In May 2015, Johnson & Johnson announced a first-of-its-kind pilot partnership between Janssen and the Division of Medical Ethics at New York University (NYU) Langone Health to form the Compassionate Use Advisory Committee (CompAC).
CompAC is a novel approach that Johnson & Johnson employs globally to provide a fair, ethical evaluation of compassionate use requests for specific investigational medicines for patients with serious or life-threatening diseases.
The Johnson & Johnson approach to evaluating individual requests for compassionate use are guided by three important ethical principles:
- The Johnson & Johnson approach to evaluating individual requests for compassionate use are guided by three important ethical principles:
- That we continue to conduct thorough scientific studies to understand the potential benefits of new medicines to provide the fundamental information needed to acquire approval from government health authorities and bring new medicines to all patients who need them
- That we treat all patients fairly and equally
After a patient’s physician submits a request, Janssen physicians conduct an initial review to determine if alternative therapies, clinical trials, or other programs are available to the patient before forwarding the request to CompAC. CompAC then evaluates each request and provides a recommendation to Janssen. Our physicians make a final decision on patient access, taking the CompAC’s recommendation into account. CompAC has clear processes, roles and responsibilities that consistently follow sound ethical principles.
CompAC has led to key learnings on how to objectively, fairly and ethically approach compassionate use requests. The company continues its commitment to share its experience from CompAC with a view to supporting this as a way to advance public health, and with the belief that CompAC is a model that has the potential for wider application within the industry.
Watch this video to learn more about this important initiative.