Johnson & Johnson announces partnership with NYU School of Medicine to launch a compassionate care committee for individual patient requests of investigational drugs.
On May 7, 2015, Johnson & Johnson announced that it would evaluate compassionate use of its investigational drugs with a third-party partnership to review requests. The partnership will be carried out with the Division of Medical Ethics at the NYU School of Medicine. The program will initially focus on a single Janssen investigational drug. If the program is deemed successful, the company will apply this review method more broadly across the company. This partnership was designed to evaluate individual patient requests from anywhere around the world for the use of investigational medicines prior to regulatory approval. According to a press release, FDA defines compassionate use as a process that enables patients suffering from serious diseases and conditions to gain access to investigational drugs, biologics, and medical devices that are not yet approved by FDA and have not been proven to be safe and effective.
A Compassionate-Use Advisory Committee (CompAC) will be launched by the NYU School of Medicine and will consist of an external group of 10 medical experts, bioethicists, and patient representatives. Because investigational drugs are normally in limited supply, the committee will turn over their carefully considered recommendations to the Janssen clinicians for final review and decision.
“Our goal is to ensure that compassionate use of specific investigational medicines still in development is guided by ethical principles, and that the selection process continues to be thorough, transparent, and fair. Compassionate use decisions are incredibly challenging, and we readily acknowledge that the current allocation system remains a work in progress. This new initiative hopes to create a more robust model to help guide these decisions,” said CompAC Chairman Art Caplan, PhD, director, division of medical ethics at the NYU School of Medicine, and the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics.
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