by Craig Klugman, Ph.D.
Johnson & Johnson’s Janssen Pharmaceutical Company announced that it has contracted with New York University’s Division of Medical Ethics to assemble an external Compassionate-Use Advisory Committee (CompAC) to examine requests for investigational new drugs (INDs) outside of clinical trials. Arthur Caplan will lead this group, which will be composed of bioethicists, physicians, and patient advocates. The goal of this group is to provide recommendations on which patients should be given compassionate use access to experimental drugs.
This step is a reaction to increasing publicity on compassionate use as well as 17 states having passed “Right to Try” laws that allow residents of those states to directly contact drug companies to request experimental drugs.
Compassionate use is also known as expanded access, a program created by the FDA in 1987 that allows people with life-threatening disease to request access to investigational new drugs outside of clinical trials. These are drugs that have not been approved by the FDA, have not been proven safe, and have not been proven effective.
To be considered for compassionate use, the FDA requires that the patient has a serious disease/condition or has an immediately life-threatening condition and:
- “There is no comparable of satisfactory alternative therapy
- “The patient cannot obtain the drug under another IND or [research] protocol
- “The potential patient benefit justifies the potential risks
- “Providing the investigational drug will not interfere with the initiation, conduct, or completion of clinical investigations”
Then the company has to agree to provide the drug under a physician that will closely monitor the patient.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.