Expanded Access

The drug development process is lengthy, complex and expensive. Treatment options can take more than a decade to get from a research concept to an actual treatment. The evidence may or may not justify approval by the FDA for use by cancer patients. In addition, the drug development process is changing as treatments shift from traditional chemotherapies to options such as biologic drugs and vaccines.

Because the drug development timeline is lengthy, CAN supports compassionate use or expanded access programs which provide experimental treatments to patients once a treatment is shown to be relatively safe and effective.

Our Efforts

• Expanded Access Program Position (HTML)
• Expanded Access FAQ (HTML)
• May 9 2003 letter to FDA Commissioner on proposal to reduce approval criteria (28K PDF file)
• June 2003 presentation to FDA advocates by Nancy Roach, MNCF (1.27 MB PowerPoint Presentation file)
• November 4 2001 letter to Samual Waksal, ImClone, requesting an expanded access program for Erbitux (30K PDF file)
• October 2001 presentation to Clinical Trials Summit V by Bob Erwin, MNCF (1.27 MB PowerPoint Presentation file)