May 8th, 2015
Patients with serious illnesses and their families who have run out of treatment options and do not qualify for clinical trials need to know that their requests for compassionate access to investigational medicines have been treated in as thoughtful and objective manner as possible. We understand the importance of making medicines available to people in urgent need, and have worked in the past to try to grant pre-approval access to medicines when appropriate for patients with no other treatment options. These decisions present some of the most difficult challenges for many reasons, including the limited information on safety and efficacy we often have early in development, and since supplies of investigational medicines are often limited while they are still being developed. With such important decisions, we believe that there is a continued need to ensure that we are as objective and as thoughtful as possible. As physicians, it is inspiring to see innovation in science offering such great potential for patients.
As an extension of Johnson & Johnson’s (J&J) long-standing commitment to the highest standards of scientific and ethical decision-making, we are announcing a first of its kind partnership between J&J and the New York University School of Medicine to obtain independent review of individual compassionate use requests for access to investigational medicines.