As a physician, mother and daughter, I have a keen understanding of the complexities and importance of fair, objective and timely decision-making when it comes to best serving the health and well-being of not only my patients, but also my parents, my siblings and my children.
My personal experiences shape how I lead our team at Johnson & Johnson in responding to the people we serve.
This is especially evident in the way that we manage access to our experimental treatments, known as compassionate use requests. It is paramount that we, as a company involved in research, respond in a timely and objective manner that balances and supports the needs of individuals in urgent need of new treatments with those of the larger patient community and future patients. Our goal, as developers and researchers of new medicines, is to drive the best possible outcomes for patients and their families today and tomorrow.
As I shared last year, Johnson & Johnson’s recognition of the need to fairly and ethically address compassionate use requests led to our partnership with the New York University (NYU) School of Medicine. Together, we instituted a first-of-its-kind pilot program—the Compassionate Use Advisory Committee (CompAC)—designed to effectively address the complex and emotional challenges associated with the use of investigational medicines.
When evaluating compassionate access requests, we remain strongly aligned to our ethical principles that include not putting patients at risk of unnecessary harm, treating all patients fairly and equally, and continuing to study new medicines with the goal of acquiring approval from government health authorities. I provide more detail about these ethical principles in this video.
How We Plan to Keep Evolving Our Compassionate Use Work
The CompAC pilot program was successful in establishing an external, independent assessment process to fairly and objectively evaluate compassionate use requests. The Janssen Pharmaceutical Companies of Johnson & Johnson approved 100% of the requests that CompAC recommended. And, as a result, over 60 patients received access to one of our cancer treatments in development that has since received approval from the U.S. Food and Drug Administration.
Today, I am proud to announce the expansion of CompAC to additional investigational medicines that are in late-state development by Janssen. We’re also looking into the possibility of future CompACs for medicines related to pediatric and behavioral health.
But we’re not stopping there.
Johnson & Johnson and NYU are also convening advocates and experts for a Pre-Approval Access Patient Advocacy Summit in Washington, D.C., to explore additional areas of collaboration related to compassionate use. We believe the CompAC model offers insights that can serve as an industry best practice for fair evaluation of compassionate use requests—and we are proud to be leading this discussion.
Our work with CompAC has also prompted greater awareness of the challenges surrounding compassionate use requests, an effort that has been recognized by the Fellowships at Auschwitz for the Study of Professional Ethics (FASPE). Next year, Johnson & Johnson will be honored with a 2017 FASPE Award for Ethical Leadership for our work on CompAC.
The decision to expand CompAC reaffirms Johnson & Johnson’s commitment to ensuring a transparent, ethical and objective approach to reviewing compassionate use requests—and is a testament to our long-standing goal of enhancing public health.
For more details about our approach to investigational medicines, visit our pre-approval access information page.
Joanne Waldstreicher, M.D., is Chief Medical Officer, Johnson & Johnson. In this role, Dr. Waldstreicher has oversight across pharmaceuticals, devices and consumer products for safety, epidemiology, clinical and regulatory operations, and development of the corporate ethical science, technology and R&D policies, including those related to clinical trial transparency and compassionate access.