Johnson & Johnson unit, college to study compassionate-use drug requests

Johnson and Johnson said on Saturday that Janssen Research and Development, LLC, a Johnson and Johnson subsidiary, is partnering with the medical-ethics division at the New York University School of Medicine to evaluate compassionate use of investigational medicines.

The partners will obtain independent advice to ensure that the evaluation of requests for investigational medicines before approval by the U.S. Food and Drug Administration or other global health authorities are treated as fairly and ethically as possible.

As part of this partnership, the NYU School of Medicine will create the Compassionate-Use Advisory Committee (CompAC), an external group of 10 internationally recognized medical experts, bioethicists and patient representatives to lead the new approach.

The collaboration will begin with one of Janssen's investigational medicines, in which the CompAC will make recommendations regarding individual patient requests from anywhere in the world. The committee's evaluation and recommendations based on its independent review will inform Janssen clinicians, who will make the final decision on the medicine.

"We have a responsibility to patients and their families to ensure their well-being in everything we do," Dr. Amrit Ray, chief medical officer for Janssen Pharmaceutical Companies of Johnson and Johnson, said. "By ensuring compassionate-use requests for our investigational medicines are evaluated by a well-informed, external committee, we can better weigh what we know about these therapies against the patient's condition and risk factors to make the most responsible decision for each patient."