Decisions on compassionate use (CU) requests are some of the most difficult that any company can face. To enhance our long-standing commitment to ethical and patient-centered decision-making, Janssen Research & Development, LLC, in partnership with the New York University (NYU) School of Medicine, launched a first-of-its-kind program to obtain independent input to assist in evaluating CU requests. This partnership seeks to further ensure that the evaluation of requests for investigational medicines prior to their approval by the U.S. Food and Drug Administration are treated in the most thoughtful, ethical and fair manner.
NYU has developed a new Compassionate-Use Advisory Committee, called “CompAC,” to independently review CU requests and to provide their external, objective recommendations to Janssen. CompAC is comprised of an external group of 10 internationally recognized medical experts, bioethicists and patient representatives.
CompAC will make recommendations regarding individual patient requests originating from anywhere in the world. Investigational medicines are still in development and usually limited in supply. The committee's careful consideration and recommendations based on its independent review will inform Janssen physicians, who will make the final decision on each request.