ARTICLE | Regulation

Scaling compassion

FDA, industry, patient groups charting compassionate use policies

November 16, 2015 8:00 AM UTC

Nearly two years after a viral media campaign saved seven-year-old Josh Hardy's life and put demands for access to unapproved medicines on front pages, drug companies, FDA, academic bioethicists, and patient advocates are beginning to chart a new course for compassionate access.

Johnson & Johnson is staking out a leadership position among pharmaceutical companies with a pilot program that uses an independent external advisory committee to review compassionate use requests for an investigational drug. The company told BioCentury it has learned several lessons about how to manage compassionate access that it plans to apply as it expands the program to additional drug candidates...