The ethical dilemmas of compassionate use of investigational drugs are under fresh scrutiny by patients and other stakeholders. Legal permission to apply for access to trial medicines does not provide for just process: access routes tend to favour those with resources or privileged contacts with decision-makers.
In 2015, Johnson & Johnson (J&J) and New York University Langone Medical Centre partnered to pioneer a compassionate use model that prioritises justice and fair decision-making: The Compassionate Use Advisory Committee (CompAC). In its first year, the CompAC reviewed compassionate use applications from around the world for an experimental drug treatment for multiple myeloma. Companies, patient advocates, IRBs and policymakers have expressed interest in extending the CompAC model into other settings and agents.
Dr Amrit Ray, Chief Medical Officer of pharmaceuticals at J&J and Prof Arthur Caplan, NYU Professor of Bioethics tell the story of why CompAC was formed and how it works. They will provide a frank evaluation of its outcomes and challenges and forecast the future implications of the model for IRBs, industry, academia and health policy. Respondents will provide perspectives on the CompAC model from the UK patient/carer community and from health law and policy.