Compassionate use, also called expanded access, is a process that allows patients with a serious or life-threatening disease such as cancer to obtain an experimental drug when there are no treatment alternatives. Getting access to experimental drugs can be time-consuming and confusing.
- an option for physicians to request help from Compassionate Use Navigator staff in completing a compassionate use application;
- step-by-step instructions on how to apply for compassionate use, including forms and templates;
- assistance in identifying points of contact at drug companies; and
- information on FDA and IRB rules for obtaining compassionate use medications.
Representative Michael McCaul (R-TX), co-chair of the congressional Childhood Cancer Caucus, expressed support for the Compassionate Use Navigator. “Kids v Cancer has made another great stride in their fight for access to potentially lifesaving treatments with today’s launch of the Compassionate Use Navigator,” McCaul said. “This new tool will help cut through the confusion and red tape of the compassionate use application process for both families and physicians. We still have more work to do in improving the compassionate use system and getting reforms like those of my Andrea Sloan CURE Act enacted into law, but private efforts to offload some of the administrative burden are a critical part of the solution. I applaud Kids v Cancer for their perseverance and dedication. This will help save lives.”
In addition, the Compassionate Use Navigator aims to fill knowledge gaps about compassionate use by collecting data on the numbers and outcomes of applications. This data will lay the groundwork for developing next steps to improve access to drugs for those in dire need.
We are also pleased to announce that the Compassionate Use Navigator will be directed by Elena Gerasimov. Elena holds MPH and MA degrees and comes to us with over 20 years of experience in the nonprofit sector and medical reporting. She can be contacted at Elena@kidsvcancer.org.