial, eligibility for a clinical trial or distance to a clinical trial prevents access. In those circumstances, expanded access may be a way for the patient to receive an investigational medical drug.
The FDA is committed to increasing awareness about the expanded access process and the procedures for getting access to investigational drugs. It is important to note that even if you meet the criteria under the law and FDA regulations, the physician, the IRB and the company all need to agree that expanded access is appropriate for you in order for you to receive the investigational medical product. In addition, there may be costs that are not covered by third-party payers such as private insurance or Medicare.
If you are considering expanded access, you should discuss with your doctor and make an application.