BioCentury
ARTICLE | Regulation

Piloting compassion

How J&J, NYU pilot made compassionate access decisions fairer, more transparent

February 15, 2016 8:00 AM UTC

A pilot program created by a pharma company and an academic center has succeeded in making the process of adjudicating compassionate use requests fairer and more transparent, according to Amrit Ray, CMO at the Janssen Pharmaceutical Companies of Johnson & Johnson, and Arthur Caplan, director of the Division of Medical Ethics at New York University Langone Medical Center.

In early 2015, Janssen funded the establishment of a 10-person Compassionate-Use Advisory Committee (CompAC), which Caplan chairs, in an effort to find better ways to make one of the toughest decisions biopharmaceutical executives face: whether to grant an individual patient's request for access to an investigational drug outside of a clinical trial. ...