October 21, 2019 | Penn Med News
How Oncologists Can Ethically Navigate the “Right-to-Try” Drug Law
Oncology is one field at the forefront of requests for unapproved drugs. An interdisciplinary team of bioethicists, oncologists, and lawyers from Penn Medicine and other institutions, along with the director of Penn’s Abramson Cancer Center, Robert H. Vonderheide, MD, DPhil, penned a commentary published online this week in the Journal of Clinical Oncology to offer recommendations to help oncologists navigate this new “Right to Try” world, while maintaining their ethical obligations to patients.
“On its face, Right to Try sounds great. Who could argue with a law that promises patients with no other options early access to the fast-growing list of investigational cancer drugs that may help them? The problem is that we didn’t need Right to Try to do that, but patients do need the protections that Right to Try gets rid of, including FDA’s input on pre-approval use and careful safety reporting requirements,” said first author Holly Fernandez Lynch, JD, MBE, an assistant professor of Medical Ethics in the department of Medical Ethics and Health Policy in the Perelman School of Medicine at the University of Pennsylvania. “In contrast, the Expanded Access pathway, which has been available for several decades, is designed to permit pre-approval access to drugs for desperate patients, while also preserving FDA’s expert oversight.”